###### State NIST

**Weights and Measures**

**Laboratories**

**Program Handbook**

**NIST Handbook 143**

March **2003**

**Preface**[]{#__RefHeading___Toc35565330 .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 Guide 58, 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) is no longer covered in this program handbook.

-   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.

-   Parts 4 and 5 substantially contain ISO/IEC 17025:1999 (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.

-   Part 6 is taken from the NVLAP Calibration Laboratories Draft
    Technical Guide (1994 Draft, as incorporated in the 1996 and 1997
    editions of this Handbook), but 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. 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
    2003 edition.

-   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:

Appropriate SI units of measure have been used throughout this document
where possible. Since commercial applications in the United States use
units other than SI or other accepted metric units, this document may
reference other common units in current use.

**Acknowledgments and History**[]{#__RefHeading___Toc35565331 .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 NIST/WMD issued "Certificates of
Participation" to States participating in the program. In 1985, WMD
started 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 and
questions regarding how those activities would impact the State
laboratories, ISO standards were circulated 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 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:

1\) reduce the number of redundant laboratory audits;

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

3\) comply with the ISO-series standards for quality.

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 NIST/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. This 2003 edition of NIST Handbook 143
incorporates 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.*

The requirements in Sections 4 and 5 of this edition are nearly
identical to those found in 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 from the previous
edition of the handbook include the following:

-   In Section 4, *Management requirements*, there are additional or
    changed requirements in the areas of document control; requests,
    tenders, and contracts; purchasing; non-conforming work; corrective
    action; preventive action; and records. These additions and changes
    incorporate and/or are consistent with ISO 9001:1994 requirements. A
    new clause, *Service to the client*, prescribes cooperation with
    clients and provides guidance on such cooperation.

-   In Section 5, *Technical requirements*, the requirements are
    described in greater detail, but most concepts are not "new" for
    accredited laboratories. There is continued reference to client
    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 will be required where methods or specifications do
    not specify sampling procedures.

This 2003 edition supersedes and replaces the 1997 edition of NIST
Handbook 143.

**Table of Contents**

[Preface iii](#__RefHeading___Toc35565330)

[Acknowledgments and History v](#__RefHeading___Toc35565331)

[1. Program Summary 2](#program-summary)

[2. General Information and Operational Requirements
4](#general-information-and-operational-requirements)

[3. Recognition Process 10](#recognition-process)

[Table 1. Submission requirements for recognition
17](#__RefHeading___Toc35565338)

[4. Management Requirements for Accreditation
18](#__RefHeading___Toc35565340)

[5. Technical Requirements for Accreditation
30](#__RefHeading___Toc35565341)

[6. Specific Technical Guidelines 49](#__RefHeading___Toc35565342)

[Table 3. Recognition parameter summary 50](#__RefHeading___Toc35565343)

[**6.1** **Technical Criteria for Dimensional Laboratories**
51](#__RefHeading___Toc35565344)

[**6.2** **Technical Criteria for Mass Laboratories**
56](#__RefHeading___Toc35565345)

[Table 4. Mass calibration echelons 56](#__RefHeading___Toc35565346)

[Table 5. Typical](#__RefHeading___Toc35565347) [Ranges of Recognition
for mass calibration 57](#ranges-of-recognition)

[Table 6. Environmental facility guidelines for mass laboratories
59](#__RefHeading___Toc35565349)

[Table 7. Environmental equipment accuracy
60](#__RefHeading___Toc35565353)

[Table 8. Summary of technical criteria for mass calibration
63](#__RefHeading___Toc35565354)

[**6.3 Technical Criteria for Volume Laboratories**
64](#__RefHeading___Toc35565355)

[Table 9. Typical Ranges](#__RefHeading___Toc35565356) [of Recognition
for volumetric calibration
64](#scope-of-recognition---nominal-value-range)

[Table 10. Environmental facility guidelines for volumetric calibration
66](#__RefHeading___Toc35565362)

[Table 11. Environmental equipment accuracy
67](#__RefHeading___Toc35565363)

[Table 12. Summary of technical criteria for volumetric calibration
69](#__RefHeading___Toc35565364)

[**6.4 Technical Criteria for Hydrometer Laboratories**
70](#__RefHeading___Toc35565366)

[**6.5 Technical Criteria for Thermometer Laboratories**
73](#__RefHeading___Toc35565367)

[**6.6 Technical Criteria for Moisture Laboratories**
81](#__RefHeading___Toc35565370)

[Table 13. Moisture determination laboratory classifications
81](#__RefHeading___Toc35565371)

[Table 14. Summary of environmental facility guidelines
88](#__RefHeading___Toc35565372)

[7. References 89](#__RefHeading___Toc35565373)

[8. Glossary 90](#glossary)

[Appendix A. List of NIST Services 95](#__RefHeading___Toc35565376)

[Appendix B. Request for Recognition, Scope of Recognition, Approved
Signatories, Authorized Representative 96](#__RefHeading___Toc35565377)

[Appendix C. Laboratory Assessment Checklist
97](#appendix-c.-laboratory-assessment-checklist)

[Appendix D. Summary of Services for Laboratory Directory
127](#__RefHeading___Toc35565380)

[Appendix E. Uncertainties Chart for Measurement Parameter
130](#__RefHeading___Toc35565381)

#   {#section .unnumbered}

# 1. Program Summary

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 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 NIST/WMD.

The general requirements in sections 4 and 5 incorporate ISO/IEC
17025:1999 (as adopted by the NVLAP Calibration Laboratories
Accreditation Program) and address internationally accepted quality
practices and good 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 NIST/WMD recognition program are nearly
identical to the NVLAP guidelines published in the draft of NIST/NVLAP
Handbook 150-2, Calibration Laboratories Technical Guide; however, WMD
does not operate a formal accreditation program. 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 checklists that
are reviewed and evaluated by NIST/WMD.

Following review and evaluation, which includes an on-site assessment
and proficiency testing, NIST/WMD may issue a Certificate of Measurement
Traceability indicat­ing recognized competence areas with defined
parameters and scope of recognition; a letter describing the quality
system in place in each laboratory is also provided. 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
management and quality system review, 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. NIST/WMD reserves the right to deny or
withdraw Recognition. In such cases, NIST/WMD will notify the State in
writing of deficiencies, 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.

# 2. General Information and Operational Requirements

**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 weights and measures
(legal metrology) 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 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 NIST/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, 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 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
their clients.

**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, or other form of Recognition by NIST as
evidence of maintaining measurement traceability for 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 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. 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 will seek to ensure the
confidentiality of all information obtained relating to the application,
on-site assessment, evaluation, and Recognition of laboratories.
*Exception: see section 2.9.9*

Results of proficiency tests are generally discussed openly at annual
RMAP meetings in the spirit of continuous improvement and teamwork.
Proficiency testing may be held confidential if any participating State
laboratory requests confidentiality of the results by writing to WMD
prior to the beginning of each interlaboratory comparison.

**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 mass and volume have been incorporated into the draft
of NIST Handbook 150-2, Calibration Laboratories Technical Guide. Draft
laboratory publications are reviewed by affected laboratories prior to
publication.

**2.7 Documentation**

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

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

a)  **NIST Special Publication (SP) 791, State Weights and Measures
    Laboratories: State Standards Program Description and Directory**

This document contains a general program description and laboratory
directory. It is updated periodically and is available on the NIST
Internet site.

b)  **NIST Handbook 145 Handbook for the Quality Assurance of
    Metrological Measurements**

This Handbook contains laboratory procedures that are used in NIST/WMD
Training Program and are recommended for use in State 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, Good Measurement Practices,
and Standard Operating Procedures.

c)  **NISTIR 5672, Advanced Mass Measurements and Measurement Assurance
    Program for State Calibration Laboratories**

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.

d)  **NISTIR 5802, Quality Manual Template**

This publication is a quality manual template developed as a model for
State weights and Measures laboratories. It conforms to ISO/IEC Guide
25, ANSI/NCSL Z540-1-1994, and earlier NVLAP documentation requirements.
It is available on the NIST Internet site.

**2.8 Records**

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

a)  traceability records for primary standards;

b)  measurement control**/**assurance data (control charts and
    surveillance tests) - latest year;

c)  training;

d)  quality manuals (latest version);

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

f)  internal audits (including management review); and

g)  on-site assessment reports.

Letters verifying the status of a laboratory's Recognition level,
traceability, and accompanying records will be provided to a State when
Certificates of Measurement Traceability are issued, and may also be
sent on behalf of the State to customers when formally requested in
writing on official letterhead. Facsimile 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/client use
as evidence of traceability. The copy of the certificate must include
the Scope of Recognition (if not incorporated into the certificate).

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

The laboratory may reference its Recognition status or traceability
status on 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 NIST/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 NIST/WMD of any changes that might affect
the quality of measurement services it provides. This includes, but is
not limited to: changes in staff, 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 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 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 Recognition with
WMD or formal accreditation. Calibration reports from laboratories that
have failed to maintain Recognition or formal accreditation should be
refused. Information on Recognition status will be made available to
States through 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
interest 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 deficiencies and be given an opportunity to submit evidence of
corrective action for whatever deficiency exists. A laboratory that has
lost Recognition status may subsequently comply with the Recognition
criteria. Laboratories are encouraged to work closely with the NIST/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 NIST/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 deficiencies and corrective action requests**

A laboratory will have a specified amount of time to respond to
deficiencies addressed through annual review, internal management
review, NIST/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 deficiencies. The laboratory has the right to
appeal WMD decisions as described later in this publication.

#   {#section-1 .unnumbered}

# 3. Recognition Process

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:

a)  an annual solicitation by WMD;

b)  technical review of submitted material (see list in Table 1);

c)  review of on-site assessment results;

d)  review of proficiency testing results; and

e)  issuance of a Certificate of Measurement Traceability, along with a
    scope of Recognition, and a letter describing the laboratory quality
    system.

**3.1 Request 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 automatically renew its Recognition; however,
the annual Request for Recognition must detail the requested Scope of
Recognition. An annual evaluation is 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 NIST/WMD. The laboratories provide
payment-in-kind through voluntary efforts for many of the activities
needed to maintain the Recognition process in partnership with WMD. As a
result of this partnership and shared responsibilities, no fees are
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 NIST via a detailed memorandum
between August 1 and September 15.

**3.2.1 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 submitted late will be processed as
expeditiously as possible once it has been received by the NIST/WMD.

**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, a completed checklist, and all
associated forms and charts must be submitted each time the
laboratory\'s Certificate of Measurement Traceability is due to expire.
A list of items is detailed in Table 1. If the Certificate of
Measurement Traceability has lapsed, it is treated as a renewal.

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

Since all laboratories were established with the technical support and
guidance of the NIST/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).

TEs use checklists, and all formal 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, training records, RMAP attendance records, results of internal
audits, results of round robin 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.

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**Figure 1.** Recognition Process.

