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STATE

WEIGHTS AND

MEASURES

LABORATORIES

Program Handbook, 5^th^ Edition

*Editor:*

Georgia L. Harris

NIST Weights and Measures Division

Gaithersburg, MD 20899

Carol T. Hockert, Chief

# U.S. Department of Commerce

*Carlos M. Gutierrez, Secretary*

## Technology Administration

*Robert Cresanti, Under Secretary*

*of Commerce for Technology*

National Institute of

Standards and Technology

*William A. Jeffrey*, *Director*

NIST Handbook~143~

2007 Edition

(Supersedes NIST Handbook 143, 2003 Edition)

Certain commercial entities, equipment, or materials may be identified
in this document in order to describe an experimental procedure or
concept adequately. Such identification is not intended to imply
recommendation or endorsement by the national Institute of Standards and
Technology, nor is it intended to imply that the entities, materials or
equipment are necessarily the best available for the purpose.

National Institute of Standards and Technology Handbook 143, 2007
Edition

Natl. Inst. Stand. Technol. Handb. 143, 2007 Ed., 116 pages (April 2007)

**Preface**[]{#__RefHeading___Toc169420756 .anchor}

The National Institute of Standards and Technology (NIST) manages the
State Laboratory Program that began with the New State Standards Program
established by Congress in 1965 as part of its continuing support to the
States. This program of the NIST Weights and Measures Division (WMD) is
designed to provide guidance, technical support, and assistance to State
legal metrology laboratories to ensure accurate and traceable
measurements from NIST to the local jurisdictions. The program operates
through continued partnership with the State laboratories to manage
numerous measurement-related activities.

Significant changes have been made to the program of Recognition for the
States and to this Program Handbook since the first edition was
published in 1985. The program has incorporated national and
international standards; although WMD does not provide formal
accreditation according to ISO standards, and although the program is
operated independently from the National Voluntary Laboratory
Accreditation Program (NVLAP), the general and technical criteria used
in both programs are nearly identical.

The following list shows key changes in this edition of the Handbook:

-   Information associated with the National Type Evaluation Program
    (NTEP) has not been covered in program handbooks since 1996.

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-   Parts 2 and 3 are policy and procedure information specific to WMD
    operations and Recognition process; Figure 1 is a flow chart showing
    the Recognition process.

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-   Parts 4 and 5 substantially contain ISO/IEC 17025:2005 (previously
    these sections referenced ANSI/NCSL Z540-1-1994 (parts I and II)
    with NVLAP additions, WMD Notes, and minor editorial changes for
    clarity). WMD Notes added to parts 4 and 5 are additional policy or
    requirements that apply generally to all legal metrology
    laboratories without regard to Recognition level.

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-   Part 6 was originally developed in WMD and published in the NVLAP
    Calibration Laboratories Draft Technical Guide (1994 Draft, as
    incorporated in the 1996 and 1997 editions of this Handbook), but
    further edited for this publication. WMD and the National Conference
    on Weights and Measures (NCWM) ISO 9000 Task Force prepared the mass
    and volume sections and reviewed them at a special NVLAP workshop in
    December 1992 (mass criteria only); at a NVLAP workshop in November
    1993; at all six regional metrology meetings in 1993 and 1994; and
    at the 1994 NCWM meeting. Laboratories performing temperature
    measurements were given the opportunity to review the temperature
    section. G. Diane Lee (NIST) prepared the moisture section; it was
    reviewed at the Southeastern Measurement Assurance Program (SEMAP)
    regional metrology meeting in 1993. These sections have all been
    reviewed and updated for this 2007 edition.

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-   For the 1997 edition, NIST management made changes in the WMD State
    Laboratory Program. As a result, the 1997 Handbook was revised to
    delete references to accreditation. References to "accreditation"
    were replaced with references to "Recognition;" references to a
    "certificate of accreditation" were replaced with references to a
    "Certificate of Measurement Traceability;" and references to the WMD
    State Laboratory Program as an "accreditation program" were replaced
    with references to a "measurement assurance program."

Note regarding SI units: This publication conforms to the concept of
primary use of the International System of Units (SI) recommended in the
Omnibus Trade and Competitiveness Act of 1988 by citing SI units before
customary inch-pound units where both units appear together and placing
separate sections containing requirements for SI units before
corresponding sections containing requirements for customary inch-pound
units. In some cases, however, laboratory standards and/or trade
practice are currently restricted to the use of customary units;
therefore, some sections in this publication will specify only customary
units. Non-SI units are predominately in common use in State legal
metrology laboratories, and/or the petroleum industry for many
volumetric measurements; therefore non-SI units have been used to
reflect the practical needs of the laboratories performing these
measurements as appropriate. SI units are used where practical and where
use or potential conversion errors will not likely impact the quality of
laboratory measurement results.

**THIS PAGE LEFT INTENTIONALLY BLANK.**

**Acknowledgments and History**[]{#__RefHeading___Toc169420757 .anchor}

This Program Handbook, first published by Henry V. Oppermann and John K.
Taylor in 1985, documented and formalized the certification program
whereby NIST Recognized the capabilities of State legal metrology
laboratories. Prior to that time, the WMD issued "Certificates of
Participation" to States participating in the program. In 1985, WMD
began certifying laboratories against the criteria in Handbook 143,
Program Handbook. The 1985 criteria were based on International
Standards Organization (ISO/IEC) Guide 25 (1982), General Requirements
for the Competence of Calibration and Testing Laboratories.

The WMD began the process of updating this Program Handbook in 1991. Due
to the many activities related to ISO 9000 in the United States at that
time and questions regarding how those activities would impact the State
laboratories, ISO standards were provided to the State laboratories in
1991.

The National Conference of Standards Laboratories (NCSL), Total Quality
Management (TQM) Committee also started working on the development and
adoption of a single U.S. national standard for calibration laboratories
in 1991. The NCSL TQM Committee included representatives from NIST,
Department of Defense, Department of Energy, Nuclear Regulatory
Commission, Federal Aviation Administration, and numerous industries.

In 1992, the National Conference on Weights and Measures (NCWM)
established an ISO 9000 Task Force. After review of the 1985 version of
the Program Handbook and ISO/IEC Guide 25 to determine the conformance
status of State laboratories, the group recommended the use of one
standard in the United States (consistent with the NCSL position) for
the accreditation of calibration laboratories to:

reduce the number of redundant laboratory audits;

improve measurement compatibility and acceptance of measurement results
between laboratories in the United States and internationally; and

comply with the ISO-series standards for quality and management.

The NCSL "TQM Committee" became an official ANSI standards writing body
(ANSI Committee Z 540) in 1994 and published the U.S. standard as
Z540-1-1994. ANSI/NCSL Z540-1-1994 incorporated ISO Guide 25 and
Mil-Std-45662A. Since NCSL published the standard in 1994:

1)  the Department of Defense rescinded Mil-Std-45662A in favor of the
    Z540-1-1994 standard;

2)  the NIST National Voluntary Laboratory Accreditation Program (NVLAP)
    adopted and referenced ANSI/NCSL Z540-1-1994;

3)  the American Association for Laboratory Accreditation (A2LA), a
    private accrediting body, also adopted the standard; and

4)  the WMD incorporated the standard into Parts 5 and 6 of the 1996 and
    1997 editions of this Handbook. Additional requirements consistent
    with NVLAP requirements and with the needs of the legal metrology
    system were included.

In 1997, NIST management made the decision that NIST would operate only
one formal accreditation program: the National Voluntary Laboratory
Accreditation Program (NVLAP). Therefore, all references to
accreditation by WMD were changed to Recognition and WMD ceased issuing
Certificates of Accreditation. WMD monitors the level of State
compliance to this Handbook and other laboratory quality standards to
ensure that adequate accuracy, traceability, and uniformity are
maintained in State weights and measures laboratories.

In 1999, ISO/IEC Guide 25 was revised and became the international
standard ISO/IEC 17025. The 2003 edition of NIST Handbook 143
incorporated revisions to the procedures and general requirements of the
NIST Weights and Measures Division (WMD) Measurement Assurance Program
for State Laboratory Recognition. The WMD procedures were revised to
ensure continued consistency with international standards and
guidelines, specifically those currently found in ISO/IEC 17025:1999,
*General requirements for the competence of testing and calibration
laboratories.*

In 2003, the requirements in Sections 4 and 5 of that edition were
updated to contain clauses 4 and 5 of ISO/IEC 17025:1999. They must be
met in order for a laboratory to be *Recognized* as competent to carry
out tests and/or calibrations. Major changes in 2003 included:

-   In Section 4, *Management requirements*, there were additional or
    changed requirements in the areas of document control; requests,
    tenders, and contracts; purchasing; non-conforming work; corrective
    action; preventive action; and records. Those additions and changes
    incorporated changes that were consistent with ISO 9001:1994
    requirements. A new clause, *Service to the customer*, prescribed
    cooperation with customers and provided guidance on such
    cooperation.

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-   In Section 5, *Technical requirements*, the requirements were
    described in greater detail, but most concepts were not "new" for
    accredited laboratories. There was continued reference to customer
    needs and greater emphasis and/or more detailed requirements on
    method validation; estimation of measurement
    uncertainty/traceability for testing laboratories; and provision for
    inclusion of interpretations and opinions on test reports. A
    sampling plan was to be required where methods or specifications did
    not specify sampling procedures.

This 2007 edition supersedes the 2003 edition of NIST Handbook 143 and
includes editorial updates and clarifications. Sections 4 and 5 have
been updated to incorporate ISO/IEC 17025:2005 to ensure continued
acceptance of measurement results from State weights and measures
laboratories and to ensure consistency with the NVLAP Program and other
accreditation bodies.

**Table of Contents**

[**Preface** iii](#__RefHeading___Toc169420756)

[**Acknowledgments and History** v](#__RefHeading___Toc169420757)

[**1.** **Program Summary** 1](#__RefHeading___Toc169420758)

[**2.** **General Information and Operational Requirements**
3](#__RefHeading___Toc169420759)

[**3.** **Recognition Process** 9](#__RefHeading___Toc169420760)

[Table 1. Submission requirements for Recognition
15](#__RefHeading___Toc169420761)

[**4.** **Management Requirements for Accreditation**
17](#__RefHeading___Toc169420762)

[**5.** **Technical Requirements for Accreditation**
27](#__RefHeading___Toc169420763)

[Table 2. Training requirements 40](#__RefHeading___Toc169420764)

[**6.** **Specific Technical Guidelines**
41](#__RefHeading___Toc169420765)

[Table 3. Recognition parameter summary
42](#__RefHeading___Toc169420766)

[6.1 Technical Criteria for Dimensional Laboratories
43](#__RefHeading___Toc169420767)

[6.2 Technical Criteria for Mass Laboratories
47](#__RefHeading___Toc169420768)

[Table 4. Mass calibration echelons 47](#__RefHeading___Toc169420769)

[Table 5. Typical 'Ranges of Recognition' for mass calibration
48](#__RefHeading___Toc169420770)

[Table 6. Environmental facility guidelines for mass laboratories
49](#__RefHeading___Toc169420771)

[Table 7. Environmental equipment accuracy
50](#__RefHeading___Toc169420772)

[Table 8. Summary of technical criteria for mass calibration
53](#__RefHeading___Toc169420773)

[6.3 Technical Criteria for Volume Laboratories
54](#__RefHeading___Toc169420774)

[Table 9. Typical 'Ranges of Recognition' for volumetric calibration
54](#__RefHeading___Toc169420775)

[Table 10. Environmental facility guidelines for volumetric calibration
56](#__RefHeading___Toc169420776)

[Table 11. Environmental equipment accuracy
57](#__RefHeading___Toc169420777)

[Table 12. Summary of technical criteria for volume calibration
58](#__RefHeading___Toc169420778)

[6.4 Technical Criteria for Hydrometer Laboratories
59](#__RefHeading___Toc169420779)

[6.5 Technical Criteria for Thermometer Laboratories
62](#__RefHeading___Toc169420780)

[6.6 Technical Criteria for Moisture Laboratories
68](#__RefHeading___Toc169420781)

[Table 13. Moisture determination laboratory classifications
68](#__RefHeading___Toc169420782)

[Table 14. Summary of environmental facility guidelines
73](#__RefHeading___Toc169420783)

[**7.** **References** 75](#__RefHeading___Toc169420784)

[**8.** **Glossary** 77](#__RefHeading___Toc169420785)

[**Appendix A. List of NIST Services** 81](#__RefHeading___Toc169420786)

[**Appendix B. Request for Recognition, Scope of Recognition, Approved
Signatories, Authorized Representative**
83](#__RefHeading___Toc169420787)

[**Appendix C. Laboratory Assessment Checklist**
85](#__RefHeading___Toc169420788)

[**Appendix D. Summary of Services for Laboratory Directory**
113](#__RefHeading___Toc169420789)

[**Appendix E. Uncertainties Chart for Measurement Parameter**
115](#__RefHeading___Toc169420790)

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**1. Program Summary**[]{#__RefHeading___Toc169420758 .anchor}

State legal metrology laboratories are custodians at the State level of
measurement standards that serve as the basis for ensuring equity in the
marketplace and as reference standards for calibration services for
indigenous industry. As part of its program to encourage a high degree
of technical and professional competence in such activities, the
National Institute of Standards and Technology (NIST) Weights and
Measures Division (WMD) has developed performance standards and
formalized procedures for Recognition of State legal metrology
laboratories on a voluntary basis. Certificates of Measurement
Traceability are issued upon evaluation of the laboratory\'s ability to
make reliable metrological measurements (princi­pally mass, volume,
length, and temperature).

**Recognition of State Legal Metrology Laboratories**

This Handbook describes the procedures followed in evaluating State (and
a few other jurisdictional) legal metrology laboratories for
competence.  To be formally Recognized, a laboratory must satisfy
general and technical requirements for each measurement area in which
recognition is desired (see Appendix B).  This program is managed by the
WMD.

The general requirements in sections 4 and 5 incorporate ISO/IEC
17025:2005 (as adopted by the NVLAP Calibration Laboratories
Accreditation Program) and address internationally accepted quality
management practices for calibration and testing laboratories. In
addition to ISO/IEC 17025 and NVLAP requirements, sections 4 and 5
contain additional general requirements as "notes" that are specific for
State legal metrology laboratories. (See Section 7, References.)

The technical criteria in Section 6 amplify general criteria (ISO/IEC
17025) for each specific measurement parameter to be used as needed.
Technical requirements of the WMD recognition program are nearly
identical to the NVLAP guidelines published in the NIST/NVLAP Handbook
150-2F (Dimensional) and 150-2G (Mechanical), Calibration Laboratories
Technical Guides; however, while WMD does not operate a formal
accreditation program it does use the technical section as requirements
rather than as guidelines. The technical requirements include
demonstration that: 1) suitable test equipment, calibration standards,
defined test procedures, and the general facilities necessary for good
metrological services are available; and 2) that staff have a
comprehensive understanding of calibration, measurement, and test
requirements and are capable of applying them.

Under this voluntary recognition program, laboratories appraise their
compliance with the requirements, completing ap­propriate forms that are
reviewed and evaluated by WMD.

Following review and evaluation, which includes proficiency testing, and
may include on-site assessments, WMD may issue a Certificate of
Measurement Traceability indicat­ing recognized competence areas with
defined parameters and scope of Recognition. Recognition may be granted
for a period up to 2 years, but on an annual basis each laboratory must
review its status, complete an internal audit, including a management
review and management system assessment, and submit the evaluation along
with a statement that no adverse changes have taken place in order for
the Recognition to remain in effect.

Types of assistance available from the National Institute of Standards
and Technology are listed in Appendix A.

**General**

Each State legal metrology laboratory is encouraged to study this
Handbook carefully and to apply for Recognition in all areas in which it
provides measurement services. WMD reserves the right to deny or
withdraw Recognition. In such cases, WMD will notify the State in
writing of nonconformities, and will provide guidelines for corrective
action.  In the case of withdrawal, NIST will attempt to reach agreement
with the State on the timing of the corrective action in order to keep
the Recognition in force conditionally for legal requirements only.

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**2. General Information and Operational
Requirements**[]{#__RefHeading___Toc169420759 .anchor}

# 

**2.1 Purpose**

The NIST Enabling Act (31 Stat. 1449, 15 USC 271, Chapter 6 Weights and
Measures), as modified by \"authorities and functions pursuant to the
Omnibus Trade and Competitiveness Act of 1988,\" provides the
legislative authority to Recognize qualifying State legal metrology
(weights and measures) laboratories. Authorization includes \"the
provision of means and methods for making measurements consistent with
those of the national standards.\" Compliance with the criteria
contained in this Handbook is the most effective means for ensuring
accurate measurements consistent with national standards.

**2.2 Description, Quality Policy, and Objectives**

In 1965, Congress funded NIST to establish the State Standards Program
to provide new standards of mass, volume, and length to the States, the
District of Columbia, Puerto Rico, and the Virgin Islands to update
their legal metrology (weights and measures) laboratories and increase
their measurement capabilities. The program also provided the laboratory
equipment necessary for the States to use the standards in their
measurement services.

As part of the States\' responsibilities in the distribution of
standards and equipment, each jurisdiction was required to provide an
acceptable laboratory facility meeting specifications established under
the State Standards Program and to maintain acceptable staffing. The
laboratory metrologist was required to complete training at NIST in the
use of the standards and equipment.

State Laboratory Program Quality Policy:

It is the policy of the State Laboratory Program to help all State
laboratories achieve and maintain Recognition and to enable State legal
metrology laboratories to provide their customers accurate and traceable
measurement services in an atmosphere of continuous quality improvement.

As part of its continuing support to the States, NIST manages the State
Laboratory Program. This is a program of the WMD designated to provide
guidance, technical support, and assistance to State legal metrology
laboratories to ensure accurate and traceable measurements from NIST to
the local jurisdictions. The program operates through continued
partnership with the State laboratories to manage numerous activities
within the program.

WMD objectives are to:

1)  support the basic level of measurement services required for legal
    metrology enforcement/oversight activities;

2)  provide technical support for the accuracy and traceability of State
    legal metrology laboratories to the national standards through
    develop­ment, training, publication of, and use of standard
    procedures, protocols, proficiency testing, and measurement
    assurance programs;

3)  provide and maintain the Recognition program for State legal
    metrology laboratories as evidence of continuing measurement
    traceability to include auditing of the use and care of the physical
    standards of mass, length, and volume; and

4)  assist the States to upgrade and expand the measurement services of
    State legal metrology laboratories to satisfy the changing needs of
    the legal metrology system and laboratory customers.

**2.3 Scope of Recognition**

**2.3.1 Voluntary and non-contractual**

The Recognition function for State legal metrology laboratories is a
voluntary, non-regulated program of support to the States. It provides a
cost-effective means for providing evidence of measurement accuracy and
traceability (See sections 2.9.8 and 2.9.9).

**2.3.2 Legal compliance requirements**

Although there are currently no Federal requirements for Recognition,
some States have weights and measures laws that require continued formal
accreditation, certification, approval, or other form of Recognition by
NIST as evidence of maintaining measurement traceability for reference
\[primary\] standards used in the enforcement of weights and measures
laws.

**2.3.3 Limitations**

The WMD Recognition program is limited in scope. It is provided for
government legal metrology laboratories only. The NIST National
Voluntary Laboratory Accreditation Program (NVLAP) offers accreditation
services to all laboratories and is not limited in the scope of whom
they may accredit.

**2.3.4 Liability**

NIST Recognition does not certify individual measurements made by a
State, but formally Recognizes that the State legal metrology laboratory
has traceable standards, the capability to perform reliable
measurements, and that the metrologist has been trained in the proper
procedures to provide these measurements and has demonstrated
measurement proficiency. Recognition also indicates that the metrologist
has submitted technical data, records, and documentation as specifically
requested by NIST. NIST assumes no liability for the accuracy and
traceability of individual measurement results provided by a Recognized
laboratory.

**2.4 Technical Support and Assistance**

WMD offers consultative and technical support through informal and
formal means to all State legal metrology laboratories regardless of
their Recognition status. Informal assistance may be in the form of
telephone, facsimile, e-mail, or mailed responses. Formal support and
assistance are available through the training program and the Regional
Measurement Assurance Program (RMAP) of the State Laboratory Program
(See Appendix A for types of technical assistance available).

5.  **Confidentiality**

To the extent permitted by applicable laws, WMD seeks to ensure the
confidentiality of all information obtained relating to the application,
on-site assessment, evaluation, and Recognition of laboratories, unless
the laboratory provides permission to share such information.
*Exceptions: see section 2.9.9, Proficiency Testing.*

Results of proficiency tests are discussed openly at annual RMAP
meetings in the spirit of continuous improvement and teamwork.
Proficiency testing confidentiality is addressed as a part of NISTIR
7082 "Proficiency Test Policy and Plan (for State Weights & Measures
Laboratories)" and NISTIR 7214 "Weights and Measures Division Quality
Manual For Proficiency Testing and Interlaboratory Comparisons." The
policy is stated as follows: "It is the policy of NIST WMD that all
PT/ILC activities are completely open, with no coded or confidential
information. All participants must agree to these conditions before
being qualified to participate in PT/ILC activities."

**2.6 Development of Requirements**

**2.6.1 Use of national and international standards wherever available**

When national or international standards are available in the area of
accreditation requirements for calibration laboratories, WMD will adopt
such standards as program criteria after suitable review. Adoption of
national or international standards, rather than independent development
of standards, is required by Federal law whenever feasible and
appropriate.

**2.6.2 Laboratory review, solicitation of comment by those affected**

The technical requirements associated with the current version of
Handbook 143 were developed in conjunction with an ISO 9000 Task Force
of the National Conference on Weights and Measures. The technical
requirements for dimensional (length) and mechanical (mass and volume)
measurements have been incorporated into NIST Handbook 150-2F and
150-2G, Calibration Laboratories Technical Guides. Draft laboratory
publications are reviewed by affected laboratories prior to publication.
This version of Handbook 143 was posted for comment between October 2005
and March 2007.

**2.7 Documentation**

General and technical requirements for Recognition and additional
documents and records to support the program for State legal metrology
laboratories are maintained and published by the WMD.

Other publications that include the general and technical requirements
for State laboratory *Recognition*, are also available:

1)  NIST Special Publication (SP) 791, State Weights and Measures
    Laboratories: State Standards Program Description and
    Directory, 2000. This electronic document contains a general program
    description and laboratory directory. It is updated periodically and
    is only available on the NIST Internet site.

2)  NIST Handbook 145 Handbook for the Quality Assurance of Metrological
    Measurements, 1986. This Handbook contains laboratory procedures
    that are used in WMD Training Program and are recommended for use in
    State legal metrology laboratories. Adequate data and evidence of
    measurement impact must be provided by the laboratory to justify
    deviating from documented procedures. This Handbook includes Good
    Laboratory Practices (GLPs), Good Measurement Practices (GMPs), and
    Standard Operating Procedures (SOPs). A number of the GLPs, GMPs,
    and SOPs from Handbook 145 have been updated or superseded by NISTIR
    5672, NISTIR 6176, NISTIR 6969, and NISTIR 7383, and this Program
    Handbook. NISTIR publications are official publications and
    procedures of the NIST Weights and Measures Division that are
    intended to be used by the State laboratories.

3)  NISTIR 5672, Advanced Mass Measurements and Measurement Assurance
    Program for State Calibration Laboratories, (2005 Ed.). This
    publication documents guidelines for facilities, equipment,
    standards, and training recommended for precision mass calibration
    and measurement control programs. It is consistent with the
    technical criteria for mass calibration and is available on the NIST
    Internet site. This publication was originally published in 1995.
    The 2005 edition contains updated Standard Operating Procedures 5
    and 28 for three-one and advanced weighing designs.

4)  NISTIR 6176, Process Measurement Assurance Program for U.S. State
    Metrology Laboratories, June 1998. This publication contains
    guidance for implementing a process measurement assurance program
    and PMAP software in the State laboratories. It contained the first
    draft of SOP 30 for process measurement assurance programs. The
    guidance and implementation does not require the use of PMAP™
    software. SOP 30 was updated as a part of NISTIR 6969 in 2003.

5)  NISTIR 6969, Selected Laboratory and Measurement Practices, and
    Procedures, to Support Basic Mass Calibrations, March 2003, with
    on-line updates December 2003. This publication contains updated
    procedures for Basic and Intermediate Mass calibrations. Many of the
    procedures were included on the NIST Special Publication 1001 and
    1001-S, Basic Mass Metrology CD-ROM training course. New GLPs, GMPs,
    and SOPs that were not published as a part of the original NIST
    Handbook 145 were included.

6)  NISTIR 7383, Selected Procedures for Volumetric Calibrations,
    November 2006. This publication contains updated procedures for
    Volumetric calibrations. New SOPs that were not published as a part
    of the original NIST Handbook 145 were included.

7)  NISTIR 5802, Quality Manual Template, December 1999. This
    publication was a quality manual template developed as a model for
    State legal metrology laboratories. It conformed to ISO/IEC Guide
    25, ANSI/NCSL Z540-1-1994, and earlier NVLAP documentation
    requirements. It is available on the NIST Internet site, but is no
    longer recommended as a model due to more recent updates in
    ISO/IEC 17025. The recommended model is now, NISTIR 7028, the
    Quality Manual for the National Type Evaluation Program, although
    care must be taken to remove references to type evaluation and
    testing terminology (in favor of calibration terminology).

8)  NISTIR 7028, Type Evaluation Laboratory Quality Manual Template,
    Developed for U.S. Type Evaluation Laboratories, July 2003. As part
    of its technical support to the U.S. commercial weights and measures
    system, WMD created this quality manual template to assist type
    evaluation laboratories in documenting their management systems. As
    such, this quality manual template is specifically designed for type
    evaluation testing laboratories. The quality manual template is
    based on ISO/IEC 17025 requirements. Although this manual is not
    numerically formatted identical to the ISO/IEC 17025 standard, the
    requirements of the standard are addressed in the quality manual.
    Each Section of the quality manual is cross-referenced to the
    ISO/IEC 17025 requirements so that auditors and others can locate
    where the requirements are addressed in the quality manual.

9)  NISTIR 7082, Proficiency Test Policy and Plan (for State Weights &
    Measures Laboratories), January 2004. This document was prepared by
    Jeff C. Gust (Quametec Corp., under contract) in collaboration with
    WMD staff, with input from State metrologists and NVLAP staff, as a
    first step in the process of enabling State weights and measures
    laboratories to comply with criteria for proficiency testing as
    noted in this Handbook and as needed for accreditation programs. The
    publication aligned NIST policies with international mutual
    recognition arrangement requirements, and intended to ensure that
    proficiency tests developed within this program meet all
    international requirements for design, development, execution,
    analysis and reporting of proficiency tests.

10) NISTIR 7214, Weights and Measures Division Quality Manual For
    Proficiency Testing and Interlaboratory Comparisons, March 2005.
    This document was prepared by Jeff C. Gust (Quametec Corp., under
    contract) in collaboration with WMD, with input from State
    metrologists and NVLAP staff, to enable State Weights and Measures
    Laboratories to comply with criteria for proficiency testing as
    noted in this Handbook and as needed for accreditation programs. It
    provides the basic quality system for Proficiency Testing and
    Interlaboratory Comparisons developed by WMD.

**2.8 Records**

Records related to Recognition or accuracy and traceability of
measurements and standards for each State are maintained in the WMD.
Procedures regarding record retention are maintained in the WMD. These
documents include, but are not limited to, the following:

1)  traceability records for reference \[primary\] standards, working
    standards, and check standards (includes traceability hierarchies
    and calibration reports);

2)  measurement assurance data (control charts and surveillance tests)
    -- latest year;

3)  uncertainty tables -- latest year;

4)  training records and records related to completion of Laboratory
    Auditing Program (LAP) problems;

5)  quality manuals, administrative procedures, and associated
    appendices -- latest version;

6)  proficiency testing (round robin reports of the RMAPs);

7)  internal audits (including management review); and

8)  on-site assessment reports.

Letters verifying the status of a laboratory's Recognition level,
traceability, and accompanying records may be provided on behalf of the
State to customers when formally requested to WMD in writing on official
letterhead. A copy of the laboratory's Certificate of Measurement
Traceability should suffice for all routine applications and these are
posted on the WMD internet site. Facsimile or e-mail requests are not
acceptable.

**2.9 Rights, Duties, Responsibilities of the Recognized Laboratory**

**2.9.1 Display of Certificates of Measurement Traceability**

The laboratory is encouraged to post its Certificate of Measurement
Traceability in the laboratory and may copy it for customer use as
evidence of traceability. The Certificate includes the Scope of
Recognition.

**2.9.2 Use of Recognition or traceability status on calibration
certificates or test reports**

The laboratory may reference its Recognition status or traceability
status on calibration certificates or test reports only if the
laboratory is Recognized in that particular measurement parameter and
scope at the level specified on the calibration report. The laboratory
must make no statements regarding Recognition for measurement parameters
or levels of uncertainty that are not covered by the Certificate of
Measurement Traceability and scope.

**2.9.3 Reference to Recognition status**

A laboratory may reference its Certificate of Measurement Traceability
in promotional literature provided that it is consistent with NIST legal
policy (15 CFR Ch. 11, 200.113) on the use of the NIST name (or NVLAP
name and logo if applicable and according to NVLAP policies). This
policy has been circulated to all State laboratories, and is available
in the WMD as well as most local libraries. A general condition on the
use of the NIST name is that it may not be used for endorsement
purposes, but may be used to make factual statements regarding
Recognition or traceability.

**2.9.4 Notification of change**

A laboratory must advise the WMD of any changes that might affect the
quality of measurement services it provides. This includes, but is not
limited to: changes in staff, relocation and renovation of its
laboratory, damage to or loss of environmental controls in its facility,
damage or change of laboratory equipment used to provide measurement
services, and damage, replacement, or recalibration of reference
\[primary\] standards used to provide measurement services (including
improvements as well as adverse changes). Any change that might
adversely affect the quality of measurement results is particularly
important and must be reported.

**2.9.5 Provide timely submissions**

WMD solicits information from all laboratories each year as a reminder
of the Recognition requirements. The laboratory must submit a report
between October 1 and November 15 annually. This submission must include
those items specifically requested, but is not limited to the items
listed in the Recognition process. Requests for technical assistance may
be made at the same time. Routine failure of a laboratory to provide
requested material in a timely manner will prevent 2-year Recognition
and may result in limited or *Conditional* Recognition.

**2.9.6 Reciprocity with other WMD‑Recognized laboratories**

Recognized State laboratories may have reciprocity with other Recognized
or accredited State laboratories as a part of the voluntary registration
program for service agents. Reciprocal acceptance of calibration reports
should be limited to laboratories that have maintained full (not
*Conditional*) Recognition with WMD or formal accreditation. Calibration
reports from laboratories that have failed to maintain Recognition,
formal accreditation, or are *Conditionally* Recognized, should be
refused. Information on Recognition status is available through the
online Special Publication 791, Laboratory Directory and through
individual status requests.

**2.9.7 Subcontracting**

State legal metrology laboratories conduct little or no subcontracting.
In the event that a laboratory determines that it is in its best interst
to subcontract calibrations, it should subcontract only to other
Recognized or accredited laboratories.

**2.9.8 Failure to maintain** **Recognition**

Any laboratory that fails to maintain Recognition will be encouraged to
correct nonconformities and be given an opportunity to submit evidence
of corrective action for whatever nonconformity exists. A laboratory
that has lost Recognition status may subsequently comply with the
Recognition criteria. Laboratories are encouraged to work closely with
the WMD to reestablish Recognition as soon as possible. WMD will assist
each laboratory as much as possible based on need and resources
available.

**2.9.9 Notification of status**

The WMD reserves the right to notify State and Federal agencies as well
as any indigenous industry of a State regarding Recognition or
accreditation status. This is generally accomplished through the
periodic publication of a laboratory directory and may include periodic
memoranda to affected parties.

**2.9.10 Response to nonconformities and corrective action requests**

A laboratory will have a specified amount of time to respond to
nonconformities addressed through annual review, internal management
review, WMD review, or through an on‑site assessment conducted by NIST
staff or its designated technical experts (TEs). At the end of the
specified time period, the laboratory may be given a \"*Conditional*
Recognition" detailed later in this publication. In the event that the
laboratory fails to respond, or fails to respond adequately, it will not
be Recognized in the particular area under question until such time as
it responds or corrects nonconformities. The laboratory has the right to
appeal WMD decisions as described later in this publication.

**3. Recognition Process**[]{#__RefHeading___Toc169420760 .anchor}

A flowchart depicting the Recognition process is shown in Figure 1.
Details of this process are provided in this section. An overview of the
Recognition process includes:

1)  an annual solicitation by WMD;

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5)  technical review of submitted material (see list in Table 1 and
    associated guidelines);

6)  review of on-site assessment results;

7)  review of proficiency testing results; and

8)  issuance of a Certificate of Measurement Traceability, which
    includes the scope of Recognition.

**3.1 Requests for Recognition and Fees**

Each State legal metrology laboratory, plus those of Puerto Rico, the
District of Columbia, the Virgin Islands, Los Angeles County, and the
Grain Inspection and Packers and Stockyards Administration (GIPSA)
Master Scale Depot, may seek Recognition. The annual Request for
Recognition must detail the requested Scope of Recognition (Appendix B),
include all additional requested components, and will include an annual
evaluation will conducted by WMD.

Responsibility for measurement accuracy and traceability as used in
commerce is cooperatively shared by a number of Federal and State
agencies. An excellent working partnership exists between the State
legal metrology laboratories and WMD. The laboratories provide
payment-in-kind through voluntary efforts for many of the activities
needed to maintain the Recognition process, procedure development,
instruction at training seminars, and the coordination and analysis of
proficiency testing in partnership with WMD. As a result of this
partnership and shared responsibilities, fees are not charged to these
laboratories to support the Recognition process.

**3.2 Annual Solicitation**

Material for Recognition and issuance of Certificates of Measurement
Traceability is annually solicited by WMD via a detailed memorandum
between August 1 and September 15.

1.  **Annual submission period**

Laboratories are to submit the Request for Recognition, along with
specifically requested items, each year between October 1 and November
15. If a laboratory fails to submit material in a timely manner, there
is a risk that the Certificate of Measurement Traceability will not be
renewed by the expiration date of the previous certificate. Certificates
expire December 31 each year (or every 2 years) and are renewed
January 1. Material must be submitted each year for the certificate to
remain in effect. Material that is received significantly late may not
be reviewed until the next review cycle.

**3.2.2 Information to be submitted**

The information to be submitted annually depends on the particular
circumstances of a laboratory\'s Recognition and will be detailed in the
solicitation memorandum. Requested information is always related to
specific criteria as described in this Handbook.

Generally, a Request for Recognition and all applicable items must be
submitted each time the laboratory\'s Certificate of Measurement
Traceability expires. A list of items is detailed in Table 1 and
includes the associated guidelines. If the Certificate of Measurement
Traceability has lapsed for any reason, it is treated as a renewal and a
complete submission must be made.

**3.3 On-site Assessments (Monitoring and Requested)**

Since all laboratories were established with the technical support and
guidance of the WMD in the late 1960\'s or early 1970\'s and have been
visited by WMD staff, all on-site assessments initiated by WMD are
considered to be technical assistance visits and/or monitoring
assessments. Essential monitoring assessments are conducted
periodically, generally in conjunction with training or regional
meetings. Additional on-site assessments may be requested by the
laboratory and will be conducted as feasible.

The primary objectives of on-site assessments are to: 1) ensure that the
laboratories maintain laboratory quality by complying with documented
criteria and 2) assist the laboratories to improve their overall
operations, facilities, equipment, standards, or staff to ensure
adequate accuracy and traceability to meet State legal requirements.
On-site assessments may be conducted by NIST staff or by contracted
Technical Experts (TEs).

Staff and TEs use checklists (and forms), and all assessment reports
follow the same general format to ensure consistency from one laboratory
assessment to another. Assessments generally take between one and three
days and are conducted to minimize disruption of normal laboratory
operations. Since most State laboratories operate with minimal staff, as
much advance notice as possible of the assessment date is given for
scheduling purposes.

All WMD records concerning a given laboratory are available to WMD
staff, NVLAP staff (if the laboratory has applied to NVLAP for formal
accreditation), or an assigned TE for evaluation. These include quality
manuals, administrative procedures, associated appendices, uncertainty
tables, training records, RMAP attendance records, results of internal
and on-site audits, management review summaries, results of
interlaboratory comparisons or other proficiency tests, control charts,
NIST calibration reports, reports of tests, and any previous
correspondence with the laboratory. During the on-site assessment, the
assessor verifies information contained in the files through meetings
with management and laboratory staff, by examination of facility,
equipment, standards, test reports, quality documents, and procedures,
and by observation of procedures. The assessor need not be given any
information that violates individual privacy such as salary, medical
information, or performance reviews outside the scope of the Recognition
program.

**3.3.1 NIST staff**

On-site assessments of laboratories may or may not be conducted by WMD
staff. However, WMD staff will prepare all final laboratory assessment
reports and communicate assessment results to the management and staff
of each laboratory.

**3.3.2 Technical Experts (TEs)**

TEs are metrologists with technical expertise, appropriate auditing
training and skills, and discretion, who have been selected to conduct
on-site assessments for the State Laboratory Program. Criteria for
selection are based on professional and academic achievement and are
maintained in the WMD.

WMD strives to ensure fairness and impartiality in its assessments**.**
TEs are required to sign a form regarding laboratory confidentiality.
Concerns regarding any TEs should be brought to WMD\'s attention in
writing. Records are maintained for the assessments that each TE has
conducted. NIST may provide additional training in auditing techniques.
TEs may draft assessment reports; however, these reports are reviewed
and finalized by WMD staff.

**3.3.3 Assessment report and invitation to respond**

Either a draft assessment report or the assessor\'s notes may be left
with laboratory staff or management at the close of a formal assessment.
A formal assessment report may be issued to the laboratory detailing
nonconformities and the expected preventive or corrective action**.**
The laboratory is given an opportunity to respond or appeal stated
nonconformities. An assessor may or may not be fully aware of specific
laboratory conditions and clarification may be appropriate, thus the
laboratory response may include clarification. The laboratory is
expected to correct nonconformities as soon as possible and to implement
preventive action as a normal course of operations. The

**Figure 1.** Recognition Process![](media/image2.wmf).

laboratory must submit a corrective action plan to WMD within thirty
days of receiving a final report. This does not mean that
nonconformities must be corrected within that time period; rather, it
means that a plan for corrective action must be completed and submitted
or that other steps have already been taken to address the
nonconformities. WMD will respond to the laboratory regarding the
acceptability of the laboratory response.

**3.3.4 Contents of assessment report**

The assessment report will contain, as a minimum, the following
information:

1)  name and address of the laboratory;

2)  date of the assessment;

3)  criteria used to conduct the assessment;

4)  parameters and scope of Recognition for the assessment;

5)  name(s) of the assessors and affiliations;

6)  name(s) of laboratory management and staff contacted during
    assessment;

7)  list of additional records reviewed in addition to the on-site
    assessment (such as the quality manual, training records, control
    charts, or proficiency test results maintained by WMD);

8)  references to the Program Handbook when nonconformities are
    identified;

9)  recommendations and preventive action for laboratory improvement and
    discussion related to cited observations; and

10) nonconformities and corrective action required to meet program
    criteria and discussion related to cited observations.

    4.  **Proficiency Testing**

Interlaboratory comparisons (round robins) are conducted nationally and
as a part of each regional measurement assurance program (RMAP) and
constitute one of the primary methods used for assessment of competence.
The other primary method is the assignment of Laboratory Auditing
Program (LAP) problems upon the completion of each training seminar.
However, on-site assessments may include demonstration of procedures,
retest of a calibration item, or test of artifacts submitted directly to
the laboratory.

Acceptable results of proficiency tests are essential for Recognition to
be granted; further investigation will be conducted to resolve any
nonconformities. Proficiency testing results will be analyzed against
accepted and/or standardized data analysis methods. As with on-site
assessments and Recognition decisions, the laboratory may contact WMD
regarding proficiency testing results if they believe an analysis was
incorrect or if insufficient information was available for a complete
evaluation.

Proficiency testing nonconformities are defined as, but not limited to,
one or more of the following:

1)  failure to meet specified proficiency testing performance
    requirements or objectives prescribed at the outset of the
    interlaboratory comparison;

2)  failure to participate in a regularly scheduled round of proficiency
    testing for which the laboratory has received instructions and/or
    materials and for which the laboratory is seeking recognition in
    compliance with the WMD policies;

3)  failure to submit laboratory control data as required specific to
    each interlaboratory comparison;

4)  performance as a statistically outlying laboratory in two successive
    rounds of proficiency testing or showing a general pattern of
    outlying results over three or more rounds; and

5)  failure to produce acceptable calibration or test results when using
    special artifacts whose properties are well-characterized and known
    to WMD.

    4.  **NIST Technical Evaluation**

Technical evaluation is conducted prior to awarding a Certificate of
Measurement Traceability, and includes a full review of all available
technical information regarding the laboratory. This may include annual
submissions, control charts, quality manuals, associated appendices,
administrative procedures, assigned training problems, on-site
assessment reports, results of proficiency tests, training records,
attendance and participation at RMAPs, formal accreditation, plus any
other relevant information affecting the quality of the laboratory\'s
measurement results.

**3.5.1 Review of submissions**

Submissions will be reviewed and feedback provided to laboratories with
the same level of significance as an on-site assessment. Preventive
action will be recommended and corrective action will be required for
noted nonconformities.

**3.5.1.1 New, renewal, or expansion**

Any laboratory that is to receive a new certificate for January 1 must
submit laboratory material between October 1 and November 15. Material
will be reviewed by WMD between November 15 and December 31.

**3.5.1.2 Maintenance**

If a laboratory has multi-year Recognition, WMD will review material
between November 15 and March 1 of the following year. In the event that
material is not submitted during the appropriate time frame, WMD will
review the material, as time is available, giving preference to
laboratories without current Recognition.

**3.6 Recognition Periods and Policy**

Selection of Recognition periods is based on WMD judgment of the degree
to which a laboratory meets criteria in this Handbook and whether the
laboratory routinely submits data in a timely manner. While minor
nonconformities may not affect a laboratory\'s ability to establish
Recognition, they will result in a shorter Recognition period to
encourage the necessary oversight to achieve corrective action.

Each laboratory will be given every opportunity to provide input to WMD
for evaluation and to provide feedback to WMD assessments and
evaluations. Any laboratory has the right to appeal Recognition
decisions in writing to the WMD. Appeal responses will likely include a
full independent on-site assessment of the laboratory according to the
criteria in this Handbook.

Complaints regarding the operation of the Recognition program, on-site
assessments, document review by NIST or any NIST‑assigned technical
expert should be forwarded to the WMD in writing.

**3.6.1 Full renewal - Two year**

For those laboratories fully meeting criteria in this Handbook, a
two-year Certificate of Measurement Traceability may be issued; however,
additional data must continue to be submitted annually for review as
requested.

**NOTE:** Until the criteria in this Handbook are fully met (including
documentation), a laboratory will not be issued a 2-year Certificate of
Measurement Traceability.

**3.6.2 One-year renewal**

For laboratories where WMD management and oversight are required, or
when minor nonconformities exist, a one-year Certificate of Measurement
Traceability may be issued based on the judgment of WMD staff that
acceptable measurements will continue to be provided to laboratory
customers. Any laboratory that cannot meet the criteria in this Handbook
should not apply for NVLAP formal accreditation.

**3.6.3 Conditional renewal**

A one-year *Conditional* Certificate of Measurement Traceability may be
granted when multiple nonconformities exist in the facilities,
equipment, standards, staff, or overall laboratory operations, and the
laboratory has provided ongoing evidence that it is working to meet
criteria in this Handbook. *Conditional* Recognition will be issued only
to meet legal weights and measures requirements and limitations will be
stated in writing. *Conditional* Recognition will be marked on the
certificate. WMD plans to minimize the use of *Conditional* Recognition
in the future.

**3.6.4 Maintenance**

If a Certificate of Measurement Traceability for a laboratory has not
expired, an annual review of submitted data and any laboratory on-site
assessments may be conducted; however, no new certificate will be issued
since the current certificate is valid.

**3.6.5 Suspension, withdrawal, denial**

In the event that circumstances change significantly during a
Recognition cycle, it is the responsibility of the laboratory to notify
WMD. Any situation that critically affects the laboratory\'s ability to
provide accurate and traceable measurements may be cause for temporary
(which may be formal or informal) suspension of the Certificate of
Measurement Traceability until criteria are met.

A laboratory may choose to withdraw from specific levels of Recognition
based on circumstances in the laboratory, but may be reinstated any time
it has demonstrated that it fully meets criteria in this Handbook.

The result of an on-site assessment or of document review may include
denial or withdrawal of Recognition. Clear evidence of nonconformities
will be provided to the laboratory in writing along with the required
minimum corrective action. Denial of Recognition may be modified based
on the laboratory response or resolution of an appeal.

**Table 1. Submission requirements for
Recognition**[]{#__RefHeading___Toc169420761 .anchor}

+--------+-----------------+--------------------+---------------------+
| Ref    | Description     | Guidance           | Submission          |
| erence |                 |                    |                     |
+========+=================+====================+=====================+
| Ap     | Request for     | Include entire     | Yes: all            |
| pendix | Recognition,    | scope of           | laboratories        |
| B      | Parameters and  | laboratory         | annually.           |
|        | Scope, Approved | services annually. |                     |
|        | Signatories,    |                    | Yes: when changes   |
|        | Authorized      |                    | occur.              |
|        | Representative  |                    |                     |
+--------+-----------------+--------------------+---------------------+
| Ap     | Uncertainty     | Must be complete   | Yes: all            |
| pendix | Charts          | for entire scope,  | laboratories        |
| E      |                 | reviewed annually, | annually.           |
|        |                 | updated as needed, |                     |
|        |                 | and submitted      | Yes: for expanding  |
|        |                 | annually.          | Scope.              |
|        |                 | Laboratories       |                     |
|        |                 | accredited by      |                     |
|        |                 | NVLAP may submit   |                     |
|        |                 | NVLAP Scope.       |                     |
|        |                 | Alternative        |                     |
|        |                 | formats (e.g.,     |                     |
|        |                 | Excel files) are   |                     |
|        |                 | acceptable.        |                     |
+--------+-----------------+--------------------+---------------------+
| 3.3.4, | Proficiency     | Include evidence   | Yes: all            |
| k      | Testing         | of corrective      | laboratories        |
|        | Follow-up Forms | action or plan     | annually, for       |
| 5.9    |                 | when appropriate.  | *each* completed    |
|        |                 | Alternative        | PT.                 |
| 4.15   |                 | formats are        |                     |
|        |                 | acceptable         |                     |
|        |                 | provided they are  |                     |
|        |                 | integrated into    |                     |
|        |                 | the laboratory     |                     |
|        |                 | management system  |                     |
|        |                 | and completely     |                     |
|        |                 | address the PT     |                     |
|        |                 | results and        |                     |
|        |                 | corrective action. |                     |
|        |                 | Multi-year         |                     |
|        |                 | assessments may be |                     |
|        |                 | requested to       |                     |
|        |                 | determine          |                     |
|        |                 | completion of      |                     |
|        |                 | previous           |                     |
|        |                 | corrective action  |                     |
|        |                 | and compliance to  |                     |
|        |                 | PT/ILC policy.     |                     |
+--------+-----------------+--------------------+---------------------+
| 3.5.1  | Previously      | Review previous    | Yes: all            |
|        | identified      | feedback for       | laboratories        |
|        | nonconformities | assurance of       | annually.           |
|        | or requests.    | compliance. Submit |                     |
|        |                 | necessary          |                     |
|        |                 | evidence.          |                     |
+--------+-----------------+--------------------+---------------------+
| Ap     | Laboratory      | Used to update     | Yes: when changes   |
| pendix | Contacts        | laboratory         | occur.              |
| D      |                 | directory and      |                     |
|        |                 | contacts database. | Yes: when           |
|        |                 | Review each year.  | requested.          |
+--------+-----------------+--------------------+---------------------+
| Ap     | Internal        | Complete as a form | Yes: if laboratory  |
| pendix | Assessment of   | with               | does not have       |
| C      | Management      | cross-references   | current or full     |
|        | System          | and details.       | Recogntion.         |
|        |                 |                    |                     |
|        |                 |                    | Yes: for renewals.  |
|        |                 |                    |                     |
|        |                 |                    | Yes: when           |
|        |                 |                    | requested.          |
+--------+-----------------+--------------------+---------------------+
| 4.14.1 | Internal        | Appendix C does    | Yes: if laboratory  |
|        | Technical       | not provide a      | does not have       |
|        | Assessment      | complete technical | current or full     |
|        |                 | audit. Contact WMD | Recogntion.         |
|        |                 | for guidance if    |                     |
|        |                 | system is not      | Yes: for renewals.  |
|        |                 | already in place.  |                     |
|        |                 |                    | Yes: when           |
|        |                 |                    | requested.          |
+--------+-----------------+--------------------+---------------------+
| 4.15   | Management      | Follow Handbook    | Yes: if laboratory  |
|        | Review          | 143, Section 4.15. | does not have       |
|        |                 | Provide a signed   | current or full     |
|        |                 | report that        | Recogntion.         |
|        |                 | includes a         |                     |
|        |                 | laboratory         | Yes: for renewals.  |
|        |                 | management review. |                     |
|        |                 |                    | Yes: when           |
|        |                 |                    | requested.          |
+--------+-----------------+--------------------+---------------------+
| 4.2    | Laboratory      | Must include       | Yes: if laboratory  |
|        | Quality Manual  | complete set of    | does not have       |
| 4.14   | and Associated  | la                 | current or full     |
|        | Appendices      | boratory-developed | Recogntion.         |
|        |                 | reference          |                     |
|        |                 | documents. New or  | Yes: when changes   |
|        |                 | major revisions    | occur.              |
|        |                 | must include the   |                     |
|        |                 | internal           | Yes: when           |
|        |                 | laboratory         | requested.          |
|        |                 | assessment of the  |                     |
|        |                 | manual and its     |                     |
|        |                 | references.        |                     |
+--------+-----------------+--------------------+---------------------+
| 4.2    | Laboratory      | Must include       | Yes: if laboratory  |
|        | Administrative  | complete set of    | does not have       |
| 4.14   | Procedures      | la                 | current or full     |
|        |                 | boratory-developed | Recogntion.         |
|        |                 | reference          |                     |
|        |                 | documents. New or  | Yes: when changes   |
|        |                 | major revisions    | occur.              |
|        |                 | must include the   |                     |
|        |                 | internal           | Yes: when           |
|        |                 | laboratory         | requested.          |
|        |                 | assessment of the  |                     |
|        |                 | manual and its     |                     |
|        |                 | references.        |                     |
+--------+-----------------+--------------------+---------------------+
| 5.2    | Laboratory      | Required as        | Yes: when complete. |
|        | Auditing        | specified in Table |                     |
| Table  | Program (LAP)   | 2.                 |                     |
| 2      | problems        |                    |                     |
|        | assigned in     |                    |                     |
|        | Training        |                    |                     |
|        | Program         |                    |                     |
+--------+-----------------+--------------------+---------------------+
| 5.4    | Labor           | Submit copies of   | Yes: when new       |
|        | atory-Developed | la                 | procedures are      |
|        | Calibration     | boratory-developed | developed.          |
|        | Procedures      | calibration        |                     |
|        |                 | procedures (and    | Yes: when           |
|        |                 | significant        | requested.          |
|        |                 | modifications of   |                     |
|        |                 | published          |                     |
|        |                 | procedures) with   |                     |
|        |                 | evidence of        |                     |
|        |                 | validation.        |                     |
+--------+-----------------+--------------------+---------------------+
| 5.6    | Calibration     | Only needed for    | Yes: submit new     |
|        | Reports         | calibrations of    | reports during      |
|        |                 | standards obtained | annual review       |
|        |                 | during the year    | cycle.              |
|        |                 | from other         |                     |
|        |                 | laboratories.      |                     |
+--------+-----------------+--------------------+---------------------+
| 5.9    | Measurement     | Must be in place   | Yes: if laboratory  |
|        | Assurance &     | for all            | does not have       |
|        | Control Charts  | measurement        | current or full     |
|        |                 | services; see      | Recogntion.         |
|        |                 | section 5.9 in     |                     |
|        |                 | this Handbook.     | Yes: when           |
|        |                 |                    | requested.          |
+--------+-----------------+--------------------+---------------------+
|        | Other Special   | May be used for    | Yes: if laboratory  |
|        | Technical       | national           | does not have       |
|        | Requests        | assessments and    | current or full     |
|        |                 | summaries as       | Recogntion.         |
|        |                 | needed. Will       |                     |
|        |                 | reference Handbook | Yes: when           |
|        |                 | criteria.          | requested.          |
+--------+-----------------+--------------------+---------------------+
| 5.2    | Examples of     | Guidance will be   | Yes: when           |
|        | Special         | provided when      | requested.          |
| 5.3    | Technical       | requests are made. |                     |
|        | Requests:       |                    |                     |
| 5.5    |                 |                    |                     |
|        |                 |                    |                     |
| 5.6    |                 |                    |                     |
|        |                 |                    |                     |
| 5.10   |                 |                    |                     |
+--------+-----------------+--------------------+---------------------+
|        | Training        |                    |                     |
|        | Records,        |                    |                     |
|        | Training Plan,  |                    |                     |
|        | Succession      |                    |                     |
|        | Planning,       |                    |                     |
+--------+-----------------+--------------------+---------------------+
|        | Assessment of   |                    |                     |
|        | Laboratory      |                    |                     |
|        | Environmental   |                    |                     |
|        | Conditions,     |                    |                     |
+--------+-----------------+--------------------+---------------------+
|        | Summary of      |                    |                     |
|        | Laboratory      |                    |                     |
|        | Equipment and   |                    |                     |
|        | Suitability,    |                    |                     |
+--------+-----------------+--------------------+---------------------+
|        | Traceability    |                    |                     |
|        | Hierarchy       |                    |                     |
|        | Assessments,    |                    |                     |
+--------+-----------------+--------------------+---------------------+
|        | Samples of      |                    |                     |
|        | Calibration     |                    |                     |
|        | Reports         |                    |                     |
+--------+-----------------+--------------------+---------------------+

**4. Management Requirements for
Accreditation**[^1][]{#__RefHeading___Toc169420762 .anchor}

**4.1 Organization**

**4.1.1** The laboratory or the organization of which it is part shall
be an entity that can be held legally responsible.

**4.1.2** It is the responsibility of the laboratory to carry out its
testing and calibration activities in such a way as to meet the
requirements of this Handbook and to satisfy the needs of the customer,
the regulatory authorities or organizations providing Recognition.

**4.1.3** The laboratory management system shall cover work carried out
in the laboratory's permanent facilities, at sites away from its
permanent facilities, or in associated temporary or mobile facilities.

**4.1.4** If the laboratory is part of an organization performing
activities other than testing and/or calibration, the responsibilities
of key personnel in the organization that have an involvement or
influence on the testing and/or calibration activities of the laboratory
shall be defined in order to identify potential conflicts of interest.

**NOTE 1:** Where a laboratory is part of a larger organization, the
organizational arrangements should be such that departments having
conflicting interests, such as production, commercial marketing or
financing do not adversely influence the laboratory\'s compliance with
the requirements of this Handbook.

**NOTE 2:** If the laboratory wishes to be Recognized as a third-party
laboratory, it should be able to demonstrate that it is impartial and
that it and its personnel are free from any undue commercial, financial
and other pressures which might influence their technical judgment. The
third-party testing or calibration laboratory should not engage in any
activities that may endanger the trust in its independence of judgment
and integrity in relation to its testing or calibration activities.

**4.1.5** The laboratory shall:

1)  have managerial and technical personnel who, irrespective of other
    responsibilities, have the authority and resources needed to carry
    out their duties, including the implementation, maintenance and
    improvement of the management system, and to identify the occurrence
    of departures from the management system or from the procedures for
    performing tests and/or calibrations, and to initiate actions to
    prevent or minimize such departures (see also 5.2);

2)  have arrangements to ensure that its management and personnel are
    free from any undue internal and external commercial, financial and
    other pressures and influences that may adversely affect the quality
    of their work;

3)  have policies and procedures to ensure the protection of its
    customers' confidential information and proprietary rights,
    including procedures for protecting the electronic storage and
    transmission of results;

4)  have policies and procedures to avoid involvement in any activities
    that would diminish confidence in its competence, impartiality,
    judgment or operational integrity;

5)  define the organization and management structure of the laboratory,
    its place in any parent organization, and the relationships between
    quality management, technical operations and support services;

6)  specify the responsibility, authority and interrelationships of all
    personnel who manage, perform or verify work affecting the quality
    of the tests and/or calibrations;

7)  provide adequate supervision of testing and calibration staff,
    including trainees, by persons familiar with methods and procedures,
    purpose of each test and/or calibration, and with the assessment of
    the test or calibration results;

8)  have technical management which has overall responsibility for the
    technical operations and the provision of the resources needed to
    ensure the required quality of laboratory operations;

9)  appoint a member of staff as quality manager (however named) who,
    irrespective of other duties and responsibilities, shall have
    defined responsibility and authority for ensuring that the
    management system related to quality is implemented and followed at
    all times; the quality manager shall have direct access to the
    highest level of management at which decisions are made on
    laboratory policy or resources;

10) appoint deputies for key managerial personnel (see Note);

11) ensure that its personnel are aware of the relevance and importance
    of their activities and how they contribute to the achievement of
    the objectives of the management system.

    **NOTE:** Individuals may have more than one function and it may be
    impractical to appoint deputies for each function.

    **4.1.6** Top management shall ensure that appropriate communication
    processes are established within the laboratory and that
    communication takes place regarding the effectiveness of the
    management system.

    **4.2 Management System**

    **4.2.1** The laboratory shall establish, implement and maintain a
    management system appropriate to the scope of its activities. The
    laboratory shall document its policies, systems, programs,
    procedures and instructions to the extent necessary to assure the
    quality of the test and/or calibration results. The system's
    documentation shall be communicated to, understood by, available to,
    and implemented by the appropriate personnel.

    **4.2.2** The laboratory's management system policies related to
    quality, including a quality policy statement shall be defined in a
    quality manual (however named). The overall objectives shall be
    established, and shall be reviewed during management review. The
    quality policy statement shall be issued under the authority of top
    management. It shall include at least the following:

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1)  the laboratory management\'s commitment to good professional
    practice and to the quality of its testing and calibration in
    servicing its customers;

2)  the management's statement of the laboratory\'s standard of service;

3)  the purpose of the management system related to quality;

4)  a requirement that all personnel concerned with testing and
    calibration activities within the laboratory familiarize themselves
    with the quality documentation and implement the policies and
    procedures in their work; and

5)  the laboratory management\'s commitment to comply with this Handbook
    and to continually improve the effectiveness of the management
    system.

**NOTE:** The quality policy statement should be concise and may include
the requirement that tests and/or calibrations shall always be carried
out in accordance with stated methods and customers' requirements. When
the test and/or calibration laboratory is part of a larger organization,
some quality policy elements may be in other documents.

**4.2.3** Top management shall provide evidence of commitment to the
development and implementation of the management system and to
continually improving its effectiveness.

4.  Top management shall communicate to the organization the importance
    of meeting customer requirements as well as statutory and regulatory
    requirements.

5.  The quality manual shall include or make reference to the supporting
    procedures including technical procedures. It shall outline the
    structure of the documentation used in the management system.

6.  The role and responsibilities of technical management and the
    quality manager, including their responsibility for ensuring
    compliance with this Handbook, shall be defined in the quality
    manual.

7.  Top management shall ensure that the integrity of the management
    system is maintained when changes to the management system are
    planned and implemented.

**WMD NOTE:** The list of items in this section is not a complete list
of all items that must be included in a quality manual. In addition to
the items in this section, the laboratory's quality manual must also
address each of the requirements in Sections 4 and 5 of this Handbook.
The WMD provides NISTIR 5802, Quality Manual Template for the State
laboratories (ISO/IEC Guide 25 compliant) and NISTIR 7028, Type
Evaluation Laboratory Quality Manual Template (ISO/IEC 17025:1999
compliant) to use as a baseline which must be sufficiently modified to
match specific program details and the requirements of Sections 4 and 5
of this Handbook. All modifications must be evaluated against these
criteria. All updates must be submitted for review.

3.  **Document Control**

    1.  **General**

        The laboratory shall establish and maintain procedures to
        control all documents that form part of its management system
        (internally generated or from external sources), such as
        regulations, standards, other normative documents, test and/or
        calibration methods, as well as drawings, software,
        specifications, instructions and manuals.

        **NOTE 1:** In this context \"documents\" could be policy
        statements, procedures, specifications, calibration tables,
        charts, text books, posters, notices, memoranda, software,
        drawings, plans, etc. These may be on various media, whether
        hard copy or electronic, and they may be digital, analog,
        photographic or written.

        **NOTE 2:** The control of data related to testing and
        calibration is covered in 5.4.7. The control of records is
        covered in 4.13.

        **4.3.2 Document approval and issue**

        **4.3.2.1** All documents issued to personnel in the laboratory
        as part of the management system shall be reviewed and approved
        for use by authorized personnel prior to issue. A master list or
        an equivalent document control procedure identifying the current
        revision status and distribution of documents in the quality
        system shall be established and be readily available to preclude
        the use of invalid and/or obsolete documents.

        2.  The procedure(s) adopted shall ensure that:

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1)  authorized editions of appropriate documents are available at all
    locations where operations essential to the effective functioning of
    the laboratory are performed;

2)  documents are periodically reviewed and, where necessary, revised to
    ensure continuing suitability and compliance with applicable
    requirements;

3)  invalid or obsolete documents are promptly removed from all points
    of issue or use, or otherwise assured against unintended use;

4)  obsolete documents retained for either legal or knowledge
    preservation purposes are suitably marked.

    **4.3.2.3** Management system documents generated by the laboratory
    shall be uniquely identified. Such identification shall include the
    date of issue and/or revision identification, page numbering, the
    total number of pages or a mark to signify the end of the document,
    and the issuing authority(ies).

    **4.3.3 Document changes**

    **4.3.3.1** Changes to documents shall be reviewed and approved by
    the same function that performed

    the original review unless specifically designated otherwise. The
    designated personnel shall have access to pertinent background
    information upon which to base their review and approval.

    **4.3.3.2** Where practicable, the altered or new text shall be
    identified in the document or the appropriate attachments.

    **4.3.3.3** If the laboratory\'s documentation control system allows
    for the amendment of documents by hand pending the reissue of the
    documents, the procedures and authorities for such amendments shall
    be defined. Amendments shall be clearly marked, initialed and dated.
    A revised document shall be formally reissued as soon as
    practicable.

    4.  Procedures shall be established to describe how changes in
        documents maintained in computerized systems are made and
        controlled.

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    3.  **Review of Requests, Tenders and Contracts**

        1.  The laboratory shall establish and maintain procedures for
            the review of requests, tenders and contracts. The policies
            and procedures for these reviews leading to a contract for
            testing and/or calibration shall ensure that:

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1)  the requirements, including the methods to be used, are adequately
    defined, documented and understood (see 5.4.2);

2)  the laboratory has the capability and resources to meet the
    requirements; and

3)  the appropriate test and/or calibration method is selected and is
    capable of meeting the customers' requirements (see 5.4.2).

    Any differences between the request or tender and the contract shall
    be resolved before any work commences. Each contract shall be
    acceptable both to the laboratory and the customer.

    **NOTE 1:** The request, tender and contract review should be
    conducted in a practical and efficient manner, and the effect of
    financial, legal and time schedule aspects should be taken into
    account. For internal customers, reviews of requests, tenders and
    contracts can be performed in a simplified way.

**NOTE 2:** The review of capability should establish that the
laboratory possesses the necessary physical, personnel and information
resources, and that the laboratory\'s personnel have the skills and
expertise necessary for the performance of the tests and/or calibrations
in question. The review may also encompass results of earlier
participation in interlaboratory comparisons or proficiency testing
and/or the running of trial test or calibration programs using samples
or items of known value in order to determine uncertainties of
measurement, limits of detection, confidence limits, etc.

**NOTE 3:** A contract may be any written or oral agreement to provide a
customer with testing and/or calibration services.

**4.4.2** Records of reviews, including any significant changes, shall
be maintained. Records shall also be maintained of pertinent discussions
with a customer relating to the customer's requirements or the results
of the work during the period of execution of the contract.

**NOTE:** For review of routine and other simple tasks, the date and the
identification (e.g., the initials) of the person in the laboratory
responsible for carrying out the contracted work are considered
adequate. For repetitive routine tasks, the review need be made only at
the initial enquiry stage or on granting of the contract for ongoing
routine work performed under a general agreement with the customer,
provided that the customer's requirements remain unchanged. For new,
complex or advanced testing and/or calibration tasks, a more
comprehensive record should be maintained.

**4.4.3** The review shall also cover any work that is subcontracted by
the laboratory.

**4.4.4** The customer shall be informed of any deviation from the
contract.

5.  If a contract is to be amended after work has commenced, the same
    contract review process shall be repeated and any amendments shall
    be communicated to all affected personnel.

    **4.5 Subcontracting of Tests and Calibrations**

    **4.5.1** When a laboratory subcontracts work whether due to
    unforeseen reasons (e.g., workload, need for further expertise or
    temporary incapacity) or on a continuing basis (e.g., through
    permanent subcontracting, agency or franchising arrangements), this
    work shall be placed with a competent subcontractor. A competent
    subcontractor is one that, for example, complies with this Handbook
    for the work in question.

    **4.5.2** The laboratory shall advise the customer of the
    arrangement in writing and, when appropriate, gain the approval of
    the customer, preferably in writing.

    **4.5.3** The laboratory is responsible to the customer for the
    subcontractor's work, except in the case where the customer or a
    regulatory authority specifies which subcontractor is to be used.

    **4.5.4** The laboratory shall maintain a register of all
    subcontractors that it uses for tests and/or calibrations and a
    record of the evidence of compliance with this Handbook for the work
    in question.

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6.  **Purchasing Services and Supplies**

    **4.6.1** The laboratory shall have a policy and procedure(s) for
    the selection and purchasing of services and supplies it uses that
    affect the quality of the tests and/or calibrations. Procedures
    shall exist for the purchase, reception and storage of reagents and
    laboratory consumable materials relevant for the tests and
    calibrations.

    **4.6.2** The laboratory shall ensure that purchased supplies and
    reagents and consumable materials that affect the quality of tests
    and/or calibrations are not used until they have been inspected or
    otherwise verified as complying with standard specifications or
    requirements defined in the methods for the tests and/or
    calibrations concerned. These services and supplies used shall
    comply with specified requirements. Records of actions taken to
    check compliance shall be maintained.

    **4.6.3** Purchasing documents for items affecting the quality of
    laboratory output shall contain data describing the services and
    supplies ordered. These purchasing documents shall be reviewed and
    approved for technical content prior to release.

    **NOTE:** The description may include type, class, grade, precise
    identification, specifications, drawings, inspection instructions,
    other technical data including approval of test results, the quality
    required, and the management system standard under which they were
    made.

    **4.6.4** The laboratory shall evaluate suppliers of critical
    consumables, supplies and services which affect the quality of
    testing and calibration, and shall maintain records of these
    evaluations and list those approved.

    **4.7 Service to the Customer**

    **4.7.1** The laboratory shall be willing to cooperate with
    customers or their representatives in clarifying the customer's
    request and in monitoring the laboratory's performance in relation
    to the work performed, provided that the laboratory ensures
    confidentiality to other customers.

    **NOTE 1:** Such cooperation may include:

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1)  providing the customer or the customer's representative reasonable
    access to relevant areas of the laboratory for the witnessing of
    tests and/or calibrations performed for the customer; and

2)  preparation, packaging, and dispatch of test and/or calibration
    items needed by the customer for verification purposes.

    **NOTE 2:** Customers value the maintenance of good communication,
    advice and guidance in technical matters, and opinions and
    interpretations based on results. Communication with the customer,

    especially in large assignments, should be maintained throughout the
    work. The laboratory should inform the customer of any delays or
    major deviations in the performance of the tests and/or
    calibrations.

**4.7.2** The laboratory shall seek feedback, both positive and
negative, from its customers. The feedback shall be used and analyzed to
improve the management system, testing and calibration activities and
customer service.

**NOTE:** Examples of the types of feedback include customer
satisfaction surveys and review of test or calibration reports with
customers.

**4.8 Complaints**

The laboratory shall have a policy and procedure for the resolution of
complaints received from customers or other parties. Records shall be
maintained of all complaints and of the investigations and corrective
actions taken by the laboratory (see also 4.11).

**4.9 Control of Non-conforming Testing and/or Calibration Work**

**4.9.1** The laboratory shall have a policy and procedures that shall
be implemented when any aspect of its testing and/or calibration work,
or the results of this work, do not conform to its own procedures or the
agreed requirements of the customer. The policy and procedures shall
ensure that:

1)  the responsibilities and authorities for the management of
    non-conforming work are designated and actions (including halting of
    work and withholding of test reports and calibration certificates,
    as necessary) are defined and taken when non-conforming work is
    identified;

2)  an evaluation of the significance of the non-conforming work is
    made;

3)  correction is taken immediately, together with any decision about
    the acceptability of the non-conforming work;

4)  where necessary, the customer is notified and work is recalled; and

5)  the responsibility for authorizing the resumption of work is
    defined.

    **NOTE:** Identification of non-conforming work or problems with the
    management system or with testing and/or calibration activities can
    occur at various places within the management system and technical
    operations. Examples are customer complaints, quality control,
    instrument calibration, checking of consumable materials, staff
    observations or supervision, test report and calibration certificate
    checking, management reviews and internal or external audits.

    2.  Where the evaluation indicates that the non-conforming work
        could recur or that there is doubt about the compliance of the
        laboratory\'s operations with its own policies and procedures,
        the corrective action procedures given in 4.11 shall be promptly
        followed.

**4.10 Improvement**

The laboratory shall continually improve the effectiveness of its
management system through the use of the quality policy, quality
objectives, audit results, analysis of data, corrective and preventive
actions and management review.

**4.11 Corrective Action**

**4.11.1 General**

The laboratory shall establish a policy and procedure and shall
designate appropriate authorities for implementing corrective action
when non-conforming work or departures from the policies and procedures
in the management system or technical operations have been identified.

**NOTE:** A problem with the management system or with the technical
operations of the laboratory may be identified through a variety of
activities, such as control of non-conforming work, internal or external
audits, management reviews, feedback from customers and from staff
observations.

**4.11.2 Cause analysis**

The procedure for corrective action shall start with an investigation to
determine the root cause(s) of the problem.

**NOTE:** Cause analysis is the key and sometimes the most difficult
part in the corrective action procedure. Often the root cause is not
obvious and thus a careful analysis of all potential causes of the
problem is required. Potential causes could include customer
requirements, the samples, sample specifications, methods and
procedures, staff skills and training, consumables, or equipment and its
calibration.

**4.11.3 Selection and implementation of corrective actions**

Where corrective action is needed, the laboratory shall identify
potential corrective actions. It shall select and implement the
action(s) most likely to eliminate the problem and to prevent
recurrence.

Corrective actions shall be to a degree appropriate to the magnitude and
the risk of the problem.

The laboratory shall document and implement any required changes
resulting from corrective action investigations.

**4.11.4 Monitoring of corrective actions**

The laboratory shall monitor the results to ensure that the corrective
actions taken have been effective.

**4.11.5 Additional audits**

Where the identification of nonconformities or departures casts doubts
on the laboratory\'s compliance with its own policies and procedures, or
on its compliance with this Handbook, the laboratory shall ensure that
the appropriate areas of activity are audited in accordance with 4.14 as
soon as possible.

**NOTE:** Such additional audits often follow the implementation of the
corrective actions to confirm their effectiveness. An additional audit
should be necessary only when a serious issue or risk to the business is
identified.

**4.12 Preventive Action**

**4.12.1** Needed improvements and potential sources of nonconformities,
either technical or concerning the management system, shall be
identified. When improvement opportunities are identified or if
preventive action is required, action plans shall be developed,
implemented and monitored to reduce the likelihood of the occurrence of
such nonconformities and to take advantage of the opportunities for
improvement.

**4.12.2** Procedures for preventive actions shall include the
initiation of such actions and application of controls to ensure that
they are effective.

**NOTE 1:** Preventive action is a proactive process to identify
opportunities for improvement rather than a reaction to the
identification of problems or complaints.

**NOTE 2:** Apart from the review of the operational procedures, the
preventive action might involve analysis of data, including trend and
risk analyses and proficiency testing results.

**4.13 Control of Records**

**4.13.1 General**

**4.13.1.1** The laboratory shall establish and maintain procedures for
identification, collection, indexing, access, filing, storage,
maintenance and disposal of quality and technical records. Quality
records shall include reports from internal audits and management
reviews as well as records of corrective and preventive actions.

**4.13.1.2** All records shall be legible and shall be stored and
retained in such a way that they are readily retrievable in facilities
that provide a suitable environment to prevent damage or deterioration
and to prevent loss. Retention times of records shall be established.

**NOTE:** Records may be in any media, such as hard copy or electronic
media.

**4.13.1.3** All records shall be held secure and in confidence.

**4.13.1.4** The laboratory shall have procedures to protect and back up
records stored electronically and to prevent unauthorized access to or
amendment of these records.

**4.13.2 Technical records**

**4.13.2.1** The laboratory shall retain records of original
observations, derived data and sufficient information to establish an
audit trail, calibration records, staff records and a copy of each test
report or calibration certificate issued, for a defined period. The
records for each test or calibration shall contain sufficient
information to facilitate, if possible, identification of factors
affecting the uncertainty and to enable the test or calibration to be
repeated under conditions as close as possible to the original. The
records shall include the identity of personnel responsible for the
sampling, performance of each test and/or calibration and checking of
results.

**NOTE 1:** In certain fields it may be impossible or impracticable to
retain records of all original observations.

**NOTE 2:** Technical records are accumulations of data (see 5.4.7) and
information which result from carrying out tests and/or calibrations and
which indicate whether specified quality or process parameters are
achieved. They may include forms, contracts, work sheets, work books,
check sheets, work notes, control graphs, external and internal test
reports and calibration certificates, customers' notes, papers and
feedback.

**4.13.2.2** Observations, data and calculations shall be recorded at
the time they are made and shall be identifiable to the specific task.

**4.13.2.3** When mistakes occur in records, each mistake shall be
crossed out, not erased, made illegible or deleted, and the correct
value entered alongside. All such alterations to records shall be signed
or initialed by the person making the correction. In the case of records
stored electronically, equivalent measures shall be taken to avoid loss
or change of original data.

**4.14 Internal Audits**

**4.14.1** The laboratory shall periodically, and in accordance with a
predetermined schedule and procedure, conduct internal audits of its
activities to verify that its operations continue to comply with the
requirements of the management system and this Handbook. The internal
audit program shall address all elements of the management system,
including the testing and/or calibration activities. It is the
responsibility of the quality manager to plan and organize audits as
required by the schedule and requested by management. Such audits will
be carried out by trained and qualified personnel who are, wherever
resources permit, independent of the activity to be audited.

**NOTE:** The cycle for internal auditing should normally be completed
in one year.

**4.14.2** When audit findings cast doubt on the effectiveness of the
operations or on the correctness or validity of the laboratory\'s test
or calibration results, the laboratory shall take timely corrective
action, and shall notify customers in writing if investigations show
that the laboratory results may have been affected.

**4.14.3** The area of activity audited, the audit findings and
corrective actions that arise from them shall be recorded.

**4.14.4** Follow-up audit activities shall verify and record the
implementation and effectiveness of the corrective action taken.

**4.15 Management Reviews**

**4.15.1** In accordance with a predetermined schedule and procedure,
the laboratory's top management shall periodically conduct a review of
the laboratory\'s management system and testing and/or calibration
activities to ensure their continuing suitability and effectiveness, and
to introduce necessary changes or improvements. The review shall take
account of:

-   the suitability of policies and procedures;

-   reports from managerial and supervisory personnel;

-   the outcome of recent internal audits (see 4.13);

-   corrective and preventive actions;

-   assessments by external bodies;

-   the results of interlaboratory comparisons or proficiency tests;

-   changes in the volume and type of the work;

-   customer feedback;

-   complaints;

-   recommendations for improvement;

-   other relevant factors, such as quality control activities,
    resources and staff training.

**NOTE 1:** A typical period for conducting a management review is once
every 12 months.

**NOTE 2:** Results should feed into the laboratory planning system and
should include the goals, objectives and action plans for the coming
year.

**NOTE 3:** A management review includes consideration of related
subjects at regular management meetings.

**4.15.2** Findings from management reviews and the actions that arise
from them shall be recorded. The management shall ensure that those
actions are carried out within an appropriate and agreed timescale.

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**5.** Number range CHAPTER**Technical Requirements for
Accreditation**[^2][]{#__RefHeading___Toc169420763 .anchor}

**5.1 General**

**5.1.1** Many factors determine the correctness and reliability of the
tests and/or calibrations performed by a laboratory. These factors
include contributions from:

> --- human factors (5.2);

--- accommodation and environmental conditions (5.3);

--- test and calibration methods and method validation (5.4);

-   equipment (5.5);

--- measurement traceability (5.6);

> --- sampling (5.7);

--- the handling of test and calibration items (5.8).

**5.1.2** The extent to which the factors contribute to the total
uncertainty of measurement differs considerably between (types of) tests
and between (types of) calibrations. The laboratory shall take account
of these factors in developing test and calibration methods and
procedures, in the training and qualification of personnel, and in the
selection and calibration of the equipment it uses.

**5.2 Personnel**

**5.2.1** The laboratory management shall ensure the competence of all
who operate specific equipment, perform tests and/or calibrations,
evaluate results, and sign test reports and calibration certificates.
When using staff who are undergoing training, appropriate supervision
shall be provided. Personnel performing specific tasks shall be
qualified on the basis of appropriate education, training, experience
and/or demonstrated skills, as required.

**NOTE 1:** In some technical areas (e.g., nondestructive testing) it
may be required that the personnel performing certain tasks hold
personnel certification. The laboratory is responsible for fulfilling
specified personnel certification requirements. The requirements for
personnel certification might be regulatory, included in the standards
for the specific technical field, or required by the customer.

**NOTE 2:** The personnel responsible for the opinions and
interpretation included in test reports should, in addition to the
appropriate qualifications, training, experience and satisfactory
knowledge of the testing carried out, also have:

-   relevant knowledge of the technology used for the manufacturing of
    the items, materials, products, etc. tested, or the way they are
    used or intended to be used, and of the defects or degradations
    which may occur during or in service;

-   knowledge of the general requirements expressed in the legislation
    and standards; and

-   an understanding of the significance of deviations found with regard
    to the normal use of the items, materials, products, etc.,
    concerned.

**5.2.2** The management of the laboratory shall formulate the goals
with respect to the education, training and skills of the laboratory
personnel. The laboratory shall have a policy and procedures for
identifying training needs and providing training of personnel. The
training program shall be relevant to the present and anticipated tasks
of the laboratory. The effectiveness of the training actions taken shall
be evaluated.

**5.2.3** The laboratory shall use personnel who are employed by, or
under contract to, the laboratory. Where contracted and additional
technical and key support personnel are used, the laboratory shall
ensure that such personnel are supervised and competent and that they
work in accordance with the laboratory\'s management system.

**5.2.4** The laboratory shall maintain current job descriptions for
managerial, technical and key support personnel involved in tests and/or
calibrations.

**NOTE:** Job descriptions can be defined in many ways. As a minimum,
the following should be defined:

-   the responsibilities with respect to performing tests and/or
    calibrations;

-   the responsibilities with respect to the planning of tests and/or
    calibrations and evaluation of results;

-   the responsibilities for reporting opinions and interpretations;

-   the responsibilities with respect to method modification and
    development and validation of new methods;

-   expertise and experience required;

-   qualifications and training programs;

-   managerial duties.

**5.2.5** The management shall authorize specific personnel to perform
particular types of sampling, test and/or calibration, to issue test
reports and calibration certificates, to give opinions and
interpretations and to operate particular types of equipment. The
laboratory shall maintain records of the relevant authorization(s),
competence, educational and professional qualifications, training,
skills and experience of all technical personnel, including contracted
personnel. This information shall be readily available and shall include
the date on which authorization and/or competence is confirmed.

**WMD NOTE 1:** This requirement also applies to Approved Signatories.

**WMD NOTE 2:** The WMD provides training to State legal metrology
laboratories. State metrologists are required to complete the
appropriate level of training as indicated in Table 2, for the
laboratory to be Recognized at designated levels. Information regarding
the training program is maintained in the WMD.

**5.3 Accommodation and Environmental Conditions**

**5.3.1** Laboratory facilities for testing and/or calibration,
including but not limited to energy sources, lighting and environmental
conditions, shall be such as to facilitate correct performance of the
tests and/or calibrations.

The laboratory shall ensure that the environmental conditions do not
invalidate the results or adversely affect the required quality of any
measurement. Particular care shall be taken when sampling and tests
and/or calibrations are undertaken at sites other than a permanent
laboratory facility. The technical requirements for accommodation and
environmental conditions that can affect the results of tests and
calibrations shall be documented.

**5.3.2** The laboratory shall monitor, control and record environmental
conditions as required by the relevant specifications, methods and
procedures or where they influence the quality of the results. Due
attention shall be paid, for example, to biological sterility, dust,
electromagnetic disturbances, radiation, humidity, electrical supply,
temperature, and sound and vibration levels, as appropriate to the
technical activities concerned. Tests and calibrations shall be stopped
when the environmental conditions jeopardize the results of the tests
and/or calibrations.

**5.3.3** There shall be effective separation between neighboring areas
in which there are incompatible activities. Measures shall be taken to
prevent cross-contamination.

**5.3.4** Access to and use of areas affecting the quality of the tests
and/or calibrations shall be controlled. The laboratory shall determine
the extent of control based on its particular circumstances.

5.  Measures shall be taken to ensure good housekeeping in the
    laboratory. Special procedures shall be prepared where necessary.

**5.4 Test and Calibration Methods and Method Validation**

**5.4.1 General**

The laboratory shall use appropriate methods and procedures for all
tests and/or calibrations within its scope. These include sampling,
handling, transport, storage and preparation of items to be tested
and/or calibrated, and, where appropriate, an estimation of the
measurement uncertainty as well as statistical techniques for analysis
of test and/or calibration data.

The laboratory shall have instructions on the use and operation of all
relevant equipment, and on the handling and preparation of items for
testing and/or calibration, or both, where the absence of such
instructions could jeopardize the results of tests and/or calibrations.
All instructions, standards, manuals and reference data relevant to the
work of the laboratory shall be kept up to date and shall be made
readily available to personnel (see 4.3). Deviation from test and
calibration methods shall occur only if the deviation has been
documented, technically justified, authorized, and accepted by the
customer.

**NOTE:** International, regional or national standards or other
recognized specifications that contain sufficient and concise
information on how to perform the tests and/or calibrations do not need
to be supplemented or rewritten as internal procedures if these
standards are written in a way that they can be used as published by the
operating staff in a laboratory. It may be necessary to provide
additional documentation for optional steps in the method or additional
details.

**WMD NOTE:** The WMD maintains NIST Handbook 145, Handbook for the
Quality Assurance of Metrological Measurements and its interim updates
that are published in NISTIR form until the entire Handbook is updated.
States must reference this Handbook (or its interim procedures) and use
it for all applicable measurement procedures unless data or other
evidence is available to support acceptable results using another
procedure. Other procedures must be submitted to WMD for review and
approval by the WMD. Use of uniform procedures is critical for
maintaining the integrity of the legal measurement system.

**5.4.2 Selection of methods**

The laboratory shall use test and/or calibration methods, including
methods for sampling, which meet the needs of the customer and which are
appropriate for the tests and/or calibrations it undertakes. Methods
published in international, regional or national standards shall
preferably be used. The laboratory shall ensure that it uses the latest
valid edition of a standard unless it is not appropriate or possible to
do so. When necessary, the standard shall be supplemented with
additional details to ensure consistent application.

When the customer does not specify the method to be used, the laboratory
shall select appropriate methods that have been published either in
international, regional or national standards, or by reputable technical
organizations, or in relevant scientific texts or journals, or as
specified by the manufacturer of the equipment. Laboratory-developed
methods or methods adopted by the laboratory may also be used if they
are appropriate for the intended use and if they are validated. The
customer shall be informed as to the method chosen. The laboratory shall
confirm that it can properly operate standard methods before introducing
the tests or calibrations. If the standard method changes, the
confirmation shall be repeated.

The laboratory shall inform the customer when the method proposed by the
customer is considered to be inappropriate or out of date.

**5.4.3 Laboratory-developed methods**

The introduction of test and calibration methods developed by the
laboratory for its own use shall be a planned activity and shall be
assigned to qualified personnel equipped with adequate resources.

Plans shall be updated as development proceeds and effective
communication amongst all personnel involved shall be ensured.

**5.4.4 Non-standard methods**

When it is necessary to use methods not covered by standard methods,
these shall be subject to agreement with the customer and shall include
a clear specification of the customer's requirements and the purpose of
the test and/or calibration. The method developed shall have been
validated appropriately before use.

**NOTE:** For new test and/or calibration methods, procedures should be
developed before tests and/or calibrations are performed and should
contain at least the following information:

1)  appropriate identification;

2)  scope;

3)  description of the type of item to be tested or calibrated;

4)  parameters or quantities and ranges to be determined;

5)  apparatus and equipment, including technical performance
    requirements;

6)  reference standards and reference materials required;

7)  environmental conditions required and any stabilization period
    needed;

8)  description of the procedure, including:

> --- affixing of identification marks, handling, transporting, storing
> and preparation of items,
>
> --- checks to be made before the work is started,
>
> --- checks that the equipment is working properly and, where required,
> calibration and adjustment of the equipment before each use,
>
> --- the method of recording the observations and results;
>
> --- any safety measures to be observed;

9)  criteria and/or requirements for approval/rejection;

10) data to be recorded and method of analysis and presentation;

11) the uncertainty or the procedure for estimating uncertainty.

**5.4.5 Validation of methods**

**5.4.5.1** Validation is the confirmation by examination and the
provision of objective evidence that the particular requirements for a
specific intended use are fulfilled.

**5.4.5.2** The laboratory shall validate non-standard methods,
laboratory-designed/developed methods, standard methods used outside
their intended scope, and amplifications and modifications of standard
methods to confirm that the methods are fit for the intended use. The
validation shall be as extensive as necessary to meet the needs of the
given application or field of application. The laboratory shall record
the results obtained, the procedure used for the validation, and a
statement as to whether the method is fit for the intended use.

**NOTE 1:** Validation may include procedures for sampling, handling and
transportation.

**NOTE 2:** The techniques used for the determination of the performance
of a method should be one of, or a combination of, the following:

> --- calibration using reference standards or reference materials;
>
> --- comparison of results achieved with other methods;
>
> --- interlaboratory comparisons;
>
> --- systematic assessment of the factors influencing the result;
>
> --- assessment of the uncertainty of the results based on scientific
> understanding of the theoretical principles of the method and
> practical experience.