**3.3.1 NIST staff**

On-site assessments of laboratories may or may not be conducted by
NIST/WMD staff. However, NIST 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 (may also be called regional assessors) 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
NIST/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
for regional assessors**.** 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
deficiencies and the expected preventive or corrective action**.** The
laboratory is given an opportunity to respond or appeal stated
deficiencies. 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 deficiencies as soon as possible and to implement
preventive action as a normal course of operations. The laboratory must
submit a corrective action plan to WMD within 30 days of receiving a
final report. This does not mean that deficiencies 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 deficiencies. 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:

a)  name and address of the laboratory;

b)  date of the assessment;

c)  criteria used to conduct the assessment;

d)  parameters and scope of Recognition for the assessment;

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

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

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

h)  references to the Program Handbook when deficiencies are identified;

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

j)  deficiencies and corrective action required to meet program criteria
    and discussion related to cited observations.

    4.  **Proficiency Testing**

Interlaboratory comparisons (round robins) are conducted as a part of
each regional measurement assurance program 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
deficiencies. 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 deficiencies are defined as, but not limited to, one
or more of the following:

a)  failure to meet specified proficiency testing performance
    requirements or objectives prescribed at the outset of the round
    robin;

b)  failure to participate in a regularly scheduled round of proficiency
    testing for which the laboratory has received instructions and/or
    materials;

c)  failure to submit laboratory control data as required specific to
    each round robin;

d)  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

e)  failure to produce acceptable calibration or test results when using
    special artifacts whose properties are well-characterized and known
    to NIST/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, 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 deficiencies.

**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 Accreditation 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
deficiencies 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 NIST/WMD.

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 NIST/WMD in writing.

**3.6.1 Full renewal - 2 year**

For those laboratories fully meeting criteria in this Handbook, a 2-year
Certificate of Measurement Traceability will be issued; however,
additional data must continue to be submitted annually for review as
requested. Any laboratory that cannot meet the criteria in this Handbook
should not apply for NVLAP formal accreditation.

**3.6.2 One-year renewal**

For laboratories where WMD management and oversight are required, or
when minor deficiencies exist, a 1-year Certificate of Measurement
Traceability may be issued based on the judgement of WMD staff that
acceptable measurements will continue to be provided to laboratory
customers.

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

**3.6.3 Conditional renewal**

A 1-year *conditional* Certificate of Measurement Traceability may be
granted when multiple deficiencies exist in the facilities, equipment,
standards, staff, or overall laboratory operations, and that the
laboratory 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.

**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
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 fully meets criteria in this Handbook.

The result of an on-site assessment or of document review may include
denial of Recognition. Clear evidence of deficiencies 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___Toc35565338 .anchor}

+-----------+---------------------------+--------+---+--------+---------+
| Reference | Item Description          | Annual |   | C      | Updated |
|           |                           | Review |   | hanges |         |
|           |                           | &      |   | or     |         |
|           |                           | Subm   |   | R      |         |
|           |                           | ission |   | enewal |         |
+-----------+---------------------------+--------+---+--------+---------+
| Appendix  | Request for Recognition,  | X      |   | Change |         |
| B         | Parameters and Scope,     |        |   |        |         |
|           | Approved Signatories,     |        |   |        |         |
|           | Authorized Representative |        |   |        |         |
+-----------+---------------------------+--------+---+--------+---------+
| Appendix  | Quality Assessment        | X      |   | C      |         |
| C         | Checklist and Management  |        |   | hange; |         |
|           | Review                    |        |   | when   |         |
|           |                           |        |   | req    |         |
|           |                           |        |   | uested |         |
+-----------+---------------------------+--------+---+--------+---------+
| Appendix  | Summary of Services       | X      |   | R      | X       |
| D         |                           |        |   | enewal |         |
+-----------+---------------------------+--------+---+--------+---------+
| Appendix  | ## Uncertainties          | X      |   |        | X       |
| E         | Charts for all parameters |        |   |        |         |
+-----------+---------------------------+--------+---+--------+---------+
|           | Technical Assessment;     | X      |   |        |         |
|           | Internal Audit Reports;   |        |   |        |         |
|           | Management Review Reports |        |   |        |         |
|           |                           |        |   |        |         |
|           | Note: no checklist is     |        |   |        |         |
|           | available                 |        |   |        |         |
+-----------+---------------------------+--------+---+--------+---------+
|           | Laboratory Quality Manual |        |   |        | X       |
|           | and Administrative        |        |   |        |         |
|           | Procedures                |        |   |        |         |
+-----------+---------------------------+--------+---+--------+---------+
|           | NIST calibration reports  |        |   |        | X       |
|           | for standards             |        |   |        |         |
+-----------+---------------------------+--------+---+--------+---------+
|           | Laboratory Auditing       |        |   |        | X       |
|           | Program (LAP) problems    |        |   |        |         |
|           | assigned in Training      |        |   |        | (com    |
|           | Program                   |        |   |        | pleted) |
+-----------+---------------------------+--------+---+--------+---------+
|           | Measurement control --    | When   |   |        |         |
|           | control charts,           | requ   |   |        |         |
|           | surveillance tests        | ested; |   |        |         |
|           |                           |        |   |        |         |
|           |                           | re     |   |        |         |
|           |                           | viewed |   |        |         |
|           |                           | during |   |        |         |
|           |                           | o      |   |        |         |
|           |                           | n-site |   |        |         |
|           |                           | asses  |   |        |         |
|           |                           | sments |   |        |         |
+-----------+---------------------------+--------+---+--------+---------+
|           | Special Technical         | When   |   |        |         |
|           | Requests                  | req    |   |        |         |
|           |                           | uested |   |        |         |
+-----------+---------------------------+--------+---+--------+---------+

**4. Management Requirements for
Accreditation**[^1][]{#__RefHeading___Toc35565340 .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 client,
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 judgement
and integrity in relation to its testing or calibration activities.

5.  The laboratory shall

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a)  have managerial and technical personnel with the authority and
    resources needed to carry out their duties and to identify the
    occurrence of departures from the quality 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);

b)  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;

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

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

    e\) 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;

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

    g\) 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;

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h)  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;

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i)  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 quality
    system 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; and

j\) appoint deputies for key managerial personnel (see note).

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

**4.2 Quality System**

**4.2.1** The laboratory shall establish, implement and maintain a
quality 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 quality system policies and objectives shall
be defined in a quality manual (however named). The overall objectives
shall be documented in a quality policy statement. The quality policy
statement shall be issued under the authority of the chief executive. It
shall include at least the following:

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

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

c)  the objectives of the quality system;

d)  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

e)  the laboratory management\'s commitment to compliance with this
    Handbook.

    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 clients\'
    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** 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 quality
    system.

    **4.2.4** 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.

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
NIST/WMD provides NISTIR 5802, Quality Manual Template for the State
laboratories to use as a baseline that complies with the requirements of
ISO/IEC Guide 25 and 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**

    **4.3.1 General**

    The laboratory shall establish and maintain procedures to control
    all documents that form part of its quality 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 4.12.

    **4.3.2 Document approval and issue**

    **4.3.2.1** All documents issued to personnel in the laboratory as
    part of the quality 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:

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

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

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

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

    **4.3.2.3** Quality 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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a)  the requirements, including the methods to be used, are adequately
    defined, documented and understood (see 5.4.2);

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

c)  the appropriate test and/or calibration method is selected and
    capable of meeting the clients\' 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 client.

    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 clients, 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
    client 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 client relating to the client\'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
    client, provided that the client\'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 client 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 client of the
        arrangement in writing and, when appropriate, gain the approval
        of the client, preferably in writing.

        **4.5.3** The laboratory is responsible to the client for the
        subcontractor's work, except in the case where the client 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 quality 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 Client**

        The laboratory shall afford clients or their representatives
        cooperation to clarify the client\'s request and to monitor the
        laboratory's performance in relation to the work performed,
        provided that the laboratory ensures confidentiality to other
        clients.

        NOTE 1 Such cooperation may include:

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

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

    NOTE 2 Clients value the maintenance of good communication, advice
    and guidance in technical matters, and opinions and interpretations
    based on results. Communication with the client, especially in large
    assignments, should be maintained throughout the work. The
    laboratory should inform the client of any delays or major
    deviations in the performance of the tests and/or calibrations.

    NOTE 3 Laboratories are encouraged to obtain other feedback, both
    positive and negative, from their clients (e.g., client surveys).
    The feedback should be used to improve the quality system, testing
    and calibration activities and client service.

    **4.8 Complaints**

    The laboratory shall have a policy and procedure for the resolution
    of complaints received from clients or other parties. Records shall
    be maintained of all complaints and of the investigations and
    corrective actions taken by the laboratory (see also 4.10).

    **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 client. The policy
    and procedures shall ensure that:

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a)  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;

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

c)  corrective actions are taken immediately, together with any decision
    about the acceptability of the non-conforming work;

d)  where necessary, the client is notified and work is recalled; and

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

    NOTE Identification of non-conforming work or problems with the
    quality system or with testing and/or calibration activities can
    occur at various places within the quality 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 4.10 shall be promptly
        followed.

        **4.10 Corrective Action**

        **4.10.1 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 quality system or technical operations
        have been identified.

        NOTE A problem with the quality 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 clients or
        staff observations.

        **4.10.2 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
        client requirements, the samples, sample specifications, methods
        and procedures, staff skills and training, consumables, or
        equipment and its calibration.

        **4.10.3 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.

        **4.10.4 Monitoring of corrective actions**

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

        **4.10.5 Additional audits**

        Where the identification of non-conformances 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 4.13 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.

        **4.11 Preventive Action**

        **4.11.1** Needed improvements and potential sources of
        non-conformances, either technical or concerning the quality
        system, shall be identified. If preventive action is required,
        action plans shall be developed, implemented and monitored to
        reduce the likelihood of the occurrence of such non-conformances
        and to take advantage of the opportunities for improvement.

        **4.11.2** 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.

        **4.12 Control of Records**

        **4.12.1 General**

        **4.12.1.1** 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.

        **4.12.1.2** 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.

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

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

        **4.12.2 Technical Records**

        **4.12.2.1** 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, clients\' notes, papers and feedback.

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

        **4.12.2.3** 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.

        **4.13 Internal Audits**

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    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 quality system and this Handbook.
        The internal audit program shall address all elements of the
        quality 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.

        **4.13.2** 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 clients in
        writing if investigations show that the laboratory results may
        have been affected.

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

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

        **4.14 Management Reviews**

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    1.  In accordance with a predetermined schedule and procedure, the
        laboratory's executive management shall periodically conduct a
        review of the laboratory\'s quality 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;

-   client feedback;

-   complaints; and

-   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.

**4.14.2** 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.

**5.** Number range CHAPTER**Technical Requirements for
Accreditation**[^2] []{#__RefHeading___Toc35565341 .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); and

--- 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 client.

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.

**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 quality 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; and

--- 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 NIST/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.

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

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
client.

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 NIST/WMD maintains NIST Handbook 145, Handbook for the
Quality Assurance of Metrological Measurements. States must reference
this Handbook 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 NIST/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 client 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 client 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
client 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 client when the method proposed by the
client 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 client and shall include a
clear specification of the client\'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:

a)  appropriate identification;

b)  scope;

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

d)  parameters or quantities and ranges to be determined;

e)  apparatus and equipment, including technical performance
    requirements;

f)  reference standards and reference materials required;

g)  environmental conditions required and any stabilization period
    needed;

h)  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, and

-   any safety measures to be observed;

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

j\) data to be recorded and method of analysis and presentation; and

k.  the uncertainty or the procedure for estimating uncertainty.

    **5.4.5 Validation of methods**

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

    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; and

-   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 client 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 client needs 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.