**NOTE 3:** For changes in the validated non-standard methods, their
influence should be documented and, if appropriate, another validation
should be carried out.

**5.4.5.3** The range and accuracy of the values obtainable from
validated methods (e.g., the uncertainty of the results, detection
limit, selectivity of the method, linearity, limit of repeatability
and/or reproducibility, robustness against external influences and/or
cross-sensitivity against interference from the matrix of the
sample/test object), as assessed for the intended use, shall be relevant
to the customer's needs.

**NOTE 1:** Validation includes specification of the requirements,
determination of the characteristics of the methods, a check that the
requirements can be fulfilled by using the method, and a statement on
the validity.

**NOTE 2:** As method development proceeds, regular review should be
carried out to verify that the needs of the customer are still being
fulfilled. Any change in requirements requiring modifications to the
development plan should be approved and authorized.

**NOTE 3:** Validation is always a balance between costs, risks and
technical possibilities. There are many cases in which the range and
uncertainty of the values (e.g., accuracy, detection limit, selectivity,
linearity, repeatability, reproducibility, robustness and
cross-sensitivity) can only be given in a simplified way due to lack of
information.

**5.4.6 Estimation of uncertainty of measurement**

**5.4.6.1** A calibration laboratory, or a testing laboratory performing
its own calibrations, shall have and shall apply a procedure to estimate
the uncertainty of measurement for all calibrations and types of
calibrations.

**5.4.6.2** Testing laboratories shall have and shall apply procedures
for estimating uncertainty of measurement. In certain cases the nature
of the test method may preclude rigorous, metrologically and
statistically valid, calculation of uncertainty of measurement. In these
cases the laboratory shall at least attempt to identify all the
components of uncertainty and make a reasonable estimation, and shall
ensure that the form of reporting of the result does not give a wrong
impression of the uncertainty. Reasonable estimation shall be based on
knowledge of the performance of the method and on the measurement scope
and shall make use of, for example, previous experience and validation
data.

**NOTE 1:** The degree of rigor needed in an estimation of uncertainty
of measurement depends on factors such as:

> --- the requirements of the test method;
>
> --- the requirements of the customer; and
>
> --- the existence of narrow limits on which decisions on conformity to
> a specification are based.

**NOTE 2:** In those cases where a well-recognized test method specifies
limits to the values of the major sources of uncertainty of measurement
and specifies the form of presentation of calculated results, the
laboratory is considered to have satisfied this clause by following the
test method and reporting instructions (see 5.10).

**5.4.6.3** When estimating the uncertainty of measurement, all
uncertainty components which are of importance in the given situation
shall be taken into account using appropriate methods of analysis.

**NOTE 1:** Sources contributing to the uncertainty include, but are not
necessarily limited to, the reference standards and reference materials
used, methods and equipment used, environmental conditions, properties
and condition of the item being tested or calibrated, and the operator.

**NOTE 2:** The predicted long-term behavior of the tested and/or
calibrated item is not normally taken into account when estimating the
measurement uncertainty.

**NOTE 3:** For further information, see ISO 5725 and the Guide to the
Expression of Uncertainty in Measurement (see References).

**WMD NOTE:** ANSI/NCSL Z540-2-1997 and NIST Technical Note 1297 are
considered to be equivalent to the Guide to the Expression of
Uncertainty in Measurement (GUM). SOP 29 contains procedures for
implementing this requirement.

**5.4.7 Control of data**

**5.4.7**.1 Calculations and data transfers shall be subject to
appropriate checks in a systematic manner.

**5.4.7.2** When computers or automated equipment are used for the
acquisition, processing, recording, reporting, storage or retrieval of
test or calibration data, the laboratory shall ensure that:

1)  computer software developed by the user is documented in sufficient
    detail and is suitably validated as being adequate for use;

2)  procedures are established and implemented for protecting the data;
    such procedures shall include, but not be limited to, integrity and
    confidentiality of data entry or collection, data storage, data
    transmission and data processing;

3)  computers and automated equipment are maintained to ensure proper
    functioning and are provided with the environmental and operating
    conditions necessary to maintain the integrity of test and
    calibration data.

**NOTE:** Commercial off-the-shelf software (e.g., word processing,
database and statistical programs) in general use within their designed
application range may be considered to be sufficiently validated.
However, laboratory software configuration/modifications should be
validated as in 5.4.7.2a.

**5.5 Equipment**

**5.5.1** The laboratory shall be furnished with all items of sampling,
measurement and test equipment required for the correct performance of
the tests and/or calibrations (including sampling, preparation of test
and/or calibration items, processing and analysis of test and/or
calibration data). In those cases where the laboratory needs to use
equipment outside its permanent control, it shall ensure that the
requirements of this Handbook are met.

**5.5.2** Equipment and its software used for testing, calibration and
sampling shall be capable of achieving the accuracy required and shall
comply with specifications relevant to the tests and/or calibrations
concerned. Calibration programs shall be established for key quantities
or values of the instruments where these properties have a significant
effect on the results. Before being placed into service, equipment
(including that used for sampling) shall be calibrated or checked to
establish that it meets the laboratory\'s specification requirements and
complies with the relevant standard specifications. It shall be checked
and/or calibrated before use (see 5.6).

**5.5.3** Equipment shall be operated by authorized personnel.
Up-to-date instructions on the use and maintenance of equipment
(including any relevant manuals provided by the manufacturer of the
equipment) shall be readily available for use by the appropriate
laboratory personnel.

**5.5.4** Each item of equipment and its software used for testing and
calibration and significant to the result shall, when practicable, be
uniquely identified.

**5.5.5** Records shall be maintained of each item of equipment and its
software significant to the tests and/or calibrations performed. The
records shall include at least the following:

1)  the identity of the item of equipment and its software;

2)  the manufacturer\'s name, type identification, and serial number or
    other unique identification;

3)  checks that equipment complies with the specification (see 5.5.2);

4)  the current location, where appropriate;

5)  the manufacturer\'s instructions, if available, or reference to
    their location;

6)  dates, results and copies of reports and certificates of all
    calibrations, adjustments, acceptance criteria, and the due date of
    next calibration;

7)  the maintenance plan, where appropriate, and maintenance carried out
    to date;

8)  any damage, malfunction, modification or repair to the equipment.

**5.5.6** The laboratory shall have procedures for safe handling,
transport, storage, use and planned maintenance of measuring equipment
to ensure proper functioning and in order to prevent contamination or
deterioration.

**NOTE:** Additional procedures may be necessary when measuring
equipment is used outside the permanent laboratory for tests,
calibrations or sampling.

**5.5.7** Equipment that has been subjected to overloading or
mishandling, gives suspect results, or has been shown to be defective or
outside specified limits, shall be taken out of service. It shall be
isolated to prevent its use or clearly labeled or marked as being out of
service until it has been repaired and shown by calibration or test to
perform correctly. The laboratory shall examine the effect of the defect
or departure from specified limits on previous tests and/or calibrations
and shall institute the \"Control of non-conforming work\" procedure
(see 4.9).

**5.5.8** Whenever practicable, all equipment under the control of the
laboratory and requiring calibration shall be labeled, coded or
otherwise identified to indicate the status of calibration, including
the date when last calibrated and the date or expiration criteria when
recalibration is due.

**5.5.9** When, for whatever reason, equipment goes outside the direct
control of the laboratory, the laboratory shall ensure that the function
and calibration status of the equipment are checked and shown to be
satisfactory before the equipment is returned to service.

**5.5.10** When intermediate checks are needed to maintain confidence in
the calibration status of the equipment, these checks shall be carried
out according to a defined procedure.

**5.5.11** Where calibrations give rise to a set of correction factors,
the laboratory shall have procedures to ensure that copies (e.g., in
computer software) are correctly updated.

**5.5.12** Test and calibration equipment, including both hardware and
software, shall be safeguarded from adjustments which would invalidate
the test and/or calibration results.

**WMD NOTE:** The quality manual templates contain a chart to list
equipment and its current performance evaluation. This information will
be requested during on-site assessments, and the chart may be requested
annually for review with measurement control documents.

**5.6 Measurement Traceability**

**5.6.1 General**

All equipment used for tests and/or calibrations, including equipment
for subsidiary measurements (e.g., for environmental conditions) having
a significant effect on the accuracy or validity of the result of the
test, calibration or sampling shall be calibrated before being put into
service. The laboratory shall have an established program and procedure
for the calibration of its equipment.

**NOTE:** Such a program should include a system for selecting, using,
calibrating, checking, controlling and maintaining measurement
standards, reference materials used as measurement standards, and
measuring and test equipment used to perform tests and calibrations.

**5.6.2** **Specific requirements**

**5.6.2.1 Calibration**

**5.6.2.1.1** For calibration laboratories, the program for calibration
of equipment shall be designed and operated so as to ensure that
calibrations and measurements made by the laboratory are traceable to
the International System of Units (SI) (Système international
d\'unités).

A calibration laboratory establishes traceability of its own measurement
standards and measuring instruments to the SI by means of an unbroken
chain of calibrations or comparisons linking them to relevant primary
standards of the SI units of measurement. The link to SI units may be
achieved by reference to national measurement standards. National
measurement standards may be primary standards, which are primary
realizations of the SI units or agreed representations of SI units based
on fundamental physical constants, or they may be secondary standards
which are standards calibrated by another national metrology institute.
When using external calibration services, traceability of measurement
shall be assured by the use of calibration services from laboratories
that can demonstrate competence, measurement capability and
traceability. The calibration certificates issued by these laboratories
shall contain the measurement results, including the measurement
uncertainty and/or a statement of compliance with an identified
metrological specification (see also 5.10.4.2).

**NOTE 1:** Calibration laboratories fulfilling the requirements of this
Handbook are considered to be competent. A calibration certificate
bearing an accreditation body logo from a calibration laboratory
accredited to this Handbook, for the calibration concerned, is
sufficient evidence of traceability of the calibration data reported.

**NOTE 2:** Traceability to SI units of measurement may be achieved by
reference to an appropriate primary standard (see VIM:1993, 6.4) or by
reference to a natural constant, the value of which in terms of the
relevant SI unit is known and recommended by the General Conference of
Weights and Measures (CGPM) and the International Committee for Weights
and Measures (CIPM).

**NOTE 3:** Calibration laboratories that maintain their own primary
standard or representation of SI units based on fundamental physical
constants can claim traceability to the SI system only after these
standards have been compared, directly or indirectly, with other similar
standards of a national metrology institute.

**NOTE 4:** The term \"identified metrological specification\" means
that it must be clear from the calibration certificate which
specification the measurements have been compared with, by including the
specification or by giving an unambiguous reference to the
specification.

**NOTE 5**: When the terms \"international standard\" or \"national
standard\" are used in connection with traceability, it is assumed that
these standards fulfill the properties of primary standards for the
realization of SI units.

**NOTE 6:** Traceability to national measurement standards does not
necessarily require the use of the national metrology institute of the
country in which the laboratory is located.

**NOTE 7:** If a calibration laboratory wishes or needs to obtain
traceability from a national metrology institute other than in its own
country, this laboratory should select a national metrology institute
that actively participates in the activities of BIPM either directly or
through regional groups.

**NOTE 8:** The unbroken chain of calibrations or comparisons may be
achieved in several steps carried out by different laboratories that can
demonstrate traceability.

**5.6.2.1.2** Some calibrations cannot currently be made strictly in SI
units. In these cases, calibration shall provide confidence in
measurements by establishing traceability to appropriate measurement
standards, such as:

> --- the use of certified reference materials provided by a competent
> supplier to give a reliable physical or chemical characterization of a
> material;
>
> --- the use of specified methods and/or consensus standards that are
> clearly described and agreed by all parties concerned.

Participation in a suitable program of interlaboratory comparisons is
required whenever possible.

**5.6.2.2 Testing**

**5.6.2.2.1** For testing laboratories, the requirements given in
5.6.2.1 apply for measuring and test equipment with measuring functions
used, unless it has been established that the associated contribution
from the calibration contributes little to the total uncertainty of the
test result. When this situation arises, the laboratory shall ensure
that the equipment used can provide the uncertainty of measurement
needed.

**NOTE:** The extent to which the requirements in 5.6.2.1 should be
followed depends on the relative contribution of the calibration
uncertainty to the total uncertainty. If calibration is the dominant
factor, the requirements should be strictly followed.

**5.6.2.2.2** Where traceability of measurements to SI units is not
possible and/or not relevant, the same requirements for traceability to,
for example, certified reference materials, agreed methods and/or
consensus standards, are required as for calibration laboratories (see
5.6.2.1.2).

**5.6.3** **Reference standards and reference materials**

**5.6.3.1** **Reference standards**

The laboratory shall have a program and procedure for the calibration of
its reference standards. Reference standards shall be calibrated by a
body that can provide traceability as described in 5.6.2.1. Such
reference standards of measurement held by the laboratory shall be used
for calibration only and for no other purpose, unless it can be

shown that their performance as reference standards would not be
invalidated. Reference standards shall be calibrated before and after
any adjustment.

**5.6.3.2 Reference materials**

Reference materials shall, where possible, be traceable to SI units of
measurement, or to certified reference materials. Internal reference
materials shall be checked as far as is technically and economically
practicable.

**5.6.3.3 Intermediate checks**

Checks needed to maintain confidence in the calibration status of
reference, primary, transfer or working standards and reference
materials shall be carried out according to defined procedures and
schedules.

**5.6.3.4 Transport and storage**

The laboratory shall have procedures for safe handling, transport,
storage and use of reference standards and reference materials in order
to prevent contamination or deterioration and in order to protect their
integrity.

**NOTE:** Additional procedures may be necessary when reference
standards and reference materials are used outside the permanent
laboratory for tests, calibrations or sampling.

**WMD NOTE:** Copies of calibration reports for reference \[primary\]
standards used in the laboratory are maintained in the WMD. The
laboratory must submit updated calibration reports as available. If
reports are not from NIST, they should be from a NIST-Recognized
laboratory or a laboratory with formal accreditation from an
accreditation body that is a signatory to the ILAC MRA (International
Laboratory Accreditation Council, Mutual Recognition Arrangement.

**5.7 Sampling**

**5.7.1** The laboratory shall have a sampling plan and procedures for
sampling when it carries out sampling of substances, materials or
products for subsequent testing or calibration. The sampling plan as
well as the sampling procedure shall be available at the location where
sampling is undertaken. Sampling plans shall, whenever reasonable, be
based on appropriate statistical methods. The sampling process shall
address the factors to be controlled to ensure the validity of the test
and calibration results.

**NOTE 1:** Sampling is a defined procedure whereby a part of a
substance, material or product is taken to provide for testing or
calibration of a representative sample of the whole. Sampling may also
be required by the appropriate specification for which the substance,
material or product is to be tested or calibrated. In certain cases
(e.g., forensic analysis), the sample may not be representative but is
determined by availability.

**NOTE 2:** Sampling procedures should describe the selection, sampling
plan, withdrawal and preparation of a sample or samples from a
substance, material or product to yield the required information.

**5.7.2** Where the customer requires deviations, additions or
exclusions from the documented sampling procedure, these shall be
recorded in detail with the appropriate sampling data and shall be
included in all documents containing test and/or calibration results,
and shall be communicated to the appropriate personnel.

**5.7.3** The laboratory shall have procedures for recording relevant
data and operations relating to sampling that forms part of the testing
or calibration that is undertaken. These records shall include the
sampling procedure used, the identification of the sampler,
environmental conditions (if relevant) and diagrams or other equivalent
means to identify the sampling location as necessary and, if
appropriate, the statistics the sampling procedures are based upon.

**5.8 Handling of Test and Calibration Items**

**5.8.1** The laboratory shall have procedures for the transportation,
receipt, handling, protection, storage, retention and/or disposal of
test and/or calibration items, including all provisions necessary to
protect the integrity of the test or calibration item, and to protect
the interests of the laboratory and the customer.

**5.8.2** The laboratory shall have a system for identifying test and/or
calibration items. The identification shall be retained throughout the
life of the item in the laboratory. The system shall be designed and
operated so as to ensure that items cannot be confused physically or
when referred to in records or other documents. The system shall, if
appropriate, accommodate a subdivision of groups of items and the
transfer of items within and from the laboratory.

**5.8.3** Upon receipt of the test or calibration item, abnormalities or
departures from normal or specified conditions, as described in the test
or calibration method, shall be recorded. When there is doubt as to the
suitability of an item for test or calibration, or when an item does not
conform to the description provided, or the test or calibration required
is not specified in sufficient detail, the laboratory shall consult the
customer for further instructions before proceeding and shall record the
discussion.

**5.8.4** The laboratory shall have procedures and appropriate
facilities for avoiding deterioration, loss or damage to the test or
calibration item during storage, handling and preparation. Handling
instructions provided with the item shall be followed. When items have
to be stored or conditioned under specified environmental conditions,
these conditions shall be maintained, monitored and recorded. Where a
test or calibration item or a portion of an item is to be held secure,
the laboratory shall have arrangements for storage and security that
protect the condition and integrity of the secured items or portions
concerned.

**NOTE 1:** Where test items are to be returned into service after
testing, special care is required to ensure that they are not damaged or
injured during the handling, testing or storing/waiting processes.

**NOTE 2:** A sampling procedure and information on storage and
transport of samples, including information on sampling factors
influencing the test or calibration result, should be provided to those
responsible for taking and transporting the samples.

**NOTE 3:** Keeping a test or calibration item secure can be for reasons
of record, safety or value, or to enable complementary tests and/or
calibrations to be performed later.

**5.9 Assuring the Quality of Test and Calibration Results**

**5.9.1** The laboratory shall have quality control procedures for
monitoring the validity of tests and calibrations undertaken. The
resulting data shall be recorded in such a way that trends are
detectable and, where practicable, statistical techniques shall be
applied to the reviewing of results. This monitoring shall be planned
and reviewed and may include, but need not be limited to, the following:

1)  regular use of certified reference materials and/or internal quality
    control using secondary reference materials;

2)  participation in interlaboratory comparison or proficiency-testing
    programs;

3)  replicate tests or calibrations using the same or different methods;

4)  retesting or recalibration of retained items;

5)  correlation of results for different characteristics of an item.

**NOTE:** The selected methods should be appropriate for the type and
volume of the work undertaken.

**WMD NOTE:** The laboratory shall maintain a list of control charts,
surveillance activities, and proficiency tests maintained or
participated in by the laboratory. Measurement control requirements must
be in place for each measurement service provided by the laboratory. The
quality manual templates (NISTIR 5802 and NISTIR 7028) contain forms
that may be used by the laboratory to list control charts, surveillance
activities, and proficiency tests. This documentation must be available
during on-site assessments and submitted to the WMD as requested.

**5.9.2** Quality control data shall be analyzed and, where they are
found to be outside pre-defined criteria, planned action shall be taken
to correct the problem and to prevent incorrect results from being
reported.

**5.10 Reporting the Results**

**5.10.1 General**

The results of each test, calibration, or series of tests or
calibrations carried out by the laboratory shall be reported accurately,
clearly, unambiguously and objectively, and in accordance with any
specific instructions in the test or calibration methods.

The results shall be reported, usually in a test report or a calibration
certificate (see note 1), and shall include all the information
requested by the customer and necessary for the interpretation of the
test or calibration results and all information required by the method
used. This information is normally that required by 5.10.2, and 5.10.3
or 5.10.4.

In the case of tests or calibrations performed for internal customers,
or in the case of a written agreement with the customer, the results may
be reported in a simplified way. Any information listed in 5.10.2 to
5.10.4 which is not reported to the customer shall be readily available
in the laboratory which carried out the tests and/or calibrations.

**NOTE 1:** Test reports and calibration certificates are sometimes
called test certificates and calibration reports, respectively.

**NOTE 2:** The test reports or calibration certificates may be issued
as hard copy or by electronic data transfer provided that the
requirements of this Handbook are met.

**5.10.2** Test reports and calibration certificates

Each test report or calibration certificate shall include at least the
following information, unless the laboratory has valid reasons for not
doing so:

1)  a title (e.g., \"Test Report\" or \"Calibration Certificate\");

2)  the name and address of the laboratory, and the location where the
    tests and/or calibrations were carried out, if different from the
    address of the laboratory;

3)  unique identification of the test report or calibration certificate
    (such as the serial number), and on each page an identification in
    order to ensure that the page is recognized as a part of the test
    report or calibration certificate, and a clear identification of the
    end of the test report or calibration certificate;

4)  the name and address of the customer;

5)  identification of the method used;

6)  a description of, the condition of, and unambiguous identification
    of the item(s) tested or calibrated;

7)  the date of receipt of the test or calibration item(s) where this is
    critical to the validity and application of the results, and the
    date(s) of performance of the test or calibration;

8)  reference to the sampling plan and procedures used by the laboratory
    or other bodies where these are relevant to the validity or
    application of the results;

9)  the test or calibration results with, where appropriate, the units
    of measurement;

10) the name(s), function(s) and signature(s) or equivalent
    identification of person(s) authorizing the test report or
    calibration certificate;

11) where relevant, a statement to the effect that the results relate
    only to the items tested or calibrated.

**NOTE 1:** Hard copies of test reports and calibration certificates
should also include the page number and total number of pages.

**NOTE 2:** It is recommended that laboratories include a statement
specifying that the test report or calibration certificate shall not be
reproduced except in full, without written approval of the laboratory.

**WMD NOTE:** WMD defines the person(s) who authorizes the test report
or calibration certificate as the Approved Signatory.

**5.10.3 Test reports**

**5.10.3.1** In addition to the requirements listed in 5.10.2, test
reports shall, where necessary for the interpretation of the test
results, include the following:

1)  deviations from, additions to, or exclusions from the test method,
    and information on specific test conditions, such as environmental
    conditions;

2)  where relevant, a statement of compliance/non-compliance with
    requirements and/or specifications;

3)  where applicable, a statement on the estimated uncertainty of
    measurement; information on uncertainty is needed in test reports
    when it is relevant to the validity or application of the test
    results, when a customer's instruction so requires, or when the
    uncertainty affects compliance to a specification limit;

4)  where appropriate and needed, opinions and interpretations (see
    5.10.5);

5)  additional information which may be required by specific methods,
    customers or groups of customers.

**5.10.3.2** In addition to the requirements listed in 5.10.2 and
5.10.3.1, test reports containing the results of sampling shall include
the following, where necessary for the interpretation of test results:

1)  the date of sampling;

2)  unambiguous identification of the substance, material or product
    sampled (including the name of the manufacturer, the model or type
    of designation and serial numbers as appropriate);

3)  the location of sampling, including any diagrams, sketches or
    photographs;

4)  a reference to the sampling plan and procedures used;

5)  details of any environmental conditions during sampling that may
    affect the interpretation of the test results;

6)  any standard or other specification for the sampling method or
    procedure, and deviations, additions to or exclusions from the
    specification concerned.

**5.10.4 Calibration certificates**

**5.10.4.1** In addition to the requirements listed in 5.10.2,
calibration certificates shall include the following, where necessary
for the interpretation of calibration results:

1)  the conditions (e.g., environmental) under which the calibrations
    were made that have an influence on the measurement results;

2)  the uncertainty of measurement and/or a statement of compliance with
    an identified metrological specification or clauses thereof;

3)  evidence that the measurements are traceable (see note 2 in
    5.6.2.1.1).

**5.10.4.2** The calibration certificate shall relate only to quantities
and the results of functional tests. If a statement of compliance with a
specification is made, this shall identify which clauses of the
specification are met or not met.

When a statement of compliance with a specification is made omitting the
measurement results and associated uncertainties, the laboratory shall
record those results and maintain them for possible future reference.

When statements of compliance are made, the uncertainty of measurement
shall be taken into account.

**5.10.4.3** When an instrument for calibration has been adjusted or
repaired, the calibration results before and after adjustment or repair,
if available, shall be reported.

4.  A calibration certificate (or calibration label) shall not contain
    any recommendation on the calibration interval except where this has
    been agreed with the customer. This requirement may be superseded by
    legal regulations.

**5.10.5 Opinions and interpretations**

When opinions and interpretations are included, the laboratory shall
document the basis upon which the opinions and interpretations have been
made. Opinions and interpretations shall be clearly marked as such in a
test report.

**NOTE 1:** Opinions and interpretations should not be confused with
inspections and product certifications as intended in ISO/IEC 17020 and
ISO/IEC Guide 65.

**NOTE 2:** Opinions and interpretations included in a test report may
comprise, but not be limited to, the following:

> --- an opinion on the statement of compliance/noncompliance of the
> results with requirements;
>
> --- fulfillment of contractual requirements;
>
> --- recommendations on how to use the results;
>
> --- guidance to be used for improvements.

**NOTE 3:** In many cases it might be appropriate to communicate the
opinions and interpretations by direct dialogue with the customer. Such
dialogue should be written down.

**5.10.6 Testing and calibration results obtained from subcontractors**

When the test report contains results of tests performed by
subcontractors, these results shall be clearly identified. The
subcontractor shall report the results in writing or electronically.

When a calibration has been subcontracted, the laboratory performing the
work shall issue the calibration certificate to the contracting
laboratory.

**5.10.7 Electronic transmission of results**

In the case of transmission of test or calibration results by telephone,
telex, facsimile or other electronic or electromagnetic means, the
requirements of this Handbook shall be met (see also 5.4.7).

**5.10.8 Format of reports and certificates**

The format shall be designed to accommodate each type of test or
calibration carried out and to minimize the possibility of
misunderstanding or misuse.

**NOTE 1:** Attention should be given to the layout of the test report
or calibration certificate, especially with regard to the presentation
of the test or calibration data and ease of assimilation by the reader.

**NOTE 2:** The headings should be standardized as far as possible.

**5.10.9 Amendments to test reports and calibration certificates**

Material amendments to a test report or calibration certificate after
issue shall be made only in the form of a further document, or data
transfer, which includes the statement:

\"Supplement to Test Report \[or Calibration Certificate\], serial
number \... \[or as otherwise identified\],\"

or an equivalent form of wording.

Such amendments shall meet all the requirements of this Handbook.

When it is necessary to issue a complete new test report or calibration
certificate, this shall be uniquely identified and shall contain a
reference to the original that it replaces.

**Table 2. Training requirements**[]{#__RefHeading___Toc169420764
.anchor}

+---------------+-------------------------+--------------+------------+
| **Recognition | **Training Required**   | **For Whom** | **How      |
| Level**       |                         |              | Often**    |
+---------------+-------------------------+--------------+------------+
| Minimum (for  | Basic Laboratory        | Usually all  | Once       |
| legal         | Metrology Seminar (2    | staff, at    | Initially  |
| metrological  | weeks)                  | least one    |            |
| activities)   |                         | staff member | Refresher  |
|               | Basic LAP problems -    |              | r          |
|               | acceptable completion   |              | ecommended |
|               |                         |              | every 10   |
|               |                         |              | years      |
|               |                         |              |            |
|               |                         |              | Once       |
+---------------+-------------------------+--------------+------------+
|               | Attendance at Regional  | At least one | Annually   |
|               | Measurement Assurance   | staff member |            |
|               | Program meeting         |              |            |
|               | annually                |              |            |
+---------------+-------------------------+--------------+------------+
| Calibration   | All of the above, plus: | Usually all  | Every 3 to |
|               |                         | staff; at    | 4 years    |
|               | Intermediate Laboratory | least one    | unless     |
|               | Metrology Seminar (1    |              | attending  |
|               | week)                   |              | RMAP       |
|               |                         |              | annually   |
|               | Intermediate LAP        |              |            |
|               | problems - acceptable   |              |            |
|               | completion              |              |            |
+---------------+-------------------------+--------------+------------+
| Advanced mass | All of the above, plus: | At least one | At least   |
| calibration   |                         | if working   | once; for  |
|               | Advanced Mass           | at this      | updates as |
|               | Measurements Seminar    | level        | needed     |
|               |                         |              |            |
|               | Advanced LAP problems   |              |            |
|               | completed               |              |            |
+---------------+-------------------------+--------------+------------+
| Thermometry   | Attendance at a NIST    | At least one | At least   |
|               | Precision Thermometry   | as needed    | once; for  |
|               | Seminar                 |              | updates as |
|               |                         |              | needed     |
+---------------+-------------------------+--------------+------------+

**NOTE:** The Quality Manual Templates (NISTIR 5802 and NISTIR 7028)
contain a form that can be used to document training and dates.

**6. Specific Technical Guidelines**[]{#__RefHeading___Toc169420765
.anchor}

The material in this section is primarily from the Calibration
Laboratories Technical Guide, NIST Handbooks 150-2A through H
(2004)**,** and is modified and used here as the technical guidelines
for evaluation of traceability resulting in the issuance of a
Certificate of Measurement Traceability. The following quote, taken from
the applicable NVLAP Guide is should be considered in its application.

> \"This guide...was developed from a NIST measurement laboratory
> perspective and provides examples and guidelines (not requirements) to
> assessors and interested calibration laboratories on good laboratory
> practices and recommended standards The guide language reflects this
> philosophy through the use of \"shoulds\" instead of \"shalls\" (along
> with other less prescriptive language) when describing criteria. The
> requirements presented here are not absolute since specific
> requirements depend on the measurement uncertainty for which an
> applicant laboratory wishes to be accredited. This is a business
> decision for each laboratory and beyond the scope of this voluntary
> program. Simply stated, to be \[Recognized or\] accredited an
> applicant laboratory must have a quality system and be able to prove
> (and document) that it does what it says it does (i.e., correctly
> calibrate to a stated uncertainty).
>
> This guide is dynamic in that new parameters may be added and existing
> criteria updated and improved.\"

**WMD NOTE:** WMD uses the technical section as requirements rather than
as guidelines. Deviation from these criteria must have a technical
basis, data, and technical analysis to support variances.

**Recognition Parameter Summary**

Each laboratory must specify the range and uncertainty level for each
parameter for which it requests Recognition. Uncertainties must be
defined at each level. For example, a chart must be available that will
state each nominal mass, each nominal volume, and so on, with the
associated uncertainty.

**Table 3. Recognition parameter summary**
[]{#__RefHeading___Toc169420766 .anchor}

+---------------+-------------------------------+----------------------+
| **Parameter** | **Range/Application**         | **Expanded           |
|               |                               | Uncertainty**        |
+===============+===============================+======================+
| #### Mass     | laboratory to detail nominal  |                      |
|               | ranges and uncertainties:     |                      |
|               | e.g., 30 kg to 1 mg; Echelon  |                      |
|               | II                            |                      |
+---------------+-------------------------------+----------------------+
| Echelon I     | ASTM Class 0, 1, OIML Class   | Must be less than    |
|               | E~1~, E~2~                    | 1/3 of the           |
|               |                               | applicable           |
|               |                               | tolerances within    |
|               |                               | the Echelon.         |
+---------------+-------------------------------+----------------------+
| Echelon II    | ASTM Class 2, 3, OIML Class   |                      |
|               | F~1~, F~2~                    |                      |
+---------------+-------------------------------+----------------------+
| Echelon III   | ASTM Class 4, 5, 6, 7, OIML   |                      |
|               | Class M~1~, M~1-2~, M~2~,     |                      |
|               | M~2-3,~ M~3~                  |                      |
|               |                               |                      |
|               | NIST Class F,                 |                      |
|               | legal/regulatory enforcement  |                      |
+---------------+-------------------------------+----------------------+
| Weight Carts  | NIST Handbook 105-8           |                      |
+---------------+-------------------------------+----------------------+
| #### Length   | laboratory to specify range:  |                      |
|               | e.g., 10 cm to 20 meter tapes |                      |
+---------------+-------------------------------+----------------------+
| Tapes, bench  | up to 25 m (100 ft)           | 0.0 001 m to 0.000   |
| method        |                               | 14 m                 |
+---------------+-------------------------------+----------------------+
| Tapes, tape   | up to 25 m (100 ft)           | 0.000 15 m to 0.000  |
| method        |                               | 25 m                 |
+---------------+-------------------------------+----------------------+
| Rules, direct | up to 0.5 cm (18 in)          | \< 0.000 05 m        |
| comparison    |                               |                      |
+---------------+-------------------------------+----------------------+
| #### Volume   | laboratory to specify ranges: |                      |
|               | e.g., 2 μL micropipettes to   |                      |
|               | 2000 mL glass flasks          |                      |
+---------------+-------------------------------+----------------------+
| Gravimetric   | syringes, micropipettes,      | 0.000 10 mL/L        |
|               | glass standards, and metal    |                      |
|               | provers                       |                      |
+---------------+-------------------------------+----------------------+
| Volume        | glass standards and metal     | \< 0.001 mL/L        |
| transfer      | provers                       |                      |
+---------------+-------------------------------+----------------------+
| ###           | laboratory to specify type    |                      |
| # Temperature | and ranges: e.g., -10 °C to   |                      |
|               | 200 °C; Echelon II            |                      |
+---------------+-------------------------------+----------------------+
| Echelon I     | SPRT\'s                       | ≤ ± 0.005 °C         |
+---------------+-------------------------------+----------------------+
| Echelon II    | Thermistors, thermocouples    | \> ± 0.005 °C to ≤ ± |
|               |                               | 0.05 °C              |
+---------------+-------------------------------+----------------------+
| Echelon III   | Liquid-in-glass thermometers  | \> ± 0.05 °C to ≤ ±  |
|               |                               | 0.20 °C              |
+---------------+-------------------------------+----------------------+
| Echelon IV    | Liquid-in-glass, dial type,   | \> ± 0.20 °C to ≤ ±  |
|               | pyrometers                    | 1.0 °C               |
+---------------+-------------------------------+----------------------+
| Echelon V     | Infrared sensors,             | \> ± 1.0 °C to ≤ ±   |
|               | thermographs                  | 5.0 °C               |
+---------------+-------------------------------+----------------------+
| ####          | as used for law enforcement   | 0.05 mph, estimate   |
|  Tuning Forks |                               | based on             |
|               |                               | interlaboratory      |
|               |                               | tests                |
+---------------+-------------------------------+----------------------+
| **            | sugar, syrup, petroleum       | Estimates noted on   |
| Hydrometers** |                               | charts               |
+---------------+-------------------------------+----------------------+
| **Time**      | stopwatches used for law      | significantly less   |
|               | enforcement                   | than tolerances;     |
|               |                               | estimated at 2 s for |
|               |                               | a 24 hr test         |
+---------------+-------------------------------+----------------------+
| **Grain       | programs for testing grain    |                      |
| Moisture**    | and commodity moisture        |                      |
+---------------+-------------------------------+----------------------+
| Oven Methods  | laboratory to specify methods | 0.2 % moisture       |
|               | and products                  | content              |
+---------------+-------------------------------+----------------------+
| Chemical      |                               | 0.2 % moisture       |
| Methods       |                               | content              |
+---------------+-------------------------------+----------------------+

**6.1 Technical Criteria for Dimensional
Laboratories**[]{#__RefHeading___Toc169420767 .anchor}[^3]

**6.1.1 Scope**

The purpose of this section is to identify the specific technical
criteria needed to meaningfully assess the competence of a calibration
laboratory that performs dimensional calibrations. The artifact
calibrations currently included in the Recognition program are:

1)  steel tapes; and

2)  rigid rules.

**NOTE:** Much of this section applies to dimensional measurements that
are more complex than the calibration of tapes and rules; however, it is
the responsibility of the laboratory to determine which sections are
applicable.

**6.1.2 References**

> \[1\] ANSI/ASME B 89.6.2, Temperature and Humidity Environment for
> Dimensional Measurements (1973, Reaffirmed 2003).

**6.1.3 Statistical process control**

**6.1.3.1** All sources of variability for the calibration should be
monitored by subsystem calibration (e.g., thermometer, force gage
calibration) and the use of check standards to ensure that the
calibrations are carried out under controlled conditions. The laboratory
should maintain and document some form of statistical process control
(SPC) commensurate with the uncertainty levels of the calibration. The
SPC control parameters should be based on measurements of check
standards (or closure parameters resulting from self-calibration or
ratio methods) and the repeatability of multiple measurements. The
frequency and number of process control checks should be appropriate for
the number of calibrations as well as the level of uncertainty and
reliability claimed for the calibration.

**6.1.3.2** The laboratory should have control artifacts that adequately
span the range of materials and sizes normally calibrated by the
laboratory. Every measured value of each control should be recorded and
compared to its historical value to determine that the process is in
control. The comparison may be made via a plotted control chart with
appropriate control limits or by numerical comparison using the
t-distribution. The expected control values should be updated at least
yearly using the most current one of more years of data.

**6.1.4 Accommodation and environment**

**6.1.4.1** The temperature in the calibration area should nominally be
20 °C (degrees Celsius) with a maximum variation and rate of change
depending on the materials and the uncertainty level needed for the
calibration. Measurements at temperatures other than 20 °C may be made
if the proper thermal expansion corrections are applied and the
component of uncertainty reflecting the uncertainty in thermal expansion
coefficients of the artifacts is calculated and added to the total
uncertainty of the calibration. For comparison measurements the
uncertainty component should reflect the uncertainty in the thermal
expansion of both the master and unknown artifacts.

**6.1.4.2** For length calibrations of the type in legal metrology
laboratories, the immediate environment should be 20 °C ± 2 °C, and
should be measured with an accuracy of 0.5 °C. The temperature variation
should be less than ± 1 °C over 24 h and ± 0.5 °C during any 1-h period.
Other environmental conditions may be acceptable as long as the effects
are included in the uncertainty determination.

**6.1.4.3** The measured length should be corrected to a reference
temperature of 20 °C using the known linear thermal expansion
coefficient of the material.

**6.1.4.4** The temperature stability of the environment should be
sufficient for the gage and measurement system to be in thermal
equilibrium. Measurements may be made in slowly changing environments if
a suitable measurement model, that includes the effects of the drift, is
used. Theoretical and experimental verification of the model should be
available.

**6.1.4.5** For typical gages made of well characterized materials
(steel, carbide or ceramic), 0.000 001 per °C should be used as the
thermal expansion coefficient uncertainty unless there is documentation
of a lower value.

**6.1.4.6** The relative humidity in the calibration area should not
exceed 50 percent to avoid problems with dimensional standards related
to rust or other corrosion.

**6.1.4.7** Excessive vibration should be avoided in the calibration
room. If an obvious source of vibration exists, precautions should be
taken to prevent adverse effects on the laboratory\'s measurements.

**6.1.4.8** The laboratory should have a documented policy regarding
responses to problems with the environment.

**6.1.5 Equipment and reference materials**

**6.1.5.1** The laboratory should have the equipment needed to make
auxiliary measurements on artifacts (e.g., flatness of gage blocks,
roundness of ring gages).

**6.1.5.2** The laboratory should have temperature measuring
capabilities suitable to the calibration procedure. Calibrations
involving direct comparisons of artifacts of similar size and materials
will, in general, have modest requirements. Absolute calibrations or
comparisons between artifacts of different sizes and/or materials will
require more accurate temperature measurement.

**6.1.5.3** A laboratory that certifies artifacts to tolerance grades
should demonstrate a measurement uncertainty which does not exceed 25 %
of the tolerance (unless otherwise stated in normative standards).
Exceptions to this ratio should be accepted for measurement systems that
are documented to be the state-of-the-art and approved by the customer.

**6.1.5.4** A laboratory that makes mechanical comparisons of masters
and test pieces of dissimilar materials should have force measuring
equipment to determine the force on the probe or probes. A correction
for differential probe penetration should be applied as long as the
probe has maintained its rounded shape. On old comparators the probe
radius may be altered to the point where a correction would induce
error.

**6.1.5.5** A laboratory that makes absolute measurements using
displacement measuring sensors, such as interferometers or linear
scales, should have environmental monitoring equipment appropriate to
the sensor.

**6.1.5.6** A laboratory that makes absolute measurements using a
contact device should have force measuring equipment to determine the
force on the probe or probes. A correction for probe penetration should
be applied if appropriate.

**6.1.5.7** A laboratory that makes interferometric measurements should
have: (1) equipment for making high-accuracy temperature measurements,
and (2) equipment for determining the index of refraction of air.

**6.1.6 Calibration methods**

**6.1.6.1** When calibrations are made by comparison to master gages of
the different nominal sizes the temperature control of the gages and the
measurement environment should be improved.

**6.1.6.2** The laboratory should have a manual outlining the procedures
to be followed for each type of calibration. For calibration of graded
sets, the procedure should name the grades that are calibrated by the
procedure.

**6.1.6.3** The procedures used for related services, such as checks of
roundness, relapping, repair, or replacement of damaged or
out-of-tolerance gages should be clearly stated.

**6.1.6.4** Procedures related to the calibration of rigid rules and
tapes used by legal metrology laboratories are as follows from NIST
Handbook 145:

1)  Bench method for tapes (SOP 11);

2)  Tape to tape method for tapes (SOP 12);

3)  Rigid rule calibration (SOP 10); and

4)  Pi tape calibration (SOP 23 - draft).

**6.1.7 Handling of calibration items**

**6.1.7.1** Artifacts should be cleaned and stored in a manner to
prevent accidental contact with material which could damage the gaging
surfaces.

**6.1.7.2** Care should be taken to prevent steel artifacts from
rusting. Steel artifacts should be coated with a rust inhibiting grease
whenever there is a potential for exposure to an environment over 50 %
relative humidity. If artifacts cannot be greased other materials (e.g.,
rust inhibiting paper) or methods should be used to inhibit rust.

**6.1.7.3** After cleaning, artifacts should be allowed to come to
adequate thermal equilibrium in the calibration environment before
measurement. Artifacts should be placed on a soaking plate or in
position on the measuring machine long enough to ensure that they are at
the proper temperature. The soaking time will depend on the size and the
thermal properties of the artifacts and plate. Specific guidelines for
soaking times should be stated in the measurement procedure. The heating
effects from optical radiation, body heat, and system location should be
minimized.

**6.1.7.4** In general, to prevent thermal changes and corrosion of the
gaging surfaces, artifacts should not be handled with bare hands. Gloves
or tongs should be used whenever possible.

**6.1.8** **Calibration certificates and test reports**

**6.1.8.1** In addition to meeting the criteria in section 5.10 of this
handbook, all calibration certificates or test reports of calibration
should contain an uncertainty statement which is scientifically
determined from measurement data and which agrees with the laboratory\'s
stated definition.

**6.1.8.2** The uncertainty should be derived from a model of the
measurement system that includes (as applicable) the uncertainties
caused by:

1)  master artifact calibration;

```{=html}
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```
1)  long term reproducibility of measurement system;

2)  thermal expansion correction for gages and measurement scales;

    a.  thermometer calibration,

    b.  thermal expansion coefficient,

    c.  thermal gradients (internal, gage-gage, gage-scale),

3)  interferometry;

    a.  measurement uncertainty of refractometer,

    b.  index of refraction formula,

    c.  environmental measurements (air temperature, air pressure,
        humidity, etc.),

    d.  calibration of light source frequency,

    e.  phase correction for reflected light,

    f.  obliquity and slit corrections,

4)  instrument geometry;

    a.  abbe offset and instrument geometry errors,

    b.  scale and gage alignment (cosine errors),

    c.  gage support geometry (anvil flatness, block flatness),

5)  probe penetration correction;

6)  rotary axis errors (radial and axial displacements, tilt);

7)  analysis algorithms (data fitting, filtering); and other factors as
    appropriate.

The method used to affix the calibration items should be described in
detail. In general, differences in fixture configurations between
calibration and use will introduce errors in the calibration.

**6.2 Technical Criteria for Mass
Laboratories**[^4][]{#__RefHeading___Toc169420768 .anchor}

**6.2.1 Scope**

The purpose of this section is to specify the specific technical
criteria needed to meaningfully assess the competence of a calibration
laboratory that performs mass calibrations.

**6.2.1.1** A laboratory should declare its measurement capability in
terms of uncertainties for each mass value. For many laboratories these
uncertainties correspond to three arbitrary echelons of measurements
that roughly correspond to weight classifications at nominal mass value
ranges of measurements. For laboratories seeking Recognition at an
uncertainty range that corresponds to a specific echelon, the scope of
Recognition should follow the echelons as defined in Table 4 with a
declared range of nominal mass values and their associated
uncertainties. Recommended ranges of mass values are provided in Table
5. A summary of sections 6.2.3, 6.2.5.1, 6.2.5.6, and 6.2.6.1 are
provided in Table 8.

**6.2.1.2** The echelon stated by the laboratory is associated with the
standards, procedures, measurement control, facilities, equipment, staff
capability, and the overall level of performance according to Table 4,
and is specifically defined by the expanded uncertainty. However,
echelons are evaluated by all of the factors in Table 8 in addition to
the laboratory's reported uncertainties.

**Table 4. Mass calibration echelons**[]{#__RefHeading___Toc169420769
.anchor}

+-----------------------+-----------------------+-----------------------+
| **Echelon**           | **Verification        | **Expanded            |
|                       | Levels**              | Uncertainty of the**  |
|                       |                       |                       |
|                       |                       | **Measurements**      |
+=======================+=======================+=======================+
| I, (Extra Fine        | OIML Classes E~1~,    | The expanded          |
| Accuracy)             | E~2~                  | uncertainty must be   |
|                       |                       | less than 1/3 of      |
|                       | ASTM Classes 0, 1     | stated tolerances at  |
|                       |                       | all levels.           |
+-----------------------+-----------------------+-----------------------+
| II, (Fine Accuracy)   | OIML Classes F~1~,    |                       |
|                       | F~2~                  |                       |
|                       |                       |                       |
|                       | ASTM Classes 2, 3     |                       |
+-----------------------+-----------------------+-----------------------+
| III, (Medium          | OIML Classes          |                       |
| Accuracy)             |                       |                       |
|                       | M~1~, M~1-2~, M~2~,   |                       |
|                       | M~2-3~, M~3~          |                       |
|                       |                       |                       |
|                       | ASTM Classes 4, 5, 6, |                       |
|                       | 7                     |                       |
|                       |                       |                       |
|                       | NIST Class F          |                       |
+-----------------------+-----------------------+-----------------------+

**Table 5. Typical \"Ranges of Recognition\" for mass
calibration**[]{#__RefHeading___Toc169420770 .anchor}

+------------------+--------------------+------------------------------+
| **Echelon**      | **Ranges of        |                              |
|                  | Recognition**      |                              |
|                  |                    |                              |
|                  | **Nominal Value    |                              |
|                  | Ranges**           |                              |
+------------------+--------------------+------------------------------+
| I                | ≥ 30 kg (define    |                              |
|                  | limit)             |                              |
+------------------+--------------------+------------------------------+
|                  | 30 kg to 1 mg      |                              |
+------------------+--------------------+------------------------------+
|                  | 1 kg to 1 mg       |                              |
+------------------+--------------------+------------------------------+
|                  | 100 g to 1 mg      |                              |
+------------------+--------------------+------------------------------+
| II               | ≥ 30 kg (define    | for special applications:    |
|                  | limit)             |                              |
+------------------+--------------------+------------------------------+
|                  | 30 kg to 1 mg      | ≥ 1000 lb (define limit)     |
+------------------+--------------------+------------------------------+
|                  | 1 kg to 1 mg       | ≥ 50 lb (define limit)       |
+------------------+--------------------+------------------------------+
|                  | 100 g to 1 mg      | 50 lb to 0.001 lb            |
+------------------+--------------------+------------------------------+
| III              | ≥ 30 kg (define    | normal applications:         |
|                  | limit)             |                              |
+------------------+--------------------+------------------------------+
|                  | 30 kg to 1 g       | ≥ 1000 lb (define limit)     |
+------------------+--------------------+------------------------------+
|                  | 1 kg to 1 g        | ≥ 50 lb (define limit)       |
+------------------+--------------------+------------------------------+
|                  | 100 g to 1 g       | 50 lb to 0.001 lb            |
+------------------+--------------------+------------------------------+

**6.2.1.3** The reported uncertainty of mass standards calibrated by a
mass calibration laboratory will vary depending on available balances,
the uncertainty of reference standards, and the nominal value of the
mass standard being tested. Thus, a laboratory may perform calibrations
at Echelon I in some ranges, for example at 1 kg, and may perform
calibrations at Echelon II, e.g., 20 kg, in other ranges. The laboratory
performs calibrations in a specified range as requested; however, all
laboratories may not be capable of meeting the requirements of all
echelons. Differing equipment, skills, knowledge, measurement control,
and demonstrated competence are required for each of the echelons.
Demonstrated competence in one echelon is not sufficient to guarantee
adequate performance in the others.

**6.2.2 References**

> \[1\] ANSI/ASTM E 617-97, Standard Specification for Laboratory
> Weights and Precision Mass Standards, March 1998.
>
> \[2\] OIML R 111-1, Weights of classes E1, E2, F1, F2, M1, M1--2, M2,
> M2--3 and M3
>
> Part 1: Metrological and technical requirements, 2004.
>
> \[3\] NIST Handbook 105-1, 105-8, Specifications and Tolerances for
> Reference Standards and Field Standard Weights and Measures,
> Specifications and Tolerances for Field Standard Weights, (NIST Class
> F), 1990, and Field Standard Weight Carts, 2003.
>
> \[4\] NBS Technical Note 844, Designs for the Calibration of Small
> Groups of Standards in the Presence of Drift, Cameron, J. M., Hailes,
> G. E., 1974.
>
> \[5\] NBS Technical Note 952, Designs for the Calibration of Standards
> of Mass, Cameron, J. M., Croarkin, M. C., Raybold, R. C., 1977.
>
> \[6\] NISTIR 5672, Advanced Mass Calibrations and Measurement
> Assurance Program Requirements for State Calibration Laboratories,
> Fraley, K. L., Harris, G. L., 2005.
>
> \[7\] NISTIR 6969, Selected Laboratory and Measurement Practices, and
> Procedures, to Support Basic Mass Calibrations, Harris, G. L., Torres,
> J. A., 2003.

**6.2.3 Statistical process control**

**6.2.3.1** Appropriate measurement assurance programs should be in
place and available for review for each echelon and nominal mass range
for which calibration data is provided. Note Table 8 for appropriate
measurement control programs for each echelon. Appropriate data includes
balance standard deviations that represent process variation and
well-characterized check standard values.

**6.2.3.2** Measurement assurance techniques should exhibit results
consistent with the procedures used to perform calibrations and should
be integral to the measurement to accurately reflect the measurement
process. For those situations where statistical information is not
inherent to the process, i.e., simple measurements without built-in
redundancy checks, additional measurements should be made to provide
experimental characterization of the measurement sufficient for an
adequate estimation of the process uncertainty. Those data should be
available for review.

**6.2.4 Accommodation and environment**

**6.2.4.1** To be deemed capable of making adequate measurements,
calibration laboratories should provide an environment with adequate
environmental controls appropriate for the level of measurements to be
made, according to echelons defined herein. The environmental conditions
are summarized in Table 6.

**Table 6. Environmental facility guidelines for mass
laboratories**[]{#__RefHeading___Toc169420771 .anchor}

+-----------------+-----------------------------+----------------------+
| **Echelon**     | **Temperature Limits\***    | **Relative Humidity  |
|                 |                             | Limits (maximum      |
|                 |                             | change per 4 h)**    |
+-----------------+-----------------------------+----------------------+
| I               | 20 °C to 23 °C, a set point | 40 % to 60 %         |
|                 | [+]{.underline} 1 °C        | [+]{.underline} 5 %  |
|                 |                             |                      |
|                 | maximum change 0.5 °C/h     |                      |
+-----------------+-----------------------------+----------------------+
| II              | 20 °C to 23 °C, a set point | 40 % to 60 %         |
|                 | [+]{.underline} 2 °C        | [+]{.underline} 10 % |
|                 |                             |                      |
|                 | maximum change 1 °C/h       |                      |
+-----------------+-----------------------------+----------------------+
| III             | 18 °C to 27 °C,             | 40 % to 60 %         |
|                 |                             | [+]{.underline} 20 % |
|                 | maximum change 1 °C/h       |                      |
+-----------------+-----------------------------+----------------------+

\*Limits established in this table are intended to provide basic
parameters to ensure temperature and humidity stability in the
laboratory. While maximum changes are noted, they do not imply rate of
change or a net change over time. Environmental changes at these limits
within a very short period of time will adversely affect mass
measurements.

**6.2.4.2** Environmental conditions must be within the specifications
of the weighing instruments where applicable. Environmental deviations
from those specified must address possible measurement impacts, identify
appropriate laboratory procedures that are used to minimize measurement
errors, and have components incorporated into measurement uncertainties.
Deviations for temperature and relative humidity controls are not
necessarily corrected by performing buoyancy corrections and may
adversely affect measurement results. Errors due to thermal convection
currents or changes to moisture layers on the surface of mass standards
may be significant when the environment is not controlled to within
these limits and/or when artifacts are not allowed to equilibrate
properly.

**6.2.4.3** Cleanliness guidelines are usually met without clean-room
type air handling systems by maintaining clean-room type practices with
suitable filtration. The laboratory must maintain limited access to the
calibration area and minimize contamination (provide a clean surface)
for locations where calibration items are being tested. Activities such
as smoking, eating, or drinking and items such as paper products,
printers, and files contribute to the difficulty of maintaining adequate
cleanliness and are not recommended. Excessive air exchange rates
negatively affect balance performance; therefore, air flow is generally
minimized to the extent possible. A positive pressure, laminar-type air
flow is usually needed to maintain cleanliness recommendations and to
minimize air currents.

**6.2.4.4** Vibration should not diminish the performance of precision
analytical balances and mass comparators. Proximity to heavy machinery,
railways, heavily traveled highways, or similar sources of known
vibration is not recommended. Steps are often taken to attenuate
vibration to an acceptable level of stability with methods such as
massive piers (solid marble or concrete tables), isolated foundations,
or elimination of the source. Balances and mass comparators used for
Echelons I and II generally require massive piers, independent piers,
and/or an isolated foundation; pneumatic or hydraulic tables are
inappropriate.

**6.2.4.5** Undesirable effects due to static electricity should be
controlled, if needed, with methods such as humidity, antistatic
deionizing radiation devices, the grounding of balances or operators, or
with the use of special conductive flooring and selection of proper
clothing for staff.

**6.2.5 Equipment and reference materials**

**6.2.5.1** Minimum reference standards should be available at each
echelon and range, for which the laboratory is Recognized, as
recommended in Table 8. Sufficient historical data and uncertainty
analysis should be available to support the standards used.

**6.2.5.2** The accuracy of auxiliary instruments for Echelons I and II,
(e.g., scale, analytical balance, and mass comparator) is less important
than the precision of the instrument due to algorithms used in mass
calibration. However if such equipment is repaired, it should be
reevaluated to ascertain its current level of precision prior to use,
and the uncertainty estimate should reflect the post repair performance.

**6.2.5.3** The precision of the scale, analytical balance, or mass
comparator, as determined through appropriate process control charts,
should be suitable for the echelon at which it is used. For an
application where external standards are used for comparison,
appropriate control charts should be maintained to evaluate the process
standard deviation. Note Table 8 summary for further evaluation.

**6.2.5.4** Means should be provided to measure barometric air pressure,
air temperature, and relative humidity of the laboratory environment as
indicated in Table 7; documentation of the accuracy and traceability is
required. These instruments should be used in close proximity to the
balance being used. For Echelon I, temperature may be measured inside
the weighing chamber when there is a difference between the air
temperature in the balance chamber and the surrounding area. For Echelon
III, where buoyancy corrections are generally negligible, recording
environmental data provides evidence to support compliance with general
environmental requirements of the previous section but the accuracy
generally does not affect measurement results when appropriate artifact
equilibration occurs.

**Table 7. Environmental equipment
accuracy**[]{#__RefHeading___Toc169420772 .anchor} (expanded
uncertainty)

  ----------------- ------------------ ----------------- -----------------
  **Parameter**     **Barometric       **Temperature**   **Relative
                    Pressure**                           Humidity**

  Echelon I         ± 65 Pa (0.5 mm    ± 0.1 °C          ± 5 %
                    Hg)                                  

  Echelon II        ± 135 Pa (1.0 mm   ± 0.5 °C          ± 10 %
                    Hg)                                  

  Echelon III       The laboratory                       
                    maintains                            
                    documented                           
                    accuracy.                            
  ----------------- ------------------ ----------------- -----------------

**6.2.5.5** For Echelon I, the laboratory should state the presence of a
possible systematic error in the combined uncertainty associated with
the use of an assumed density in the primary or reference standards
(additional Type B component) or the laboratory should have appropriate
means to measure the density of mass standards. If the magnetic
susceptibility of the mass standards is evaluated, it should be
indicated on calibration reports. The methods used to determine density
or magnetic susceptibility should be documented.

**6.2.5.6** Each mass standard used as a reference standard by the
laboratory should be calibrated by NIST or by an accredited or
Recognized laboratory with capability adequate to sustain the accuracy
required and maintain traceability to the SI. The laboratory should
provide evidence, such as periodic surveillance, that the standard is,
in principle, acceptable for providing calibration services at each
echelon. Note Table 8 for traceability guidelines.

**6.2.5.7** Balances used as a direct comparison to the mass unit,
should be given a verification test or calibration prior to use. For an
application requiring balance accuracy, the laboratory should choose
appropriate and correct calibration algorithms. Balances used as
dividers and multipliers of the mass unit should be capable of the
appropriate accuracy and linearity requirements of the accuracy class
for which they are used. Calibration of built-in standards should be
performed periodically and should be verified prior to use. History from
measurement control programs (surveillance testing) may be used to
determine calibration intervals.

Instruments used to monitor environmental conditions in the laboratory
should be traceable to a suitable national laboratory (directly or via
an accredited or Recognized laboratory) and be recalibrated periodically
unless defining standards are employed. Calibration periods will be
documented by the laboratory.

**6.2.5.7** Balances used as a direct comparison to the mass unit,
should be given a verification test or calibration prior to use. For an
application requiring balance accuracy, the laboratory should choose
appropriate and correct calibration algorithms. Balances used as
dividers and multipliers of the mass unit should be capable of the
appropriate accuracy and linearity requirements of the accuracy class
for which they are used. Calibration of built-in standards should be
performed periodically and should be verified prior to use. History from
measurement control programs (surveillance testing) may be used to
determine calibration intervals.

**6.2.5.8** Instruments used to monitor environmental conditions in the
laboratory should be traceable to a suitable national laboratory
(directly or via an accredited or Recognized laboratory) and be
recalibrated periodically unless defining standards are employed.
Calibration periods will be documented by the laboratory.

**6.2.6 Calibration methods**

**6.2.6.1** The algorithm chosen for the measurement, the reference
standard to be used, and the equipment to be used for a particular
calibration should provide acceptable levels of uncertainty for that
calibration. A documented procedure should be available in the
laboratory to determine the correct algorithm. Note Table 8 for
guidelines.

**6.2.6.2** Computer programs should have passed software quality
analysis. Computer programs should be tested, using standard data sets
designed to magnify errors, as an effective way of showing that program
errors are not present which do not affect some measurements but cause
others to be incorrect. Computer programs should be documented in
detail. The documentation should include technical references that
provide the basis for the algorithm, the weighing equation, and the data
set used to test the program for errors.

**6.2.7 Handling of calibration items**

**6.2.7.1** The laboratory should have documented procedures to ensure
adequate chain-of-custody of calibration items if required by law.

**6.2.7.2** The laboratory will document appropriate procedures to
ensure that cleaning, if performed, ensures the integrity of the
standards, and to provide for thermal conditioning, where appropriate.

**6.2.7.3** The laboratory must allow adequate stabilization time for
mass standards to ensure environmental and thermal stability prior to
calibration.

**6.2.7.4** Documented procedures to ensure adequate tracking of
calibration items should be appropriate to the class of mass standard.
Strings, tags, or labels fastened to the standard are inappropriate.

**6.2.8 Calibration certificates and test reports**

**6.2.8.1** In addition to meeting the criteria in section 5.10 of this
handbook, calibration certificates and test reports should describe the
mass standards mentioned in the report with sufficient detail to avoid
any ambiguity. For Echelons I and II, additional items to be included on
a test report, are: mass (true mass) values, conventional (apparent)
mass values, reference density, uncertainties, material, thermal
coefficient of expansion (if used in calculations), construction,
density (measured or assumed), and any identifying markings.

**6.2.8.2** Environmental parameters measured during the test should be
provided on certificates and reports for Echelons I and II. Typical
ranges are acceptable for reporting conditions for Echelon III. These
include laboratory temperature, barometric pressure and relative
humidity.

**6.2.8.3** Information regarding cleaning methods (if requested) should
be provided on the test report.

**6.2.8.4** Reports may include reference to NIST, OIML or ASTM
classification schemes and tolerances. Calibration items being tested
should meet appropriate specifications for evaluation as well as
tolerances. It is the responsibility of the requestor of the calibration
to select classifications acceptable for their needs. In the case where
magnetism, surface finish, and density are not tested for Echelon I and
II, a statement to that effect should be included on the calibration
report.

**6.2.8.5** The weight surface of a mass standard should be free of any
sign of abuse or damage. Signs of abuse or misuse include the placement
of labels, tags, wires or other material on mass standards. In addition,
visible dirt and fingerprints are signs of misuse for Echelons I and II.
It is recommended that the calibration laboratory establish appropriate
means for notifying customers regarding any unusual factors such as
signs of abuse regarding the mass standard being tested should be
included on the report. Out of tolerance conditions should be reported
when significant or when requested.

**Table 8. Summary of technical criteria for mass
calibration**[]{#__RefHeading___Toc169420773 .anchor}

+--------+----------------+---------------+--------------+------------+
| **Ech  | **Minimum      | **Minimum     | **Minimum    | **Minimum  |
| elon** | Measurement    | Reference     | Tr           | C          |
|        | Assurance**    | Standards     | aceability** | alibration |
|        |                | (5.6)**       |              | Methods    |
|        | **(5.9)**      |               | **(5.6)**    | (5.4)**    |
+--------+----------------+---------------+--------------+------------+
| I      | -   Process    | -   OIML      | -   NIST, or | -          |
| (Extra |     control    |     Class     |     other    | Documented |
| Fine)  |     charts     |     E~1~, or  |     national |            |
|        |                |     E~2~      |     level    |   weighing |
|        | -   Check      |               |              |            |
|        |     standards  | > Or          |  calibration |    designs |
|        |     for each   |               |     every 2  |            |
|        |     decade,    | -   ASTM      |     to 5     | consisting |
|        |     with long  |     Class 0,  |     years    |     of     |
|        |     term       |     1         |     based on |            |
|        |     standard   |               |              |  redundant |
|        |     deviation  | -   single    |  measurement |     co     |
|        |                |     piece,    |     process  | mparisons, |
|        | -              |     highly    |     data and |     with   |
|        |   Surveillance |     polished  |              |            |
|        |     of all     |               |  independent |   built-in |
|        |     standards  |               |     v        |            |
|        |                |               | erification, |    process |
|        | -              |               |     and      |            |
|        |    Proficiency |               |              |   controls |
|        |     Testing    |               | -   Suitable |     such   |
|        |                |               |              |     as     |
|        | -on-site       |               | surveillance |     those  |
|        | assessment     |               |     testing  |     used   |
|        |                |               |     and      |     at the |
|        | -round robin   |               |     p        |            |
|        | participation  |               | articipation |   national |
|        |                |               |     in PTs   |     level. |
|        |                |               |     at this  |            |
|        |                |               |     level    | > For      |
|        |                |               |              | > example: |
|        |                |               | -            |            |
|        |                |               |   Documented | -          |
|        |                |               |     with GMP |  Technical |
|        |                |               |     11 and   |     Notes, |
|        |                |               |     13       |     952    |
|        |                |               |              |     and    |
|        |                |               |              |     844,   |
|        |                |               |              |     SOP 5, |
|        |                |               |              |     SOP 28 |
+--------+----------------+---------------+--------------+------------+
| II     | -   Process    | -   OIML      | -   NIST     | -          |
| (Fine) |     control    |     Class     |              | Documented |
|        |     charts     |     E~1~, or  |  calibration |            |
|        |                |     E~2~      |     every 2  | comparison |
|        | -   Check      |               |     to 5     |     c      |
|        |     standards  | -   ASTM      |     years    | alibration |
|        |     for each   |     Class 0,  |     based on |            |
|        |     decade,    |     1; or     |              |  procedure |
|        |     with long  |               |  measurement |            |
|        |     term       | -   single    |     process  | > For      |
|        |     standard   |     piece,    |     data and | > example: |
|        |     deviation, |     highly    |              |            |
|        |     per SOP 9  |     polished  |  independent | -   NISTIR |
|        |                |               |     v        |     6969,  |
|        | -              |               | erification, |     SOP 4, |
|        |   Surveillance |               |     or       |     SOP 5, |
|        |     of         |               |              |     or     |
|        |     selected   |               | -            |            |
|        |     standards  |               |  Calibration | equivalent |
|        |                |               |     by       |            |
|        |    Proficiency |               |              |  validated |
|        |     Testing    |               |   accredited |            |
|        |                |               |     or       |  procedure |
|        | -   -on-site   |               |              |            |
|        |     assessment |               |   Recognized |            |
|        |                |               |     Echelon  |            |
|        | -   -round     |               |     I        |            |
|        |     robin      |               |              |            |
|        |                |               |  laboratory, |            |
|        |  participation |               |     if       |            |
|        |                |               |              |            |
|        |                |               |  uncertainty |            |
|        |                |               |              |            |
|        |                |               | requirements |            |
|        |                |               |     can be   |            |
|        |                |               |     met.     |            |
|        |                |               |              |            |
|        |                |               | -            |            |
|        |                |               |   Documented |            |
|        |                |               |     with GMP |            |
|        |                |               |     11 and   |            |
|        |                |               |     13       |            |
+--------+----------------+---------------+--------------+------------+
| III    | -   Process    | -   Working   | -            | -   Use of |
| (M     |     control    |     standards |  Calibration |            |
| edium) |     charts     |     such as:  |     of all   |   annually |
|        |                |               |     working  |            |
|        | -   Check      | -   ASTM      |              | calibrated |
|        |     standards  |     Class 2,  |    standards |            |
|        |     for each   |     3         |     by NIST  |    balance |
|        |     balance    |               |     every 2  |     with   |
|        |     per SOP 9  | > Or          |     to 5     |            |
|        |                |               |     years    | documented |
|        | -              | -   OIML      |     based on |     and    |
|        |    Proficiency |     Class     |              |            |
|        |     Testing    |     F~1~      |  measurement |  validated |
|        |                |               |     process  |     ve     |
|        | -on-site       | -   two piece |     data and | rification |
|        | assessment     |               |              |            |
|        |                |   acceptable, |  independent |  procedure |
|        | -round robin   |     fine      |     v        |     prior  |
|        | participation  |     finish    | erification, |     to     |
|        |                |               |     or       |     each   |
|        |                |               |              |     use    |
|        |                |               | -            |            |
|        |                |               |  Calibration | -   NISTIR |
|        |                |               |     of all   |     6969,  |
|        |                |               |     working  |     SOP 8, |
|        |                |               |              |     SOP 7  |
|        |                |               |    standards |            |
|        |                |               |     by an    | -   Other  |
|        |                |               |     Echelon  |            |
|        |                |               |     I or II  | documented |
|        |                |               |              |     and    |
|        |                |               |   accredited |            |
|        |                |               |     or       |   verified |
|        |                |               |              |            |
|        |                |               |   Recognized |  procedure |
|        |                |               |     labs     |            |
|        |                |               |     every 2  |            |
|        |                |               |     to 5     |            |
|        |                |               |     years    |            |
|        |                |               |     based on |            |
|        |                |               |              |            |
|        |                |               |  measurement |            |
|        |                |               |     process  |            |
|        |                |               |     data and |            |
|        |                |               |              |            |
|        |                |               |  independent |            |
|        |                |               |              |            |
|        |                |               | verification |            |
|        |                |               |              |            |
|        |                |               | -            |            |
|        |                |               |   Documented |            |
|        |                |               |     with     |            |
|        |                |               |     GMP 11   |            |
|        |                |               |     and 13   |            |
+--------+----------------+---------------+--------------+------------+

**6.3** **Technical Criteria for Volume
Laboratories**[^5][]{#__RefHeading___Toc169420774 .anchor}

**6.3.1** **Scope**

The purpose of this section is to specify the specific technical
criteria needed to meaningfully assess the competence of a calibration
laboratory that performs volume calibrations. It should be noted that
the procedures affect the achievable uncertainty.

**Table 9. Typical "Ranges of Recognition" for volumetric
calibration**[]{#__RefHeading___Toc169420775 .anchor}

+-----------+-------------+-------------+------------------------------+
| **Pr      | **Scope of  |             |                              |
| ocedure** | Re          |             |                              |
|           | cognition** |             |                              |
| **Types** |             |             |                              |
|           | **Nominal   |             |                              |
| **&       | Value       |             |                              |
| Echelon** | Range**     |             |                              |
+-----------+-------------+-------------+------------------------------+
| **Echelon | Glassware   |             | Metal Test Measures or       |
| I**       |             |             | Provers                      |
|           |             |             |                              |
| **Grav    |             |             |                              |
| imetric** |             |             |                              |
+-----------+-------------+-------------+------------------------------+
|           | Standard    | Pipettes &  |                              |
|           |             | Syringes    |                              |
+-----------+-------------+-------------+------------------------------+
|           | ≥ 1 L       |             | ≥ 2 000 L **or** ≥ 500 gal   |
+-----------+-------------+-------------+------------------------------+
|           | 1 L to 100  |             | 100 L \< V \< 2 000 L **or** |
|           | mL          |             | 25 \< V \< 500 gal           |
+-----------+-------------+-------------+------------------------------+
|           | 100 mL to 1 | 100 mL to 1 | ≤ 100 L **or** ≤ 25 gal      |
|           | μL          | μL          |                              |
+-----------+-------------+-------------+------------------------------+
| **Echelon | Glassware   |             | Metal Test Measures or       |
| II**      |             |             | Provers                      |
|           |             |             |                              |
| **Volume  |             |             |                              |
| T         |             |             |                              |
| ransfer** |             |             |                              |
+-----------+-------------+-------------+------------------------------+
|           | ≥ 1 L       |             | ≥ 2 000 L **or** ≥ 500 gal   |
|           | **or** 1 qt |             |                              |
+-----------+-------------+-------------+------------------------------+
|           | 100 mL \< V |             | 100 L \< V \< 2 000 L **or** |
|           | \< 1 L      |             | 25 \< V \< 500 gal           |
|           | **or** 1    |             |                              |
|           | gill \< V   |             |                              |
|           | \< 1 qt     |             |                              |
+-----------+-------------+-------------+------------------------------+
|           | ...         |             | ≤ 100 L **or** ≤ 25 gal      |
+-----------+-------------+-------------+------------------------------+

**6.3.1.1** Volumetric units are derived from mass units. Volume
calibrations may be determined by either a gravimetric (weighing
procedure) or a volume transfer (comparative) method. The two methods
require different technical requirements and both are defined here. The
measurement of volume by metering methods (and meter calibration) is
outside the scope of this document.

**6.3.1.2** The gravimetric procedure is based on the conservation of
mass principle where a determination of the mass of water contained in
or delivered from the vessel that is being calibrated is used to define
volume. The mass values are determined in air, are corrected for air
buoyancy effects, and are corrected to appropriate reference
temperatures. The accuracy and precision will vary depending on balances
used, the purity of the water, the ability to make accurate temperature
measurements, the nominal value of the volume standard being tested, and
the ability to make adequate mass measurements.

**6.3.1.3** In the volume transfer procedure, water is delivered from a
primary volume standard to the vessel under test. Temperature
corrections are made to compensate for the cubical coefficients of
thermal expansion of the standard, test vessel, and water to a specified
reference temperature. The accuracy and precision will vary considerably
depending on the presence of a meniscus, the cleanliness and drain
characteristics of the container, the cleanliness and purity of the
water, and the ability to make adequate temperature measurements.

**6.3.2 References**

> \[1\] ANSI/ASTM E 287-02, Standard Specification for Laboratory Glass
> Graduated Burets (2002).
>
> \[2\] ANSI/ASTM E 288-06, Standard Specification for Laboratory Glass
> Volumetric Flasks (2006).
>
> \[3\] ANSI/ASTM E 438-92 e1, Standard Specification for Glasses in
> Laboratory Apparatus (2006).
>
> \[4\] ANSI/ASTM E 542-01, Standard Practice for Calibration of
> Volumetric Apparatus (2001).
>
> \[5\] ANSI/ASTM E 694-99, Standard Specification for Laboratory Glass
> Volumetric Apparatus (2005).
>
> \[6\] ANSI/ASTM E 969-02, Standard Specification for Glass Volumetric
> (Transfer) Pipets (2002).
>
> \[7\] OIML R 4, Volumetric Flasks (one mark) in Glass (1972).
>
> \[8\] OIML R 40, Graduated Pipettes for Verification Officers (1981).
>
> \[9\] OIML R 41, Standard Burettes for Verification Officers (1981).
>
> \[10\] OIML R 43, Standard Graduated Glass Flasks for Verification
> Officers (1981).
>
> \[11\] NIST Handbook 105-2, 105-3, 105-4, 105-7 Specifications and
> Tolerances for Reference Standards and Field Standard Weights and
> Measures; Specifications and Tolerances for Field Standard Glass
> Flasks, Open-neck Provers, LPG Volumetric Provers, Dynamic Small
> Volume Provers.
>
> \[12\] API Manual of Petroleum Measurement Standards, Chapter 4 -
> Proving Systems; Section 3, Small Volume Provers, 1988; Section 4,
> Tank Provers, 1998 (Reaffirmed November 2005); Section 7, Field
> Standard Test Measures, 1998 (Reaffirmed October 2003).
>
> \[13\] NISTIR 7383, Selected Procedures for Volumetric Calibrations,
> November 2006.
>
> \[14\] NIST Special Publication, 250-72, NIST Calibration Services for
> Liquid Volume, March 2006.

**6.3.3 Statistical process control**

**6.3.3.1** Appropriate measurement control programs should be in place
and available for review for each measurement type (based on procedures)
and nominal volume range for which calibration data is provided. Note
Table 12 for appropriate measurement control programs for each
measurement type. Appropriate data includes standard deviations and
range values that represent process variation and well characterized
check standard values.

**6.3.3.2** Measurement control techniques should exhibit results
consistent with the procedures used to perform calibrations and should
be integrated into the measurement to accurately reflect the measurement
process. For those situations where statistical information is not
inherent to the process, i.e., simple measurements without built-in
redundancy checks, additional measurements should be made to provide
experimental characterization of the measurement sufficient for an
adequate estimation of the process uncertainty. Those data should be
available for review.

**6.3.4 Accommodation and environment**

**6.3.4.1** To be deemed capable of making adequate measurements,
calibration laboratories should provide a facility with adequate
environmental controls appropriate for the level of measurements to be
made, according to procedure types as shown in Table 10. Lower relative
humidity may increase measurement error due to evaporation.

**Table 10. Environmental facility guidelines for volumetric
calibration**[]{#__RefHeading___Toc169420776 .anchor}

+-----------------+--------------------------+-------------------------+
| **Echelon &     | **Temperature**          | **Relative Humidity**   |
| Procedure**     |                          |                         |
|                 |                          | **(maximum range per 4  |
|                 |                          | hours)**                |
+-----------------+--------------------------+-------------------------+
| I               | 20 °C to 23 °C, set      | 40 % to 60 % ± 10 %     |
|                 | point ± 2 °C             |                         |
| Gravimetric     |                          |                         |
|                 | maximum change 1.0 °C/h  |                         |
+-----------------+--------------------------+-------------------------+
| II              | 18 °C to 27 °C           | 40 % to 60 % ± 20 %     |
|                 |                          |                         |
| Volume Transfer | maximum change 2.0 °C/h  |                         |
+-----------------+--------------------------+-------------------------+

**NOTE:** The environmental conditions should also be within the
specifications of applicable equipment. Gravimetric calibrations must
comply with the comparable sections of 6.2 for mass calibrations because
this procedure is a high-precision mass calibration with additional
complexities.

**6.3.4.2** The environment in which testing activities are undertaken
should not invalidate the results or adversely affect the required
accuracy. Particular care should be taken when such calibration
practices are undertaken at sites other than the permanent laboratory
facility to minimize the effects of uncontrolled environments (e.g.,
outside or in open bays.)

**6.3.4.3** Vibration, air currents, rapid temperature fluctuations, and
other environmental concerns should not diminish the accuracy and
precision of volume transfer methods or the performance of precision
balances or scales when gravimetric methods are used.

**6.3.4.4** The quality of water used as a calibration medium should be
of adequate purity (potable) and cleanliness, and should be free from
excess air entrapment. For gravimetric procedures the density should be
calculated/measured to the nearest 0.00001 g/cm^3^.

**6.3.5 Equipment and reference materials**

**6.3.5.1** Mass standards used as reference standards should be
traceable to a national laboratory (such as NIST) and be available at
each class and range, for which the laboratory is Recognized, as
recommended in Table 12. Sufficient historical data and uncertainty
analysis should be available to support the standards used.

**6.3.5.2** Volume standards used as reference standards in the
laboratory should be traceable to a national laboratory (such as NIST)
and the laboratory should have appropriate procedures in place for
verification and recalibration. The accuracy of the primary volume
standards of the laboratory should be appropriate for the accuracy class
of services provided.

**6.3.5.3** Gravimetric methods, which generally use water as
calibration media, require the verification of an adequate supply of
deionized or distilled water.

**6.3.5.4** Gravimetric methods require the use of weighing equipment
with adequate accuracy and precision for the uncertainty of the
measurement procedure. Appropriate control charts or range charts should
be maintained to verify the measurement process.

**6.3.5.5** Gravimetric methods require the means to adequately measure
barometric air pressure, air temperature, water temperature, and
relative humidity of the laboratory environment. Volumetric methods
require temperature measurements. Environmental measuring equipment
should be available with the accuracy indicated in Table 11. Relative
humidity may need to be monitored more closely if evaporation is a
concern.

**Table 11. Environmental equipment
accuracy**[]{#__RefHeading___Toc169420777 .anchor} (expanded
uncertainty)

+------------------+----------------+-----------------+----------------+
| **Procedure      | **Barometric** | **Temperature** | **Relative     |
| Type**           |                |                 | Humidity**     |
|                  | **Pressure**   | **water/air**   |                |
+------------------+----------------+-----------------+----------------+
| Gravimetric      | ± 135 Pa       | ± 0.1 °C / ±    | ± 10 %         |
|                  |                | 0.5 °C          |                |
|                  | (1.0 mm Hg)    |                 |                |
+------------------+----------------+-----------------+----------------+
| Volume Transfer  | Not essential  | ± 0.5 °C        | Not essential  |
+------------------+----------------+-----------------+----------------+

**6.3.6 Calibration methods**

**6.3.6.1** The algorithm chosen for the measurement, the reference
standard to be used, and the equipment to be used for a particular
calibration should be correct for that calibration. A documented
procedure should be available in the laboratory to determine the correct
algorithm. (Examples are provided in NIST Handbook 145 Standard
Operating Procedures, SOPs.)

**6.3.6.2** Computer programs should have passed software quality
analysis. Computer programs should be documented in detail. The
documentation should include technical references that provided the
basis for the algorithm, any weighing equations, and data set used to
test the program for errors.

**6.3.7 Handling of calibration items**

1.  The laboratory should have documented procedures to ensure adequate
    chain-of-custody of calibration items if required by law.

**6.3.7.2** Appropriate procedures should be documented to ensure
adequate tracking of calibration items that are appropriate for glass or
metal volumetric standards.

**6.3.8 Calibration certificates and test reports**

**6.3.8.1** In addition to meeting the criteria in section 5.10 of this
handbook, calibration certificates and test reports should describe the
volume standards mentioned in the report with sufficient detail to avoid
any ambiguity. Additional items to be included on a test report are:
volume, uncertainty, reference temperature, material, thermal
coefficient of expansion (assumed or measured), construction, any
identifying markings, and any tolerances if appropriate.

Environmental parameters measured during the test should be provided on
the test report as appropriate. These include laboratory temperature,
volume standard temperature, barometric pressure and relative humidity.

**6.3.8.3** Volume standards being tested should meet the appropriate
specifications such as NIST, ASTM, API, or OIML, if required by
laboratory customers. It is the responsibility of laboratory customers
to determine acceptable accuracy levels for their needs.

**6.3.8.4** The calibration item (volume standard) should be free of any
sign of abuse or damage. Signs of abuse or misuse include dents, chips,
improper draining due to lack of cleanliness, and dirty sight gages. Out
of tolerance conditions should be reported.

**Table 12. Summary of technical criteria for volumetric
calibration**[]{#__RefHeading___Toc169420778 .anchor}

+--------+-------------+------------+---------------+----------------+
| **Ech  | **Minimum** | *          | **Minimum**   | **Minimum**    |
| elon** |             | *Minimum** |               |                |
|        | **Me        |            | **T           | *              |
|        | asurement** | **R        | raceability** | *Calibration** |
|        |             | eference** |               |                |
|        | **Control** |            |               | **Methods**    |
|        |             | **         |               |                |
|        |             | Standard** |               |                |
+--------+-------------+------------+---------------+----------------+
| I      | -   Process | -   A      | -   NIST, or  | -   Documented |
|        |     control | ppropriate |     national  |     comparison |
| Gravi  |     charts  |     mass   |     level     |                |
| metric |             |            |               |    calibration |
|        | -   Check   |  standards |   calibration |     procedure  |
|        |             |            |               |                |
|        |   standards | ```{=html} | periodically, | or             |
|        |             | <!-- -->   |     based on  |                |
|        | -   S       | ```        |               | -   NISTIR     |
|        | urveillance | -   ASTM   |   independent |     7383, SOP  |
|        |     of all  |     Class  |               |     14 (for    |
|        |             |     2 or   |    historical |     example)   |
|        |   standards |     3; or  |     data      |                |
|        |     used to |            |               | or             |
|        |     provide | -   OIML   |  verification |                |
|        |             |     Class  |               | -   Use of     |
|        | measurement |     F~1~   | or            |     calibrated |
|        |             |     or     |               |     balance    |
|        |    services |     F~2~;  | -   \- Test   |                |
|        |             |            |     of        |                |
|        | -           | or         |     weighing  |                |
|        | Proficiency |            |     equipment |                |
|        |     testing | -          |     using     |                |
|        |             | Calibrated |     correct   |                |
|        | \- On-site  |            |     methods   |                |
|        | assessment  |    Balance |     of        |                |
|        |             |            |               |                |
|        | \- Round    |            |   calibration |                |
|        | robin       |            |     and       |                |
|        | pa          |            |               |                |
|        | rticipation |            |    adjustment |                |
|        |             |            |     with      |                |
|        |             |            |     traceable |                |
|        |             |            |     mass      |                |
|        |             |            |     standards |                |
+--------+-------------+------------+---------------+----------------+
| II     | -   Process | Primary    | -   Original  | Documented     |
|        |     control | volume     |     NIST      | volume         |
| Volume |     charts  | standards  |               | transfer (or   |
|        |             | with       |   calibration | water draw)    |
| Tr     | -   Check   | accuracy   |     and       | procedure      |
| ansfer |             | and        |     periodic  | recognized by  |
|        |   standards | rep        |               | NIST, OIML,    |
|        |             | eatability |   independent | ASTM, or API   |
|        | -   S       | chara      |               |                |
|        | urveillance | cteristics |  verification |                |
|        |     of      |            |               |                |
|        |             | acceptable | or            |                |
|        |    selected | for the    |               |                |
|        |             | type of    | -             |                |
|        |   standards | service    |   Calibration |                |
|        |             | provided   |     by        |                |
|        | -           |            |               |                |
|        | Proficiency |            |    accredited |                |
|        |     testing |            |     or        |                |
|        |             |            |               |                |
|        | \- On-site  |            |    Recognized |                |
|        | assessment  |            |               |                |
|        |             |            |   laboratory, |                |
|        | \- Round    |            |     if        |                |
|        | robin       |            |               |                |
|        | pa          |            |   uncertainty |                |
|        | rticipation |            |               |                |
|        |             |            |  requirements |                |
|        |             |            |     can be    |                |
|        |             |            |     met       |                |
+--------+-------------+------------+---------------+----------------+

**6.4 Technical Criteria for Hydrometer
Laboratories**[^6][]{#__RefHeading___Toc169420779 .anchor}

**6.4.1 Scope**

This section outlines the specific technical requirements in accordance
with which a laboratory should demonstrate that it operates if it is to
be Recognized as competent to carry out calibrations of hydrometers.

**6.4.2 References**

> \[1\] ASTM E 100-05: Standard Specification for ASTM Hydrometers
> (2005).
>
> \[2\] ASTM E 126-05a: Standard Test Method for Inspection,
> Calibration, and Verification of ASTM Hydrometers (2005).

**6.4.3 Statistical process control**

**6.4.3.1** All sources of variability for the hydrometer calibration
should be monitored. Check standards should be used to ensure that the
calibrations are carried out under controlled conditions. The laboratory
should maintain statistical process control (SPC) commensurate with the
accuracy levels needed for the calibration. The SPC control parameters
should be based on measurements of check standards (or closure
parameters) and the repeatability of multiple measurements. The
frequency and number of process control checks should be appropriate for
the level of uncertainty claimed for the calibration.

**6.4.3.2** The laboratory should have control hydrometers that
adequately span the range of materials and sizes normally calibrated by
the laboratory. Every measured value of each control should be recorded
and compared to its historic value to determine whether or not the
process is in control. These values should be plotted on a control chart
that has upper and lower control limits.

**6.4.4 Accommodation and environment**

**6.4.4.1** The environmental conditions (i.e., temperature, atmospheric
pressure and relative humidity) in the hydrometer calibration area
should have no more than the maximum variations permitted, depending on
the materials and the accuracy level needed for the calibration. The
reference temperature for a particular hydrometer scale may vary from
15.56 °C (15.56 °C is approximately 60 °F, which is the reference
temperature for petroleum products in the United States) to 20 °C. The
laboratory should have the appropriate instrumentation required to
measure the environmental conditions.

**6.4.4.2** The density of the water used in hydrometer calibrations
should be known to within 0.000005 g/cm3. Specific gravity is expressed
as the ratio of the density of a liquid to the density of water at a
specified temperature.

**6.4.4.3** Vibration of equipment used in the hydrometer calibrations
should be reduced to non-influential levels. If an obvious source of
vibration exists, it should not adversely affect the laboratory\'s
claimed uncertainty level.

**6.4.4.4** Any laboratory that makes hydrometer comparisons should have
an appropriate supply of calibration fluids with suitable surface
tensions. Hydrometers should be calibrated in the liquids in which they
are to be used.

**6.4.4.5** Calibration liquids should be stored in an approved safety
cabinet. Laboratories that make hydrometer comparisons should abide by
all safety requirements set forth by a regulatory counsel, (e.g.,
chemical labeling, EPA and OSHA guidelines, etc.).

**6.4.5 Equipment and reference materials**

**6.4.5.1** The laboratory should have the appropriate equipment
required to perform hydrometer calibrations at the Recognized level. All
equipment should be properly maintained.

**6.4.5.2** The laboratory that performs hydrometer comparisons should
have master hydrometers for which the calibrations are directly
traceable to the appropriate national standards laboratory. The
appropriate calibration corrections to these master hydrometers should
be applied.

**6.4.5.3** The laboratory should have the equipment needed to make
auxiliary measurements of hydrometers, (e.g., balances, mass standards,
knowledge of water density, etc.).

**6.4.5.4** Any laboratory that makes hydrometer comparisons should
abide by all safety requirements set forth by a regulatory counsel,
(e.g., chemical labeling, EPA and OSHA guidelines, etc.).

**6.4.5.5** The laboratory should have temperature measuring
capabilities suitable to the calibration procedure. In the case of
measuring the specific gravity of a liquid with a master hydrometer,
temperature measurement of the liquid accurate to ± 0.01 °C is required.

**6.4.5.6** A laboratory that makes hydrometer comparisons should have a
ventilated chemical hood to exhaust any harmful fumes from the working
area.

**6.4.6 Calibration methods**

**6.4.6.1** The wide use of hydrometers for many different purposes has
led to various stem scales for unique applications (e.g., specific
gravity, percentage alcohol, degrees API, degrees Baume and Brix). The
appropriate stem scale should be evaluated.

**6.4.6.2** Ideally, hydrometers under test are compared directly to
master hydrometers in the kinds of liquids in which they are to be used.
This comparison is performed in a clear, smooth glass cylinder of
suitable size. The calibration liquid should be well stirred before each
comparison to minimize temperature gradient in the liquid.

**6.4.6.3** The laboratory should have a manual detailing the procedures
to follow for each type of hydrometers being calibrated. This manual
should contain all pertinent information needed for calibration at a
given Recognition level.

**6.4.7 Handling of calibration items**

**6.4.7.1** Hydrometers should be cleaned and stored in a manner that
prevents accidental contact with material that could damage the
calibration surfaces. Since hydrometers are made of glass and can be
easily broken, they should be handled only by an experienced operator.

**6.4.7.2** Inspection should be made of all hydrometers for calibration
for bent stems, twisted scales, and loose material inside the body of
the hydrometer.

**6.4.7.3** The hydrometer should be wiped with alcohol and dried to
ensure a clean surface before it is immersed in the calibration liquid.

**6.4.8 Calibration certificates and test reports**

**6.4.8.1** Summary sheets and data sheets should be used to document
all calibrations. This documentation should be dated and initialed by
the operator. A historical registry should be kept.

**6.4.8.2** The uncertainty reported for the hydrometer should be
derived from a model of the measurement system that includes, as
applicable, the uncertainties due to:

1)  master hydrometer;

2)  long-term reproducibility of measurement system

3)  thermal expansion; and

4)  other appropriate factors.

**6.5 Technical Criteria for Thermometer
Laboratories**[^7][]{#__RefHeading___Toc169420780 .anchor}

**6.5.1 Scope**

**6.5.1.1** This section contains the specific technical criteria in
accordance with which a laboratory should demonstrate that it operates,
if it is to be Recognized as competent to carry out thermometer
calibrations.

**6.5.1.2** This section may also be used as a guide by thermometer
calibration laboratories in the development and implementation of their
quality systems.

*Echelon:* Level of performance associated with the level of total
uncertainty, according to the following table:

  ----------------- -----------------------------------------------------
  **Echelon**       **Expanded Uncertainty**

  I                 ≤ ± 0.005 °C

  II                \> ± 0.005 °C to ≤ ± 0.05 °C

  III               \> ± 0.05 °C to ≤ ± 0.20 °C

  IV                \> ± 0.20 °C to ≤ ± 1.0 °C

  V                 \> ± 1.0 °C to ≤ ± 5.0 °C
  ----------------- -----------------------------------------------------

**NOTE:** The uncertainty of thermometers calibrated by the laboratory
will vary depending upon the temperature range of application, even for
the same thermometer. Thus, a laboratory may perform calibrations at
Echelon II in some cases and Echelon III or IV in other cases because of
the temperature ranges involved. Also, the echelon assigned is dependent
on the types of thermometers calibrated.

**6.5.2 References**

> \[1\] ASTM Annual Book of Standards, Volume 14.03, Standards Relating
> to Temperature Measurement (2007).
>
> \[2\] NIST Handbook 105-6, Specifications and Tolerances for Field
> Standard Thermometers (1997).
>
> \[3\] NIST SP 250-23, Liquid-In-Glass Thermometer Calibration Service
> (1988).
>
> \[4\] NBS Monograph 174, Thermometer Calibration, A Model for State
> Calibration Laboratories (Appendix A: NBS Monograph 150,
> Liquid-In-Glass Thermometry) (1985).

**6.5.3 Statistical process control**

**6.5.3.1 Fixed-point cell and triple point of water as the reference
standards**

When the reference standard used by the laboratory is a fixed-point
cell, the three action items described below are required as indicated
by the application table that follows their description.

**6.5.3.1.1** Records of complete phase equilibrium plateaus obtained
for each cell upon receipt and every six months thereafter should be
maintained. This should include either manually recorded temperatures at
consistent intervals, or a graphical representation of the equilibrium
plateau, as measured by the monitoring sensor.

**6.5.3.1.2** A separate check thermometer should be used for each cell
and control charts maintained.

**6.5.3.1.3** The triple point of water should be measured after every
measurement at another temperature.

  ------------- ------------- ----------- ----------- ----------- -----------
  **Item**      **Echelon**                                       

                **I**         **II**      **III**     **IV**      **V**

  6.5.3.1.1     X             X           X           X           

  6.5.3.1.2     X             X           X           X           

  6.5.3.1.3     X                                                 
  ------------- ------------- ----------- ----------- ----------- -----------

**6.5.3.2** **SPRT or RIRT as the reference standard**

When the reference standard used by the laboratory is a standard
platinum resistance thermometer (SPRT) or a rhodium-iron resistance
thermometer (RIRT), the two action items described below are recommended
as indicated by the application table that follows them.

**6.5.3.2.1** There should be documentation (i.e., control charts) to
show that the resistance of the instrument at the triple point of water
has not changed since its last calibration by more than the equivalent
shown in the table below.

**6.5.3.2.2** If a digital voltmeter (DVM), digital multi-meter (DMM),
or digital temperature indicator is used, the calibration of the
temperature indicating system (indicator and sensor) should be checked
periodically at either the water triple point or at the ice point.

  ------------ ------------- ----------- ----------- ----------- -----------
  **Item**     **Echelon**                                       

               **I**         **II**      **III**     **IV**      **V**

  6.5.3.2.1    2 mK          2 mK        5 mK        10 mK       10 mK

  6.5.3.2.2    X                         X           X           X
  ------------ ------------- ----------- ----------- ----------- -----------

**6.5.3.3 Thermistor thermometer as the reference standard**

When the reference standard used by the laboratory is a thermistor
thermometer, the two action items described below are recommended as
indicated by the application table that follows them.

**6.5.3.3.1** The calibration of the thermistor thermometer should be
checked frequently (monthly or weekly) depending on the particular
application, and control charts should be kept.

**6.5.3.3.2** If, since the last calibration, the resistance of the
thermistor thermometer has changed at a reference check point
(fixed-point, preferably) by the equivalent shown in the next table, a
new calibration should be done.

  ----------- ------------- ----------- ----------- ----------- -----------
  **Item**    **Echelon**                                       

              **I**         **II**      **III**     **IV**      **V**

  6.5.3.3.1                 x           x           x           x

  6.5.3.3.2                 2 mK        5 mK        10 mK       
  ----------- ------------- ----------- ----------- ----------- -----------

**6.5.3.4 Thermocouple as the reference standard**

When the reference standard used by the laboratory is a thermocouple,
control charts should show the reproducibility at appropriate fixed
points.

**6.5.3.4.1** L**iquid-in-glass thermometer as the reference standard**

When the reference standard used by the laboratory is a liquid-in-glass
thermometer, the two action items described below are recommended as
indicated by the application table that follows them.

**6.5.3.4.1.1** The total-immersion mercury-in-glass thermometer should
be checked according to good laboratory practice. One method is to check
at the ice point on a daily basis after use and maintain records.

**6.5.3.4.1.2** The total-immersion liquid-in-glass thermometer should
be checked according to good laboratory practice. One method is to check
at the ice point weekly and maintain control charts.

  -------------------- ------------- -------- ---------- ---------- ----------
  **Item**             **Echelon**                                  

                       **I**         **II**   **III**    **IV**     **V**

  6.5.3.4.1.1                                 X          X          

  6.5.3.4.1.2                                                       X
  -------------------- ------------- -------- ---------- ---------- ----------

**6.5.4 Accommodation and environment**

**6.5.4.1** For all echelons, the environmental conditions of the
laboratory should be controlled.

**6.5.4.2** The temperature of the laboratory should be controlled to ±
2 °C.

**6.5.4.3** The relative humidity should be controlled between 40 % and
60 %.

**6.5.4.4** Vibrations in the laboratory should be minimized.

**6.5.5 Equipment and reference materials**

1.  **Reference standards**

The following table indicates which reference standard is acceptable for
each echelon.

  ---------------------------- ------------- -------- --------- -------- --------
  **Acceptable reference       **Echelon**                               
  standard**                                                             

                               **I**         **II**   **III**   **IV**   **V**

  Fixed-point cell             X             X        X         X        

  SPRT and/or RIRT             X             X        X         X        X

  Thermistor thermometer                     X        X         X        X

  Gold/platinum thermocouple                 X        X         X        X

  Type S, R or B thermocouple                         X         X        X

  Total-immersion                                     X         X        X
  liquid-in-glass                                                        
  ---------------------------- ------------- -------- --------- -------- --------

**6.5.5.2 Fixed-point cell as the reference standard**

**6.5.5.2.1** The purity of the fixed-point material should be at least
99.999 9 % and the other starting materials of construction of the cells
should be of ultra-high purity also. If the cells are unsealed, they
should be filled at all times with an inert gas such as argon.

**6.5.5.2.2** The cells should be of the defining fixed points of the
ITS 90, or well-characterized, stable and reproducible secondary fixed
points.

**6.5.5.3 SPRT or RIRT as the reference standard**

**6.5.5.3.1** A system having adequate resolution and uncertainty should
be used to measure a reference SPRT or RIRT. Recommendations for
specific situations are given below.

**6.5.5.3.2** A resistance bridge having at least the resolution shown
below, as a function of claimed total uncertainty, is recommended. A