    6.  **Estimation of uncertainty of measurement**

        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:

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-   the requirements of the test method;

-   the requirements of the client; and

-   the existence of narrow limits on which decisions on conformance 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 1.4).

    WMD NOTE ANSI/NCSL Z540-2-1997 and NIST Technical Note 1297, 1994
    edition, are considered to be equivalent to the Guide to the
    Expression of Uncertainty in Measurement (GUM).

    **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:

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

b)  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; and

c)  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:

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

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

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

d)  the current location, where appropriate;

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

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

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

h)  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 template contains 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.

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; and

-   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.

    1.  **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.

        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).

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    2.  **Reference standards and reference materials**

        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.

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.

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

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 primary standards used in the
laboratory are maintained in the NIST/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 a recognized accreditation body.

6.  **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 client 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 client.

    **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.

    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 client 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**

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:

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; and

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.

WMD NOTE The laboratory shall maintain a list of control charts,
surveillance activities, and round robins 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
template contains 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 NIST/WMD as requested.

**5.10 Reporting the Results**

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 client 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 clients, or
in the case of a written agreement with the client, 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 client 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:

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

b)  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;

c)  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;

d)  the name and address of the client;

e)  identification of the method used;

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

g)  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;

h)  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;

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

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

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

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

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.

**5.10.3 Test reports**

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:

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

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

c)  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 client\'s instruction so requires, or when the
    uncertainty affects compliance to a specification limit;

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

e)  additional information which may be required by specific methods,
    clients or groups of clients.

    **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:

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a)  the date of sampling;

b)  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);

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

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

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

f)  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:

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

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

c)  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 client. 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; and

-   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 client.
    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**

+---------------+-------------------------+--------------+------------+
| **Recognition | **Training Required**   | **For Whom** | **How      |
| Level**       |                         |              | Often**    |
+---------------+-------------------------+--------------+------------+
| Minimum (for  | · Basic Laboratory      | Usually all  | Once       |
| legal         | Metrology Seminar (2    | staff, at    |            |
| metrological  | weeks)                  | least one    | Once       |
| activities)   |                         | staff member |            |
|               | · Basic LAP problems -  |              |            |
|               | acceptable completion   |              |            |
+---------------+-------------------------+--------------+------------+
|               | · Attendance at         | At least one | Annually   |
|               | Regional Measurement    | staff member |            |
|               | Assurance Program       |              |            |
|               | meeting annually        |              |            |
+---------------+-------------------------+--------------+------------+
| Calibration   | · All of the above,     | Usually all  | Every 3 to |
|               | plus:                   | staff; at    | 4 years    |
|               |                         | least one    | unless     |
|               | · Intermediate          |              | attending  |
|               | Laboratory Metrology    |              | RMAP       |
|               | Seminar (1 week)        |              | annually   |
|               |                         |              |            |
|               | · Intermediate LAP      |              |            |
|               | problems - acceptable   |              |            |
|               | completion              |              |            |
+---------------+-------------------------+--------------+------------+
| Advanced mass | · All of the above,     | At least one | At least   |
| calibration   | plus:                   | if working   | once; for  |
|               |                         | at this      | updates as |
|               | · Advanced Mass         | level        | needed     |
|               | Measurements Seminar    |              |            |
|               |                         |              |            |
|               | · 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 Template (NISTIR 5802) contains a form that can
be used to document training and dates.

**6. Specific Technical Guidelines**[]{#__RefHeading___Toc35565342
.anchor}

The material in this section is primarily from the Calibration
Laboratories Draft Technical Guide (1994)**,** 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 NVLAP Guide is should be considered
in its application.

> \"This section provides examples and guidelines, not requirements, to
> technical experts and interested calibration laboratories, on good
> laboratory practices and recommended standards. Therefore, the guide
> language reflects this philosophy through the use of \"shoulds\"
> instead of \"shalls\" (along with other less prescriptive language)
> when describing criteria. Absolute requirements are not presented here
> since they 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: Deviation from these recommended criteria must have a
technical basis, data, and technical analysis to support the 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___Toc35565343 .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   | 0.25 mg at 1 kg, and |
|               | E~1~, E~2~                    | 1 to 5 mg/kg         |
+---------------+-------------------------------+----------------------+
| Echelon II    | ASTM Class 2, 3, OIML Class   | 1 mg/kg to 20 mg/kg  |
|               | F~1~, F~2~                    |                      |
+---------------+-------------------------------+----------------------+
| Echelon III   | ASTM Class 4, 5, 6, 7, OIML   | 20 mg/kg to 1 000    |
|               | Class M~1~, M~2~, M~3~        | mg/kg                |
|               |                               |                      |
|               | NIST Class F,                 |                      |
|               | legal/regulatory enforcement  |                      |
+---------------+-------------------------------+----------------------+
| #### 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       | Estimate             |
| Hydrometers** |                               |                      |
+---------------+-------------------------------+----------------------+
| **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**[^3]
[]{#__RefHeading___Toc35565344 .anchor}

**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:

a)  steel tapes; and

b)  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 1 or 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.

**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:

a)  Bench method for tapes**.** (SOP 11);

b)  Tape to tape method for tapes**.** (SOP 12);

c)  Rigid rule calibration**.** (SOP 10); and

d)  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** **Certificates and Reports**

**6.1.8.1** All certificates or 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:

a)  master artifact calibration;

b)  long term reproducibility of measurement system;

c)  thermal expansion correction for gages and measurement scales;

    a.  thermometer calibration,

    b.  thermal expansion coefficient,

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

d)  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

e)  instrument geometry;

    a.  abbe offset and instrument geometry errors,

    b.  scale and gage alignment (cosine errors),

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

f)  probe penetration correction;

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

h)  analysis algorithms (data fitting, filtering); and

i)  other factors as appropriate.

**6.1.8.3** 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___Toc35565345 .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.

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.
    Echelons are evaluated by all of these factors in addition to the
    laboratory's reported uncertainties.

**Table 4. Mass calibration echelons** []{#__RefHeading___Toc35565346
.anchor}

+-----------------------+-----------------------+-----------------------+
| Echelon               | Verification Levels   | Expanded 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 M~1~,    |                       |
| Accuracy)             | M~2~, M~3~            |                       |
|                       |                       |                       |
|                       | ASTM Classes 4, 5, 6, |                       |
|                       | 7                     |                       |
|                       |                       |                       |
|                       | NIST Class F          |                       |
+-----------------------+-----------------------+-----------------------+

**Table 5. Typical \"Ranges of Recognition\" for mass calibration**
[]{#__RefHeading___Toc35565347 .anchor}

+------------------+--------------------+------------------------------+
| Echelon          | ## Ran             |                              |
|                  | ges 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            |
+------------------+--------------------+------------------------------+

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, Standard Specification for Laboratory Weights and
Precision Mass Standards, 1997.

\[2\] OIML R 111, Weights of Classes E~1~, E~2~, F~1~, F~2~, M~1~, M~2~,
M~3~, 1994 (*under revision* in *2003*).

\[3\] NIST Handbook 105-1, Specifications and tolerances for Reference
Standards and field Standard Weights and Measures, Specifications and
Tolerances for Field Standard Weights, (NIST Class F), 1990.

\[4\] 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., 1995.

\[7\] 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**

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___Toc35565349 .anchor}

+-------+------------------------------------------+-------------------+
| Ec    | ## Temperature                           | Relative Humidity |
| helon |                                          |                   |
|       |                                          | (maximum per 4    |
|       |                                          | hours)            |
+-------+------------------------------------------+-------------------+
| ## I  | 20 °C to 23 °C, a set point ± 1 °C       | 40 % to 60 % ± 5  |
|       |                                          | %                 |
|       | maximum change 0.5 °C/h                  |                   |
+-------+------------------------------------------+-------------------+
| II    | 20 °C to 23 °C, a set point ± 2 °C       | 40 % to 60 % ± 10 |
|       |                                          | %                 |
|       | maximum change 1.0 °C/h                  |                   |
+-------+------------------------------------------+-------------------+
| #     | 18 °C to 27 °C                           | 40 % to 60 % ± 20 |
| # III |                                          | %                 |
|       | maximum change 2 °C/h                    |                   |
+-------+------------------------------------------+-------------------+

NOTE: The environmental conditions should also be within the
specifications of the weighing instruments where applicable.

**6.2.4.2** Cleanliness guidelines are usually met without clean-room
type air handling systems by maintaining clean-room type practices.
Excessive air exchange rates negatively affect balance performance. The
laboratory should 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. A positive pressure, laminar-type air flow is usually
needed to maintain cleanliness recommendations and to minimize air
currents.

**6.2.4.3** 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.

**6.2.4.4** 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, 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 is useful in the support of general environmental
requirements of the previous section but the accuracy generally does not
affect measurement results.

**Table 7. Environmental equipment
accuracy**[]{#__RefHeading___Toc35565353 .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 BIPM. 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.

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.

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 Certificates and Reports**

**6.2.8.1** Certificates and 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 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 a sign 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___Toc35565354 .anchor}