ratio bridge and standard resistors may also be used:

+--------+---------------+--------------------------------------------+
| **Ech  | **Claimed     | **Minimum**                                |
| elon** | expanded      |                                            |
|        | uncertainty** | **bridge resolution**                      |
+--------+---------------+--------------------------------------------+
| I      | ≤ ± 0.01 °C   | 10 μΩ                                      |
+--------+---------------+--------------------------------------------+
| II     | ± 0.05 °C     | 50 μΩ                                      |
+--------+---------------+--------------------------------------------+
| III    | near ± 0.20   | 200 μΩ                                     |
|        | °C            |                                            |
+--------+---------------+--------------------------------------------+
| IV     | near ± 1.0 °C | 1 mΩ                                       |
+--------+---------------+--------------------------------------------+

**6.5.5.3.3** Alternatively, a DVM or DMM with the resolution shown
below, and a constant-current source with provision for reversing the
current, may be used. The current should be known to the same accuracy
as the DVM or DMM.

+------------------------+---------------------------------------------+
| **Echelon**            | **DVM or DMM resolution**                   |
|                        |                                             |
|                        | **(digits)**                                |
+------------------------+---------------------------------------------+
| I                      | 6.5                                         |
+------------------------+---------------------------------------------+
| II                     | 6.5                                         |
+------------------------+---------------------------------------------+
| III                    | 6.5                                         |
+------------------------+---------------------------------------------+
| IV                     | 6.5                                         |
+------------------------+---------------------------------------------+

**6.5.5.4 Thermocouple as the reference standard**

If the reference standard is a noble metal thermocouple used with a
scanner, a scanner with low thermal switches should be used.

**6.5.6 Measurement traceability and calibration**

**6.5.6.1 Fixed-point cell as the reference standard**

When the reference standard is a fixed-point cell, the four action items
described below are recommended as indicated by the application table
that follows them.

**6.5.6.1.1** The cell should be evaluated by NIST; or

**6.5.6.1.2** The cell may have been evaluated by the supplier, if the
supplier documented in detail the preparation and evaluation, showing
direct traceability to NIST, or is NVLAP accredited; or

**6.5.6.1.3** The cell should have been evaluated by a NVLAP accredited
supplier.

**6.5.6.1.4** The maximum uncertainty of the temperature of the cell
should be as indicated in the next table:

  -------------------- ------------- ------------ ----------- ------------
  **Item**             **Echelon**                            

                       **I**         **II**       **III**     **IV**

  6.5.6.1.1            X             X^\*^                    

  6.5.6.1.2                          X^\*\*^                  

  6.5.6.1.3                                       X           X

  6.5.6.1.4            ± l mK        ≤ ± 0.005   0.01 °C     ± 0.02 °C
                                     °C                       
  -------------------- ------------- ------------ ----------- ------------

\* for total uncertainties ≤± 0.01 °C

\*\* for total uncertainties in range ± 0.01 °C to ± 0.05 °C

**6.5.6.2 SPRT or RIRT as the reference standard**

When the reference standard is an SPRT or RIRT, the four action items
described below are recommended as indicated by the application table
that follows them.

**6.5.6.2.1** The SPRT or RIRT should be calibrated by NIST or a NVLAP
accredited laboratory every 2 years but may be calibrated by NIST every
2 to 5 years if adequate measurement process data is evident.

**6.5.6.2.2** The SPRT or RIRT should be calibrated annually, and all
reference resistors used with the bridge should be calibrated traceable
to NIST.

**6.5.6.2.3** If a bridge is used, it should be calibrated annually, and
all reference resistors used with the bridge should be calibrated
traceable to NIST.

**6.5.6.2.4** If a DVM or DMM is used, it should be calibrated annually.

  ------------------ ------------- ---------- ---------- ---------- ---------
  **Item**           **Echelon**                                    

                     **I**         **II**     **III**    **IV**     **V**

  6.5.6.2.1          X             X          X          X          

  6.5.6.2.2                                                         X

  6.5.6.2.3          X             X          X          X          

  6.5.6.2.4          X             X          X          X          X
  ------------------ ------------- ---------- ---------- ---------- ---------

**6.5.6.3** If a thermistor thermometer is the reference standard, it
should be calibrated traceable to NIST.

**6.5.6.4** If a thermocouple is the reference standard, documentation
should show that its calibration is traceable to NIST and indicate the
annealing procedure used during the thermocouple\'s use.

**6.5.6.5** If a liquid-in-glass thermometer is the reference standard,
it should be calibrated traceable to NIST.

**6.5.7 Calibration methods**

**6.5.7.1** All computer programs used in data logging and analysis
should be documented in detail. Also, all algorithms and equipment
should be correct for the task.

**6.5.7.2** When calibrations are performed by comparison against an
SPRT or an RIRT, or a thermistor thermometer, or a liquid-in-glass
thermometer, the five action items described below are recommended as
indicated by the application table that follows them.

**6.5.7.2.1** f a liquid medium is used, it should be stirred vigorously
and a comparison block should be located in the bath to aid in improving
the uniformity.

**6.5.7.2.2** If a liquid medium is used, it should be adequately
stirred and a comparison block should be located in the bath to aid in
improving the uniformity.

**6.5.7.2.3** If the comparison medium is a liquid, it should be
adequately stirred.

**6.5.7.2.4** The uniformity of the comparison medium should be measured
by means of a fast-responding thermometer.

**6.5.7.2.5** The temperature stability and uniformity of the comparison
medium should be as shown in the next table.

  ----------------- ------------- ---------- ---------- ---------- ----------
  **Item**          **Echelon**                                    

                    **I**         **II**     **III**    **IV**     **V**

  6.5.7.2.1         X             X                                

  6.5.7.2.2                                  X          X          

  6.5.7.2.3                                                        X

  6.5.7.2.4                                  X          X          

  6.5.7.2.5         ± 0.5 mK      ± 0.5      \(a\)      \(a\)      \(a\)
                                  mK^\*^                           
  ----------------- ------------- ---------- ---------- ---------- ----------

^\*^For claimed expanded uncertainty \< ± 0.01 °C. For claimed expanded
uncertainty \> ± 0.01 °C, at least 10 times better than the claimed
expanded uncertainty.

\(a\) At least 10 times better than the claimed expanded uncertainty.

**6.5.7.3** When the reference standard is a total-immersion
mercury-in-glass thermometer, corrections obtained from measurements at
the ice point should be made for all temperature measurements.

**6.5.7.4** The ice-point bath should be made according to accepted
procedures from ice made from distilled water. This applies to Echelons
III, IV and V.

**6.5.8 Handling of calibration items**

In addition to the general requirements set forth for all calibration
items, it should be noted that SPRT\'s are susceptible to and need
protection from shock and vibration in shipping, handling, and storage.

**6.6 Technical Criteria for Moisture
Laboratories**[^8][]{#__RefHeading___Toc169420781 .anchor}- Grain and/or
Commodities

**6.6.1 Scope**

**6.6.1.1** The purpose of this section is to specify the specific
technical criteria needed to meaningfully assess the competence of a
testing laboratory that performs moisture analyses.

**6.6.1.2** This document may also be used as a guide by moisture
laboratories in the development and implementation of their quality
systems.

**6.6.1.3** Laboratories may be Recognized based on procedures used to
determine moisture. These four procedural categories identify the method
of moisture determination and the reference methods. The scope of
Recognition follows the categories as defined in Table 13. Laboratories
may be Recognized under two or more categories if they have the
necessary equipment, skills, knowledge, measurement control and
demonstrated competence to perform adequately in each category.

**NOTE:** The national laboratory for grain moisture in the United
States is the Grain Inspection Packers and Stockyards Administration
(GIPSA) formerly known as the Federal Grain Inspection Service (FGIS).
The standard method recognized by the GIPSA laboratory is the Air Oven
Method. Grain moisture testing laboratories should reference the Air
Oven Method and participate in interlaboratory comparisons to ensure
comparability of measurements with the national laboratory.

**Table 13. Moisture determination laboratory
classifications**[]{#__RefHeading___Toc169420782 .anchor}

+--------------+-----+-------------------+----------------------------+
| **Procedural | *   |                   | **Reference Methods**      |
| Category**   | *Mo |                   |                            |
|              | ist |                   |                            |
|              | ure |                   |                            |
|              | D   |                   |                            |
|              | ete |                   |                            |
|              | rmi |                   |                            |
|              | nat |                   |                            |
|              | ion |                   |                            |
|              | Me  |                   |                            |
|              | tho |                   |                            |
|              | d** |                   |                            |
+--------------+-----+-------------------+----------------------------+
| I            | Ia  | Air Oven          | GIPSA, Technical Services  |
|              |     |                   | Division, Air Oven         |
| Oven Methods |     |                   | Moisture Reference         |
|              |     |                   | Laboratory Working         |
|              |     |                   | Instructions               |
+--------------+-----+-------------------+----------------------------+
|              | Ib  | Vacuum Oven       | AOAC Official Methods of   |
|              |     |                   | Analysis, 17th ed.         |
|              |     |                   | Revision 1, 2002, vacuum   |
|              |     |                   | oven methods, Sec. 32      |
+--------------+-----+-------------------+----------------------------+
| II           | IIa | Karl Fischer      | AOAC Official Methods of   |
|              |     | chemical analysis | Analysis, 17th ed.         |
| Chemical     |     |                   | Revision 1, 2002, Karl     |
| Method       |     |                   | Fischer methods            |
|              |     |                   |                            |
|              |     |                   | AOAC, Automatic Karl       |
|              |     |                   | Fischer Titration of       |
|              |     |                   | Moisture in Grain, (Vol.   |
|              |     |                   | 64, No. 6, 1981)           |
+--------------+-----+-------------------+----------------------------+
|              | IIb | Basic Reference   | ISO 711, Cereals and       |
|              |     | Method            | Cereal Products-           |
|              |     |                   | Determination of Moisture  |
|              |     |                   | Content                    |
+--------------+-----+-------------------+----------------------------+

**6.6.1.4** Laboratories should document the grains and/or commodities
tested and maintain replicate results within ± 0.2 %. The scope of
Recognition should indicate identified grains and/or commodities and the
uncertainty limits. Uncertainty analysis should be completed according
to the ISO Guide for the Expression of Uncertainty in Measurement.

**6.6.1.5** Important definitions in this section follow:

***Moisture content*** - The loss in mass, expressed as a percentage,
undergone by the product under the conditions specified in this
document.

***Air Oven*** - A device that uses gravity convection or mechanical
convection (forced-draft) to heat air in a chamber to its controlled
temperature.

***Vacuum Oven*** - A device that uses a vacuum to alter the pressure
within the oven chamber and maintain a temperature at that specific
pressure.

***Karl Fischer Titration*** - A procedure that involves the
simultaneous grinding of grain/commodity and extraction of the water
with methanol and the subsequent titration of the extract with Karl
Fisher reagent.

***Basic Reference Method*** - An ISO procedure (ISO Guide 711) using
oven and chemicals to determine moisture content of a product.

**6.6.2 References**

> \[1\] United States Department of Agriculture, Grain Inspection
> Packers and Stockyards Administration, (GIPSA), Technical Services
> Division, Air Oven Moisture Reference Laboratory Working Instructions,
> September 2002 (Internal Documents).
>
> \[2\] ASTM E 145-94, Standard Specification for Gravity Convection and
> Forced-Ventilation Ovens (2006).
>
> \[3\] Association of Official Analytical Chemists (AOAC), Official
> Methods of Analysis, 17th Edition Revision 1, 2002.
>
> \[4\] AOAC, Automatic Karl Fischer Titration of Moisture in Grain,
> Volume 64, No. 6, 1981.
>
> \[5\] Anderson, J. E. \"Storage of Cereal Grains and Their Products,\"
> Chapter 1, Moisture - Its Significance, Behavior, and Measurement.
> (Hunt, W. Haward, Pixton, S. W.).
>
> \[6\] ISO 711, International Standard, Cereals and Cereal Products -
> Determination of Moisture Content (Basic Reference Method) Second
> edition, 1985.
>
> \[7\] Scholz, Eugen, Karl Fischer Titration, 1984.

**6.6.3 Statistical process control**

**6.6.3.1** An appropriate statistical process control system should be
in place including procedures for measurement verification through
participation in interlaboratory comparisons between the laboratory,
GIPSA and other laboratories.

**6.6.3.2** It is critical that testing results remain consistent with
previous laboratory test results; repeated tests should remain within
the laboratories documented uncertainties and be evaluated using
statistical methods.

**6.6.3.3** A laboratory should have an operating procedure to review
data for trends and failures to indicate where failure has occurred.
Records of corrective action, repair, or recalibration should also be
maintained.

**6.6.4 Accommodation and environment**

**6.6.4.1** To make adequate measurements, moisture determination
laboratories should have a facility with adequate environmental controls
appropriate for the laboratory classification.

**6.6.4.2** Due to the extreme hygroscopic properties of ground grain
(oven methods) and methanol (Karl Fischer chemical method), humidity and
temperature should be controlled within the following parameters:

Temperature: 20 °C to 23 °C, set point ± 2 °C, maximum change of 1.0
°C/h; and

Humidity: 40 % to 60 % ± 10 %

**NOTE:** Sample exposure to the environment should be minimized
throughout the collection, storage, and testing process.

**6.6.4.3** To prevent contamination of test samples, from grain and/or
commodity dust particles, adequate cleanliness should be maintained.

**6.6.4.4** Adequate space should be available for sample storage,
preparation and testing and be appropriately organized for efficient
operation. Laboratory equipment should be logically placed to
accommodate handling of samples, operation and maintenance of equipment
and to prevent accidental sample substitution.

**6.6.4.5** Grains and/or commodities under test should be kept in
refrigerated storage areas. The refrigerated storage areas should be
maintained between 1.5 °C and 7.0 °C.

**6.6.4.6** Excess vibration may adversely affect the performance of
precision analytical balances and mass comparators and should be
prevented. Proximity to heavy machinery, railways, heavily traveled
highways, or similar sources of known vibration is not recommended.
Steps should be taken to reduce vibration to an acceptable level of
stability with methods such as isolated foundations for balances or
elimination of the source.

**6.6.4.7** Laboratories should ensure that electrical disturbances that
affect moisture results are kept at a minimum.

**6.6.4.8** Undesirable effects due to static electricity should be
controlled as needed by maintaining appropriate laboratory humidity or
with antistatic deionizing radiation devices. The grounding of balances
or operators, or the use of special conductive flooring may also be
used.

**6.6.5 Equipment and reference materials**

**6.6.5.1 Standard reference materials**

**6.6.5.1.1** Category Ia and Ib laboratories - The grains and/or
commodities are prepared for use as reference standards according to
documented procedures for oven testing. During preparation, storage and
distribution, care should be taken to ensure reference sample integrity.

**6.6.5.1.2** Category IIa and IIb laboratories - Specified reagents are
used according to manufacturers\' instructions for the specific type of
Karl Fischer titration equipment in use. Category IIb laboratories
generally should use chemicals specified in International Standard ISO
711, Sec. 7. During sample preparation, the integrity of the reagents
and samples is critical.

**6.6.5.2 Primary equipment - oven methods**

**6.6.5.2.1** Category Ia laboratories should have appropriate equipment
for the moisture determination of grain and/or commodity moisture:
mechanical (forced draft) or gravity convection ovens, desiccator, mill,
moisture dishes, and analytical balance. Reference GIPSA Technical
Services Division, Air Oven Moisture Reference Laboratory Working
Instructions for equipment specifications.

**NOTE 1:** The use of a mechanical convection (forced draft) oven is
strongly recommended. Tests have shown that ovens of the forced-draft
type have more uniform temperature due to heat circulation, the
temperature recovery is more rapid after insertion of samples and will
accommodate more samples than gravity convection ovens.

**NOTE 2:** Laboratories should have temperature monitoring devices with
suitable accuracy and traceability to record oven temperatures during
moisture testing.

**6.6.5.2.2** Category Ib laboratories should have appropriate equipment
for the moisture determination of grain and/or commodities: vacuum oven
desiccator, mill, moisture dishes, and analytical balance with the same
requirements as class Ia laboratories. Reference AOAC, Official Methods
of Test for equipment specifications.

**6.6.5.3 Primary equipment - Karl Fischer chemical analysis**

**6.6.5.3.1** Category IIa laboratories should have appropriate
equipment for the moisture determination of grain and/or commodities:
Karl Fischer Titration Assembly (manual or automatic with a stirrer),
mill, centrifuge, and analytical balance. Reference manufacturers\'
instructions and *Karl Fischer Titration*, Eugen Scholz, 1984.

**6.6.5.3.2** Category IIb laboratories should have appropriate
equipment for the moisture determination of grain and/or commodities:
analytical balance, apparatus for reducing pressure, mill, dishes, cup,
drying tube, oven, air-drying train, and desiccator. Reference
International Standard ISO 711 for equipment specifications.

**6.6.5.4 Secondary equipment**

**6.6.5.4.1** Laboratories should measure air temperature and relative
humidity of the laboratory environment. Instruments are used in close
proximity to the grain and/or commodity tested. Laboratory ovens should
be equipped with calibrated, accurate and traceable thermometers
(accurate within ± 0.5 C) to ensure the accuracy of the oven
temperature.

**6.6.5.4.2** Samples should be stored in clean, air-tight and
moisture-proof glass containers or plastic bags to prevent the loss or
gain of moisture in the product. Plastic bags should have a thickness of
at least 0.1 mm (4 mil, 0.004 in). A thickness of 0.15 mm (6 mil, 0.006
in) is preferred due to greater durability.

**6.6.6 Measurement traceability and calibration**

**6.6.6.1** Since direct traceability to a standard (national
measurement unit) is not possible for moisture measurements of the type
described here, and the Federal standard for grain moisture is defined
by comparison to GIPSA results, it is critical for the laboratory to
participate in interlaboratory comparison programs to establish
\"comparability\" of the results between the laboratories.

**6.6.6.2** It is essential that moisture testing equipment that affects
the accuracy of the moisture measurement (e.g., to include thermometers
and balances) be periodically calibrated or verified for accuracy and
traceability.

**6.6.6.3** Balances used in determining moisture content should be
periodically verified or calibrated prior to use.

**6.6.6.4** Instruments used to monitor environmental conditions in the
laboratory should be periodically recalibrated. Appropriate calibration
intervals should be established and documented by the laboratory.

**6.6.7 Moisture determination methods**

**6.6.7.1** The types of moisture determination methods employed, and
equipment used, should be appropriate for the grains and/or commodities
being tested based on the procedural category. Measurement methods
should provide acceptable repeatability. A documented procedure for each
method should be available.

**6.6.7.2** Computer programs used in the moisture determination of
grains and/or commodities should have passed software quality analysis.
Computer programs may be tested, using standard data sets designed to
magnify errors, as an effective way of showing that program errors do
not effect some measurements but cause others to be incorrect. Computer
programs should be documented in detail. Documentation should include
technical references that provide the basis for the algorithm, the
moisture equations, and the data set used to test the program for
errors.

**6.6.8 Handling of grain and/or commodities for moisture
determination**

**6.6.8.1** The laboratory should have documented procedures to ensure
that all samples are properly and uniquely marked upon receipt to
include: the type of sample and a nonrepetitive identification number to
ensure adequate tracking of samples in laboratory and field.

**6.6.8.2** The laboratory should document appropriate procedures for
proper cleaning and storage of samples to ensure integrity.

**6.6.8.3** Documented procedures should be maintained that ensure that
subportions of the sample under test are representative of the whole.

**NOTE:** Care should be taken during sample collection and handling to
prevent contamination of the sample with body oil or moisture, and to
protect the sample from extreme environmental moisture and temperature.

**6.6.9 Test reports**

**6.6.9.1** In addition to meeting the criteria in section 5.10 of this
handbook, test reports when necessary, should include: moisture
determination results, sample type, condition and identification number,
type of moisture determination used to ascertain the results, and the
precision of measurement (repeatability between the dishes or duplicate
runs.)

**6.6.9.2** Environmental parameters measured during the test should be
provided on reports. These include laboratory temperature and relative
humidity.

**6.6.9.3** Information regarding cleaning methods (if performed) should
be provided on the test report.

**Table 14. Summary of environmental facility
guidelines**[]{#__RefHeading___Toc169420783 .anchor} (as described in
Section 6)

+--------+--------+------+-------+-------+----------+-------+------+
| **     | *      | **±  | **Max | **±   | **       | **RH  | **   |
| Parame | *Tempe | Temp | c     | T     | Relative | %     | Pres |
| ter,** | rature | var  | hange | emp** | Humidity | accur | sure |
|        | range  | iabi | per   |       | (RH)**   | acy** | ac   |
| **Ech  | °C**   | lity | hour  | **acc |          |       | cura |
| elon** |        | °C** | °C**  | uracy | **%      | *     | cy** |
|        | **(set |      |       | °C**  | range**  | *(max |      |
|        | po     |      |       |       |          | c     | **   |
|        | int)** |      |       |       |          | hange | Pa** |
|        |        |      |       |       |          | per 4 |      |
|        |        |      |       |       |          | h)**  |      |
+--------+--------+------+-------+-------+----------+-------+------+
| Mass I | 20 to  | 1.0  | 0.5   | 0.1   | 40 to 60 | 5     | 65   |
|        | 23     |      |       |       |          |       |      |
+--------+--------+------+-------+-------+----------+-------+------+
| Mass   | 20 to  | 2.0  | 1.0   | 0.5   | 40 to 60 | 10    | 135  |
| II     | 23     |      |       |       |          |       |      |
+--------+--------+------+-------+-------+----------+-------+------+
| Mass   | 18 to  |      | 2.0   |       | 40 to 60 | 20    |      |
| III    | 27     |      |       |       |          |       |      |
+--------+--------+------+-------+-------+----------+-------+------+
| Gravi  | 20 to  | 2.0  | 1.0   | 0.    | 40 to 60 | 10    |      |
| metric | 23     |      |       | 1/0.5 |          |       |      |
| I      |        |      |       |       |          |       |      |
|        |        |      |       | (H    |          |       |      |
| Volume |        |      |       | ~2~O, |          |       |      |
|        |        |      |       | air)  |          |       |      |
+--------+--------+------+-------+-------+----------+-------+------+
| Volume | 18 to  | 2.0  | 2.0   | 0.5   | 40 to 60 | 20    | 135  |
| Tr     | 27     |      |       |       |          |       |      |
| ansfer |        |      |       |       |          |       |      |
| II     |        |      |       |       |          |       |      |
+--------+--------+------+-------+-------+----------+-------+------+
| Dimen  | 20 (18 | 1.0  |       | 0.5   | \< 50    | 20    |      |
| sional | to 22) |      |       |       |          |       |      |
+--------+--------+------+-------+-------+----------+-------+------+
| Tempe  |        | 2.0  |       |       | 40 to 60 | 10    |      |
| rature |        |      |       |       |          |       |      |
+--------+--------+------+-------+-------+----------+-------+------+
| Tuning |        |      |       |       |          |       |      |
| Forks  |        |      |       |       |          |       |      |
+--------+--------+------+-------+-------+----------+-------+------+
| Hydro  |        |      |       | 0.01  |          |       |      |
| meters |        |      |       | (     |          |       |      |
|        |        |      |       | bath) |          |       |      |
+--------+--------+------+-------+-------+----------+-------+------+
| Time   |        |      |       |       |          |       |      |
+--------+--------+------+-------+-------+----------+-------+------+
| Grain  | 20 to  | 2.0  | 1.0   | 0.5   | 40 to 60 |       |      |
| Mo     | 23     |      |       |       |          |       |      |
| isture |        |      |       |       |          |       |      |
+--------+--------+------+-------+-------+----------+-------+------+

**THIS PAGE LEFT INTENTIONALLY BLANK**

**7. References**[]{#__RefHeading___Toc169420784 .anchor}

Asia Pacific laboratory Accreditation Cooperation (APLAC) SEC 045,
Procedure for Management Review and Internal Audits, Issue No. 4, July
2006.

APLAC TC 002, Internal Audits for Laboratories and Inspection Bodies,
Issue No. 3, May 2006.

ANSI/NCSL Z540.1-1994 (R2002), American National Standards Institute,
National Conference of Standards Laboratories, American National
Standard, *General Requirements for Calibration Laboratories and
Measuring and Test Equipment*.

ISO/IEC 10012-1, International Organization for Standardization,
International Standard 10012‑1, *Quality Assurance Requirements for
Measuring Equipment, Part 1, Metrological Confirmation System for
Measuring Equipment*, 1992.

ISO/IEC 17025, International Organization for Standardization, *General
Requirements for the Competence of Testing and Calibration
Laboratories*, 2005.

*International Vocabulary of Basic and General Terms in Metrology*
(VIM), BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML, Definition 6.10, 2^nd^
ed., 1993.

NCSL Recommended Practice RP-7: *Laboratory Design,* November 2000.

NBS Handbook 145, *Handbook for the Quality Assurance of Metrological
Measurements*, Oppermann, H.V., Taylor, J., 1986.

NIST Handbook 150, *National Voluntary Laboratory Accreditation Program,
NVLAP,* *Procedures and General Requirements*, Faison, C. D., Horlick,
J., Merkel, W. R., White, V. R., Editors, February 2006.

NIST HB 150-2F, *NVLAP Calibration Laboratories Technical Guide for
Dimensional Measurements*, Faison, C. D. and Brickenkamp, C. S.,
Editors, September 2003.

NIST HANDBOOK 150-2G, *Calibration Laboratories Technical Guide for
Mechanical Measurements*, Faison, C. D. and Brickenkamp, C. S, Editors,
March 2004.

NIST HANDBOOK 150-2H, *Calibration Laboratories Technical Guide for
Thermodynamic Measurements*, Faison,C.D. and Brickenkamp,C.S. Editors,
February 2004.

NIST Special Publication (SP) 791, *State Weights and Measures
Laboratories: State Standards Program Description and Directory*,
Harris, G. L., 2000.

NISTIR 5672, *Advanced Mass Measurements and Measurement Assurance
Program for State Calibration Laboratories, (2005 Ed.)*, Fraley, K. L.,
Harris, G. L., 2005.

NISTIR 6176, *Process Measurement Assurance Program For U.S. State
Metrology Laboratories*, Everhart, J. L., Harris, G. L., June 1998.

NISTIR 6969, *Selected Laboratory and Measurement Practices, and
Procedures, to Support Basic Mass Calibrations*, Harris, G. L., Torres,
J. A., March 2003, with on-line updates December 2003.

NISTIR 7383, *Selected Procedures for Volumetric Calibrations*, Harris,
G. L., November 2006.

NISTIR 5802, *Quality Manual Template for State Weights and Measures
Laboratories*, Lee, G. D., 1995.

NISTIR 7028, *Type Evaluation Laboratory Quality Manual Template,
Developed for U.S. Type Evaluation Laboratories*, Lee, G. D. July 2003.

NISTIR 7082, *Proficiency Test Policy and Plan (for State Weights &
Measures Laboratories)*, Gust, J., Harris, G. L., January 2004.

NISTIR 7214, *Weights and Measures Division Quality Manual For
Proficiency Testing and Interlaboratory Comparisons*, Gust, J., Harris,
G. L., March 2005.

**8. Glossary**[]{#__RefHeading___Toc169420785 .anchor}

The following section contains the definitions of a number of terms in
the sense in which they are used throughout this Handbook. Where
applicable, definitions are taken from: 1) NIST Handbook 150, NVLAP
Procedures and General Requirements, 2006 wherever possible; 2) The
International Vocabulary of Basic and General Terms in Metrology
(VIM:1994); or 3) NIST Handbook 143, Program Handbook, 2003 edition.
Many of the NIST Handbook 150 definitions are taken from the VIM:1994.

***Accreditation -*** a formal Recognition that a laboratory is
competent to carry out specific tests or calibrations or types of tests
or calibrations. (HB 150)

***Accreditation Process -*** the process of demonstrating whether a
calibration laboratory is capable of fulfilling specified accreditation
requirements.

***Approved Signatory (of an accredited laboratory) -*** an individual
who is Recognized by WMD as competent to sign official laboratory
calibration certificates or test reports. (HB 150, modified)

5)  NOTE: The Approved Signatory is responsible for the technical
    content of the report and is the person to be contacted by WMD,
    laboratory customers, or others in case of questions or problems
    with the report. Approved Signatories shall be persons with
    responsibility, authority, and technical capability within the
    organization for the results produced. The laboratory must maintain
    a list of Approved Signatories and make that list available for
    review during on-site assessments and to WMD upon request.

***Authorized Representative (of a Recognized laboratory) -*** an
individual who is authorized by the laboratory or the parent
organization to sign the WMD Request for Recognition form and commit the
laboratory to fulfill the WMD requirements. The Authorized
Representative reports to NIST/WMD changes that may affect the
laboratory's capability, scope of recognition, or compliance with
recognition requirements. (The Authorized Representative may also be
recommended by the laboratory as an Approved Signatory. Only the
Authorized Representative can authorize a change in the scope or nature
of the laboratory\'s Request for Recognition.) (HB 150, modified)

***Calibration -*** a set of operations which establish, under specified
conditions, the relationship between values indicated by a measuring
instrument or measuring system, or values represented by a material
measure, and the corresponding known values of a measurand. (HB 150)

Also: comparison of a measurement standard or instrument with another
standard or instrument to detect, correlate, report, or eliminate by
adjustment any inaccuracy of the compared.

***Certificate of Measurement Traceability* -** a certificate issued to
a State legal metrology laboratory indicating that the laboratory has
traceable standards, can make and provide traceable measurements, and
complies with the requirements of NIST Handbook 143, Program Handbook.

***Corrective Action -*** an action taken to eliminate the causes of an
existing nonconformity or other undesirable situation in order to
prevent recurrence.

***Customer -*** any person or organization that engages the services of
a testing or calibration laboratory. (HB 150)

***Good Laboratory Practices (GLP) -*** an acceptable way to perform
some basic operation or activity in a laboratory, that is known, or
believed to influence, the quality of its outputs. GLPs ordinarily are
essentially independent of the measurement techniques used. (HB 143,
1997)

***Good Measurement Practices (GMP) -*** an acceptable way to perform
some operation associated with a specific measurement technique, and
which is known or believed to influence the quality of the measurement.
(HB 143, 1997)

***Interlaboratory Comparisons -*** organization, performance and
evaluation of calibrations or tests on the same or similar items or
materials by two or more laboratories in accordance with predetermined
conditions. (HB 150)

***Internal Assessment -*** the process of self-appraisal of a
calibration or testing laboratory using specified general and technical
criteria and checklists to evaluate compliance to Recognition (or
accreditation) requirements; may be used as a management system review
as well.

***Laboratory -*** an organization that performs tests and/or
calibrations. When a laboratory is part of an organization that carries
out activities additional to calibration and testing, the term
\"laboratory\" refers only to those parts of that organization that are
involved in the calibration and testing process. A laboratory's
activities may be carried out at a permanent location, temporary, or
remote location. A laboratory may be further defined as being a physical
entity- that is, a testing or calibration facility that is separate and
apart physically from any other laboratory whether or not sharing common
ownership, management, or management systems with any other
laboratory(s). (HB 150, modified)

***Length Laboratory -*** a specific area, within a metrology
laboratory, that is used solely for calibration or tolerance testing of
length standards. (HB 143, 1997)

***Management system --*** system to establish policy and objectives and
to achieve those objectives.

NOTE A management system of an organization may include different
management systems, such as a quality management system, a financial
management system, or an environmental management system. (HB 150, ISO
9000:2000, 2.2.2)

***Mass Laboratory -*** a specific area, within a metrology laboratory,
that is used solely for calibration or tolerance testing of mass
standards or test weights; generally divided into small mass (≤ 10 kg)
and large mass (\> 10 kg) areas. (HB 143, 1997)

***Measurement Assurance -*** a process to ensure adequate measurement
results that may include, but is not limited to: 1) use of good
experimental design principles so that the entire measurement process,
its components, and relevant influence factors can be well
characterized, monitored, and controlled; 2) complete experimental
characterization of the measurement process uncertainty including
statistical variations, contributions from all known or suspected
influence factors, imported uncertainties, and the propagation of
uncertainties throughout the measurement process; and 3) continuously
monitoring the performance and state of statistical control of the
measurement process with proven statistical process control techniques
including the measurement of well-characterized check standards along
with the normal workload and the use of appropriate control charts. (HB
150)

***Measuring and test equipment (M & TE) --*** all of the measuring
instruments, measurement standards, reference materials, auxiliary
apparatus and instructions that are necessary to perform a measurement.
This term includes measuring equipment used in the course of testing and
inspection, as well as that used in calibration.

NOTE In the context of this handbook, the term "measuring and test
equipment" is taken to encompass "measurement instruments" and
"measurement standards." Moreover, a "reference material" is considered
to be a type of "measurement standard." (HB 150)

***NVLAP -*** the NIST National Voluntary Laboratory Accreditation
Program.

***Nonconformity -*** the non-fulfillment of NIST/WMD conditions and/or
criteria for Recognition (or accreditation); previously referred to as a
deficiency. (HB 150, modified)

***On-Site Assessment -*** systematic, independent, documented process
for determining laboratory competence and for obtaining records,
statements of fact or other relevant information by assessors at the
laboratory facilities and other places where test or calibration
services are provided with the objective of determining the extent to
which the criteria of this handbook are fulfilled. (HB 150)

***Proficiency Testing -*** the determination of laboratory performance
by means of comparing and evaluating calibrations or tests on the same
or similar items or materials by two or more laboratories in accordance
with predetermined conditions. (HB 150, modified)

***Preventive Action -*** an action taken to eliminate the cause of a
potential nonconformity or other undesirable situation in order to
prevent occurrence.

***Quality Audit -*** a systematic and independent examination to
determine whether quality activities and related results comply with
planned arrangements and whether these arrangements are implemented
effectively, and are suitable to achieve objectives. (HB 150)

***Quality Control -*** the operational techniques and activities that
are used to fulfill requirements for quality.

***Quality Manual -*** a document stating the quality policy, management
system, and quality practices of an organization. The quality manual may
reference other laboratory documentation. (HB 150, modified)

***Recognition* *- ***the evaluation and issuance of a Certificate of
Measurement Traceability and letter regarding the laboratory management
system for State weights and measures metrology laboratories (not a
formal accreditation).

***RMAP -*** Regional Measurement Assurance Program. A regional approach
to ensuring measurement assurance through periodic gathering to conduct
training, interlaboratory comparisons, and continuous improvement
activities. WMD jointly operates six regional MAPs in cooperation with
the State laboratories.

***Scope of Recognition -*** a statement or document issued by NIST/WMD
which lists the test methods or services, or calibration services for
which the laboratory is recognized. The scope for each measurement area
includes the range at each level.

***Standard, Check (or control) -*** a standard that is used as part of
a process measurement assurance program to provide a \"check\" on the
process and standards to ensure that the standards, measurement results,
and measurement processes are within acceptable statistical limits.

***Standard, Intrinsic*** - intrinsic standards are based on
well-characterized laws of physics, fundamental constants, or invariant
properties of materials, and they make ideal stable, precise, and
accurate measurement standards if properly designed, characterized,
operated, monitored and maintained. (NCSL, Traceability Resolution
Meeting. 1/25/96)

***Standard, Primary -*** a standard that is designated or widely
acknowledged as having the highest metrological qualities and whose
value is accepted without reference to other standards of the same
quantity. (HB 150)

***Standard, Reference -*** a standard, generally of the highest
metrological quality available at a given location, from which
measurements made at that location are derived. (HB 150)

***Standard, Secondary -*** a standard whose value is assigned by
comparison with a reference \[primary\] standard of the same quantity.
(HB 150)

***Standard, Working -*** a standard that is usually calibrated against
a reference standard, and is used routinely to calibrate or check
material measures, measuring instruments, or reference materials. (HB
150)

***Standard Operating Procedure (SOP) -*** a procedure adopted for
repetitive use when performing a specific measurement or sampling
operation. It may be a standard method or one developed by the user. (HB
143, 1997)

***State Laboratory Program -*** a program of the NIST Weights and
Measures Division designated to provide guidance, technical support, and
assistance to State legal metrology laboratories to ensure accurate and
traceable measurements from NIST to the local jurisdictions.

***Temperature Laboratory -*** a specific area, within a metrology
laboratory, that is used solely for calibration or tolerance testing of
temperature standards.

***Tolerance Testing -*** a measurement operation performed to determine
whether the actual value of a standard, artifact, or instrument is
within a permitted tolerance of its nominal value. An error and
uncertainty value must first be determined before one can assess the
tolerance status. (HB 143, 1997)

***Traceability -*** the property of the result of a measurement or the
value of a standard whereby it can be related to stated references,
usually national or international standards, through an unbroken chain
of comparisons all having stated uncertainties. (VIM:1993)

A measurement quality assurance system and periodic verification are
required to ensure that the accuracy of the measurement is within the
stated limits of uncertainty.

***Uncertainty -*** parameter, associated with the result of a
measurement, that characterizes the dispersion of the values that could
reasonably be attributed to the measurand. (HB 150)

***Volume Laboratory -*** a specific area, within a metrology
laboratory, that is used solely for calibration or tolerance testing of
volume standards; generally divided into small volume (≤ 20 L) and large
volume (\> 20 L) areas. (HB 143, 1997)

***WMD -*** the NIST Weights and Measures Division; Formerly NIST Office
of Weights and Measures (OWM).

**Appendix A. List of Services**[]{#__RefHeading___Toc169420786 .anchor}
**Available from NIST**

It is the objective of NIST to encourage all State laboratories to seek
full Recognition and formal accreditation. Technical assistance and
consultation includes the following:

1\. BASIC metrology training in mass, length, and volume (2 week
seminar). Corresponding NIST Special Publication 1001 and 1001-S, Basic
Mass Metrology CD-ROM training course (English & Spanish).

2\. INTERMEDIATE metrology training in mass, length, and volume (1 week
seminar). Prerequisite completion of BASIC course and BASIC LAP problems
or equivalent.

3\. NIST Precision Measurement Seminars. Seminars on special measurement
techniques (2 to 5 day duration). Examples - Precision Thermometry
Seminar, Advanced Mass Seminar.

4\. Recommended standard operating procedures, good laboratory
practices, and good measurement practices for:

a\. mass calibrations: three Echelons

\- weighing designs

\- comparison procedures

\- weight carts

c\. volume calibration: two Echelons

\- gravimetric

\- volume transfer

\- dynamic small volume provers

d\. length calibration

\- length bench

\- tape to tape

\- rigid rules

\- pi tapes

e\. temperature NBS Monograph 150

5\. Time and frequency information Special Publication 960-12, Stopwatch
and Timer Calibrations, Gust, J. C., Graham, R. M., Lombardi, M. A., May
2004.

6\. Measurement assurance information NBSIR 77 1240, six regional
measurement assurance programs, and proficiency testing nationally and
through the regional groups:

\- Caribbean Measurement Assurance Program, CaMAP

\- Southeast Measurement Assurance Program, SEMAP

\- Northeast Measurement Assurance Program, NEMAP

\- Southwest Assurance Program, SWAP

\- Western Regional Assurance Program, WRAP

\- MidAmerican Measurement Assurance Program, MidMAP.

7\. NIST evaluation of laboratory auditing program problems.

8\. NIST evaluation of laboratory facilities by on site visit.

9\. Measurement assurance programs in selected measurement areas.

For further details on any of the above, general information, or
assistance in areas not listed above, or in the case of special
measurement problems, contact:

Weights and Measures Division

National Institute of Standards and Technology

Gaithersburg, MD 20899

Phone: 301/975-4004

Fax: 301/975-8091

http://www.nist.gov/labmetrology

**Appendix B. Request for Recognition, Scope of Recognition, Approved
Signatories, Authorized Representative**[]{#__RefHeading___Toc169420787
.anchor}

**Name of laboratory**

**Address of laboratory**

**Scope of Recognition** - complete Appendix D with uncertainty
estimates included

**Approved Signatories** - have assigned responsibility for validity of
laboratory reports

**Authorized Representative** - contact for administration of laboratory
Recognition

**THIS PAGE LEFT INTENTIONALLY BLANK.**

**Appendix C. Laboratory Assessment
Checklist**[]{#__RefHeading___Toc169420788 .anchor}

(from NVLAP Handbook 150, 2006)

**GENERAL OPERATIONS CHECKLIST**

**Instructions to the Assessor (or Quality Manager):** This checklist
addresses the general accreditation criteria prescribed in NIST Handbook
150, *NVLAP Procedures and General Requirements* (2006 edition)*.* The
checklist items are numbered to correspond to the requirements found in
4 and 5 of the Handbook.

Place an \"X\" beside each checklist item that represents nonconformity.
Place a \"C\" beside each item on which you are commenting for other
reasons. Record the item number and written noncomformity explanation
and/or comment on the comment sheet(s) at the end of the checklist.
Write \"OK\" beside all other items you observed or verified as
compliant at the laboratory. Identify policies and procedures where
called for.

  -----------------------------------------------------------------------
  **4 Management requirements for accreditation**

  **4.1 Organization**
  -----------------------------------------------------------------------

  ------------ ----------- ------------------------------------------------------------------------
  **\_\_\_**   **4.1.1**   The laboratory or the organization of which it is part shall be an
                           entity that can be held legally responsible.

                           

                           Legal name of laboratory ownership:
                           \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

                           

  **\_\_\_**   **4.1.2**   It is the responsibility of the laboratory to carry out its testing and
                           calibration activities in such a way as to meet the requirements of this
                           Handbook and to satisfy the needs of the customer, the regulatory
                           authorities or organizations providing recognition.

                           

  \_\_\_       **4.1.3**   The laboratory management system shall cover work carried out in the
                           laboratory's permanent facilities, at sites away from its permanent
                           facilities, or in associated temporary or mobile facilities.

                           

  \_\_\_       **4.1.4**   If the laboratory is part of an organization performing activities other
                           than testing and/or calibration, the responsibilities of key personnel
                           in the organization that have an involvement or influence on the testing
                           and/or calibration activities of the laboratory shall be defined in
                           order to identify potential conflicts of interest.
  ------------ ----------- ------------------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 1:** Where a laboratory is part of a larger organization,
       the organizational arrangements should be such that departments
       having conflicting interests, such as production, commercial
       marketing or financing do not adversely influence the
       laboratory\'s compliance with the requirements of this Handbook.

       

       **NOTE 2:** If the laboratory wishes to be Recognized as a
       third-party laboratory, it should be able to demonstrate that it
       is impartial and that it and its personnel are free from any undue
       commercial, financial and other pressures which might influence
       their technical judgment. The third-party testing or calibration
       laboratory should not engage in any activities that may endanger
       the trust in its independence of judgment and integrity in
       relation to its testing or calibration activities.

       
  ---- ------------------------------------------------------------------

+---+------------------------------------------------------------------+
|   | 5.  The laboratory shall:                                        |
+---+------------------------------------------------------------------+

  -------- ----- ------------------------------------------------------------
  \_\_\_   1\)   have managerial and technical personnel who, irrespective of
                 other responsibilities, have the authority and resources
                 needed to carry out their duties, including the
                 implementation, maintenance and improvement of the
                 management system, and to identify the occurrence of
                 departures from the management system or from the procedures
                 for performing tests and/or calibrations, and to initiate
                 actions to prevent or minimize such departures (see also
                 5.2);

  -------- ----- ------------------------------------------------------------

  -------- ----- ------------------------------------------------------------
  \_\_\_   2\)   have arrangements to ensure that its management and
                 personnel are free from any undue internal and external
                 commercial, financial and other pressures and influences
                 that may adversely affect the quality of their work;

  -------- ----- ------------------------------------------------------------

  ------------ ----- ------------- ------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------
  \_\_\_             3\)           have policies and procedures to ensure the protection of its customers' confidential information and proprietary   
                                   rights, including procedures for protecting the electronic storage and transmission of results;                    

                                                                                                                                                      

  \_\_\_             4\)           have policies and procedures to avoid involvement in any activities that would diminish confidence in its          
                                   competence, impartiality, judgment or operational integrity;                                                       

                                                                                                                                                      

  \_\_\_             5\)           define the organization and management structure of the laboratory, its place in any parent organization, and the  
                                   relationships between quality management, technical operations and support services;                               

                                                                                                                                                      

  \_\_\_             6\)           specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work   
                                   affecting the quality of the tests and/or calibrations;                                                            

                                                                                                                                                      

  \_\_\_             7\)           provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with        
                                   methods and procedures, purpose of each test and/or calibration, and with the assessment of the test or            
                                   calibration results;                                                                                               

                                                                                                                                                      

  \_\_\_             8\)           have technical management which has overall responsibility for the technical operations and the provision of the   
                                   resources needed to ensure the required quality of laboratory operations;                                          

                                                                                                                                                      

                                   Name of person:                                                                                                    
                                   \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_               

                                   Area of responsibility:                                                                                            
                                   \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                       

                                   Repeat as necessary: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_  

                                                                                                                                                      

  \_\_\_             9\)           appoint a member of staff as quality manager (however named) who, irrespective of other duties and                 
                                   responsibilities, shall have defined responsibility and authority for ensuring that the management system related  
                                   to quality is implemented and followed at all times; the quality manager shall have direct access to the highest   
                                   level of management at which decisions are made on laboratory policy or resources;                                 

                                                                                                                                                      

                                   Name of person:                                                                                                    
                                   \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_               

  \_\_\_             10\)          appoint deputies for key managerial personnel (see note).                                                          

                                                                                                                                                      

                                   Name(s):                                                                                                           
                                   \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_   

  \_\_\_             11\)          ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to 
                                   the achievement of the objectives of the management system.                                                        

                                                                                                                                                      

                     **NOTE:**                                                                                                                        
                     Individuals                                                                                                                      
                     may have more                                                                                                                    
                     than one                                                                                                                         
                     function and                                                                                                                     
                     it may be                                                                                                                        
                     impractical                                                                                                                      
                     to appoint                                                                                                                       
                     deputies for                                                                                                                     
                     every                                                                                                                            
                     function.                                                                                                                        

  \_\_\_             **4.1.6**                                                                                                                        Top management shall ensure that the appropriate
                                                                                                                                                      communication processes are established within the
                                                                                                                                                      laboratory and that communication takes place regarding the
                                                                                                                                                      effectiveness of the management system.

                                                                                                                                                      

  **4.2                                                                                                                                               
  Management                                                                                                                                          
  system**                                                                                                                                            

                                                                                                                                                      

  **4.2.1**                                                                                                                                           

                                                                                                                                                      

  \_\_\_       1\)                 The laboratory shall establish, implement and maintain a management system appropriate to the scope of its         
                                   activities.                                                                                                        

                                                                                                                                                      

  \_\_\_       2\)                 The laboratory shall document its policies, systems, programs, procedures and instructions to the extent necessary 
                                   to assure the quality of the test and/or calibration results.                                                      

                                                                                                                                                      

  \_\_\_       3\)                 The system's documentation shall be communicated to, understood by, available to, and implemented by the           
                                   appropriate personnel.                                                                                             
  ------------ ----- ------------- ------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------

  -------- ----------- ----------- --------------- --------------- ------------------------------------------------------------
  \_\_\_               **4.2.2**                                   The laboratory's management system policies related to
                                                                   quality, including a quality policy statement, shall be
                                                                   defined in a quality manual (however named). The overall
                                                                   objectives shall be established, and shall be reviewed
                                                                   during management review. The quality policy statement shall
                                                                   be issued under the authority of top management. It shall
                                                                   include at least the following:

                                                                   

  \_\_\_               1\)                         the laboratory  
                                                   management\'s   
                                                   commitment to   
                                                   good            
                                                   professional    
                                                   practice and to 
                                                   the quality of  
                                                   its testing and 
                                                   calibration in  
                                                   servicing its   
                                                   customers;      

                                                                   

  \_\_\_               2\)                         the             
                                                   management's    
                                                   statement of    
                                                   the             
                                                   laboratory\'s   
                                                   standard of     
                                                   service;        

                                                                   

  \_\_\_               3\)                         the purpose of  
                                                   the management  
                                                   system related  
                                                   to quality;     

                                                                   

  \_\_\_               4\)                         a requirement   
                                                   that all        
                                                   personnel       
                                                   concerned with  
                                                   testing and     
                                                   calibration     
                                                   activities      
                                                   within the      
                                                   laboratory      
                                                   familiarize     
                                                   themselves with 
                                                   the quality     
                                                   documentation   
                                                   and implement   
                                                   the policies    
                                                   and procedures  
                                                   in their work;  
                                                   and             

                                                                   

  \_\_\_               5\)                         the laboratory  
                                                   management\'s   
                                                   commitment to   
                                                   comply with     
                                                   this Handbook   
                                                   and to          
                                                   continually     
                                                   improve the     
                                                   effectiveness   
                                                   of the          
                                                   management      
                                                   system.         

                                                                   

                                   **NOTE:** The                   
                                   quality policy                  
                                   statement                       
                                   should be                       
                                   concise and may                 
                                   include the                     
                                   requirement                     
                                   that tests                      
                                   and/or                          
                                   calibrations                    
                                   shall always be                 
                                   carried out in                  
                                   accordance with                 
                                   stated methods                  
                                   and customers'                  
                                   requirements.                   
                                   When the test                   
                                   and/or                          
                                   calibration                     
                                   laboratory is                   
                                   part of a                       
                                   larger                          
                                   organization,                   
                                   some quality                    
                                   policy elements                 
                                   may be in other                 
                                   documents.                      

                                                                   

           **4.2.3**                                               Top management shall provide evidence of commitment to the
                                                                   development and implementation of the management system and
                                                                   to continually improve its effectiveness.

                                                                   

                                                                   

  \_\_\_               **4.2.4**                   Top management  
                                                   shall           
                                                   communicate to  
                                                   the             
                                                   organization    
                                                   the importance  
                                                   of meeting      
                                                   customer        
                                                   requirements as 
                                                   well as         
                                                   statutory and   
                                                   regulatory      
                                                   requirements.   

                                                                   

  \_\_\_               **4.2.5**                                   

                                                                   

  \_\_\_               1\)                         The quality     
                                                   manual shall    
                                                   include or make 
                                                   reference to    
                                                   the supporting  