+-----+--------------------+------------+-------------+-------------+
| E   | Minimum            | Minimum    | Minimum     | Minimum     |
| che | Measurement        | Reference  | T           | Calibration |
| lon | Control            | Standards  | raceability | Methods     |
+-----+--------------------+------------+-------------+-------------+
| I   | -   Process        | -   OIML   | -   NIST,   | -           |
| (Ex |     control charts |     Class  |     or      |  Documented |
| tra |                    |     E~1~,  |     other   |             |
| Fi  | -   Check          |     or     |             |    weighing |
| ne) |     standards for  |     E~2~   |    national |     designs |
|     |     each decade,   |     or     |     level   |             |
|     |     with long term |            |             |  consisting |
|     |     standard       | -   ASTM   | calibration |     of      |
|     |     deviation      |     Class  |     every 2 |             |
|     |                    |     0, 1   |     to 5    |   redundant |
|     | -   Surveillance   |            |     years   |     c       |
|     |     of all         | -   single |     based   | omparisons, |
|     |     standards      |     piece, |     on      |     with    |
|     |                    |     highly |             |             |
|     | -   Proficiency    |            | measurement |    built-in |
|     |     Testing        |   polished |     process |     process |
|     |                    |            |     data    |             |
|     | -on-site           |            |     and     |    controls |
|     | assessment         |            |             |     such as |
|     |                    |            | independent |     those   |
|     | -round robin       |            |     ve      |     used at |
|     | participation      |            | rification, |     the     |
|     |                    |            |     or      |             |
|     |                    |            |             |    national |
|     |                    |            | -   NIST    |     level.  |
|     |                    |            |     Mass    |             |
|     |                    |            |     MAP, or | For         |
|     |                    |            |             | example:    |
|     |                    |            | -   User    |             |
|     |                    |            |             | -           |
|     |                    |            |    operated |   Technical |
|     |                    |            |     mass    |     Notes,  |
|     |                    |            |             |     952 and |
|     |                    |            | calibration |     844,    |
|     |                    |            |             |     SOP 28  |
|     |                    |            |    package, |             |
|     |                    |            |     on-site |             |
|     |                    |            |     to      |             |
|     |                    |            |     verify  |             |
|     |                    |            |     t       |             |
|     |                    |            | raceability |             |
|     |                    |            |     (when   |             |
|     |                    |            |             |             |
|     |                    |            | available). |             |
+-----+--------------------+------------+-------------+-------------+
| II  | -   Process        | -   OIML   | -   NIST    | -           |
| (Fi |     control charts |     Class  |             |  Documented |
| ne) |                    |     E~1~,  | calibration |             |
|     | -   Check          |     or     |     every 2 |  comparison |
|     |     standards for  |     E~2~   |     to 5    |             |
|     |     each decade,   |            |     years   | calibration |
|     |     with long term | -   ASTM   |     based   |             |
|     |     standard       |     Class  |     on      |   procedure |
|     |     deviation      |     0, 1;  |             |             |
|     |                    |     or     | measurement | For         |
|     | -   Surveillance   |            |     process | example:    |
|     |     of selected    | -   single |     data    |             |
|     |     standards      |     piece, |     and     | -   NIST    |
|     |     Proficiency    |     highly |             |             |
|     |     Testing        |            | independent |    Handbook |
|     |                    |   polished |     ve      |     145,    |
|     | -on-site           |            | rification, |     double  |
|     | assessment         |            |     or      |     su      |
|     |                    |            |             | bstitution, |
|     | -round robin       |            | -           |     or 3-1  |
|     | participation      |            | Calibration |             |
|     |                    |            |     by      |    weighing |
|     |                    |            |             |     design, |
|     |                    |            |  accredited |     or      |
|     |                    |            |     or      |             |
|     |                    |            |             | equivalent, |
|     |                    |            |  Recognized |     SOP 4,  |
|     |                    |            |     Echelon |     SOP 5   |
|     |                    |            |     I       |             |
|     |                    |            |             |             |
|     |                    |            | laboratory, |             |
|     |                    |            |     if      |             |
|     |                    |            |             |             |
|     |                    |            | uncertainty |             |
|     |                    |            |     r       |             |
|     |                    |            | equirements |             |
|     |                    |            |     can be  |             |
|     |                    |            |     met.    |             |
+-----+--------------------+------------+-------------+-------------+
| III | -   Process        | -          | -           | -   Use of  |
| (M  |     control charts |    Working | Calibration |             |
| edi |                    |            |     of all  |    annually |
| um) | -   Check          |  standards |     working |             |
|     |     standards for  |     such   |             |  calibrated |
|     |     each balance   |     as:    |   standards |     balance |
|     |     Proficiency    |            |     by NIST |     with    |
|     |     Testing        | -   ASTM   |     every 2 |             |
|     |                    |     Class  |     to 5    |  documented |
|     | -on-site           |     2, 3   |     years   |     v       |
|     | assessment         |            |     based   | erification |
|     |                    | > Or       |     on      |             |
|     | -round robin       |            |             |   procedure |
|     | participation      | -   OIML   | measurement |     prior   |
|     |                    |     Class  |     process |     to each |
|     |                    |     F~1~   |     data    |     use     |
|     |                    |            |     and     |             |
|     |                    | -   two    |             | -   Use of  |
|     |                    |     piece  | independent |             |
|     |                    |     a      |     ve      |    modified |
|     |                    | cceptable, | rification, |     s       |
|     |                    |     fine   |     or      | ubstitution |
|     |                    |     finish |             |     (NIST   |
|     |                    |            | -           |             |
|     |                    |            | Calibration |    Handbook |
|     |                    |            |     of all  |     145)    |
|     |                    |            |     working |             |
|     |                    |            |             | -   Other   |
|     |                    |            |   standards |             |
|     |                    |            |     by an   |  documented |
|     |                    |            |     Echelon |     and     |
|     |                    |            |     I or II |             |
|     |                    |            |             |    verified |
|     |                    |            |  accredited |             |
|     |                    |            |     or      |   procedure |
|     |                    |            |             |             |
|     |                    |            |  Recognized |             |
|     |                    |            |     labs    |             |
|     |                    |            |     every 2 |             |
|     |                    |            |     to 5    |             |
|     |                    |            |     years   |             |
|     |                    |            |     based   |             |
|     |                    |            |     on      |             |
|     |                    |            |             |             |
|     |                    |            | measurement |             |
|     |                    |            |     process |             |
|     |                    |            |     data    |             |
|     |                    |            |     and     |             |
|     |                    |            |             |             |
|     |                    |            | independent |             |
|     |                    |            |     v       |             |
|     |                    |            | erification |             |
+-----+--------------------+------------+-------------+-------------+

**6.3 Technical Criteria for Volume Laboratories**[^5]
[]{#__RefHeading___Toc35565355 .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___Toc35565356 .anchor}

+-----------+-------------+-------------+------------------------------+
| Procedure | #           |             |                              |
| Types     | # Scope of  |             |                              |
|           | Recognition |             |                              |
|           |  - Nominal  |             |                              |
|           | Value Range |             |                              |
+-----------+-------------+-------------+------------------------------+
| ## Gr     | #           |             | ## Me                        |
| avimetric | # Glassware |             | tal Test Measures or Provers |
+-----------+-------------+-------------+------------------------------+
|           | Standard    | Pipets &    |                              |
|           |             | 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          |                              |
+-----------+-------------+-------------+------------------------------+
| Volume    | #           |             | Metal Test Measures or       |
| Transfer  | # Glassware |             | Provers                      |
+-----------+-------------+-------------+------------------------------+
|           | ≥ 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 288-94 (1988), Standard Specification for Laboratory
Glass Volumetric Flasks.

\[3\] ANSI/ASTM E 438-92 (2001) e1, Standard Specification for Glasses
in Laboratory Apparatus.

\[4\] ANSI/ASTM E 542-01, Standard Practice for Calibration of
Volumetric Apparatus.

\[5\] ANSI/ASTM E 694-99, Standard Specification for Laboratory Glass
Volumetric Apparatus.

\[6\] ANSI/ASTM E 969-02, Standard Specification for Glass Volumetric
(Transfer) Pipets.

\[7\] OIML R 4 (1972), Volumetric Flasks (one mark) in Glass.

\[8\] OIML R 40 (1981), Graduated Pipettes for Verification Officers.

\[9\] OIML R 41 (1977), Standard Burettes for Verification Officers.

\[10\] OIML R 43 (1977), Standard Graduated Glass Flasks for
Verification Officers.

\[11\] NIST Handbook 105-2, 105-3, 105-4 Specifications and Tolerances
for Reference Standards and Field Standard Weights and Measures;
Specifications and Tolerances for Field Standard Glass Flasks, Open-neck
Provers, and LPG Volumetric Provers.

\[12\] API Manual of Petroleum Measurement Standards, Chapter 4 -
Proving Systems; Section 3, Small Volume Provers, 1988; Section 4, Tank
Provers, 1988; Section 7, Field Standard Test Measures, 1998.

**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___Toc35565362 .anchor}

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

NOTE: The environmental conditions should also be within the
specifications of applicable equipment.

**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.

**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___Toc35565363 .anchor} (expanded uncertainty)

+------------------+---------------+-----------------+-----------------+
| Procedure Type   | Barometric    | Temperature     | Relative        |
|                  |               |                 | 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**

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**

**6.3.7.1** 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 Certificates and reports**

**6.3.8.1** Calibration 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.

**6.3.8.2** 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___Toc35565364 .anchor}

+-------+--------------+------------+---------------+----------------+
| Proc  | ## Minimum   | Minimum    | Minimum       | Minimum        |
| edure |              |            |               |                |
|       | Measurement  | Reference  | Traceability  | Calibration    |
|       |              |            |               |                |
|       | Control      | Standard   |               | Methods        |
+-------+--------------+------------+---------------+----------------+
| I     | -   Process  | -   A      | -   NIST, or  | -   Documented |
|       |     control  | ppropriate |     national  |     comparison |
| G     |     charts   |     mass   |     level     |                |
| ravim |              |            |               |    calibration |
| etric | -   Check    |  standards |   calibration |     procedure  |
|       |              |            |               |                |
|       |    standards | ```{=html} | periodically, | or             |
|       |              | <!-- -->   |     based on  |                |
|       | -            | ```        |               | -   NIST       |
|       | Surveillance | -   ASTM   |   independent |     Handbook   |
|       |     of all   |     Class  |               |     145,       |
|       |              |     2 or   |    historical |     double     |
|       |    standards |     3; or  |     data      |                |
|       |     used to  |            |               |   substitution |
|       |     provide  | -   OIML   |  verification |     (for       |
|       |              |     Class  |               |     example)   |
|       |  measurement |     F~1~   | or            |                |
|       |     services |     or     |               | or             |
|       |              |     F~2~;  | -   \- Test   |                |
|       | -            |            |     of        | -   \- Use of  |
|       |  Proficiency | or         |     weighing  |     calibrated |
|       |     testing  |            |     equipment |     balance    |
|       |              | -          |     using     |                |
|       | \- On-site   | Calibrated |     correct   |                |
|       | assessment   |            |     methods   |                |
|       |              |    Balance |     of        |                |
|       | \- Round     |            |               |                |
|       | robin        |            |   calibration |                |
|       | p            |            |     and       |                |
|       | articipation |            |               |                |
|       |              |            |    adjustment |                |
|       |              |            |     with      |                |
|       |              |            |     traceable |                |
|       |              |            |     mass      |                |
|       |              |            |     standards |                |
+-------+--------------+------------+---------------+----------------+
| II    | -   Process  | Primary    | -   Original  | Documented     |
|       |     control  | volume     |     NIST      | volume         |
| V     |     charts   | standards  |               | transfer (or   |
| olume |              | with       |   calibration | water draw)    |
|       | -   Check    | accuracy   |     and       | procedure      |
| Tra   |              | and        |     periodic  | recognized by  |
| nsfer |    standards | rep        |               | NIST, OIML,    |
|       |              | eatability |   independent | ASTM, or API   |
|       | -            | chara      |               |                |
|       | Surveillance | cteristics |  verification |                |
|       |     of       |            |               |                |
|       |     selected | acceptable | or            |                |
|       |              | for the    |               |                |
|       |    standards | type of    | -             |                |
|       |              | service    |   Calibration |                |
|       | -            | provided   |     by        |                |
|       |  Proficiency |            |               |                |
|       |     testing  |            |    accredited |                |
|       |              |            |     or        |                |
|       | \- On-site   |            |               |                |
|       | assessment   |            |    Recognized |                |
|       |              |            |               |                |
|       | \- Round     |            |   laboratory, |                |
|       | robin        |            |     if        |                |
|       | p            |            |               |                |
|       | articipation |            |   uncertainty |                |
|       |              |            |               |                |
|       |              |            |  requirements |                |
|       |              |            |     can be    |                |
|       |              |            |     met       |                |
+-------+--------------+------------+---------------+----------------+

**6.4 Technical Criteria for Hydrometer Laboratories**[^6]
[]{#__RefHeading___Toc35565366 .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 100-95 (2001): Standard Specification for ASTM Hydrometers.

\[2\] ASTM E 126-92 (1998): Standard Method for Inspection and
Verification of Hydrometers.

**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.

2.  The density of the water used in hydrometer calibrations should be
    known to within

0.000005 g/cm^3^. 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 Certificates and 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:

a)  master hydrometer;

b)  long term reproducibility of measurement system;

c)  thermal expansion; and

d)  other appropriate factors.