                                                   procedures      
                                                   including       
                                                   technical       
                                                   procedures.     

  \_\_\_               2\)                         It shall        
                                                   outline the     
                                                   structure of    
                                                   the             
                                                   documentation   
                                                   used in the     
                                                   management      
                                                   system.         

                                                                   
  -------- ----------- ----------- --------------- --------------- ------------------------------------------------------------

  ----------- ----------------- ------------------------------------------------------------
              **4.2.6**         The roles and responsibilities of technical management and
                                the quality manager, including their responsibility for
                                ensuring compliance with this Handbook, shall be defined in
                                the quality manual.

                                

              **4.2.7**         Top management shall ensure that the integrity of the
                                management system is maintained when changes to the
                                management system are planned and implemented.

                                

  **4.3                         
  Document                      
  control**                     

                                

  **4.3.1                       
  General**                     

                                

  \_\_\_      The laboratory    
              shall establish   
              and maintain      
              procedures to     
              control all       
              documents that    
              form part of its  
              management system 
              (internally       
              generated or from 
              external          
              sources), such as 
              regulations,      
              standards, other  
              normative         
              documents, test   
              and/or            
              calibration       
              methods, as well  
              as drawings,      
              software,         
              specifications,   
              instructions and  
              manuals.          
  ----------- ----------------- ------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 1** In this context \"document\" could be policy
       statements, procedures, specifications, calibration tables,
       charts, text books, posters, notices, memoranda, software,
       drawings, plans, etc. These may be on various media, whether hard
       copy or electronic, and they may be digital, analog, photographic
       or written.

       

       **NOTE 2** The control of data related to testing and calibration
       is covered in 5.4.7. The control of records is covered in 4.13.
  ---- ------------------------------------------------------------------

  ------------- ----- -------------------------------------------------------------
  **4.3.2             
  Document            
  approval and        
  issue**             

                      

  **4.3.2.1**         

                      

  \_\_\_        1\)   All documents issued to personnel in the laboratory as part
                      of the management system shall be reviewed and approved for
                      use by authorized personnel prior to issue.

                      

  \_\_\_        2\)   A master list or an equivalent document control procedure
                      identifying the current revision status and distribution of
                      documents in the management system shall be established and
                      be readily available to preclude the use of invalid and/or
                      obsolete documents.
  ------------- ----- -------------------------------------------------------------

  -------------- ----- -------------------------------------------------------------
  **4.3.2.2**          
  The                  
  procedure(s)         
  adopted shall        
  ensure that:         

                       

  \_\_\_         1\)   authorized editions of appropriate documents are available at
                       all locations where operations essential to the effective
                       functioning of the laboratory are performed;

                       

  \_\_\_         2\)   documents are periodically reviewed and, where necessary,
                       revised to ensure continuing suitability and compliance with
                       applicable requirements;

                       

  \_\_\_         3\)   invalid or obsolete documents are promptly removed from all
                       points of issue or use, or otherwise assured against
                       unintended use;

                       

  \_\_\_         4\)   obsolete documents retained for either legal or knowledge
                       preservation purposes are suitably marked.
  -------------- ----- -------------------------------------------------------------

  ----------- ------------- ------------- ----------------- ---------------------------------------------------------
                            **4.3.2.3**                     Management system documents generated by the laboratory
                                                            shall be uniquely identified. Such identification shall
                                                            include:

                                                            

  \_\_\_      1\)                         the date of issue 
                                          and/or revision   
                                          identification,   

                                                            

  \_\_\_      2\)                         page numbering,   

                                                            

  \_\_\_      3\)                         the total number  
                                          of pages or a     
                                          mark to signify   
                                          the end of the    
                                          document, and     

  \_\_\_      4\)                         the issuing       
                                          authority(ies).   

                                                            

  **4.3.3                                                   
  Document                                                  
  changes**                                                 

                                                            

  \_\_\_      **4.3.3.1**                                   Changes to documents shall be reviewed and approved by
                                                            the same function that performed the original review
                                                            unless specifically designated otherwise. The designated
                                                            personnel shall have access to pertinent background
                                                            information upon which to base their review and approval.

                                                            

  \_\_\_      **4.3.3.2**                                   Where practicable, the altered or new text shall be
                                                            identified in the document or the appropriate
                                                            attachments.

                                                            

                            **4.3.3.3**                     
  ----------- ------------- ------------- ----------------- ---------------------------------------------------------

  -------- ----- -------------------------------------------------------------
  \_\_\_   1\)   If the laboratory\'s documentation control system allows for
                 the amendment of documents by hand pending the reissue of the
                 documents, the procedures and authorities for such amendments
                 shall be defined.

                 

  \_\_\_   2\)   Amendments shall be clearly marked, initialed and dated. A
                 revised document shall be formally reissued as soon as
                 practicable.
  -------- ----- -------------------------------------------------------------

  -------- ------------- --- ---------------------------------------------------------
  \_\_\_   **4.3.3.4**       Procedures shall be established to describe how changes
                             in documents maintained in computerized systems are made
                             and controlled.

                             
  -------- ------------- --- ---------------------------------------------------------

+---+----+------------------------------------------------------------+
| 4 |    |                                                            |
| . |    |                                                            |
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| * |    |                                                            |
| * |    |                                                            |
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| i |    |                                                            |
| e |    |                                                            |
| w |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
| o |    |                                                            |
| f |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
| r |    |                                                            |
| e |    |                                                            |
| q |    |                                                            |
| u |    |                                                            |
| e |    |                                                            |
| s |    |                                                            |
| t |    |                                                            |
| s |    |                                                            |
| , |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
| t |    |                                                            |
| e |    |                                                            |
| n |    |                                                            |
| d |    |                                                            |
| e |    |                                                            |
| r |    |                                                            |
| s |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
| a |    |                                                            |
| n |    |                                                            |
| d |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
|   |    |                                                            |
| c |    |                                                            |
| o |    |                                                            |
| n |    |                                                            |
| t |    |                                                            |
| r |    |                                                            |
| a |    |                                                            |
| c |    |                                                            |
| t |    |                                                            |
| s |    |                                                            |
| * |    |                                                            |
| * |    |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
| \ | *  | The laboratory shall establish and maintain procedures for |
| _ | *4 | the review of requests, tenders and contracts. The         |
| \ | .4 | policies and procedures for these reviews leading to a     |
| _ | .1 | contract for testing and/or calibration shall ensure that: |
| \ | ** |                                                            |
| _ |    |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
| \ | 1  | the requirements, including the methods to be used, are    |
| _ | \) | adequately defined, documented and understood (see 5.4.2); |
| \ |    |                                                            |
| _ |    |                                                            |
| \ |    |                                                            |
| _ |    |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
| \ | 2  | the laboratory has the capability and resources to meet    |
| _ | \) | the requirements;                                          |
| \ |    |                                                            |
| _ |    |                                                            |
| \ |    |                                                            |
| _ |    |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
| \ | 3  | the appropriate test and/or calibration method is selected |
| _ | \) | and is capable of meeting the customers' requirements (see |
| \ |    | 5.4.2).                                                    |
| _ |    |                                                            |
| \ |    |                                                            |
| _ |    |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
| \ | 4  | Any differences between the request or tender and the      |
| _ | \) | contract shall be resolved before any work commences. Each |
| \ |    | contract shall be acceptable both to the laboratory and    |
| _ |    | the customer .                                             |
| \ |    |                                                            |
| _ |    |                                                            |
+---+----+------------------------------------------------------------+

  ---- ------------------------------------------------------------------
       **NOTE 1:** The request, tender and contract review should be
       conducted in a practical and efficient manner, and the effect of
       financial, legal and time schedule aspects should be taken into
       account. For internal customers, reviews of requests, tenders and
       contracts can be performed in a simplified way.

       

       **NOTE 2:** The review of capability should establish that the
       laboratory possesses the necessary physical, personnel and
       information resources, and that the laboratory\'s personnel have
       the skills and expertise necessary for the performance of the
       tests and/or calibrations in question. The review may also
       encompass results of earlier participation in interlaboratory
       comparisons or proficiency testing and/or the running of trial
       test or calibration programs using samples or items of known value
       in order to determine uncertainties of measurement, limits of
       detection, confidence limits, etc.

       

       **NOTE 3:** A contract may be any written or oral agreement to
       provide a customer with testing and/or calibration services.
  ---- ------------------------------------------------------------------

  -------- ----------- ---------------- ------------------------------------------------------------
  \_\_\_   **4.4.2**                    Records of reviews, including any significant changes, shall
                                        be maintained. Records shall also be maintained of pertinent
                                        discussions with a customer relating to the customer's
                                        requirements or the results of the work during the period of
                                        execution of the contract.

                                        

                       **NOTE:** For    
                       review of        
                       routine and      
                       other simple     
                       tasks, the date  
                       and the          
                       identification   
                       (e.g., the       
                       initials) of the 
                       person in the    
                       laboratory       
                       responsible for  
                       carrying out the 
                       contracted work  
                       are considered   
                       adequate. For    
                       repetitive       
                       routine tasks,   
                       the review need  
                       be made only at  
                       the initial      
                       enquiry stage or 
                       on granting of   
                       the contract for 
                       ongoing routine  
                       work performed   
                       under a general  
                       agreement with   
                       the customer,    
                       provided that    
                       the customer's   
                       requirements     
                       remain           
                       unchanged. For   
                       new, complex or  
                       advanced testing 
                       and/or           
                       calibration      
                       tasks, a more    
                       comprehensive    
                       record should be 
                       maintained.      
  -------- ----------- ---------------- ------------------------------------------------------------

  ---------------- ----------------- ----------- -------------------------------------------------------------
  \_\_\_           **4.4.3**                     The review shall also cover any work that is subcontracted by
                                                 the laboratory.

                                                 

  \_\_\_           **4.4.4**                     The customer shall be informed of any deviation from the
                                                 contract.

                                                 

  \_\_\_           **4.4.5**                     If a contract needs to be amended after work has commenced,
                                                 the same contract review process shall be repeated and any
                                                 amendments shall be communicated to all affected personnel.

                                                 

  **4.5                                          
  Subcontracting                                 
  of tests and                                   
  calibrations**                                 

                                                 

  \_\_\_           **4.5.1**                     When a laboratory subcontracts work whether because of
                                                 unforeseen reasons (e.g., workload, need for further
                                                 expertise or temporary incapacity) or on a continuing basis
                                                 (e.g., through permanent subcontracting, agency or
                                                 franchising arrangements), this work shall be placed with a
                                                 competent subcontractor. A competent subcontractor is one
                                                 that, for example, complies with this Handbook for the work
                                                 in question.

                                                 

  \_\_             **4.5.2**                     The laboratory shall advise the customer of the arrangement
                                                 in writing and, when appropriate, gain the approval of the
                                                 customer, preferably in writing.

                                                 

  \_\_\_           **4.5.3**                     The laboratory is responsible to the customer for the
                                                 subcontractor's work, except in the case where the customer
                                                 or a regulatory authority specifies which subcontractor is to
                                                 be used.

                                                 

  \_\_             **4.5.4**                     The laboratory shall maintain a register of all
                                                 subcontractors that it uses for tests and/or calibrations and
                                                 a record of the evidence of compliance with this Handbook for
                                                 the work in question.

                                                 

  **4.6 Purchasing                               
  services and                                   
  supplies**                                     

                                                 

  \_\_\_           **4.6.1**                     The laboratory shall have a policy and procedure(s) for the
                                                 selection and purchasing of services and supplies it uses
                                                 that affect the quality of the tests and/or calibrations.
                                                 Procedures shall exist for the purchase, reception and
                                                 storage of reagents and laboratory consumable materials
                                                 relevant for the tests and calibrations.

                                                 

                                     **4.6.2**   

                                                 

  \_\_\_           1\)                           The laboratory shall ensure that purchased supplies and
                                                 reagents and consumable materials that affect the quality of
                                                 tests and/or calibrations are not used until they have been
                                                 inspected or otherwise verified as complying with standard
                                                 specifications or requirements defined in the methods for the
                                                 tests and/or calibrations concerned. These services and
                                                 supplies used shall comply with specified requirements.

                                                 

  \_\_\_           2\)                           Records of actions taken to check compliance shall be
                                                 maintained.

                                                 

  \_\_\_           **4.6.3**                     Purchasing documents for items affecting the quality of
                                                 laboratory output shall contain data describing the services
                                                 and supplies ordered. These purchasing documents shall be
                                                 reviewed and approved for technical content prior to release.

                                                 

                   **NOTE** The                  
                   description may               
                   include type,                 
                   class, grade,                 
                   precise                       
                   identification,               
                   specifications,               
                   drawings,                     
                   inspection                    
                   instructions,                 
                   other technical               
                   data including                
                   approval of test              
                   results, the                  
                   quality required              
                   and the                       
                   management system             
                   standard under                
                   which they were               
                   made.                         
  ---------------- ----------------- ----------- -------------------------------------------------------------

  -------- ----------- -------------------------------------------------------------
           **4.6.4**   

                       

  \_\_\_   1\)         The laboratory shall evaluate suppliers of critical
                       consumables, supplies and services which affect the quality
                       of testing and calibration, and

                       

  \_\_\_   2\)         shall maintain records of these evaluations and list those
                       approved.
  -------- ----------- -------------------------------------------------------------

  --------- ----------------- ------------------------------------------------------------
  **4.7**   **Service to the  
            customer**        

                              

  \_\_\_    The laboratory    
            shall be willing  
            to cooperate with 
            customers or      
            their             
            representatives   
            in clarifying the 
            customer's        
            request and in    
            monitoring the    
            laboratory\'s     
            performance in    
            relation to the   
            work performed,   
            provided that the 
            laboratory        
            ensures           
            confidentiality   
            to other          
            customers.        

                              

            **NOTE 1:** Such  
            cooperation may   
            include:          

                              

            1\)               providing the customer or the customer's representative
                              reasonable access to relevant areas of the laboratory for
                              the witnessing of tests and/or calibrations performed for
                              the customer;

                              

            2\)               preparation, packaging, and dispatch of test and/or
                              calibration items needed by the customer for verification
                              purposes.

                              

            **NOTE 2:**       
            Customers value   
            the maintenance   
            of good           
            communication,    
            advice and        
            guidance in       
            technical         
            matters, and      
            opinions and      
            interpretations   
            based on results. 
            Communication     
            with the          
            customer,         
            especially in     
            large             
            assignments,      
            should be         
            maintained        
            throughout the    
            work. The         
            laboratory should 
            inform the        
            customer of any   
            delays or major   
            deviations in the 
            performance of    
            the tests and/or  
            calibrations.     
  --------- ----------------- ------------------------------------------------------------

  -------------- ----------- -------------- ------------------------------------------------------------
  \_\_\_                     **4.7.2**      The laboratory shall seek feedback, both positive and
                                            negative, from its customers. The feedback shall be used and
                                            analyzed to improve the management system, testing and
                                            calibration activities and customer service.

                                            

                             **NOTE:**      
                             Examples of    
                             the types of   
                             feedback       
                             include        
                             customer       
                             satisfaction   
                             surveys and    
                             review of test 
                             or calibration 
                             reports with   
                             customers.     

                                            

  **4.8                                     
  Complaints**                              

                                            

  \_\_\_         **4.8.1**                  The laboratory shall have a policy and procedure for the
                                            resolution of complaints received from customers or other
                                            parties.

                                            

  \_\_\_         **4.8.2**                  Records shall be maintained of all complaints and of the
                                            investigations and corrective actions taken by the
                                            laboratory (see also 4.11).
  -------------- ----------- -------------- ------------------------------------------------------------

  ---------------- ---------------- ------------------------------------------------------------
  **4.9 Control of                  
  non-conforming                    
  testing and/or                    
  calibration                       
  work**                            

                                    

  \_\_\_           **4.9.1**        The laboratory shall have a policy and procedures that shall
                                    be implemented when any aspect of its testing and/or
                                    calibration work, or the results of this work, do not
                                    conform to its own procedures or the agreed requirements of
                                    the customer. The policy and procedures shall ensure that:

                                    

  \_\_\_           1\)              the responsibilities and authorities for the management of
                                    non-conforming work are designated and actions (including
                                    halting of work and withholding of test reports and
                                    calibration certificates, as necessary) are defined and
                                    taken when non-conforming work is identified;

                                    

  \_\_\_           2\)              an evaluation of the significance of the non-conforming work
                                    is made;

                                    

  \_\_\_           3\)              correction is taken immediately, together with any decision
                                    about the acceptability of the non-conforming work;

                                    

  \_\_\_           4\)              where necessary, the customer is notified and work is
                                    recalled;

                                    

  \_\_\_           5\)              the responsibility for authorizing the resumption of work is
                                    defined.

                                    

                   **NOTE:**        
                   Identification   
                   of               
                   non-conforming   
                   work or problems 
                   with the         
                   management       
                   system or with   
                   testing and/or   
                   calibration      
                   activities can   
                   occur at various 
                   places within    
                   the management   
                   system and       
                   technical        
                   operations.      
                   Examples are     
                   customer         
                   complaints,      
                   quality control, 
                   instrument       
                   calibration,     
                   checking of      
                   consumable       
                   materials, staff 
                   observations or  
                   supervision,     
                   test report and  
                   calibration      
                   certificate      
                   checking,        
                   management       
                   reviews and      
                   internal or      
                   external audits. 
  ---------------- ---------------- ------------------------------------------------------------

  --------------- ----------- ----- ---------------- ------------------------------------------------------------
  \_\_\_          **4.9.2**         Where the        
                                    evaluation       
                                    indicates that   
                                    the              
                                    non-conforming   
                                    work could recur 
                                    or that there is 
                                    doubt about the  
                                    compliance of    
                                    the              
                                    laboratory\'s    
                                    operations with  
                                    its own policies 
                                    and procedures,  
                                    the corrective   
                                    action           
                                    procedures given 
                                    in 4.11 shall be 
                                    promptly         
                                    followed.        

                                                     

  **4.10                                             
  Improvement**                                      

                                                     

  **\_\_\_**                                         The laboratory shall continually improve the effectiveness
                                                     of its management system through the use of the quality
                                                     policy, quality objectives, audit results, analysis of data,
                                                     corrective and preventive actions and management review.

                                                     

  **4.11                                             
  Corrective                                         
  action**                                           

                                                     

  **4.11.1                                           
  General**                                          
  --------------- ----------- ----- ---------------- ------------------------------------------------------------

  -------- ------------------------------------------------------------------
  \_\_\_   The laboratory shall establish a policy and procedure and shall
           designate appropriate authorities for implementing corrective
           action when non-conforming work or departures from the policies
           and procedures in the management system or technical operations
           have been identified.

           

           **NOTE:** A problem with the management system or with the
           technical operations of the laboratory may be identified through a
           variety of activities, such as control of non-conforming work,
           internal or external audits, management reviews, feedback from
           customers and from staff observations.
  -------- ------------------------------------------------------------------

  ------------ ------------------------------------------------------------------
  **4.11.2     
  Cause        
  analysis**   

               

  \_\_\_       The procedure for corrective action shall start with an
               investigation to determine the root cause(s) of the problem.

               

               **NOTE:** Cause analysis is the key and sometimes the most
               difficult part in the corrective action procedure. Often the root
               cause is not obvious and thus a careful analysis of all potential
               causes of the problem is required. Potential causes could include
               customer requirements, the samples, sample specifications, methods
               and procedures, staff skills and training, consumables, or
               equipment and its calibration.
  ------------ ------------------------------------------------------------------

  ---------------- ----- ------------------------------------------------------------
  **4.11.3               
  Selection and          
  implementation         
  of corrective          
  actions**              

                         

  \_\_\_           1\)   Where corrective action is needed, the laboratory shall
                         identify potential corrective actions. It shall select and
                         implement the action(s) most likely to eliminate the problem
                         and to prevent recurrence.

                         

  \_\_\_           2\)   Corrective actions shall be to a degree appropriate to the
                         magnitude and the risk of the problem.

  \_\_\_           3\)   The laboratory shall document and implement any required
                         changes resulting from corrective action investigations.
  ---------------- ----- ------------------------------------------------------------

  ------------ ------------------------------------------------------------------
  **4.11.4     
  Monitoring   
  of           
  corrective   
  actions**    

               

  \_\_\_       The laboratory shall monitor the results to ensure that the
               corrective actions taken have been effective.
  ------------ ------------------------------------------------------------------

  ------------ ------------------------------------------------------------------
  **4.11.5     
  Additional   
  audits**     

               

  \_\_\_       Where the identification of nonconformities or departures casts
               doubts on the laboratory\'s compliance with its own policies and
               procedures, or on its compliance with this Handbook, the
               laboratory shall ensure that the appropriate areas of activity are
               audited in accordance with 4.14 as soon as possible.

               

               **NOTE** Such additional audits often follow the implementation of
               the corrective actions to confirm their effectiveness. An
               additional audit should be necessary only when a serious issue or
               risk to the business is identified.
  ------------ ------------------------------------------------------------------

  ------------ ------------ ------------------ -----------------------------------------------------------
  **4.12                                       
  Preventive                                   
  action**                                     

                                               

  **4.12.1**                                   

                                               

  \_\_\_       1\)          Needed             
                            improvements and   
                            potential sources  
                            of                 
                            nonconformities,   
                            either technical   
                            or concerning the  
                            management system, 
                            shall be           
                            identified.        

                                               

  \_\_\_       2\)          When improvement   
                            opportunities are  
                            identified or if   
                            preventive action  
                            is required,       
                            action plans shall 
                            be developed,      
                            implemented and    
                            monitored to       
                            reduce the         
                            likelihood of the  
                            occurrence of such 
                            nonconformities    
                            and to take        
                            advantage of the   
                            opportunities for  
                            improvement.       

                                               

  \_\_\_       **4.12.2**                      Procedures for preventive actions shall include the
                                               initiation of such actions and application of controls to
                                               ensure that they are effective.
  ------------ ------------ ------------------ -----------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 1** Preventive action is a proactive process to identify
       opportunities for improvement rather than a reaction to the
       identification of problems or complaints.

       **NOTE 2** Apart from the review of the operational procedures,
       the preventive action might involve analysis of data, including
       trend and risk analyses and proficiency-testing results.
  ---- ------------------------------------------------------------------

  ----------- -------------- ----------------------------------------------------------
  **4.13                     
  Control of                 
  records**                  

                             

  **4.13.1                   
  General**                  

                             

  \_\_\_      **4.13.1.1**   The laboratory shall establish and maintain procedures for
                             identification, collection, indexing, access, filing,
                             storage, maintenance and disposal of quality and technical
                             records. Quality records shall include reports from
                             internal audits and management reviews as well as records
                             of corrective and preventive actions.
  ----------- -------------- ----------------------------------------------------------

  -------------- -------------- --------------- ----------------------------------------------------------
  **4.13.1.2**                                  

                                                

  \_\_\_         1\)            All records     
                                shall be        
                                legible and     
                                shall be stored 
                                and retained in 
                                such a way that 
                                they are        
                                readily         
                                retrievable in  
                                facilities that 
                                provide a       
                                suitable        
                                environment to  
                                prevent damage  
                                or              
                                deterioration   
                                and to prevent  
                                loss.           

                                                

  \_\_\_         2\)            Retention times 
                                of records      
                                shall be        
                                established.    

                                                

                 **NOTE**                       
                 Records may be                 
                 in any media,                  
                 such as hard                   
                 copy or                        
                 electronic                     
                 media.                         

                                                

  \_\_\_         **4.13.1.3**                   All records shall be held secure and in confidence.

                                                

  \_\_\_         **4.13.1.4**                   The laboratory shall have procedures to protect and back
                                                up records stored electronically and to prevent
                                                unauthorized access to or amendment of these records.
  -------------- -------------- --------------- ----------------------------------------------------------

  -------------- --------------- ------------------------------------------------------------
  **4.13.2                       
  Technical                      
  records**                      

                                 

  **4.13.2.1**                   

                                 

  \_\_\_         1\)             The laboratory shall retain records of original
                                 observations, derived data and sufficient information to
                                 establish an audit trail, calibration records, staff records
                                 and a copy of each test report or calibration certificate
                                 issued, for a defined period.

                                 

  \_\_\_         2\)             The records for each test or calibration shall contain
                                 sufficient information to facilitate, if possible,
                                 identification of factors affecting the uncertainty and to
                                 enable the test or calibration to be repeated under
                                 conditions as close as possible to the original.

                                 

  \_\_\_         3\)             The records shall include the identity of personnel
                                 responsible for the sampling, performance of each test
                                 and/or calibration and checking of results.

                                 

                 **NOTE 1:** In  
                 certain fields  
                 it may be       
                 impossible or   
                 impracticable   
                 to retain       
                 records of all  
                 original        
                 observations.   

                                 

                 **NOTE 2:**     
                 Technical       
                 records are     
                 accumulations   
                 of data (see    
                 5.4.7) and      
                 information     
                 which result    
                 from carrying   
                 out tests       
                 and/or          
                 calibrations    
                 and which       
                 indicate        
                 whether         
                 specified       
                 quality or      
                 process         
                 parameters are  
                 achieved. They  
                 may include     
                 forms,          
                 contracts, work 
                 sheets, work    
                 books, check    
                 sheets, work    
                 notes, control  
                 graphs,         
                 external and    
                 internal test   
                 reports and     
                 calibration     
                 certificates,   
                 customers'      
                 notes, papers   
                 and feedback.   
  -------------- --------------- ------------------------------------------------------------

  -------- -------------- ----------------------------------------------------------
  \_\_\_   **4.13.2.2**   Observations, data and calculations shall be recorded at
                          the time they are made and shall be identifiable to the
                          specific task.

  -------- -------------- ----------------------------------------------------------

  -------------- ----- -------------------------------------------------------------
  **4.13.2.3**         

                       

  \_\_\_         1\)   When mistakes occur in records, each mistake shall be crossed
                       out, not erased, made illegible or deleted, and the correct
                       value entered alongside. All such alterations to records
                       shall be signed or initialed by the person making the
                       correction.

                       

  \_\_\_         2\)   In the case of records stored electronically, equivalent
                       measures shall be taken to avoid loss or change of original
                       data.
  -------------- ----- -------------------------------------------------------------

  ------------ ----- ----------- -------------------------------------------------------------
  **4.14                         
  Internal                       
  audits**                       

                                 

  **4.14.1**                     

                                 

  \_\_\_       1\)               The laboratory shall periodically, and in accordance with a
                                 predetermined schedule and procedure, conduct internal audits
                                 of its activities to verify that its operations continue to
                                 comply with the requirements of the management system and
                                 this Handbook. The internal audit program shall address all
                                 elements of the management system, including the testing
                                 and/or calibration activities. It is the responsibility of
                                 the quality manager to plan and organize audits as required
                                 by the schedule and requested by management.

                                 

  \_\_\_       2\)               Such audits shall be carried out by trained and qualified
                                 personnel who are, wherever resources permit, independent of
                                 the activity to be audited.

                                 

                     **NOTE:**   
                     The cycle   
                     for         
                     internal    
                     auditing    
                     should      
                     normally be 
                     completed   
                     in one      
                     year.       
  ------------ ----- ----------- -------------------------------------------------------------

  ------------ ------------ ----------------- -----------------------------------------------------------
  \_\_\_       **4.14.2**                     When audit findings cast doubt on the effectiveness of the
                                              operations or on the correctness or validity of the
                                              laboratory\'s test or calibration results, the laboratory
                                              shall take timely corrective action, and shall notify
                                              customers in writing if investigations show that the
                                              laboratory results may have been affected.

                                              

  \_\_\_       **4.14.3**                     The area of activity audited, the audit findings and
                                              corrective actions that arise from them shall be recorded.

                                              

  \_\_\_       **4.14.4**                     Follow-up audit activities shall verify and record the
                                              implementation and effectiveness of the corrective action
                                              taken.

                                              

  **4.15                                      
  Management                                  
  reviews**                                   

                                              

  \_\_\_       **4. 15.1**  In accordance     
                            with a            
                            predetermined     
                            schedule and      
                            procedure, the    
                            laboratory\'s top 
                            management shall  
                            periodically      
                            conduct a review  
                            of the            
                            laboratory\'s     
                            management system 
                            and testing       
                            and/or            
                            calibration       
                            activities to     
                            ensure their      
                            continuing        
                            suitability and   
                            effectiveness,    
                            and to introduce  
                            necessary changes 
                            or improvements.  
                            The review shall  
                            take account of:  

                                              

  \_\_\_       1\)          the suitability   
                            of policies and   
                            procedures;       

                                              

  \_\_\_       2\)          reports from      
                            managerial and    
                            supervisory       
                            personnel;        

                                              

  \_\_\_       3\)          the outcome of    
                            recent internal   
                            audits;           

                                              

  \_\_\_       4\)          corrective and    
                            preventive        
                            actions;          

                                              

  \_\_\_       5\)          assessments by    
                            external bodies;  

                                              

  \_\_\_       6\)          the results of    
                            interlaboratory   
                            comparisons or    
                            proficiency       
                            tests;            

                                              

  \_\_\_       7\)          changes in the    
                            volume and type   
                            of the work;      

                                              

  \_\_\_       8\)          customer          
                            feedback;         

                                              

  \_\_\_       9\)          complaints;       

                                              

  \_\_\_       10\)         recommendations   
                            for improvement;  

                                              

  \_\_\_       11\)         other relevant    
                            factors, such as  
                            quality control   
                            activities,       
                            resources and     
                            staff training.   
  ------------ ------------ ----------------- -----------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 1:** A typical period for conducting a management review is
       once every 12 months.

       

       **NOTE 2:** Results should feed into the laboratory planning
       system and should include the goals, objectives and action plans
       for the coming year.

       

       **NOTE 3:** A management review includes consideration of related
       subjects at regular management meetings.
  ---- ------------------------------------------------------------------

  ------------ ----- -------------------------------------------------------------
  **4.15.2**         

                     

  \_\_\_       1\)   Findings from management reviews and the actions that arise
                     from them shall be recorded.

                     

  \_\_\_       2\)   The management shall ensure that those actions are carried
                     out within an appropriate and agreed timescale.
  ------------ ----- -------------------------------------------------------------

+---+----+------------------------------------------------------------+
| # |    |                                                            |
| # |    |                                                            |
| # |    |                                                            |
| # |    |                                                            |
| # |    |                                                            |
| # |    |                                                            |
|   |    |                                                            |
| 5 |    |                                                            |
|   |    |                                                            |
| T |    |                                                            |
| e |    |                                                            |
| c |    |                                                            |
| h |    |                                                            |
| n |    |                                                            |
| i |    |                                                            |
| c |    |                                                            |
| a |    |                                                            |
| l |    |                                                            |
|   |    |                                                            |
| r |    |                                                            |
| e |    |                                                            |
| q |    |                                                            |
| u |    |                                                            |
| i |    |                                                            |
| r |    |                                                            |
| e |    |                                                            |
| m |    |                                                            |
| e |    |                                                            |
| n |    |                                                            |
| t |    |                                                            |
| s |    |                                                            |
|   |    |                                                            |
| f |    |                                                            |
| o |    |                                                            |
| r |    |                                                            |
|   |    |                                                            |
| a |    |                                                            |
| c |    |                                                            |
| c |    |                                                            |
| r |    |                                                            |
| e |    |                                                            |
| d |    |                                                            |
| i |    |                                                            |
| t |    |                                                            |
| a |    |                                                            |
| t |    |                                                            |
| i |    |                                                            |
| o |    |                                                            |
| n |    |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
| * |    |                                                            |
| * |    |                                                            |
| 5 |    |                                                            |
| . |    |                                                            |
| 1 |    |                                                            |
| G |    |                                                            |
| e |    |                                                            |
| n |    |                                                            |
| e |    |                                                            |
| r |    |                                                            |
| a |    |                                                            |
| l |    |                                                            |
| * |    |                                                            |
| * |    |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
|   | *  | Many factors determine the correctness and reliability of  |
|   | *5 | the tests and/or calibrations performed by a laboratory.   |
|   | .1 | These factors include contributions from:                  |
|   | .1 |                                                            |
|   | ** |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
|   | \_ | human factors (5.2);                                       |
|   | \_ |                                                            |
|   | \_ |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
|   | \_ | accommodation and environmental conditions (5.3);          |
|   | \_ |                                                            |
|   | \_ |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
|   | \_ | test and calibration methods and method validation (5.4);  |
|   | \_ |                                                            |
|   | \_ |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
|   | \_ | equipment (5.5);                                           |
|   | \_ |                                                            |
|   | \_ |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
|   | \_ | measurement traceability (5.6 and Annex B);                |
|   | \_ |                                                            |
|   | \_ |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
|   | \_ | sampling (5.7);                                            |
|   | \_ |                                                            |
|   | \_ |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
|   | \_ | the handling of test and calibration items (5.8).          |
|   | \_ |                                                            |
|   | \_ |                                                            |
+---+----+------------------------------------------------------------+
|   |    |                                                            |
+---+----+------------------------------------------------------------+
| \ | *  | The extent to which the factors contribute to the total    |
| _ | *5 | uncertainty of measurement differs considerably between    |
| \ | .1 | (types of) tests and between (types of) calibrations. The  |
| _ | .2 | laboratory shall take account of these factors in          |
| \ | ** | developing test and calibration methods and procedures, in |
| _ |    | the training and qualification of personnel, and in the    |
|   |    | selection and calibration of the equipment it uses.        |
+---+----+------------------------------------------------------------+

  ------------- ----- -------------------------------------------------------------
  **5.2               
  Personnel**         

                      

  **5.2.1**           

                      

  \_\_\_        1\)   The laboratory management shall ensure the competence of all
                      who operate specific equipment, perform tests and/or
                      calibrations, evaluate results, and sign test reports and
                      calibration certificates.

                      

  \_\_\_        2\)   When using staff who are undergoing training, appropriate
                      supervision shall be provided. Personnel performing specific
                      tasks shall be qualified on the basis of appropriate
                      education, training, experience and/or demonstrated skills,
                      as required.
  ------------- ----- -------------------------------------------------------------

  ---- ----------------- ------------------------------------------------------------
       **NOTE 1:** In    
       some technical    
       areas (e.g.,      
       nondestructive    
       testing) it may   
       be required that  
       the personnel     
       performing        
       certain tasks     
       hold personnel    
       certification.    
       The laboratory is 
       responsible for   
       fulfilling        
       specified         
       personnel         
       certification     
       requirements. The 
       requirements for  
       personnel         
       certification     
       might be          
       regulatory,       
       included in the   
       standards for the 
       specific          
       technical field,  
       or required by    
       the customer.     

                         

       **NOTE 2:** The   
       personnel         
       responsible for   
       the opinions and  
       interpretation    
       included in test  
       reports should,   
       in addition to    
       the appropriate   
       qualifications,   
       training,         
       experience and    
       satisfactory      
       knowledge of the  
       testing carried   
       out, also have:   

                         

       \_\_\_            relevant knowledge of the technology used for the
                         manufacturing of the items, materials, products, etc.,
                         tested, or the way they are used or intended to be used, and
                         of the defects or degradations which may occur during or in
                         service;

                         

       \_\_\_            knowledge of the general requirements expressed in the
                         legislation and standards; and

                         

       \_\_\_            an understanding of the significance of deviations found
                         with regard to the normal use of the items, materials,
                         products, etc. concerned.
  ---- ----------------- ------------------------------------------------------------

  ----------- ----------- -------------------------------------------------------------
              **5.2.2**   

                          

  \_\_\_      1\)         The management of the laboratory shall formulate the goals
                          with respect to the education, training and skills of the
                          laboratory personnel.

                          

  \_\_\_      2\)         The laboratory shall have a policy and procedures for
                          identifying training needs and providing training of
                          personnel.

                          

  \_\_\_      3\)         The training program shall be relevant to the present and
                          anticipated tasks of the laboratory.

                          

  \_\_\_      4\)         The effectiveness of the training actions taken shall be
                          evaluated.

                          

  **5.2.3**               

                          

  \_\_\_      1\)         The laboratory shall use personnel who are employed by, or
                          under contract to, the laboratory.

                          

  \_\_\_      2\)         Where contracted and additional technical and key support
                          personnel are used, the laboratory shall ensure that such
                          personnel are supervised and competent and that they work in
                          accordance with the laboratory\'s management system.
  ----------- ----------- -------------------------------------------------------------

  -------- ----------- -------------------------------------------------------------
  \_\_\_   **5.2.4**   The laboratory shall maintain current job descriptions for
                       managerial, technical and key support personnel involved in
                       tests and/or calibrations.

  -------- ----------- -------------------------------------------------------------

  ---- -------------- ------------------------------------------------------------
       **NOTE:** Job  
       descriptions   
       can be defined 
       in many ways.  
       As a minimum,  
       the following  
       should be      
       defined:       

                      

       \_\_\_         the responsibilities with respect to performing tests and/or
                      calibrations;

                      

       \_\_\_         the responsibilities with respect to the planning of tests
                      and/or calibrations and evaluation of results;

                      

       \_\_\_         the responsibilities for reporting opinions and
                      interpretations;

                      

       \_\_\_         the responsibilities with respect to method modification and
                      development and validation of new methods;

                      

       \_\_\_         expertise and experience required;

                      

       \_\_\_         qualifications and training programs;

       \_\_\_\_\_     managerial duties.
  ---- -------------- ------------------------------------------------------------

  -------- ------------- -------------------------------------------------------------
           **5.2.5**     

                         

  \_\_\_   1\)           The management shall authorize specific personnel to perform
                         particular types of sampling, test and/or calibration, to
                         issue test reports and calibration certificates, to give
                         opinions and interpretations and to operate particular types