**6.5 Technical Criteria for Thermometer
Laboratories**[^7][]{#__RefHeading___Toc35565367 .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 (latest edition).

\[2\] 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 6 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 Liquid-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.

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**

**6.5.5.1** **Reference standards**

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

+---------------------------+-------+-------+-------+-------+-------+
| Acceptable reference      | Ec    |       |       |       |       |
| standard                  | helon |       |       |       |       |
+---------------------------+-------+-------+-------+-------+-------+
|                           | 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             |       | X     | X     | X     | X     |
| thermocouple              |       |       |       |       |       |
+---------------------------+-------+-------+-------+-------+-------+
| Type S, R or B            |       |       | X     | X     | X     |
| thermocouple              |       |       |       |       |       |
+---------------------------+-------+-------+-------+-------+-------+
| 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:

+--------+---------------+--------------------------------------------+
| E      | Claimed       | Minimum                                    |
| chelon | 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** If 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   | ± 0.5   | \(a\)   | \(a\)   | \(a\)   |
|                | mK      | 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.

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___Toc35565370 .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___Toc35565371 .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, April 1998
(Internal Documents).

\[2\] ASTM E 145-68, Standard Specification for Gravity‑Convection and
Forced-Ventilation Ovens (reapproved 1987).

\[3\] 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: 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: 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.

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** 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___Toc35565372 .anchor} (as described in
Section 6)

+--------+--------+-------+-------+--------+--------+--------+--------+
| Lab    | Tempe  | ±     | Max   | Temp   | RH %   | RH %   | Pr     |
|        | rature | Temp  | c     |        | range  | ac     | essure |
|        | range  | v     | hange | ac     |        | curacy | ac     |
|        | °C     | ariab | per   | curacy |        |        | curacy |
|        |        | ility | hour  | °C     |        | (      |        |
|        | (set   | °C    | °C    |        |        | change | Pa     |
|        | point) |       |       |        |        | per 4  |        |
|        |        |       |       |        |        | hours) |        |
+--------+--------+-------+-------+--------+--------+--------+--------+
| Mass I | 20 to  | 1.0   | 0.5   | 0.1    | 40 to  | 5      | 65     |
|        | 23     |       |       |        | 60     |        |        |
+--------+--------+-------+-------+--------+--------+--------+--------+
| Mass   | 20 to  | 2.0   | 1.0   | 0.5    | 40 to  | 10     | 135    |
| II     | 23     |       |       |        | 60     |        |        |
+--------+--------+-------+-------+--------+--------+--------+--------+
| Mass   | 18 to  |       | 2.0   |        | 40 to  | 20     |        |
| III    | 27     |       |       |        | 60     |        |        |
+--------+--------+-------+-------+--------+--------+--------+--------+
| Vo     | 20 to  | 2.0   | 1.0   | 0      | 40 to  | 10     |        |
| lume - | 23     |       |       | .1/0.5 | 60     |        |        |
| G      |        |       |       |        |        |        |        |
|        |        |       |       | (      |        |        |        |
|        |        |       |       | H~2~O, |        |        |        |
|        |        |       |       | air)   |        |        |        |
+--------+--------+-------+-------+--------+--------+--------+--------+
| Vo     | 18 to  | 1.0   | 2.0   | 0.5    | 40 to  |        | 135    |
| lume - | 27     |       |       |        | 60     |        |        |
| T      |        |       |       |        |        |        |        |
+--------+--------+-------+-------+--------+--------+--------+--------+
| Dimen  | 20 (18 | 1.0   |       | 0.5    | \> 50  | 20     |        |
| sional | to 22) |       |       |        |        |        |        |
+--------+--------+-------+-------+--------+--------+--------+--------+
| Tempe  |        | 2.0   |       |        | 40 to  | 10     |        |
| rature |        |       |       |        | 60     |        |        |
+--------+--------+-------+-------+--------+--------+--------+--------+
| Tuning |        |       |       |        |        |        |        |
| Forks  |        |       |       |        |        |        |        |
+--------+--------+-------+-------+--------+--------+--------+--------+
| Hydro  |        |       |       | 0.01   |        |        |        |
| meters |        |       |       | (bath) |        |        |        |
+--------+--------+-------+-------+--------+--------+--------+--------+
| Time   |        |       |       |        |        |        |        |
+--------+--------+-------+-------+--------+--------+--------+--------+
| Grain  | 20 to  | 2.0   | 1.0   | 0.5    | 40 to  |        |        |
| Mo     | 23     |       |       |        | 60     |        |        |
| isture |        |       |       |        |        |        |        |
+--------+--------+-------+-------+--------+--------+--------+--------+

**7. References**[]{#__RefHeading___Toc35565373 .anchor}

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 Guide 17025, International Organization for Standardization,
*General Requirements for the Competence of Testing and Calibration
Laboratories*, 1999.

NCSL Recommended Practice RP-7: *Laboratory Design,* July 1993.

NCSL Recommended Practice RP-11: *Reports and Certificates of
Calibration,* October 1991.

NBS Handbook 145, *Handbook for the Quality Assurance of Metrological
Measurements*, Oppermann, H.V., Taylor, J., 1985.

NIST Handbook 150, National Voluntary Laboratory Accreditation Program,
NVLAP, *Procedures and General Requirements*, Alderman, D. F., Faison,
C. D., White, V. R., editors, July 2001.

#   {#section-2 .unnumbered}

# 8. Glossary

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, 1994, wherever possible; 2) The
International Vocabulary of Basic and General Terms in Metrology
(VIM:1994); or 3) NIST Handbook 143, Program Handbook, 1997 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 Criteria -*** a set of requirements used by an
accrediting body which a laboratory must meet in order to be accredited.
(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 or test reports. (HB 150, modified)

NOTE: The Approved Signatory is responsible for the technical content of
the report and is the person to be contacted by WMD, laboratory clients,
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 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 weights and measures 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 deficiency or other undesirable situation in order to prevent
recurrence.

***Deficiency -*** the non-fulfillment of NIST/WMD conditions and/or
criteria for Recognition (or accreditation). (HB 150, modified)

***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 accreditation
requirements; may be used as a quality management review as well.

***Laboratory -*** an organization that performs calibrations and/or
tests. 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. The laboratory
activities may be carried out at or from a permanent location, at or
from a temporary facility, or in or from a mobile facility. (HB 150)

***Length Laboratory -*** a specific area, within a metrology
laboratory, that is used solely for calibration or tolerance testing of
length standards. (HB 143, 1997)

***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)

***NVLAP -*** the NIST National Voluntary Laboratory Accreditation
Program.

***On-Site Assessment -*** a formal examination or official inspection
of a calibration or testing laboratory to evaluate its compliance with
specific laboratory accreditation criteria.

***OWM -*** The NIST Office of Weights and Measures (now Weights and
Measures Division).

***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)

***Preventive Action -*** an action taken to eliminate the cause of a
potential deficiency 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, quality
system, and quality practices of an organization. The quality manual may
reference other laboratory documentation. (HB 150)

***Recognition* *- ***the evaluation and issuance of a Certificate of
Measurement Traceability and letter regarding the laboratory quality
system for weights and measures 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 Accreditation -*** A document issued by an accreditation
body which lists the test methods or services, or calibration services
for which the laboratory is accredited. The scope for each measurement
area includes the range and the best uncertainty reported at each level.
(HB 150)

***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 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:1994)

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___Toc35565376 .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).

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 test procedures for:

> a\. mass tolerance testing
>
> b\. mass calibration weighing designs
>
> c\. volume calibration
>
> ‑ volume transfer
>
> ‑ gravimetric
>
> d\. length calibration
>
> ‑ length bench
>
> \- tape‑to‑tape
>
> \- rigid rules
>
> e\. temperature ‑ NBS Monograph 150

5\. Time and frequency information ‑ NBS Special Publications 432 and
559.

6\. Measurement assurance information ‑ NBSIR 77‑1240 and regional
measurement assurance programs.

7\. NIST evaluation of laboratory auditing problems.

8\. NIST evaluation of laboratory facilities by on‑site visit.

9\. Measurement control 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, State Laboratory Program

National Institute of Standards and Technology

Gaithersburg, MD 20899

Phone: 301/975-4004

Fax: 301/926-0647

http://www.nist.gov/owm

**Appendix B. Request for Recognition, Scope of Recognition, Approved
Signatories, Authorized Representative**[]{#__RefHeading___Toc35565377
.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

#   {#section-3 .unnumbered}

# Appendix C. Laboratory Assessment Checklist

(from NVLAP Handbook 150, 2001)

**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* (2001 edition)*.* The
checklist items are numbered to correspond to the requirements found in
Sections 4 and 5 of the Handbook. Items marked with a  were not
sufficiently addressed in the previous version of this Handbook.

Place an \"X\" beside each checklist item that represents a deficiency.
Place a \"C\" beside each item on which you are commenting for other
reasons. Record the item number and written deficiency 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 client, 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:                                             |
+-----------------------------------------------------------------------+

  ---------- ----- -----------------------------------------------------------
  \_\_\_\_   a\)   have managerial and technical personnel with the authority
                   and resources needed to carry out their duties and to
                   identify the occurrence of departures from the quality
                   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);

  ---------- ----- -----------------------------------------------------------

  ---------- ----- -----------------------------------------------------------
  \_\_\_\_   b\)   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;

  ---------- ----- -----------------------------------------------------------

  ---------- ----- -----------------------------------------------------------
  \_\_\_\_   c\)   have policies and procedures to ensure the protection of
                   its clients\' confidential information and proprietary
                   rights, including procedures for protecting the electronic
                   storage and transmission of results;