                         of equipment.

                         

  \_\_\_   2\)           The laboratory shall maintain records of the relevant
                         authorization(s), competence, educational and professional
                         qualifications, training, skills and experience of all
                         technical personnel, including contracted personnel.

                         

  \_\_\_   3\)           This information shall be readily available and shall include
                         the date on which authorization and/or competence is
                         confirmed.

                         

           **WMD Note:** 
           This          
           requirement   
           also applies  
           to Approved   
           Signatories   
           (see 1.5.4).  
  -------- ------------- -------------------------------------------------------------

  --------------- ----------- -------------------------------------------------------------
  **5.3                       
  Accommodation               
  and                         
  environmental               
  conditions**                

                              

                  **5.3.1**   

                              

  \_\_\_          1\)         Laboratory facilities for testing and/or calibration,
                              including but not limited to energy sources, lighting and
                              environmental conditions, shall be such as to facilitate
                              correct performance of the tests and/or calibrations.

                              

                              The laboratory shall ensure that the environmental conditions
                              do not invalidate the results or adversely affect the
                              required quality of any measurement. Particular care shall be
                              taken when sampling and tests and/or calibrations are
                              undertaken at sites other than a permanent laboratory
                              facility.

                              

  \_\_\_          2\)         The technical requirements for accommodation and
                              environmental conditions that can affect the results of tests
                              and calibrations shall be documented.
  --------------- ----------- -------------------------------------------------------------

  ----------- ----- -------------------------------------------------------------
  **5.3.2**         

                    

  \_\_\_      1\)   The laboratory shall monitor, control and record
                    environmental conditions as required by the relevant
                    specifications, methods and procedures or where they
                    influence the quality of the results. Due attention shall be
                    paid, for example, to biological sterility, dust,
                    electromagnetic disturbances, radiation, humidity, electrical
                    supply, temperature, and sound and vibration levels, as
                    appropriate to the technical activities concerned.

                    

  \_\_\_      2\)   Tests and calibrations shall be stopped when the
                    environmental conditions jeopardize the results of the tests
                    and/or calibrations.
  ----------- ----- -------------------------------------------------------------

  -------- ----------- -------------------------------------------------------------
  \_\_\_   **5.3.3**   There shall be effective separation between neighboring areas
                       in which there are incompatible activities. Measures shall be
                       taken to prevent cross-contamination.

                       

  \_\_\_   **5.3.4**   Access to and use of areas affecting the quality of the tests
                       and/or calibrations shall be controlled. The laboratory shall
                       determine the extent of control based on its particular
                       circumstances.

                       

  \_\_\_   **5.3.5**   Measures shall be taken to ensure good housekeeping in the
                       laboratory. Special procedures shall be prepared where
                       necessary.
  -------- ----------- -------------------------------------------------------------

  -------------- ----- ----- --------------- ------------------------------------------------------------
  **5.4 Test and                             
  calibration                                
  methods and                                
  method                                     
  validation**                               

                                             

  **5.4.1                                    
  General**                                  

                                             

  \_\_\_\_             1\)                   The laboratory shall use appropriate methods and procedures
                                             for all tests and/or calibrations within its scope. These
                                             include sampling, handling, transport, storage and
                                             preparation of items to be tested and/or calibrated, and,
                                             where appropriate, an estimation of the measurement
                                             uncertainty as well as statistical techniques for analysis
                                             of test and/or calibration data.

                                             

  \_\_\_         2\)         The laboratory  
                             shall have      
                             instructions on 
                             the use and     
                             operation of    
                             all relevant    
                             equipment, and  
                             on the handling 
                             and preparation 
                             of items for    
                             testing and/or  
                             calibration, or 
                             both, where the 
                             absence of such 
                             instructions    
                             could           
                             jeopardize the  
                             results of      
                             tests and/or    
                             calibrations.   

                                             

  \_\_\_         3\)         All             
                             instructions,   
                             standards,      
                             manuals and     
                             reference data  
                             relevant to the 
                             work of the     
                             laboratory      
                             shall be kept   
                             up to date and  
                             shall be made   
                             readily         
                             available to    
                             personnel (see  
                             4.3).           

                                             

  \_\_\_         4\)         Deviation from  
                             test and        
                             calibration     
                             methods shall   
                             occur only if   
                             the deviation   
                             has been        
                             documented,     
                             technically     
                             justified,      
                             authorized, and 
                             accepted by the 
                             customer.       
  -------------- ----- ----- --------------- ------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE:** International, regional or national standards or other
       recognized specifications that contain sufficient and concise
       information on how to perform the tests and/or calibrations do not
       need to be supplemented or rewritten as internal procedures if
       these standards are written in a way that they can be used as
       published by the operating staff in a laboratory. It may be
       necessary to provide additional documentation for optional steps
       in the method or additional details.

  ---- ------------------------------------------------------------------

  ----------- ----- -------------------------------------------------------------
  **5.4.2           
  Selection         
  of                
  methods**         

                    

  \_\_\_      1\)   The laboratory shall use test and/or calibration methods,
                    including methods for sampling, which meet the needs of the
                    customer and which are appropriate for the tests and/or
                    calibrations it undertakes. Methods published in
                    international, regional or national standards shall
                    preferably be used. The laboratory shall ensure that it uses
                    the latest valid edition of a standard unless it is not
                    appropriate or possible to do so.

                    

  \_\_\_      2\)   When necessary, the standard shall be supplemented with
                    additional details to ensure consistent application.

                    

  \_\_\_      3\)   When the customer does not specify the method to be used, the
                    laboratory shall select appropriate methods that have been
                    published either in international, regional or national
                    standards, or by reputable technical organizations, or in
                    relevant scientific texts or journals, or as specified by the
                    manufacturer of the equipment. Laboratory-developed methods
                    or methods adopted by the laboratory may also be used if they
                    are appropriate for the intended use and if they are
                    validated.

                    

  \_\_\_      4\)   The customer shall be informed as to the method chosen.

                    

  \_\_\_      5\)   The laboratory shall confirm that it can properly operate
                    standard methods before introducing the tests or
                    calibrations. If the standard method changes, the
                    confirmation shall be repeated.

                    

  \_\_\_      6\)   The laboratory shall inform the customer when the method
                    proposed by the customer is considered to be inappropriate or
                    out of date.
  ----------- ----- -------------------------------------------------------------

  ---------------------- ----- ------------------------------------------------------------
  **5.4.3                      
  Laboratory-developed         
  methods**                    

                               

  \_\_\_                 1\)   The introduction of test and calibration methods developed
                               by the laboratory for its own use shall be a planned
                               activity and shall be assigned to qualified personnel
                               equipped with adequate resources.

  \_\_\_                 2\)   Plans shall be updated as development proceeds and effective
                               communication amongst all personnel involved shall be
                               ensured.
  ---------------------- ----- ------------------------------------------------------------

  -------------- ----- -------------------------------------------------------------
  **5.4.4              
  Non-standard         
  methods**            

                       

  \_\_\_         1\)   When it is necessary to use methods not covered by standard
                       methods, these shall be subject to agreement with the
                       customer and shall include a clear specification of the
                       customer's requirements and the purpose of the test and/or
                       calibration.

                       

  \_\_\_         2\)   The method developed shall have been validated appropriately
                       before use.
  -------------- ----- -------------------------------------------------------------

  ---- -------------- ------------------------------------------------------------
       **NOTE:** For  
       new test       
       and/or         
       calibration    
       methods,       
       procedures     
       should be      
       developed      
       prior to the   
       tests and/or   
       calibrations   
       being          
       performed and  
       should contain 
       at least the   
       following      
       information:   

                      

       1\)            appropriate identification;

                      

       2\)            scope;

                      

       3\)            description of the type of item to be tested or calibrated;

                      

       4\)            parameters or quantities and ranges to be determined;

                      

       5\)            apparatus and equipment, including technical performance
                      requirements;

                      

       6\)            reference standards and reference materials required;

                      

       7\)            environmental conditions required and any stabilization
                      period needed;

                      

       8\)            description of the procedure, including:
  ---- -------------- ------------------------------------------------------------

  -------- ------ --------------------- ------------------------------------------------------------
  \_\_\_                                affixing of identification marks, handling, transporting,
                                        storing and preparation of items,

  \_\_\_                                checks to be made before the work is started,

  \_\_\_                                checks that the equipment is working properly and, where
                                        required, calibration and adjustment of the equipment before
                                        each use,

  \_\_\_                                the method of recording the observations and results,

  \_\_\_                                any safety measures to be observed;

           9\)    criteria and/or       
                  requirements for      
                  approval/rejection;   

                                        

           10\)   data to be recorded   
                  and method of         
                  analysis and          
                  presentation;         

                                        

           11\)   the uncertainty or    
                  the procedure for     
                  estimating            
                  uncertainty.          
  -------- ------ --------------------- ------------------------------------------------------------

  ------------ ------------- -----------------------------------------------------------
  **5.4.5                    
  Validation                 
  of methods**               

                             

               **5.4.5.1**   Validation is the confirmation by examination and the
                             provision of objective evidence that the particular
                             requirements for a specific intended use are fulfilled.
  ------------ ------------- -----------------------------------------------------------

  ------------- ----- -------------------------------------------------------------
  **5.4.5.2**         

                      

  \_\_\_        1\)   The laboratory shall validate non-standard methods,
                      laboratory-designed/developed methods, standard methods used
                      outside their intended scope, and amplifications and
                      modifications of standard methods to confirm that the methods
                      are fit for the intended use. The validation shall be as
                      extensive as is necessary to meet the needs of the given
                      application or field of application.

                      

  \_\_\_        2\)   The laboratory shall record the results obtained, the
                      procedure used for the validation, and a statement as to
                      whether the method is fit for the intended use.
  ------------- ----- -------------------------------------------------------------

  ---- ----------------- ------------------------------------------------------------
       **NOTE 1:**       
       Validation may    
       include           
       procedures for    
       sampling,         
       handling and      
       transportation.   

                         

       **NOTE 2:** The   
       techniques used   
       for the           
       determination of  
       the performance   
       of a method       
       should be one of, 
       or a combination  
       of, the           
       following:        

                         

       \_\_\_            calibration using reference standards or reference
                         materials;

                         

       \_\_\_            comparison of results achieved with other methods;

                         

       \_\_\_            interlaboratory comparisons;

                         

       \_\_\_            systematic assessment of the factors influencing the result;

                         

       \_\_\_            assessment of the uncertainty of the results based on
                         scientific understanding of the theoretical principles of
                         the method and practical experience.
  ---- ----------------- ------------------------------------------------------------

  -------- -------------------- -----------------------------------------------------------
           **NOTE 3:** When     
           some changes are     
           made in the          
           validated            
           non-standard         
           methods, the         
           influence of such    
           changes should be    
           documented and, if   
           appropriate, a new   
           validation should be 
           carried out.         

                                

  \_\_\_   **5.4.5.3**          The range and accuracy of the values obtainable from
                                validated methods (e.g., the uncertainty of the results,
                                detection limit, selectivity of the method, linearity,
                                limit of repeatability and/or reproducibility, robustness
                                against external influences and/or cross-sensitivity
                                against interference from the matrix of the sample/test
                                object), as assessed for the intended use, shall be
                                relevant to the customer's needs.

                                

           **NOTE 1:**          
           Validation includes  
           specification of the 
           requirements,        
           determination of the 
           characteristics of   
           the methods, a check 
           that the             
           requirements can be  
           fulfilled by using   
           the method, and a    
           statement on the     
           validity.            

                                

           **NOTE 2:** As       
           method-development   
           proceeds, regular    
           review should be     
           carried out to       
           verify that the      
           needs of the         
           customer are still   
           being fulfilled. Any 
           change in            
           requirements         
           requiring            
           modifications to the 
           development plan     
           should be approved   
           and authorized.      
  -------- -------------------- -----------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 3:** Validation is always a balance between costs, risks
       and technical possibilities. There are many cases in which the
       range and uncertainty of the values (e.g., accuracy, detection
       limit, selectivity, linearity, repeatability, reproducibility,
       robustness and cross-sensitivity) can only be given in a
       simplified way due to lack of information.

  ---- ------------------------------------------------------------------

  --------------- ------------- -----------------------------------------------------------
  **5.4.6                       
  Estimation of                 
  uncertainty of                
  measurement**                 

                                

  \_\_\_          **5.4.6.1**   A calibration laboratory, or a testing laboratory
                                performing its own calibrations, shall have and shall apply
                                a procedure to estimate the uncertainty of measurement for
                                all calibrations and types of calibrations.

                                

  \_\_\_          **5.4.6.2**   Testing laboratories shall have and shall apply procedures
                                for estimating uncertainty of measurement. In certain cases
                                the nature of the test method may preclude rigorous,
                                metrologically and statistically valid, calculation of
                                uncertainty of measurement. In these cases the laboratory
                                shall at least attempt to identify all the components of
                                uncertainty and make a reasonable estimation, and shall
                                ensure that the form of reporting of the result does not
                                give a wrong impression of the uncertainty. Reasonable
                                estimation shall be based on knowledge of the performance
                                of the method and on the measurement scope and shall make
                                use of, for example, previous experience and validation
                                data.
  --------------- ------------- -----------------------------------------------------------

  ---- ------------- ------------------------------------------------------------
       **NOTE:** The 
       degree of     
       rigor needed  
       in an         
       estimation of 
       uncertainty   
       of            
       measurement   
       depends on    
       factors such  
       as:           

                     

                     the requirements of the test method;

                     

                     the requirements of the customer;

                     

                     the existence of narrow limits on which decisions on
                     conformity to a specification are based.
  ---- ------------- ------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 2:** In those cases where a well recognized test method
       specifies limits to the values of the major sources of uncertainty
       of measurement and specifies the form of presentation of
       calculated results, the laboratory is considered to have satisfied
       this clause by following the test method and reporting
       instructions (see 5.10).

  ---- ------------------------------------------------------------------

  -------- --------------- -----------------------------------------------------------
  \_\_\_   **5.4.6.3**     When estimating the uncertainty of measurement, all
                           uncertainty components which are of importance in the given
                           situation shall be taken into account using appropriate
                           methods of analysis.

           **NOTE 1:**     
           Sources         
           contributing to 
           the uncertainty 
           include, but    
           are not         
           necessarily     
           limited to, the 
           reference       
           standards and   
           reference       
           materials used, 
           methods and     
           equipment used, 
           environmental   
           conditions,     
           properties and  
           condition of    
           the item being  
           tested or       
           calibrated, and 
           the operator.   

                           

           **NOTE 2:** The 
           predicted       
           long-term       
           behavior of the 
           tested and/or   
           calibrated item 
           is not normally 
           taken into      
           account when    
           estimating the  
           measurement     
           uncertainty.    

                           

           **NOTE :** For  
           further         
           information,    
           see ISO 5725    
           and the Guide   
           to the          
           Expression of   
           Uncertainty in  
           Measurement     
           (see 1.4).      

                           

           **WMD NOTE:**   
           ANSI/NCSL       
           Z540-2 and NIST 
           Technical Note  
           1297, are       
           considered to   
           be equivalent   
           to the Guide to 
           the Expression  
           of Uncertainty  
           in Measurement  
           (GUM). SOP 29   
           contains        
           procedures for  
           implementing    
           this            
           requirement.    
  -------- --------------- -----------------------------------------------------------

  --------- ----------------------------- -----------------------------------------------------------
  **5.4.7                                 
  Control                                 
  of data**                               

                                          

  \_\_\_    **5.4.7.1**                   Calculations and data transfers shall be subject to
                                          appropriate checks in a systematic manner.

                                          

            **5.4.7.2**                   When computers or automated equipment are used for the
                                          acquisition, processing, recording, reporting, storage or
                                          retrieval of test or calibration data, the laboratory shall
                                          ensure that:

  \_\_\_    1\)                           computer software developed by the user is documented in
                                          sufficient detail and is suitably validated as being
                                          adequate for use;

                                          

  \_\_\_    2\)                           procedures are established and implemented for protecting
                                          the data; such procedures shall include, but not be limited
                                          to, integrity and confidentiality of data entry or
                                          collection, data storage, data transmission and data
                                          processing;

                                          

  \_\_\_    3\)                           computers and automated equipment are maintained to ensure
                                          proper functioning and are provided with the environmental
                                          and operating conditions necessary to maintain the
                                          integrity of test and calibration data.

            **NOTE:** Commercial          
            off-the-shelf software (e.g., 
            word processing, database and 
            statistical programs) in      
            general use within their      
            designed application range    
            may be considered to be       
            sufficiently validated.       
            However, laboratory software  
            configuration/modifications   
            should be validated as in     
            5.4.7.2a).                    
  --------- ----------------------------- -----------------------------------------------------------

  ------------- ----- ----------- -------------------------------------------------------------
  **5.5                           
  Equipment**                     

                                  

                      **5.5.1**   

                                  

  \_\_\_        1\)               The laboratory shall be furnished with all items of sampling,
                                  measurement and test equipment required for the correct
                                  performance of the tests and/or calibrations (including
                                  sampling, preparation of test and/or calibration items,
                                  processing and analysis of test and/or calibration data).

                                  

  \_\_\_        2\)               In those cases where the laboratory needs to use equipment
                                  outside its permanent control, it shall ensure that the
                                  requirements of this Handbook are met.
  ------------- ----- ----------- -------------------------------------------------------------

  ----------- ----- -------------------------------------------------------------
  **5.5.2**         

                    

  \_\_\_      1\)   Equipment and its software used for testing, calibration and
                    sampling shall be capable of achieving the accuracy required
                    and shall comply with specifications relevant to the tests
                    and/or calibrations concerned.

                    

  \_\_\_      2\)   Calibration programs shall be established for key quantities
                    or values of the instruments where these properties have a
                    significant effect on the results.

                    

  \_\_\_      3\)   Before being placed into service, equipment (including that
                    used for sampling) shall be calibrated or checked to
                    establish that it meets the laboratory\'s specification
                    requirements and complies with the relevant standard
                    specifications. It shall be checked and/or calibrated before
                    use (see 5.6).
  ----------- ----- -------------------------------------------------------------

  -------- ----------- -------------------------------------------------------------
  \_\_\_   **5.5.3**   Equipment shall be operated by authorized personnel.
                       Up-to-date instructions on the use and maintenance of
                       equipment (including any relevant manuals provided by the
                       manufacturer of the equipment) shall be readily available for
                       use by the appropriate laboratory personnel.

                       

  \_\_\_   **5.5.4**   Each item of equipment and its software used for testing and
                       calibration and significant to the result shall, when
                       practicable, be uniquely identified.

                       

  \_\_\_   **5.5.5**   Records shall be maintained of each item of equipment and its
                       software significant to the tests and/or calibrations
                       performed. The records shall include at least the following:
  -------- ----------- -------------------------------------------------------------

  -------- ----- -------------------------------------------------------------
  \_\_\_   1\)   the identity of the item of equipment and its software;

                 

  \_\_\_   2\)   the manufacturer\'s name, type identification, and serial
                 number or other unique identification;

                 

  \_\_\_   3\)   checks that equipment complies with the specification (see
                 5.5.2);

                 

  \_\_\_   4\)   the current location, where appropriate;

                 

  \_\_\_   5\)   the manufacturer\'s instructions, if available, or reference
                 to their location;

                 

  \_\_\_   6\)   dates, results and copies of reports and certificates of all
                 calibrations, adjustments, acceptance criteria, and the due
                 date of next calibration;

                 

  \_\_\_   7\)   the maintenance plan, where appropriate, and maintenance
                 carried out to date;

                 

  \_\_\_   8\)   any damage, malfunction, modification or repair to the
                 equipment.
  -------- ----- -------------------------------------------------------------

  -------- ----------- -------------------------------------------------------------
  \_\_\_   **5.5.6**   The laboratory shall have procedures for safe handling,
                       transport, storage, use and planned maintenance of measuring
                       equipment to ensure proper functioning and in order to
                       prevent contamination or deterioration.

  -------- ----------- -------------------------------------------------------------

  ----------- -------------- ------------------------------------------------------------
              **NOTE:**      
              Additional     
              procedures may 
              be necessary   
              when measuring 
              equipment is   
              used outside   
              the permanent  
              laboratory for 
              tests,         
              calibrations   
              or sampling.   

                             

  **5.5.7**                  

                             

  \_\_\_      1\)            Equipment that has been subjected to overloading or
                             mishandling, gives suspect results, or has been shown to be
                             defective or outside specified limits, shall be taken out of
                             service. It shall be isolated to prevent its use or clearly
                             labeled or marked as being out of service until it has been
                             repaired and shown by calibration or test to perform
                             correctly.

                             

  \_\_\_      2\)            The laboratory shall examine the effect of the defect or
                             departure from specified limits on previous tests and/or
                             calibrations and shall institute the \"Control of
                             non-conforming work\" procedure (see 4.9).
  ----------- -------------- ------------------------------------------------------------

  -------- ----------- -------------------------------------------------------------
  \_\_\_   **5.5.8**   Whenever practicable, all equipment under the control of the
                       laboratory and requiring calibration shall be labeled, coded
                       or otherwise identified to indicate the status of
                       calibration, including the date when last calibrated and the
                       date or expiration criteria when recalibration is due.

                       

  \_\_\_   **5.5.9**   When, for whatever reason, equipment goes outside the direct
                       control of the laboratory, the laboratory shall ensure that
                       the function and calibration status of the equipment are
                       checked and shown to be satisfactory before the equipment is
                       returned to service.
  -------- ----------- -------------------------------------------------------------

  -------- ------------ -----------------------------------------------------------
  \_\_\_   **5.5.10**   When intermediate checks are needed to maintain confidence
                        in the calibration status of the equipment, these checks
                        shall be carried out according to a defined procedure.

                        

  \_\_\_   **5.5.11**   Where calibrations give rise to a set of correction
                        factors, the laboratory shall have procedures to ensure
                        that copies (e.g., in computer software) are correctly
                        updated.

                        

  \_\_\_   **5.5.12**   Test and calibration equipment, including both hardware and
                        software, shall be safeguarded from adjustments which would
                        invalidate the test and/or calibration results.
  -------- ------------ -----------------------------------------------------------

  ---------------- ----- -------------------------------------------------------------
  **5.6                  
  Measurement            
  traceability**         

                         

  **5.6.1                
  General**              

                         

  \_\_\_           1\)   All equipment used for tests and/or calibrations, including
                         equipment for subsidiary measurements (e.g., for
                         environmental conditions) having a significant effect on the
                         accuracy or validity of the result of the test, calibration
                         or sampling shall be calibrated before being put into
                         service.

                         

  \_\_\_           2\)   The laboratory shall have an established program and
                         procedure for the calibration of its equipment.
  ---------------- ----- -------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE:** Such a program should include a system for selecting,
       using, calibrating, checking, controlling and maintaining
       measurement standards, reference materials used as measurement
       standards, and measuring and test equipment used to perform tests
       and calibrations.

       
  ---- ------------------------------------------------------------------

  ---------------- --------------- ----------------------------------------------------------
  **5.6.2 Specific                 
  requirements**                   

                                   

  **5.6.2.1                        
  Calibration**                    

                                   

                   **5.6.2.1.1**   
  ---------------- --------------- ----------------------------------------------------------

  -------- ----- ------------------------------------------------------------
  \_\_\_   1\)   For calibration laboratories, the program for calibration of
                 equipment shall be designed and operated so as to ensure
                 that calibrations and measurements made by the laboratory
                 are traceable to the International System of Units (SI)
                 (*Système international d\'unités*).

                 

                 A calibration laboratory establishes traceability of its own
                 measurement standards and measuring instruments to the SI by
                 means of an unbroken chain of calibrations or comparisons
                 linking them to relevant primary standards of the SI units
                 of measurement. The link to SI units may be achieved by
                 reference to national measurement standards. National
                 measurement standards may be primary standards, which are
                 primary realizations of the SI units or agreed
                 representations of SI units based on fundamental physical
                 constants, or they may be secondary standards which are
                 standards calibrated by another national metrology
                 institute.
  -------- ----- ------------------------------------------------------------

  -------- ----- -------------------------------------------------------------
  \_\_\_   2\)   When using external calibration services, traceability of
                 measurement shall be assured by the use of calibration
                 services from laboratories that can demonstrate competence,
                 measurement capability and traceability.

                 

  \_\_\_   3\)   The calibration certificates issued by these laboratories
                 shall contain the measurement results, including the
                 measurement uncertainty and/or a statement of compliance with
                 an identified metrological specification (see also 5.10.4.2).
  -------- ----- -------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 1:** Calibration laboratories fulfilling the requirements
       of this Handbook are considered to be competent. A calibration
       certificate bearing an accreditation body logo from a calibration
       laboratory accredited to this Handbook, for the calibration
       concerned, is sufficient evidence of traceability of the
       calibration data reported.

  ---- ------------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 2:** Traceability to SI units of measurement may be
       achieved by reference to an appropriate primary standard (see
       VIM:1993, 6.4) or by reference to a natural constant, the value of
       which in terms of the relevant SI unit is known and recommended by
       the General Conference of Weights and Measures (CGPM) and the
       International Committee for Weights and Measures (CIPM).

  ---- ------------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 3:** Calibration laboratories that maintain their own
       primary standard or representation of SI units based on
       fundamental physical constants can claim traceability to the SI
       system only after these standards have been compared, directly or
       indirectly, with other similar standards of a national metrology
       institute.

  ---- ------------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 4:** The term \"identified metrological specification\"
       means that it must be clear from the calibration certificate which
       specification the measurements have been compared with, by
       including the specification or by giving an unambiguous reference
       to the specification.

  ---- ------------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 5:** When the terms \"international standard\" or
       \"national standard\" are used in connection with traceability, it
       is assumed that these standards fulfill the properties of primary
       standards for the realization of SI units.

  ---- ------------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 6:** Traceability to national measurement standards does
       not necessarily require the use of the national metrology
       institute of the country in which the laboratory is located.

  ---- ------------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 7:** If a calibration laboratory wishes or needs to obtain
       traceability from a national metrology institute other than in its
       own country, this laboratory should select a national metrology
       institute that actively participates in the activities of BIPM
       either directly or through regional groups.

  ---- ------------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 8:** The unbroken chain of calibrations or comparisons may
       be achieved in several steps carried out by different laboratories
       that can demonstrate traceability.

  ---- ------------------------------------------------------------------

  -------- --------------- ------------------ ----------------------------------------------------------
  \_\_\_   **5.6.2.1.2**                      There are certain calibrations that currently cannot be
                                              strictly made in SI units. In these cases calibration
                                              shall provide confidence in measurements by establishing
                                              traceability to appropriate measurement standards such as:

                                              

  \_\_\_   1\)             the use of         
                           certified          
                           reference          
                           materials provided 
                           by a competent     
                           supplier to give a 
                           reliable physical  
                           or chemical        
                           characterization   
                           of a material;     

                                              

  \_\_\_   2\)             the use of         
                           specified methods  
                           and/or consensus   
                           standards that are 
                           clearly described  
                           and agreed by all  
                           parties concerned. 

                                              

  \_\_\_   3\)             Participation in a 
                           suitable program   
                           of interlaboratory 
                           comparisons is     
                           required where     
                           possible.          
  -------- --------------- ------------------ ----------------------------------------------------------

  ----------- --------------- -- ----------------------------------------------------------
  **5.6.2.2                      
  Testing**                      

                                 

  \_\_\_      **5.6.2.2.1**      For testing laboratories, the requirements given in
                                 5.6.2.1 apply for measuring and test equipment with
                                 measuring functions used, unless it has been established
                                 that the associated contribution from the calibration
                                 contributes little to the total uncertainty of the test
                                 result. When this situation arises, the laboratory shall
                                 ensure that the equipment used can provide the uncertainty
                                 of measurement needed.

                                 

              **NOTE:** The      
              extent to which    
              the                
              requirements in    
              5.6.2.1 should     
              be followed        
              depends on the     
              relative           
              contribution of    
              the calibration    
              uncertainty to     
              the total          
              uncertainty. If    
              calibration is     
              the dominant       
              factor, the        
              requirements       
              should be          
              strictly           
              followed.          

                                 

  \_\_\_      **5.6.2.2.2**      Where traceability of measurements to SI units is not
                                 possible and/or not relevant, the same requirements for
                                 traceability to, for example, certified reference
                                 materials, agreed methods and/or consensus standards, are
                                 required as for calibration laboratories (see 5.6.2.1.2).
  ----------- --------------- -- ----------------------------------------------------------

  ------------- ----- -------------------------------------------------------------
  **5.6.3             
  Reference           
  standards and       
  reference           
  materials**         

                      

  **5.6.3.1           
  Reference           
  standards**         

                      

  \_\_\_        1\)   The laboratory shall have a program and procedure for the
                      calibration of its reference standards.

                      

  \_\_\_        2\)   Reference standards shall be calibrated by a body that can
                      provide traceability as described in 5.6.2.1.

                      

  \_\_\_        3\)   Such reference standards of measurement held by the
                      laboratory shall be used for calibration only and for no
                      other purpose, unless it can be shown that their performance
                      as reference standards would not be invalidated. Reference
                      standards shall be calibrated before and after any
                      adjustment.
  ------------- ----- -------------------------------------------------------------

  -------------- ------------------------------------------------------------------
  **5.6.3.2      
  Reference      
  materials**    

                 

  \_\_\_         Reference materials shall, where possible, be traceable to SI
                 units of measurement, or to certified reference materials.
                 Internal reference materials shall be checked as far as is
                 technically and economically practicable.

                 

  **5.6.3.3      
  Intermediate   
  checks**       

                 

  \_\_\_         Checks needed to maintain confidence in the calibration status of
                 reference, primary, transfer or working standards and reference
                 materials shall be carried out according to defined procedures and
                 schedules
  -------------- ------------------------------------------------------------------

  ----------- ------------------------------------------------------------------
  **5.6.3.4   
  Transport   
  and         
  storage**   

              

  \_\_\_      The laboratory shall have procedures for safe handling, transport,
              storage and use of reference standards and reference materials in
              order to prevent contamination or deterioration and in order to
              protect their integrity.

              

              **NOTE:** Additional procedures may be necessary when reference
              standards and reference materials are used outside the permanent
              laboratory for tests, calibrations or sampling.
  ----------- ------------------------------------------------------------------

  ------------ ----- -------------------------------------------------------------
  **5.7              
  Sampling**         

                     

  **5.7.1**          

                     

  \_\_\_       1\)   The laboratory shall have a sampling plan and procedures for
                     sampling when it carries out sampling of substances,
                     materials or products for subsequent testing or calibration.

                     

  \_\_\_       2\)   The sampling plan as well as the sampling procedure shall be
                     available at the location where sampling is undertaken.
                     Sampling plans shall, whenever reasonable, be based on
                     appropriate statistical methods. The sampling process shall
                     address the factors to be controlled to ensure the validity
                     of the test and calibration results.
  ------------ ----- -------------------------------------------------------------

  ---- ----------------------------------------------------------------- --
       **NOTE 1:** Sampling is a defined procedure whereby a part of a   
       substance, material or product is taken to provide for testing or 
       calibration of a representative sample of the whole. Sampling may 
       also be required by the appropriate specification for which the   
       substance, material or product is to be tested or calibrated. In  
       certain cases (e.g., forensic analysis), the sample may not be    
       representative but is determined by availability.                 

                                                                         

       **NOTE 2:** Sampling procedures should describe the selection,    
       sampling plan, withdrawal and preparation of a sample or samples  
       from a substance, material or product to yield the required       
       information.                                                      
  ---- ----------------------------------------------------------------- --

  -------- ----------- -------------------------------------------------------------
  \_\_\_   **5.7.2**   Where the customer requires deviations, additions or
                       exclusions from the documented sampling procedure, these
                       shall be recorded in detail with the appropriate sampling
                       data and shall be included in all documents containing test
                       and/or calibration results, and shall be communicated to the
                       appropriate personnel.

                       

  \_\_\_   **5.7.3**   The laboratory shall have procedures for recording relevant
                       data and operations relating to sampling that forms part of
                       the testing or calibration that is undertaken. These records
                       shall include the sampling procedure used, the identification
                       of the sampler, environmental conditions (if relevant) and
                       diagrams or other equivalent means to identify the sampling
                       location as necessary and, if appropriate, the statistics the
                       sampling procedures are based upon.
  -------- ----------- -------------------------------------------------------------

  ------------- ----------- -------------------------------------------------------------
  **5.8                     
  Handling of               
  test and                  
  calibration               
  items**                   

                            

  \_\_\_        **5.8.1**   The laboratory shall have procedures for the transportation,
                            receipt, handling, protection, storage, retention and/or
                            disposal of test and/or calibration items, including all
                            provisions necessary to protect the integrity of the test or
                            calibration item, and to protect the interests of the
                            laboratory and the customer.

                **5.8.2**   

                            

  \_\_\_        1\)         The laboratory shall have a system for identifying test
                            and/or calibration items.

                            

  \_\_\_        2\)         The identification shall be retained throughout the life of
                            the item in the laboratory.

                            

  \_\_\_        3\)         The system shall be designed and operated so as to ensure
                            that items cannot be confused physically or when referred to
                            in records or other documents.

                            

  \_\_\_        4\)         The system shall, if appropriate, accommodate a sub-division
                            of groups of items and the transfer of items within and from
                            the laboratory.
  ------------- ----------- -------------------------------------------------------------

  ----------- ----- -------------------------------------------------------------
  **5.8.3**         

                    

  \_\_\_      1\)   Upon receipt of the test or calibration item, abnormalities
                    or departures from normal or specified conditions, as
                    described in the test or calibration method, shall be
                    recorded.

                    

  \_\_\_      2\)   When there is doubt as to the suitability of an item for test
                    or calibration, or when an item does not conform to the
                    description provided, or the test or calibration required is
                    not specified in sufficient detail, the laboratory shall
                    consult the customer for further instructions before
                    proceeding and shall record the discussion.
  ----------- ----- -------------------------------------------------------------

  ----------- ----- -------------------------------------------------------------
  **5.8.4**         

                    

  \_\_\_      1\)   The laboratory shall have procedures and appropriate
                    facilities for avoiding deterioration, loss or damage to the
                    test or calibration item during storage, handling and
                    preparation.

                    

  \_\_\_      2\)   Handling instructions provided with the item shall be
                    followed.

                    

  \_\_\_      3\)   When items have to be stored or conditioned under specified
                    environmental conditions, these conditions shall be
                    maintained, monitored and recorded.

                    

  \_\_\_      4\)   Where a test or calibration item or a portion of an item is
                    to be held secure, the laboratory shall have arrangements for
                    storage and security that protect the condition and integrity
                    of the secured items or portions concerned.
  ----------- ----- -------------------------------------------------------------

  ---- ------------------------------------------------------------------
       **NOTE 1:** Where test items are to be returned into service after
       testing, special care is required to ensure that they are not
       damaged or injured during the handling, testing or storing/waiting
       processes.

       

       **NOTE 2:** A sampling procedure and information on storage and
       transport of samples, including information on sampling factors
       influencing the test or calibration result, should be provided to
       those responsible for taking and transporting the samples.

       

       **NOTE 3:** Reasons for keeping a test or calibration item secure
       can be for reasons of record, safety or value, or to enable
       complementary tests and/or calibrations to be performed later.
  ---- ------------------------------------------------------------------

  ------------- ----------- -------------- ------------------------------------------------------------
  **5.9                                    
  Assuring the                             
  quality of                               
  test and                                 
  calibration                              
  results**                                

                                           

                **5.9.1**                  

                                           

  \_\_\_        1\)         The laboratory 
                            shall have     
                            quality        
                            control        
                            procedures for 
                            monitoring the 
                            validity of    
                            tests and      
                            calibrations   
                            undertaken.    

                                           

  \_\_\_        2\)         The resulting  
                            data shall be  
                            recorded in    
                            such a way     
                            that trends    
                            are detectable 
                            and, where     
                            practicable,   
                            statistical    
                            techniques     
                            shall be       
                            applied to the 
                            reviewing of   
                            the results.   

                                           

  \_\_\_        3\)         This           
                            monitoring     
                            shall be       
                            planned and    
                            reviewed and   
                            may include,   
                            but not be     
                            limited to,    
                            the following: 
  ------------- ----------- -------------- ------------------------------------------------------------

  ------------ ------------- ----- ----- ------------- ------------ -------------------------------------------------------
               \_\_\_\_      a\)                       regular use  
                                                       of certified 
                                                       reference    
                                                       materials    
                                                       and/or       
                                                       internal     
                                                       quality      
                                                       control      
                                                       using        
                                                       secondary    
                                                       reference    
                                                       materials;   

                                                                    

               \_\_\_\_            b\)                              participation in interlaboratory comparison or
                                                                    proficiency-testing programs;

                                                                    

               \_\_\_\_            c\)                              replicate tests or calibrations using the same or
                                                                    different methods;

               \_\_\_\_            d\)                              retesting or recalibration of retained items;

                                                                    

               \_\_\_\_            e\)                              correlation of results for different characteristics of
                                                                    an item.

                                                                    

               **NOTE:** The                                        
               selected                                             
               methods                                              
               should be                                            
               appropriate                                          
               for the type                                         
               and volume of                                        
               the work                                             
               undertaken.                                          

                                                                    

  **\_\_\_**   **5.9.2**                 Quality                    
                                         control data               
                                         shall be                   
                                         analyzed and,              
                                         where they                 
                                         are found to               
                                         be outside                 
                                         pre-defined                
                                         criteria,                  
                                         planned                    
                                         action shall               
                                         be taken to                
                                         correct the                
                                         problem and                
                                         to prevent                 
                                         incorrect                  
                                         results from               
                                         being                      
                                         reported.                  
  ------------ ------------- ----- ----- ------------- ------------ -------------------------------------------------------

  ----------- --------------- ------------------------------------------------------------
  **5.10                      
  Reporting                   
  the                         
  results**                   

                              

  **5.10.1                    
  General**                   

                              

  \_\_\_      1\)             The results of each test, calibration, or series of tests or
                              calibrations carried out by the laboratory shall be reported
                              accurately, clearly, unambiguously and objectively, and in
                              accordance with any specific instructions in the test or
                              calibration methods.

                              

  \_\_\_      2\)             The results shall be reported, usually in a test report or a
                              calibration certificate (see note 1), and shall include all
                              the information requested by the customer and necessary for
                              the interpretation of the test or calibration results and
                              all information required by the method used. This
                              information is normally that required by 5.10.2, and 5.10.3
                              or 5.10.4.

                              

  \_\_\_      3\)             In the case of tests or calibrations performed for internal
                              customer, or in the case of a written agreement with the
                              customer, the results may be reported in a simplified way.
                              Any information listed in 5.10.2 to 5.10.4 which is not
                              reported to the customer shall be readily available in the
                              laboratory which carried out the tests and/or calibrations.

                              

              **NOTE 1:**     
              Test reports    
              and calibration 
              certificates    
              are sometimes   
              called test     
              certificates    
              and calibration 
              reports,        
              respectively.   

                              

              **NOTE 2:** The 
              test reports or 
              calibration     
              certificates    
              may be issued   
              as hard copy or 
              by electronic   
              data transfer   
              provided that   
              the             
              requirements of 
              this Handbook   
              are met.        
  ----------- --------------- ------------------------------------------------------------

  ---------------- ------------------------------------------------------------------
  **5.10.2 Test    
  reports and      
  calibration      
  certificates**   

                   

                   Each test report or calibration certificate shall include at least
                   the following information, unless the laboratory has valid reasons
                   for not doing so:
  ---------------- ------------------------------------------------------------------

+---+---+----+---+---------------------------------------------------------+
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+---+---+----+---+---------------------------------------------------------+
|   |   |    |   |                                                         |
+---+---+----+---+---------------------------------------------------------+
| \ | 2 |    | t |                                                         |
| _ | \ |    | h |                                                         |
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|   |   |    | h |                                                         |
|   |   |    | a |                                                         |
|   |   |    | t |                                                         |
|   |   |    | t |                                                         |
|   |   |    | h |                                                         |
|   |   |    | e |                                                         |
|   |   |    | r |                                                         |
|   |   |    | e |                                                         |
|   |   |    | s |                                                         |
|   |   |    | u |                                                         |
|   |   |    | l |                                                         |
|   |   |    | t |                                                         |
|   |   |    | s |                                                         |
|   |   |    | r |                                                         |
|   |   |    | e |                                                         |
|   |   |    | l |                                                         |
|   |   |    | a |                                                         |
|   |   |    | t |                                                         |
|   |   |    | e |                                                         |
|   |   |    | o |                                                         |
|   |   |    | n |                                                         |
|   |   |    | l |                                                         |
|   |   |    | y |                                                         |
|   |   |    | t |                                                         |
|   |   |    | o |                                                         |
|   |   |    | t |                                                         |
|   |   |    | h |                                                         |
|   |   |    | e |                                                         |
|   |   |    | i |                                                         |
|   |   |    | t |                                                         |
|   |   |    | e |                                                         |
|   |   |    | m |                                                         |
|   |   |    | s |                                                         |
|   |   |    | t |                                                         |
|   |   |    | e |                                                         |