  ---------- ----- -----------------------------------------------------------

+----+---+----+-----------------------------------------------------------+
| \_ | d |    | have policies and procedures to avoid involvement in any  |
| \_ | \ |    | activities that would diminish confidence in its          |
| \_ | ) |    | competence, impartiality, judgement or operational        |
| \_ |   |    | integrity;                                                |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
| \_ | e |    | 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;                          |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
| \_ | f |    | Specify the responsibility, authority and                 |
| \_ | \ |    | interrelationships of all personnel who manage, perform   |
| \_ | ) |    | or verify work affecting the quality of the tests and/or  |
| \_ |   |    | calibrations;                                             |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
| \_ | g |    | 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;                                      |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
| \_ | h |    | 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:                                      |
|    |   |    | \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\                       |
|    |   |    | _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
| \_ | i |    | 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 quality system 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;                                      |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
| \_ | j |    | Name of person:                                           |
| \_ | \ |    | \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\               |
| \_ | ) |    | _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| \_ |   |    |                                                           |
|    |   |    | appoint deputies for key managerial personnel (see note). |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
|    |   |    | Name(s):                                                  |
|    |   |    | \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\   |
|    |   |    | _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+----+---+----+-----------------------------------------------------------+
|    |   | ** |                                                           |
|    |   | NO |                                                           |
|    |   | TE |                                                           |
|    |   | ** |                                                           |
|    |   | I  |                                                           |
|    |   | nd |                                                           |
|    |   | iv |                                                           |
|    |   | id |                                                           |
|    |   | ua |                                                           |
|    |   | ls |                                                           |
|    |   | m  |                                                           |
|    |   | ay |                                                           |
|    |   | ha |                                                           |
|    |   | ve |                                                           |
|    |   | mo |                                                           |
|    |   | re |                                                           |
|    |   | th |                                                           |
|    |   | an |                                                           |
|    |   | o  |                                                           |
|    |   | ne |                                                           |
|    |   | fu |                                                           |
|    |   | nc |                                                           |
|    |   | ti |                                                           |
|    |   | on |                                                           |
|    |   | a  |                                                           |
|    |   | nd |                                                           |
|    |   | it |                                                           |
|    |   | m  |                                                           |
|    |   | ay |                                                           |
|    |   | be |                                                           |
|    |   | i  |                                                           |
|    |   | mp |                                                           |
|    |   | ra |                                                           |
|    |   | ct |                                                           |
|    |   | ic |                                                           |
|    |   | al |                                                           |
|    |   | to |                                                           |
|    |   | a  |                                                           |
|    |   | pp |                                                           |
|    |   | oi |                                                           |
|    |   | nt |                                                           |
|    |   | de |                                                           |
|    |   | pu |                                                           |
|    |   | ti |                                                           |
|    |   | es |                                                           |
|    |   | f  |                                                           |
|    |   | or |                                                           |
|    |   | e  |                                                           |
|    |   | ve |                                                           |
|    |   | ry |                                                           |
|    |   | f  |                                                           |
|    |   | un |                                                           |
|    |   | ct |                                                           |
|    |   | io |                                                           |
|    |   | n. |                                                           |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
| *  |   |    |                                                           |
| *4 |   |    |                                                           |
| .2 |   |    |                                                           |
| Q  |   |    |                                                           |
| ua |   |    |                                                           |
| li |   |    |                                                           |
| ty |   |    |                                                           |
| sy |   |    |                                                           |
| st |   |    |                                                           |
| em |   |    |                                                           |
| ** |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
| *  |   |    |                                                           |
| *4 |   |    |                                                           |
| .2 |   |    |                                                           |
| .1 |   |    |                                                           |
| ** |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
| \_ | a |    | The laboratory shall establish, implement and maintain a  |
| \_ | \ |    | quality system appropriate to the scope of its            |
| \_ | ) |    | activities.                                               |
| \_ |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
| \_ | b |    | 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.                                      |
+----+---+----+-----------------------------------------------------------+
|    |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+
| \_ | c |    | The system's documentation shall be communicated to,      |
| \_ | \ |    | understood by, available to, and implemented by the       |
| \_ | ) |    | appropriate personnel.                                    |
| \_ |   |    |                                                           |
+----+---+----+-----------------------------------------------------------+

  ----------- ----------- --------------- ------------------ -----------------------------------------------------------
  \_\_\_\_    **4.2.2**                                      The laboratory's quality system policies and objectives
                                                             shall be defined in a quality manual (however named). The
                                                             overall objectives shall be documented in a quality policy
                                                             statement. The quality policy statement shall be issued
                                                             under the authority of the chief executive. It shall
                                                             include at least the following:

                                                             

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

                                                             

  \_\_\_     b\)                         the management's   
                                          statement of the   
                                          laboratory\'s      
                                          standard of        
                                          service;           

                                                             

  \_\_\_\_    c\)                         the objectives of  
                                          the quality        
                                          system;            

                                                             

  \_\_\_\_    d\)                         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    

                                                             

  \_\_\_\_    e\)                         the laboratory     
                                          management\'s      
                                          commitment to      
                                          compliance with    
                                          this Handbook.     

                                                             

                          **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 clients\'                      
                          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**                                                  

                                                             

  \_\_\_\_    a\)                         The quality manual 
                                          shall include or   
                                          make reference to  
                                          the supporting     
                                          procedures         
                                          including          
                                          technical          
                                          procedures.        

                                                             

  \_\_\_     b\)                         It shall outline   
                                          the structure of   
                                          the documentation  
                                          used in the        
                                          quality system.    

                                                             

  \_\_\_\_    **4.2.4**                   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.            

                                                             

  **4.3                                                      
  Document                                                   
  control**                                                  

                                                             

  **4.3.1                                                    
  General**                                                  
  ----------- ----------- --------------- ------------------ -----------------------------------------------------------

  ---------- -----------------------------------------------------------------
  \_\_\_\_   The laboratory shall establish and maintain procedures to control
             all documents that form part of its quality 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 4.12.
  ----- -----------------------------------------------------------------

  -----------------------------------------------------------------------
  **4.3.2 Document approval and issue**

  **4.3.2.1**
  -----------------------------------------------------------------------

  --------- ----- -----------------------------------------------------------
  \_\_\_   a\)   All documents issued to personnel in the laboratory as part
                  of the quality system shall be reviewed and approved for
                  use by authorized personnel prior to issue.

                  

  \_\_\_   b\)   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.
  --------- ----- -----------------------------------------------------------

  -----------------------------------------------------------------------
  **4.3.2.2** The procedure(s) adopted shall ensure that:

  -----------------------------------------------------------------------

  --------- ----- -----------------------------------------------------------
  \_\_\_   a\)   authorized editions of appropriate documents are available
                  at all locations where operations essential to the
                  effective functioning of the laboratory are performed;

                  

  \_\_\_   b\)   documents are periodically reviewed and, where necessary,
                  revised to ensure continuing suitability and compliance
                  with applicable requirements;

                  

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

                  

  \_\_\_   d\)   obsolete documents retained for either legal or knowledge
                  preservation purposes are suitably marked.
  --------- ----- -----------------------------------------------------------

  ----- ------------- --------------------------------------------------------
        **4.3.2.3**   Quality system documents generated by the laboratory
                      shall be uniquely identified. Such identification shall
                      include:

  ----- ------------- --------------------------------------------------------

  ----------- ----- -----------------------------------------------------------
  \_\_\_     a\)   the date of issue and/or revision identification,

                    

  \_\_\_     b\)   page numbering,

                    

  \_\_\_     c\)   the total number of pages or a mark to signify the end of
                    the document, and

                    

  \_\_\_     d\)   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**   
  --------- ------------- ------------- --------------------------------------------------------

  --------- ----- -----------------------------------------------------------
  \_\_\_   a\)   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.

                  

  \_\_\_   b\)   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.  **Review of requests, tenders and contracts**                     |
+-----------------------------------------------------------------------+

  ---------- ----------- -----------------------------------------------------------
  \_\_\_\_   **4.4.1**   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:

  ---------- ----------- -----------------------------------------------------------

  ---------- ----- -----------------------------------------------------------
  \_\_\_    a\)   the requirements, including the methods to be used, are
                   adequately defined, documented and understood (see 5.4.2);

                   

  \_\_\_\_   b\)   the laboratory has the capability and resources to meet the
                   requirements;

                   

  \_\_\_    c\)   the appropriate test and/or calibration method is selected
                   and capable of meeting the clients\' requirements (see
                   5.4.2).
  ---------- ----- -----------------------------------------------------------

  --------- ----- -----------------------------------------------------------
  \_\_\_   d\)   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
                  client.

  --------- ----- -----------------------------------------------------------

  ----- -----------------------------------------------------------------
        **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 clients, 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 client 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 client relating to the
                        client\'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 client, provided that the client\'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 client 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 client of the arrangement
                           in writing and, when appropriate, gain the approval of the
                           client, preferably in writing.

                           

  \_\_\_      **4.5.3**   The laboratory is responsible to the client for the
                           subcontractor's work, except in the case where the client
                           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**   

                                     

  \_\_\_\_   a\)                     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.

                                     

  \_\_\_\_   b\)                     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 quality system standard
        under which they were made.

  ----- -----------------------------------------------------------------

  ---------- ----------- -----------------------------------------------------------
             **4.6.4**   

                         

  \_\_\_\_   a\)         The laboratory shall evaluate suppliers of critical
                         consumables, supplies and services which affect the quality
                         of testing and calibration, and

                         

  \_\_\_\_   b\)         shall maintain records of these evaluations and list those
                         approved.
  ---------- ----------- -----------------------------------------------------------

  --------- -----------------------------------------------------------------
  **4.7**   **Service to the client**

            

  \_\_\_   The laboratory shall afford clients or their representatives
            cooperation to clarify the client\'s request and to monitor the
            laboratory\'s performance in relation to the work performed,
            provided that the laboratory ensures confidentiality to other
            clients.
  --------- -----------------------------------------------------------------

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

                                        

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

                                        

                      b\)               preparation, packaging, and dispatch of test and/or
                                        calibration items needed by the client for verification
                                        purposes.

                                        

                                        

                      **NOTE 2** Such   
                      cooperation may   
                      include: Clients  
                      value the         
                      maintenance of    
                      good              
                      communication,    
                      advice and        
                      guidance in       
                      technical         
                      matters, and      
                      opinions and      
                      interpretations   
                      based on results. 
                      Communication     
                      with the client,  
                      especially in     
                      large             
                      assignments,      
                      should be         
                      maintained        
                      throughout the    
                      work. The         
                      laboratory should 
                      inform the client 
                      of any delays or  
                      major deviations  
                      in the            
                      performance of    
                      the tests and/or  
                      calibrations.     
  ----- ------------- ----------------- -----------------------------------------------------------

  ----- -----------------------------------------------------------------
        **NOTE 3** Laboratories are encouraged to obtain other feedback,
        both positive and negative, from their clients (e.g., client
        surveys). The feedback should be used to improve the quality
        system, testing and calibration activities and client service.

  ----- -----------------------------------------------------------------

  -----------------------------------------------------------------------
  **4.8 Complaints**

  -----------------------------------------------------------------------

  ---------- ----------- -----------------------------------------------------------
  \_\_\_\_   **4.8.1**   The laboratory shall have a policy and procedure for the
                         resolution of complaints received from clients 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 4.10).
  ---------- ----------- -----------------------------------------------------------

  ---------------- ---------------- -----------------------------------------------------------
  **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 client. The policy and procedures shall ensure that:

                                    

  \_\_\_          a\)              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;

                                    

  \_\_\_\_         b\)              an evaluation of the significance of the non-conforming
                                    work is made;

                                    

  \_\_\_          c\)              corrective actions are taken immediately, together with any
                                    decision about the acceptability of the non-conforming
                                    work;

                                    

  \_\_\_\_         d\)              where necessary, the client is notified and work is
                                    recalled;

                                    

  \_\_\_          e\)              the responsibility for authorizing the resumption of work
                                    is defined.

                                    

                   **NOTE**         
                   Identification   
                   of               
                   non-conforming   
                   work or problems 
                   with the quality 
                   system or with   
                   testing and/or   
                   calibration      
                   activities can   
                   occur at various 
                   places within    
                   the quality      
                   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 4.10
                                    shall be promptly followed.

                                    

  **4.10                            
  Corrective                        
  action**                          

                                    

  **4.10.1                          
  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 quality system or technical operations have
             been identified.

             

             **NOTE** A problem with the quality 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 clients or
             staff observations.
  ---------- -----------------------------------------------------------------

  ------------ -----------------------------------------------------------------
  **4.10.2     
  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
               client requirements, the samples, sample specifications, methods
               and procedures, staff skills and training, consumables, or
               equipment and its calibration.
  ------------ -----------------------------------------------------------------

  ---------------- ----- -----------------------------------------------------------
  **4.10.3               
  Selection and          
  implementation         
  of corrective          
  actions**              

                         

  \_\_\_          a\)   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.

                         

  \_\_\_          b\)   Corrective actions shall be to a degree appropriate to the
                         magnitude and the risk of the problem.

                         

  \_\_\_          c\)   The laboratory shall document and implement any required
                         changes resulting from corrective action investigations.
  ---------------- ----- -----------------------------------------------------------

  ------------ -----------------------------------------------------------------
  **4.10.4     
  Monitoring   
  of           
  corrective   
  actions**    

               

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

  ------------ -----------------------------------------------------------------
  **4.10.5     
  Additional   
  audits**     

               

  \_\_\_\_     Where the identification of non-conformances 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 4.13 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.
  ------------ -----------------------------------------------------------------

  ------------ ------------ ------------------- ----------------------------------------------------------
  **4.11                                        
  Preventive                                    
  action**                                      

                                                

  **4.11.1**                                    

                                                

  \_\_\_      a\)          Needed improvements 
                            and potential       
                            sources of          
                            non-conformances,   
                            either technical or 
                            concerning the      
                            quality system,     
                            shall be            
                            identified.         

                                                

  \_\_\_      b\)          If preventive       
                            action is required, 
                            action plans shall  
                            be developed,       
                            implemented and     
                            monitored to reduce 
                            the likelihood of   
                            the occurrence of   
                            such                
                            non-conformances    
                            and to take         
                            advantage of the    
                            opportunities for   
                            improvement.        

                                                

  \_\_\_      **4.11.2**                       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.
  ----- -----------------------------------------------------------------

  -----------------------------------------------------------------------
  **4.12 Control of records**

  **4.12.1 General**

  -----------------------------------------------------------------------

  ---------- -------------- ---------------------------------------------------------
  \_\_\_\_   **4.12.1.1**   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.

  ---------- -------------- ---------------------------------------------------------

  -------------- -------------- --------------- --------------------------------------------------------
  **4.12.1.2**                                  

                                                

  \_\_\_\_       a\)            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.           

                                                

  \_\_\_\_       b\)            Retention times 
                                of records      
                                shall be        
                                established.    

                                                

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

                                                

  \_\_\_\_       **4.12.1.3**                   All records shall be held secure and in confidence.

                                                

  \_\_\_\_       **4.12.1.4**                   The laboratory shall have procedures to protect and back
                                                up records stored electronically and to prevent
                                                unauthorized access to or amendment of these records.
  -------------- -------------- --------------- --------------------------------------------------------

  -------------- ----- -----------------------------------------------------------
  **4.12.2             
  Technical            
  records**            

                       

  **4.12.2.1**         

                       

  \_\_\_\_       a\)   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.

                       

  \_\_\_\_       b\)   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.

                       

  \_\_\_\_       c\)   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, clients\' notes, papers and feedback.
  ----- -----------------------------------------------------------------

  --------- -------------- ---------------------------------------------------------
  \_\_\_   **4.12.2.2**   Observations, data and calculations shall be recorded at
                           the time they are made and shall be identifiable to the
                           specific task.

  --------- -------------- ---------------------------------------------------------

  -------------- ----- -----------------------------------------------------------
  **4.12.2.3**         

                       

  \_\_\_        a\)   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.

                       

  \_\_\_\_       b\)   In the case of records stored electronically, equivalent
                       measures shall be taken to avoid loss or change of original
                       data.
  -------------- ----- -----------------------------------------------------------

  -----------------------------------------------------------------------
  **4.13 Internal audits**

  -----------------------------------------------------------------------

  ------------ ----- ----------- -----------------------------------------------------------
  **4.13.1**                     

                                 

  \_\_\_\_     a\)               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 quality
                                 system and this Handbook. The internal audit program shall
                                 address all elements of the quality 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.

                                 

  \_\_\_\_     b\)               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.       
  ------------ ----- ----------- -----------------------------------------------------------

  ------------ ------------ ----------------- -------------------------------------------------------- --
  \_\_\_\_     **4.13.2**                     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 clients in writing if investigations show   
                                              that the laboratory results may have been affected.      

                                                                                                       

  \_\_\_\_     **4.13.3**                     The area of activity audited, the audit findings and     
                                              corrective actions that arise from them shall be         
                                              recorded.                                                

                                                                                                       

  \_\_\_\_     **4.13.4**                     Follow-up audit activities shall verify and record the   
                                              implementation and effectiveness of the corrective       
                                              action taken.                                            

                                                                                                       

  **4.14                                                                                               
  Management                                                                                           
  reviews**                                                                                            

                                                                                                       

  \_\_\_\_     **4.14.1**   In accordance                                                              
                            with a                                                                     
                            predetermined                                                              
                            schedule and                                                               
                            procedure, the                                                             
                            laboratory\'s                                                              
                            executive                                                                  
                            management shall                                                           
                            periodically                                                               
                            conduct a review                                                           
                            of the                                                                     
                            laboratory\'s                                                              
                            quality 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:                                                           

                                                                                                       

  \_\_\_      a\)          the suitability                                                            
                            of policies and                                                            
                            procedures;                                                                

                                                                                                       

  \_\_\_      b\)          reports from                                                               
                            managerial and                                                             
                            supervisory                                                                
                            personnel;                                                                 

                                                                                                       

  \_\_\_      c\)          the outcome of                                                             
                            recent internal                                                            
                            audits;                                                                    

                                                                                                       

  \_\_\_      d\)          corrective and                                                             
                            preventive                                                                 
                            actions;                                                                   

                                                                                                       

  \_\_\_      e\)          assessments by                                                             
                            external bodies;                                                           

                                                                                                       

  \_\_\_      f\)          the results of                                                             
                            interlaboratory                                                            
                            comparisons or                                                             
                            proficiency                                                                
                            tests;                                                                     

                                                                                                       

  \_\_\_      g\)          changes in the                                                             
                            volume and type                                                            
                            of the work;                                                               

                                                                                                       

  \_\_\_      h\)          client feedback;                                                           

                                                                                                       

  \_\_\_      i\)          complaints;                                                                

                                                                                                       

  \_\_\_      j\)          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.
  ----- -----------------------------------------------------------------

  ------------ ----- -----------------------------------------------------------
  **4.14.2**         

                     

  \_\_\_\_     a\)   Findings from management reviews and the actions that arise
                     from them shall be recorded.

                     

  \_\_\_\_     b\)   The management shall ensure that those actions are carried
                     out within an appropriate and agreed timescale.
  ------------ ----- -----------------------------------------------------------

+----+----+-----------------------------------------------------------+
| #  |    |                                                           |
| ## |    |                                                           |
| ## |    |                                                           |
| #  |    |                                                           |
| 5  |    |                                                           |
| Te |    |                                                           |
| ch |    |                                                           |
| ni |    |                                                           |
| ca |    |                                                           |
| l  |    |                                                           |
| re |    |                                                           |
| qu |    |                                                           |
| ir |    |                                                           |
| em |    |                                                           |
| en |    |                                                           |
| ts |    |                                                           |
|  f |    |                                                           |
| or |    |                                                           |
|  a |    |                                                           |
| cc |    |                                                           |
| re |    |                                                           |
| di |    |                                                           |
| ta |    |                                                           |
| ti |    |                                                           |
| on |    |                                                           |
+----+----+-----------------------------------------------------------+
|    |    |                                                           |
+----+----+-----------------------------------------------------------+
|    |    |                                                           |
+----+----+-----------------------------------------------------------+
| *  |    |                                                           |
| *5 |    |                                                           |
| .1 |    |                                                           |
| G  |    |                                                           |
| en |    |                                                           |
| er |    |                                                           |
| al |    |                                                           |
| ** |    |                                                           |
+----+----+-----------------------------------------------------------+
|    |    |                                                           |
+----+----+-----------------------------------------------------------+
|    | *  | 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**           

                      

  \_\_\_\_      a\)   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.

                      

  \_\_\_\_      b\)   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 client.       

                          

        **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.

  ---------- ----------- -----------------------------------------------------------

  ----------- ----- -----------------------------------------------------------
  **5.2.3**         

                    

  \_\_\_     a\)   The laboratory shall use personnel who are employed by, or
                    under contract to, the laboratory.

                    

  \_\_\_     b\)   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 quality 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.
  ----- -------------- -----------------------------------------------------------

g.  

  ---------- -------------- -----------------------------------------------------------
             **5.2.5**      

                            

  \_\_\_    a\)            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.

                            

  \_\_\_\_   b\)            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.

                            

  \_\_\_    c\)            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.   
  ---------- -------------- -----------------------------------------------------------

  --------------- ----------- -----------------------------------------------------------
  **5.3                       
  Accommodation               
  and                         
  environmental               
  conditions**                

                              

                  **5.3.1**   

                              
  --------------- ----------- -----------------------------------------------------------

  ---------- ----- -----------------------------------------------------------
  \_\_\_\_   a\)   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.

                   

  \_\_\_    b\)   The technical requirements for accommodation and
                   environmental conditions that can affect the results of
                   tests and calibrations shall be documented.
  ---------- ----- -----------------------------------------------------------

  ----------- ----- -----------------------------------------------------------
  **5.3.2**         

                    

  \_\_\_\_    a\)   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.

                    