|   |   |    | s |                                                         |
|   |   |    | t |                                                         |
|   |   |    | e |                                                         |
|   |   |    | d |                                                         |
|   |   |    | o |                                                         |
|   |   |    | r |                                                         |
|   |   |    | c |                                                         |
|   |   |    | a |                                                         |
|   |   |    | l |                                                         |
|   |   |    | i |                                                         |
|   |   |    | b |                                                         |
|   |   |    | r |                                                         |
|   |   |    | a |                                                         |
|   |   |    | t |                                                         |
|   |   |    | e |                                                         |
|   |   |    | d |                                                         |
|   |   |    | . |                                                         |
+---+---+----+---+---------------------------------------------------------+
|   |   |    |   |                                                         |
+---+---+----+---+---------------------------------------------------------+
|   |   | ** |   |                                                         |
|   |   | NO |   |                                                         |
|   |   | TE |   |                                                         |
|   |   | 1: |   |                                                         |
|   |   | ** |   |                                                         |
|   |   | Ha |   |                                                         |
|   |   | rd |   |                                                         |
|   |   | co |   |                                                         |
|   |   | pi |   |                                                         |
|   |   | es |   |                                                         |
|   |   | of |   |                                                         |
|   |   | te |   |                                                         |
|   |   | st |   |                                                         |
|   |   | r  |   |                                                         |
|   |   | ep |   |                                                         |
|   |   | or |   |                                                         |
|   |   | ts |   |                                                         |
|   |   | a  |   |                                                         |
|   |   | nd |   |                                                         |
|   |   | c  |   |                                                         |
|   |   | al |   |                                                         |
|   |   | ib |   |                                                         |
|   |   | ra |   |                                                         |
|   |   | ti |   |                                                         |
|   |   | on |   |                                                         |
|   |   | ce |   |                                                         |
|   |   | rt |   |                                                         |
|   |   | if |   |                                                         |
|   |   | ic |   |                                                         |
|   |   | at |   |                                                         |
|   |   | es |   |                                                         |
|   |   | sh |   |                                                         |
|   |   | ou |   |                                                         |
|   |   | ld |   |                                                         |
|   |   | al |   |                                                         |
|   |   | so |   |                                                         |
|   |   | i  |   |                                                         |
|   |   | nc |   |                                                         |
|   |   | lu |   |                                                         |
|   |   | de |   |                                                         |
|   |   | t  |   |                                                         |
|   |   | he |   |                                                         |
|   |   | pa |   |                                                         |
|   |   | ge |   |                                                         |
|   |   | nu |   |                                                         |
|   |   | mb |   |                                                         |
|   |   | er |   |                                                         |
|   |   | a  |   |                                                         |
|   |   | nd |   |                                                         |
|   |   | t  |   |                                                         |
|   |   | ot |   |                                                         |
|   |   | al |   |                                                         |
|   |   | nu |   |                                                         |
|   |   | mb |   |                                                         |
|   |   | er |   |                                                         |
|   |   | of |   |                                                         |
|   |   | pa |   |                                                         |
|   |   | ge |   |                                                         |
|   |   | s. |   |                                                         |
+---+---+----+---+---------------------------------------------------------+
|   |   |    |   |                                                         |
+---+---+----+---+---------------------------------------------------------+
| 6 |   | ** |   |                                                         |
| ) |   | NO |   |                                                         |
|   |   | TE |   |                                                         |
|   |   | 2: |   |                                                         |
|   |   | ** |   |                                                         |
|   |   | It |   |                                                         |
|   |   | is |   |                                                         |
|   |   | r  |   |                                                         |
|   |   | ec |   |                                                         |
|   |   | om |   |                                                         |
|   |   | me |   |                                                         |
|   |   | nd |   |                                                         |
|   |   | ed |   |                                                         |
|   |   | th |   |                                                         |
|   |   | at |   |                                                         |
|   |   | la |   |                                                         |
|   |   | bo |   |                                                         |
|   |   | ra |   |                                                         |
|   |   | to |   |                                                         |
|   |   | ri |   |                                                         |
|   |   | es |   |                                                         |
|   |   | i  |   |                                                         |
|   |   | nc |   |                                                         |
|   |   | lu |   |                                                         |
|   |   | de |   |                                                         |
|   |   | a  |   |                                                         |
|   |   | s  |   |                                                         |
|   |   | ta |   |                                                         |
|   |   | te |   |                                                         |
|   |   | me |   |                                                         |
|   |   | nt |   |                                                         |
|   |   | sp |   |                                                         |
|   |   | ec |   |                                                         |
|   |   | if |   |                                                         |
|   |   | yi |   |                                                         |
|   |   | ng |   |                                                         |
|   |   | th |   |                                                         |
|   |   | at |   |                                                         |
|   |   | t  |   |                                                         |
|   |   | he |   |                                                         |
|   |   | te |   |                                                         |
|   |   | st |   |                                                         |
|   |   | re |   |                                                         |
|   |   | po |   |                                                         |
|   |   | rt |   |                                                         |
|   |   | or |   |                                                         |
|   |   | c  |   |                                                         |
|   |   | al |   |                                                         |
|   |   | ib |   |                                                         |
|   |   | ra |   |                                                         |
|   |   | ti |   |                                                         |
|   |   | on |   |                                                         |
|   |   | c  |   |                                                         |
|   |   | er |   |                                                         |
|   |   | ti |   |                                                         |
|   |   | fi |   |                                                         |
|   |   | ca |   |                                                         |
|   |   | te |   |                                                         |
|   |   | s  |   |                                                         |
|   |   | ha |   |                                                         |
|   |   | ll |   |                                                         |
|   |   | n  |   |                                                         |
|   |   | ot |   |                                                         |
|   |   | be |   |                                                         |
|   |   | re |   |                                                         |
|   |   | pr |   |                                                         |
|   |   | od |   |                                                         |
|   |   | uc |   |                                                         |
|   |   | ed |   |                                                         |
|   |   | ex |   |                                                         |
|   |   | ce |   |                                                         |
|   |   | pt |   |                                                         |
|   |   | in |   |                                                         |
|   |   | f  |   |                                                         |
|   |   | ul |   |                                                         |
|   |   | l, |   |                                                         |
|   |   | w  |   |                                                         |
|   |   | it |   |                                                         |
|   |   | ho |   |                                                         |
|   |   | ut |   |                                                         |
|   |   | w  |   |                                                         |
|   |   | ri |   |                                                         |
|   |   | tt |   |                                                         |
|   |   | en |   |                                                         |
|   |   | ap |   |                                                         |
|   |   | pr |   |                                                         |
|   |   | ov |   |                                                         |
|   |   | al |   |                                                         |
|   |   | of |   |                                                         |
|   |   | t  |   |                                                         |
|   |   | he |   |                                                         |
|   |   | l  |   |                                                         |
|   |   | ab |   |                                                         |
|   |   | or |   |                                                         |
|   |   | at |   |                                                         |
|   |   | or |   |                                                         |
|   |   | y. |   |                                                         |
+---+---+----+---+---------------------------------------------------------+
| 7 |   |    |   |                                                         |
| ) |   |    |   |                                                         |
|   |   |    |   |                                                         |
|   |   |    |   |                                                         |
+---+---+----+---+---------------------------------------------------------+
| * |   |    |   |                                                         |
| * |   |    |   |                                                         |
| W |   |    |   |                                                         |
| M |   |    |   |                                                         |
| D |   |    |   |                                                         |
| N |   |    |   |                                                         |
| O |   |    |   |                                                         |
| T |   |    |   |                                                         |
| E |   |    |   |                                                         |
| : |   |    |   |                                                         |
| * |   |    |   |                                                         |
| * |   |    |   |                                                         |
| W |   |    |   |                                                         |
| M |   |    |   |                                                         |
| D |   |    |   |                                                         |
| d |   |    |   |                                                         |
| e |   |    |   |                                                         |
| f |   |    |   |                                                         |
| i |   |    |   |                                                         |
| n |   |    |   |                                                         |
| e |   |    |   |                                                         |
| s |   |    |   |                                                         |
| t |   |    |   |                                                         |
| h |   |    |   |                                                         |
| e |   |    |   |                                                         |
| p |   |    |   |                                                         |
| e |   |    |   |                                                         |
| r |   |    |   |                                                         |
| s |   |    |   |                                                         |
| o |   |    |   |                                                         |
| n |   |    |   |                                                         |
| ( |   |    |   |                                                         |
| s |   |    |   |                                                         |
| ) |   |    |   |                                                         |
| w |   |    |   |                                                         |
| h |   |    |   |                                                         |
| o |   |    |   |                                                         |
| a |   |    |   |                                                         |
| u |   |    |   |                                                         |
| t |   |    |   |                                                         |
| h |   |    |   |                                                         |
| o |   |    |   |                                                         |
| r |   |    |   |                                                         |
| i |   |    |   |                                                         |
| z |   |    |   |                                                         |
| e |   |    |   |                                                         |
| s |   |    |   |                                                         |
| t |   |    |   |                                                         |
| h |   |    |   |                                                         |
| e |   |    |   |                                                         |
| t |   |    |   |                                                         |
| e |   |    |   |                                                         |
| s |   |    |   |                                                         |
| t |   |    |   |                                                         |
| r |   |    |   |                                                         |
| e |   |    |   |                                                         |
| p |   |    |   |                                                         |
| o |   |    |   |                                                         |
| r |   |    |   |                                                         |
| t |   |    |   |                                                         |
| o |   |    |   |                                                         |
| r |   |    |   |                                                         |
| c |   |    |   |                                                         |
| a |   |    |   |                                                         |
| l |   |    |   |                                                         |
| i |   |    |   |                                                         |
| b |   |    |   |                                                         |
| r |   |    |   |                                                         |
| a |   |    |   |                                                         |
| t |   |    |   |                                                         |
| i |   |    |   |                                                         |
| o |   |    |   |                                                         |
| n |   |    |   |                                                         |
| c |   |    |   |                                                         |
| e |   |    |   |                                                         |
| r |   |    |   |                                                         |
| t |   |    |   |                                                         |
| i |   |    |   |                                                         |
| f |   |    |   |                                                         |
| i |   |    |   |                                                         |
| c |   |    |   |                                                         |
| a |   |    |   |                                                         |
| t |   |    |   |                                                         |
| e |   |    |   |                                                         |
| a |   |    |   |                                                         |
| s |   |    |   |                                                         |
| t |   |    |   |                                                         |
| h |   |    |   |                                                         |
| e |   |    |   |                                                         |
| A |   |    |   |                                                         |
| p |   |    |   |                                                         |
| p |   |    |   |                                                         |
| r |   |    |   |                                                         |
| o |   |    |   |                                                         |
| v |   |    |   |                                                         |
| e |   |    |   |                                                         |
| d |   |    |   |                                                         |
| S |   |    |   |                                                         |
| i |   |    |   |                                                         |
| g |   |    |   |                                                         |
| n |   |    |   |                                                         |
| a |   |    |   |                                                         |
| t |   |    |   |                                                         |
| o |   |    |   |                                                         |
| r |   |    |   |                                                         |
| y |   |    |   |                                                         |
| . |   |    |   |                                                         |
+---+---+----+---+---------------------------------------------------------+
|   |   |    |   |                                                         |
+---+---+----+---+---------------------------------------------------------+
| * |   |    |   |                                                         |
| * |   |    |   |                                                         |
| 5 |   |    |   |                                                         |
| . |   |    |   |                                                         |
| 1 |   |    |   |                                                         |
| 0 |   |    |   |                                                         |
| . |   |    |   |                                                         |
| 3 |   |    |   |                                                         |
| T |   |    |   |                                                         |
| e |   |    |   |                                                         |
| s |   |    |   |                                                         |
| t |   |    |   |                                                         |
| r |   |    |   |                                                         |
| e |   |    |   |                                                         |
| p |   |    |   |                                                         |
| o |   |    |   |                                                         |
| r |   |    |   |                                                         |
| t |   |    |   |                                                         |
| s |   |    |   |                                                         |
| * |   |    |   |                                                         |
| * |   |    |   |                                                         |
+---+---+----+---+---------------------------------------------------------+
|   |   |    |   |                                                         |
+---+---+----+---+---------------------------------------------------------+
|   | * |    |   | In addition to the requirements listed in 5.10.2, test  |
|   | * |    |   | reports shall, where necessary for the interpretation   |
|   | 5 |    |   | of the test results, include the following:             |
|   | . |    |   |                                                         |
|   | 1 |    |   |                                                         |
|   | 0 |    |   |                                                         |
|   | . |    |   |                                                         |
|   | 3 |    |   |                                                         |
|   | . |    |   |                                                         |
|   | 1 |    |   |                                                         |
|   | * |    |   |                                                         |
|   | * |    |   |                                                         |
+---+---+----+---+---------------------------------------------------------+

  -------- ----- -------------------------------------------------------------
  \_\_\_   1\)   deviations from, additions to, or exclusions from the test
                 method, and information on specific test conditions, such as
                 environmental conditions;

  \_\_\_   2\)   where relevant, a statement of compliance/non-compliance with
                 requirements and/or specifications;

                 

  \_\_\_   3\)   where applicable, a statement on the estimated uncertainty of
                 measurement; information on uncertainty is needed in test
                 reports when it is relevant to the validity or application of
                 the test results, when a customer's instruction so requires,
                 or when the uncertainty affects compliance to a specification
                 limit;

                 

  \_\_\_   4\)   where appropriate and needed, opinions and interpretations
                 (see 5.10.5);

                 

  \_\_\_   5\)   additional information which may be required by specific
                 methods, customers or groups of customers.
  -------- ----- -------------------------------------------------------------

  -------- -------------- ---------------- ----------------------------------------------------------
           **5.10.3.2**                    In addition to the requirements listed in 5.10.2 and
                                           5.10.3.1, test reports containing the results of sampling
                                           shall include the following, where necessary for the
                                           interpretation of test results:

                                           

  \_\_\_   1\)            the date of      
                          sampling;        

                                           

  \_\_\_   2\)            unambiguous      
                          identification   
                          of the           
                          substance,       
                          material or      
                          product sampled  
                          (including the   
                          name of the      
                          manufacturer,    
                          the model or     
                          type of          
                          designation and  
                          serial numbers   
                          as appropriate); 

                                           

  \_\_\_   3\)            the location of  
                          sampling,        
                          including any    
                          diagrams,        
                          sketches or      
                          photographs;     

                                           

  \_\_\_   4\)            a reference to   
                          the sampling     
                          plan and         
                          procedures used; 

                                           

  \_\_\_   5\)            details of any   
                          environmental    
                          conditions       
                          during sampling  
                          that may affect  
                          the              
                          interpretation   
                          of the test      
                          results;         

  \_\_\_   6\)            any standard or  
                          other            
                          specification    
                          for the sampling 
                          method or        
                          procedure, and   
                          deviations,      
                          additions to or  
                          exclusions from  
                          the              
                          specification    
                          concerned.       
  -------- -------------- ---------------- ----------------------------------------------------------

  ---------------- -------------- ---------------- ----------------------------------------------------------
  **5.10.4                                         
  Calibration                                      
  certificates**                                   

                                                   

                   **5.10.4.1**                    In addition to the requirements listed in 5.10.2,
                                                   calibration certificates shall include the following,
                                                   where necessary for the interpretation of calibration
                                                   results:

                                                   

  \_\_\_           1\)            the conditions   
                                  (e.g.,           
                                  environmental)   
                                  under which the  
                                  calibrations     
                                  were made that   
                                  have an          
                                  influence on the 
                                  measurement      
                                  results;         

                                                   

  \_\_\_           2\)            the uncertainty  
                                  of measurement   
                                  and/or a         
                                  statement of     
                                  compliance with  
                                  an identified    
                                  metrological     
                                  specification or 
                                  clauses thereof; 

                                                   

  \_\_\_           3\)            evidence that    
                                  the measurements 
                                  are traceable    
                                  (see note 2 in   
                                  5.6.2.1.1).      
  ---------------- -------------- ---------------- ----------------------------------------------------------

  -------------- ----- -------------------------------------------------------------
  **5.10.4.2**         

                       

  \_\_\_         1\)   The calibration certificate shall relate only to quantities
                       and the results of functional tests.

                       

  \_\_\_         2\)   If a statement of compliance with a specification is made,
                       this shall identify which clauses of the specification are
                       met or not met.

                       

  \_\_\_         3\)   When a statement of compliance with a specification is made
                       omitting the measurement results and associated
                       uncertainties, the laboratory shall record those results and
                       maintain them for possible future reference.

                       

  \_\_\_         4\)   When statements of compliance are made, the uncertainty of
                       measurement shall be taken into account.
  -------------- ----- -------------------------------------------------------------

  -------- -------------- ----------------------------------------------------------
  \_\_\_   **5.10.4.3**   When an instrument for calibration has been adjusted or
                          repaired, the calibration results before and after
                          adjustment or repair, if available, shall be reported.

                          

  \_\_\_   **5.10.4.4**   A calibration certificate (or calibration label) shall not
                          contain any recommendation on the calibration interval
                          except where this has been agreed with the customer. This
                          requirement may be superseded by legal regulations.
  -------- -------------- ----------------------------------------------------------

  ------------------- ------------------------------------------------------------------
  **5.10.5 Opinions   
  and                 
  interpretations**   

                      

  \_\_\_              When opinions and interpretations are included, the laboratory
                      shall document the basis upon which the opinions and
                      interpretations have been made. Opinions and interpretations shall
                      be clearly marked as such in a test report.

                      

                      **NOTE 1:** Opinions and interpretations should not be confused
                      with inspections and product certifications as intended in ISO/IEC
                      17020 and ISO/IEC Guide 65.

                      

                      **NOTE 2:** Opinions and interpretations included in a test report
                      may comprise, but not be limited to, the following:
  ------------------- ------------------------------------------------------------------

  ---- ----------------- ------------------------------------------------------------
       \_\_\_            an opinion on the statement of compliance/noncompliance of
                         the results with requirements;

                         

       \_\_\_            fulfillment of contractual requirements;

                         

       \_\_\_            recommendations on how to use the results;

                         

       \_\_\_            guidance to be used for improvements.

                         

       **NOTE 3:** In    
       many cases it     
       might be          
       appropriate to    
       communicate the   
       opinions and      
       interpretations   
       by direct         
       dialogue with the 
       customer. Such    
       dialogue should   
       be written down.  
  ---- ----------------- ------------------------------------------------------------

  ------------------ ----- -------------------------------------------------------------
  **5.10.6 Testing         
  and calibration          
  results obtained         
  from                     
  subcontractors**         

                           

  \_\_\_             1\)   When the test report contains results of tests performed by
                           subcontractors, these results shall be clearly identified.

                           

  \_\_\_             2\)   The subcontractor shall report the results in writing or
                           electronically.

                           

  \_\_\_             3\)   When a calibration has been subcontracted, the laboratory
                           performing the work shall issue the calibration certificate
                           to the contracting laboratory.
  ------------------ ----- -------------------------------------------------------------

+---+---+----+------------------------------------------------------------+
| * |   |    |                                                            |
| * |   |    |                                                            |
| 5 |   |    |                                                            |
| . |   |    |                                                            |
| 1 |   |    |                                                            |
| 0 |   |    |                                                            |
| . |   |    |                                                            |
| 7 |   |    |                                                            |
| E |   |    |                                                            |
| l |   |    |                                                            |
| e |   |    |                                                            |
| c |   |    |                                                            |
| t |   |    |                                                            |
| r |   |    |                                                            |
| o |   |    |                                                            |
| n |   |    |                                                            |
| i |   |    |                                                            |
| c |   |    |                                                            |
| t |   |    |                                                            |
| r |   |    |                                                            |
| a |   |    |                                                            |
| n |   |    |                                                            |
| s |   |    |                                                            |
| m |   |    |                                                            |
| i |   |    |                                                            |
| s |   |    |                                                            |
| s |   |    |                                                            |
| i |   |    |                                                            |
| o |   |    |                                                            |
| n |   |    |                                                            |
| o |   |    |                                                            |
| f |   |    |                                                            |
| r |   |    |                                                            |
| e |   |    |                                                            |
| s |   |    |                                                            |
| u |   |    |                                                            |
| l |   |    |                                                            |
| t |   |    |                                                            |
| s |   |    |                                                            |
| * |   |    |                                                            |
| * |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
|   |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
| \ | I |    |                                                            |
| _ | n |    |                                                            |
| \ | t |    |                                                            |
| _ | h |    |                                                            |
| \ | e |    |                                                            |
| _ | c |    |                                                            |
|   | a |    |                                                            |
|   | s |    |                                                            |
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|   | i |    |                                                            |
|   | s |    |                                                            |
|   | s |    |                                                            |
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|   | a |    |                                                            |
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|   | s |    |                                                            |
|   | H |    |                                                            |
|   | a |    |                                                            |
|   | n |    |                                                            |
|   | d |    |                                                            |
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|   | k |    |                                                            |
|   | s |    |                                                            |
|   | h |    |                                                            |
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|   | ( |    |                                                            |
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|   | 5 |    |                                                            |
|   | . |    |                                                            |
|   | 4 |    |                                                            |
|   | . |    |                                                            |
|   | 7 |    |                                                            |
|   | ) |    |                                                            |
|   | . |    |                                                            |
+---+---+----+------------------------------------------------------------+
|   |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
| * |   |    |                                                            |
| * |   |    |                                                            |
| 5 |   |    |                                                            |
| . |   |    |                                                            |
| 1 |   |    |                                                            |
| 0 |   |    |                                                            |
| . |   |    |                                                            |
| 8 |   |    |                                                            |
| F |   |    |                                                            |
| o |   |    |                                                            |
| r |   |    |                                                            |
| m |   |    |                                                            |
| a |   |    |                                                            |
| t |   |    |                                                            |
| o |   |    |                                                            |
| f |   |    |                                                            |
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| p |   |    |                                                            |
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| t |   |    |                                                            |
| s |   |    |                                                            |
| a |   |    |                                                            |
| n |   |    |                                                            |
| d |   |    |                                                            |
| c |   |    |                                                            |
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| r |   |    |                                                            |
| t |   |    |                                                            |
| i |   |    |                                                            |
| f |   |    |                                                            |
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| c |   |    |                                                            |
| a |   |    |                                                            |
| t |   |    |                                                            |
| e |   |    |                                                            |
| s |   |    |                                                            |
| * |   |    |                                                            |
| * |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
|   |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
| \ |   | T  |                                                            |
| _ |   | he |                                                            |
| \ |   | fo |                                                            |
| _ |   | rm |                                                            |
| \ |   | at |                                                            |
| _ |   | s  |                                                            |
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| _ |   | ll |                                                            |
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|   |   | ed |                                                            |
|   |   | to |                                                            |
|   |   | a  |                                                            |
|   |   | cc |                                                            |
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|   |   | da |                                                            |
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|   |   | ea |                                                            |
|   |   | ch |                                                            |
|   |   | ty |                                                            |
|   |   | pe |                                                            |
|   |   | of |                                                            |
|   |   | te |                                                            |
|   |   | st |                                                            |
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|   |   | c  |                                                            |
|   |   | al |                                                            |
|   |   | ib |                                                            |
|   |   | ra |                                                            |
|   |   | ti |                                                            |
|   |   | on |                                                            |
|   |   | c  |                                                            |
|   |   | ar |                                                            |
|   |   | ri |                                                            |
|   |   | ed |                                                            |
|   |   | o  |                                                            |
|   |   | ut |                                                            |
|   |   | a  |                                                            |
|   |   | nd |                                                            |
|   |   | to |                                                            |
|   |   | mi |                                                            |
|   |   | ni |                                                            |
|   |   | mi |                                                            |
|   |   | ze |                                                            |
|   |   | t  |                                                            |
|   |   | he |                                                            |
|   |   | p  |                                                            |
|   |   | os |                                                            |
|   |   | si |                                                            |
|   |   | bi |                                                            |
|   |   | li |                                                            |
|   |   | ty |                                                            |
|   |   | of |                                                            |
|   |   | mi |                                                            |
|   |   | su |                                                            |
|   |   | nd |                                                            |
|   |   | er |                                                            |
|   |   | st |                                                            |
|   |   | an |                                                            |
|   |   | di |                                                            |
|   |   | ng |                                                            |
|   |   | or |                                                            |
|   |   | m  |                                                            |
|   |   | is |                                                            |
|   |   | us |                                                            |
|   |   | e. |                                                            |
+---+---+----+------------------------------------------------------------+
|   |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
|   |   | ** |                                                            |
|   |   | NO |                                                            |
|   |   | TE |                                                            |
|   |   | 1: |                                                            |
|   |   | ** |                                                            |
|   |   | A  |                                                            |
|   |   | tt |                                                            |
|   |   | en |                                                            |
|   |   | ti |                                                            |
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|   |   | ou |                                                            |
|   |   | ld |                                                            |
|   |   | be |                                                            |
|   |   | g  |                                                            |
|   |   | iv |                                                            |
|   |   | en |                                                            |
|   |   | to |                                                            |
|   |   | t  |                                                            |
|   |   | he |                                                            |
|   |   | la |                                                            |
|   |   | yo |                                                            |
|   |   | ut |                                                            |
|   |   | of |                                                            |
|   |   | t  |                                                            |
|   |   | he |                                                            |
|   |   | te |                                                            |
|   |   | st |                                                            |
|   |   | re |                                                            |
|   |   | po |                                                            |
|   |   | rt |                                                            |
|   |   | or |                                                            |
|   |   | c  |                                                            |
|   |   | al |                                                            |
|   |   | ib |                                                            |
|   |   | ra |                                                            |
|   |   | ti |                                                            |
|   |   | on |                                                            |
|   |   | ce |                                                            |
|   |   | rt |                                                            |
|   |   | if |                                                            |
|   |   | ic |                                                            |
|   |   | at |                                                            |
|   |   | e, |                                                            |
|   |   | es |                                                            |
|   |   | pe |                                                            |
|   |   | ci |                                                            |
|   |   | al |                                                            |
|   |   | ly |                                                            |
|   |   | wi |                                                            |
|   |   | th |                                                            |
|   |   | re |                                                            |
|   |   | ga |                                                            |
|   |   | rd |                                                            |
|   |   | to |                                                            |
|   |   | t  |                                                            |
|   |   | he |                                                            |
|   |   | pr |                                                            |
|   |   | es |                                                            |
|   |   | en |                                                            |
|   |   | ta |                                                            |
|   |   | ti |                                                            |
|   |   | on |                                                            |
|   |   | of |                                                            |
|   |   | t  |                                                            |
|   |   | he |                                                            |
|   |   | te |                                                            |
|   |   | st |                                                            |
|   |   | or |                                                            |
|   |   | c  |                                                            |
|   |   | al |                                                            |
|   |   | ib |                                                            |
|   |   | ra |                                                            |
|   |   | ti |                                                            |
|   |   | on |                                                            |
|   |   | da |                                                            |
|   |   | ta |                                                            |
|   |   | a  |                                                            |
|   |   | nd |                                                            |
|   |   | ea |                                                            |
|   |   | se |                                                            |
|   |   | of |                                                            |
|   |   | as |                                                            |
|   |   | si |                                                            |
|   |   | mi |                                                            |
|   |   | la |                                                            |
|   |   | ti |                                                            |
|   |   | on |                                                            |
|   |   | by |                                                            |
|   |   | t  |                                                            |
|   |   | he |                                                            |
|   |   | r  |                                                            |
|   |   | ea |                                                            |
|   |   | de |                                                            |
|   |   | r. |                                                            |
+---+---+----+------------------------------------------------------------+
|   |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
| 8 |   | ** |                                                            |
| ) |   | NO |                                                            |
|   |   | TE |                                                            |
|   |   | 2: |                                                            |
|   |   | ** |                                                            |
|   |   | T  |                                                            |
|   |   | he |                                                            |
|   |   | he |                                                            |
|   |   | ad |                                                            |
|   |   | in |                                                            |
|   |   | gs |                                                            |
|   |   | sh |                                                            |
|   |   | ou |                                                            |
|   |   | ld |                                                            |
|   |   | be |                                                            |
|   |   | st |                                                            |
|   |   | an |                                                            |
|   |   | da |                                                            |
|   |   | rd |                                                            |
|   |   | iz |                                                            |
|   |   | ed |                                                            |
|   |   | as |                                                            |
|   |   | f  |                                                            |
|   |   | ar |                                                            |
|   |   | as |                                                            |
|   |   | p  |                                                            |
|   |   | os |                                                            |
|   |   | si |                                                            |
|   |   | bl |                                                            |
|   |   | e. |                                                            |
+---+---+----+------------------------------------------------------------+
| 9 |   |    |                                                            |
| ) |   |    |                                                            |
|   |   |    |                                                            |
|   |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
| * |   |    |                                                            |
| * |   |    |                                                            |
| 5 |   |    |                                                            |
| . |   |    |                                                            |
| 1 |   |    |                                                            |
| 0 |   |    |                                                            |
| . |   |    |                                                            |
| 9 |   |    |                                                            |
| A |   |    |                                                            |
| m |   |    |                                                            |
| e |   |    |                                                            |
| n |   |    |                                                            |
| d |   |    |                                                            |
| m |   |    |                                                            |
| e |   |    |                                                            |
| n |   |    |                                                            |
| t |   |    |                                                            |
| s |   |    |                                                            |
| t |   |    |                                                            |
| o |   |    |                                                            |
| t |   |    |                                                            |
| e |   |    |                                                            |
| s |   |    |                                                            |
| t |   |    |                                                            |
| r |   |    |                                                            |
| e |   |    |                                                            |
| p |   |    |                                                            |
| o |   |    |                                                            |
| r |   |    |                                                            |
| t |   |    |                                                            |
| s |   |    |                                                            |
| a |   |    |                                                            |
| n |   |    |                                                            |
| d |   |    |                                                            |
| c |   |    |                                                            |
| a |   |    |                                                            |
| l |   |    |                                                            |
| i |   |    |                                                            |
| b |   |    |                                                            |
| r |   |    |                                                            |
| a |   |    |                                                            |
| t |   |    |                                                            |
| i |   |    |                                                            |
| o |   |    |                                                            |
| n |   |    |                                                            |
| c |   |    |                                                            |
| e |   |    |                                                            |
| r |   |    |                                                            |
| t |   |    |                                                            |
| i |   |    |                                                            |
| f |   |    |                                                            |
| i |   |    |                                                            |
| c |   |    |                                                            |
| a |   |    |                                                            |
| t |   |    |                                                            |
| e |   |    |                                                            |
| s |   |    |                                                            |
| * |   |    |                                                            |
| * |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
|   |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
|   | 1 |    | Material amendments to a test report or calibration        |
|   | \ |    | certificate after issue shall be made only in the form of  |
|   | ) |    | a further document, or data transfer, which includes the   |
|   |   |    | statement:                                                 |
+---+---+----+------------------------------------------------------------+
|   |   |    | \"Supplement to Test Report \[or Calibration               |
|   |   |    | Certificate\], serial number \... \[or as otherwise        |
|   |   |    | identified\],\" or an equivalent form of wording.          |
+---+---+----+------------------------------------------------------------+
|   |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
| \ | 2 |    | Such amendments shall meet all the requirements of this    |
| _ | \ |    | Handbook.                                                  |
| \ | ) |    |                                                            |
| _ |   |    |                                                            |
| \ |   |    |                                                            |
| _ |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
|   |   |    |                                                            |
+---+---+----+------------------------------------------------------------+
| \ | 3 |    | When it is necessary to issue a complete new test report   |
| _ | \ |    | or calibration certificate, this shall be uniquely         |
| \ | ) |    | identified and shall contain a reference to the original   |
| _ |   |    | that it replaces.                                          |
| \ |   |    |                                                            |
| _ |   |    |                                                            |
+---+---+----+------------------------------------------------------------+

**Appendix D. Summary of Services for Laboratory
Directory**[]{#__RefHeading___Toc169420789
.anchor}![](media/image3.wmf){width="0.6916666666666667in"
height="7.291666666666667e-2in"}

######## State

Recognition Period: \_\_\_\_\_\_\_\_\_\_

+--------------------------+---------------------+---------------------+
| **Laboratory Staff &     | **Address**         | **Communications**  |
| Titles**                 |                     |                     |
+--------------------------+---------------------+---------------------+
|                          |                     | Phone:              |
+--------------------------+---------------------+---------------------+
|                          |                     | Fax:                |
|                          |                     |                     |
|                          |                     | e-mail:             |
|                          |                     |                     |
|                          |                     | URL:                |
+--------------------------+---------------------+---------------------+

  ----------------------------------- -----------------------------------
  **National Type Evaluation Program  
  (NTEP)**                            

  Address                             Telephone Number

                                      

                                      

                                      

                                      
  ----------------------------------- -----------------------------------

  ----------------------------------- -----------------------------------
  **Commercial Measuring Device       
  Testing (non-NTEP)**                

  Address                             Telephone Number

                                      

                                      

                                      

                                      
  ----------------------------------- -----------------------------------

  ----------------------------------- -----------------------------------
  **Grain Moisture Testing**          

  Address                             Telephone Number

                                      

                                      

                                      
  ----------------------------------- -----------------------------------

  ----------------------------------- -----------------------------------
  **Petroleum Quality Testing**       

  Address                             Telephone Number

                                      

                                      

                                      
  ----------------------------------- -----------------------------------

**Appendix E. Uncertainties Chart for**

**Measurement Parameter & Procedure**[]{#__RefHeading___Toc169420790
.anchor}**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

####### **Laboratory\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

+-------+--------+--------+--------+-------------+------------------+
| **Ra  | **Type | **Type | **Comb | **Expanded  | **Comments**     |
| nge** | A**    | B**    | ined** | Standard**  |                  |
|       |        |        |        |             |                  |
|       | **U    | **U    | **U    | **Un        |                  |
|       | ncerta | ncerta | ncerta | certainty** |                  |
|       | inty** | inty** | inty** |             |                  |
|       |        |        |        | **(k -- 2   |                  |
|       |        |        |        | or o3)**    |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+
|       |        |        |        |             |                  |
+-------+--------+--------+--------+-------------+------------------+

[^1]: Section 4 substantially references the text of ISO/IEC 17025:2005,
    with additional NVLAP notes, WMD notes, and minor editorial changes
    for clarity. Where "this Handbook" is used in Section 4, it refers
    to the criteria in ISO/IEC 17025 as applied to this Program Handbook
    unless otherwise stated. WMD does not accredit laboratories;
    however, WMD assesses State laboratories that participate in the
    Recognition program for conformance to these requirements.

[^2]: Section 5 substantially references the text of ISO/IEC 17025:2005,
    with additional NVLAP notes, WMD notes, and minor editorial changes
    for clarity. Where "this Handbook" is used in Section 5, it refers
    to the criteria in ISO/IEC 17025 as applied to this Program Handbook
    unless otherwise stated. WMD does not Accredit laboratories;
    however, WMD assesses State laboratories that participate in the
    Recognition program for conformance to these requirements.

[^3]: This section is adapted from the NVLAP Handbook 150-2F,
    Calibration Laboratories Technical Guide and is modified for WMD
    application.

[^4]: This section was originally developed by WMD for adoption in the
    NVLAP Calibration Laboratories Technical Guide (NIST HB 150-2G); it
    is modified here for WMD application.

[^5]: This section was originally developed by WMD for adoption in the
    NVLAP Calibration Laboratories Draft Technical Guide (NIST HB
    150-2G); it is modified here for WMD application.

[^6]: ^6^ This section is adapted from the NVLAP Calibration
    Laboratories Draft Technical Guide (NIST HB 150-2G); it is modified
    here for WMD application.

[^7]: This section is adapted from the NVLAP Calibration Laboratories
    Draft Technical Guide (NIST HB 150-2H); it is modified here for WMD
    application.

[^8]: This section was originally developed by WMD.