  \_\_\_\_    b\)   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 |   |    |   |                                                           |
| Te |   |    |   |                                                           |
| st |   |    |   |                                                           |
| a  |   |    |   |                                                           |
| nd |   |    |   |                                                           |
| c  |   |    |   |                                                           |
| al |   |    |   |                                                           |
| ib |   |    |   |                                                           |
| ra |   |    |   |                                                           |
| ti |   |    |   |                                                           |
| on |   |    |   |                                                           |
| m  |   |    |   |                                                           |
| et |   |    |   |                                                           |
| ho |   |    |   |                                                           |
| ds |   |    |   |                                                           |
| a  |   |    |   |                                                           |
| nd |   |    |   |                                                           |
| me |   |    |   |                                                           |
| th |   |    |   |                                                           |
| od |   |    |   |                                                           |
| va |   |    |   |                                                           |
| li |   |    |   |                                                           |
| da |   |    |   |                                                           |
| ti |   |    |   |                                                           |
| on |   |    |   |                                                           |
| ** |   |    |   |                                                           |
+----+---+----+---+-----------------------------------------------------------+
|    |   |    |   |                                                           |
+----+---+----+---+-----------------------------------------------------------+
| *  |   |    |   |                                                           |
| *5 |   |    |   |                                                           |
| .4 |   |    |   |                                                           |
| .1 |   |    |   |                                                           |
| G  |   |    |   |                                                           |
| en |   |    |   |                                                           |
| er |   |    |   |                                                           |
| al |   |    |   |                                                           |
| ** |   |    |   |                                                           |
+----+---+----+---+-----------------------------------------------------------+
|    |   |    |   |                                                           |
+----+---+----+---+-----------------------------------------------------------+
| \_ |   | a  |   | > 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.                                                   |
+----+---+----+---+-----------------------------------------------------------+
|    |   |    |   |                                                           |
+----+---+----+---+-----------------------------------------------------------+
| \_ | b |    | T |                                                           |
| \_ | \ |    | h |                                                           |
| \_ | ) |    | e |                                                           |
| \_ |   |    | l |                                                           |
|    |   |    | a |                                                           |
|    |   |    | b |                                                           |
|    |   |    | o |                                                           |
|    |   |    | r |                                                           |
|    |   |    | a |                                                           |
|    |   |    | t |                                                           |
|    |   |    | o |                                                           |
|    |   |    | r |                                                           |
|    |   |    | y |                                                           |
|    |   |    | s |                                                           |
|    |   |    | h |                                                           |
|    |   |    | a |                                                           |
|    |   |    | l |                                                           |
|    |   |    | l |                                                           |
|    |   |    | h |                                                           |
|    |   |    | a |                                                           |
|    |   |    | v |                                                           |
|    |   |    | e |                                                           |
|    |   |    | i |                                                           |
|    |   |    | n |                                                           |
|    |   |    | s |                                                           |
|    |   |    | t |                                                           |
|    |   |    | r |                                                           |
|    |   |    | u |                                                           |
|    |   |    | c |                                                           |
|    |   |    | t |                                                           |
|    |   |    | i |                                                           |
|    |   |    | o |                                                           |
|    |   |    | n |                                                           |
|    |   |    | s |                                                           |
|    |   |    | o |                                                           |
|    |   |    | n |                                                           |
|    |   |    | t |                                                           |
|    |   |    | h |                                                           |
|    |   |    | e |                                                           |
|    |   |    | u |                                                           |
|    |   |    | s |                                                           |
|    |   |    | e |                                                           |
|    |   |    | a |                                                           |
|    |   |    | n |                                                           |
|    |   |    | d |                                                           |
|    |   |    | o |                                                           |
|    |   |    | p |                                                           |
|    |   |    | e |                                                           |
|    |   |    | r |                                                           |
|    |   |    | a |                                                           |
|    |   |    | t |                                                           |
|    |   |    | i |                                                           |
|    |   |    | o |                                                           |
|    |   |    | n |                                                           |
|    |   |    | o |                                                           |
|    |   |    | f |                                                           |
|    |   |    | a |                                                           |
|    |   |    | l |                                                           |
|    |   |    | l |                                                           |
|    |   |    | r |                                                           |
|    |   |    | e |                                                           |
|    |   |    | l |                                                           |
|    |   |    | e |                                                           |
|    |   |    | v |                                                           |
|    |   |    | a |                                                           |
|    |   |    | n |                                                           |
|    |   |    | t |                                                           |
|    |   |    | e |                                                           |
|    |   |    | q |                                                           |
|    |   |    | u |                                                           |
|    |   |    | i |                                                           |
|    |   |    | p |                                                           |
|    |   |    | m |                                                           |
|    |   |    | e |                                                           |
|    |   |    | n |                                                           |
|    |   |    | t |                                                           |
|    |   |    | , |                                                           |
|    |   |    | a |                                                           |
|    |   |    | n |                                                           |
|    |   |    | d |                                                           |
|    |   |    | o |                                                           |
|    |   |    | n |                                                           |
|    |   |    | t |                                                           |
|    |   |    | h |                                                           |
|    |   |    | e |                                                           |
|    |   |    | h |                                                           |
|    |   |    | a |                                                           |
|    |   |    | n |                                                           |
|    |   |    | d |                                                           |
|    |   |    | l |                                                           |
|    |   |    | i |                                                           |
|    |   |    | n |                                                           |
|    |   |    | g |                                                           |
|    |   |    | a |                                                           |
|    |   |    | n |                                                           |
|    |   |    | d |                                                           |
|    |   |    | p |                                                           |
|    |   |    | r |                                                           |
|    |   |    | e |                                                           |
|    |   |    | p |                                                           |
|    |   |    | a |                                                           |
|    |   |    | r |                                                           |
|    |   |    | a |                                                           |
|    |   |    | t |                                                           |
|    |   |    | i |                                                           |
|    |   |    | o |                                                           |
|    |   |    | n |                                                           |
|    |   |    | o |                                                           |
|    |   |    | f |                                                           |
|    |   |    | i |                                                           |
|    |   |    | t |                                                           |
|    |   |    | e |                                                           |
|    |   |    | m |                                                           |
|    |   |    | s |                                                           |
|    |   |    | f |                                                           |
|    |   |    | o |                                                           |
|    |   |    | r |                                                           |
|    |   |    | t |                                                           |
|    |   |    | e |                                                           |
|    |   |    | s |                                                           |
|    |   |    | t |                                                           |
|    |   |    | i |                                                           |
|    |   |    | n |                                                           |
|    |   |    | g |                                                           |
|    |   |    | a |                                                           |
|    |   |    | n |                                                           |
|    |   |    | d |                                                           |
|    |   |    | / |                                                           |
|    |   |    | o |                                                           |
|    |   |    | r |                                                           |
|    |   |    | c |                                                           |
|    |   |    | a |                                                           |
|    |   |    | l |                                                           |
|    |   |    | i |                                                           |
|    |   |    | b |                                                           |
|    |   |    | r |                                                           |
|    |   |    | a |                                                           |
|    |   |    | t |                                                           |
|    |   |    | i |                                                           |
|    |   |    | o |                                                           |
|    |   |    | n |                                                           |
|    |   |    | , |                                                           |
|    |   |    | o |                                                           |
|    |   |    | r |                                                           |
|    |   |    | b |                                                           |
|    |   |    | o |                                                           |
|    |   |    | t |                                                           |
|    |   |    | h |                                                           |
|    |   |    | , |                                                           |
|    |   |    | w |                                                           |
|    |   |    | h |                                                           |
|    |   |    | e |                                                           |
|    |   |    | r |                                                           |
|    |   |    | e |                                                           |
|    |   |    | t |                                                           |
|    |   |    | h |                                                           |
|    |   |    | e |                                                           |
|    |   |    | a |                                                           |
|    |   |    | b |                                                           |
|    |   |    | s |                                                           |
|    |   |    | e |                                                           |
|    |   |    | n |                                                           |
|    |   |    | c |                                                           |
|    |   |    | e |                                                           |
|    |   |    | o |                                                           |
|    |   |    | f |                                                           |
|    |   |    | s |                                                           |
|    |   |    | u |                                                           |
|    |   |    | c |                                                           |
|    |   |    | h |                                                           |
|    |   |    | i |                                                           |
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|    |   |    | u |                                                           |
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|    |   |    | i |                                                           |
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|    |   |    | s |                                                           |
|    |   |    | c |                                                           |
|    |   |    | o |                                                           |
|    |   |    | u |                                                           |
|    |   |    | l |                                                           |
|    |   |    | d |                                                           |
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|    |   |    | e |                                                           |
|    |   |    | o |                                                           |
|    |   |    | p |                                                           |
|    |   |    | a |                                                           |
|    |   |    | r |                                                           |
|    |   |    | d |                                                           |
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|    |   |    | t |                                                           |
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|    |   |    | s |                                                           |
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|    |   |    | d |                                                           |
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|    |   |    | n |                                                           |
|    |   |    | s |                                                           |
|    |   |    | . |                                                           |
+----+---+----+---+-----------------------------------------------------------+
|    |   |    |   |                                                           |
+----+---+----+---+-----------------------------------------------------------+
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| \_ |   |    | i |                                                           |
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|    |   |    | a |                                                           |
|    |   |    | b |                                                           |
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|    |   |    | a |                                                           |
|    |   |    | t |                                                           |
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|    |   |    | s |                                                           |
|    |   |    | h |                                                           |
|    |   |    | a |                                                           |
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|    |   |    | l |                                                           |
|    |   |    | b |                                                           |
|    |   |    | e |                                                           |
|    |   |    | k |                                                           |
|    |   |    | e |                                                           |
|    |   |    | p |                                                           |
|    |   |    | t |                                                           |
|    |   |    | u |                                                           |
|    |   |    | p |                                                           |
|    |   |    | t |                                                           |
|    |   |    | o |                                                           |
|    |   |    | d |                                                           |
|    |   |    | a |                                                           |
|    |   |    | t |                                                           |
|    |   |    | e |                                                           |
|    |   |    | a |                                                           |
|    |   |    | n |                                                           |
|    |   |    | d |                                                           |
|    |   |    | s |                                                           |
|    |   |    | h |                                                           |
|    |   |    | a |                                                           |
|    |   |    | l |                                                           |
|    |   |    | l |                                                           |
|    |   |    | b |                                                           |
|    |   |    | e |                                                           |
|    |   |    | m |                                                           |
|    |   |    | a |                                                           |
|    |   |    | d |                                                           |
|    |   |    | e |                                                           |
|    |   |    | r |                                                           |
|    |   |    | e |                                                           |
|    |   |    | a |                                                           |
|    |   |    | d |                                                           |
|    |   |    | i |                                                           |
|    |   |    | l |                                                           |
|    |   |    | y |                                                           |
|    |   |    | a |                                                           |
|    |   |    | v |                                                           |
|    |   |    | a |                                                           |
|    |   |    | i |                                                           |
|    |   |    | l |                                                           |
|    |   |    | a |                                                           |
|    |   |    | b |                                                           |
|    |   |    | l |                                                           |
|    |   |    | e |                                                           |
|    |   |    | t |                                                           |
|    |   |    | o |                                                           |
|    |   |    | p |                                                           |
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|    |   |    | r |                                                           |
|    |   |    | s |                                                           |
|    |   |    | o |                                                           |
|    |   |    | n |                                                           |
|    |   |    | n |                                                           |
|    |   |    | e |                                                           |
|    |   |    | l |                                                           |
|    |   |    | ( |                                                           |
|    |   |    | s |                                                           |
|    |   |    | e |                                                           |
|    |   |    | e |                                                           |
|    |   |    | 4 |                                                           |
|    |   |    | . |                                                           |
|    |   |    | 3 |                                                           |
|    |   |    | ) |                                                           |
|    |   |    | . |                                                           |
+----+---+----+---+-----------------------------------------------------------+
|    |   |    |   |                                                           |
+----+---+----+---+-----------------------------------------------------------+
| \_ | d |    | D |                                                           |
| \_ | \ |    | e |                                                           |
| \_ | ) |    | v |                                                           |
| \_ |   |    | i |                                                           |
|    |   |    | a |                                                           |
|    |   |    | t |                                                           |
|    |   |    | i |                                                           |
|    |   |    | o |                                                           |
|    |   |    | n |                                                           |
|    |   |    | f |                                                           |
|    |   |    | r |                                                           |
|    |   |    | o |                                                           |
|    |   |    | m |                                                           |
|    |   |    | t |                                                           |
|    |   |    | e |                                                           |
|    |   |    | s |                                                           |
|    |   |    | t |                                                           |
|    |   |    | a |                                                           |
|    |   |    | n |                                                           |
|    |   |    | d |                                                           |
|    |   |    | c |                                                           |
|    |   |    | a |                                                           |
|    |   |    | l |                                                           |
|    |   |    | i |                                                           |
|    |   |    | b |                                                           |
|    |   |    | r |                                                           |
|    |   |    | a |                                                           |
|    |   |    | t |                                                           |
|    |   |    | i |                                                           |
|    |   |    | o |                                                           |
|    |   |    | n |                                                           |
|    |   |    | m |                                                           |
|    |   |    | e |                                                           |
|    |   |    | t |                                                           |
|    |   |    | h |                                                           |
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|    |   |    | d |                                                           |
|    |   |    | s |                                                           |
|    |   |    | s |                                                           |
|    |   |    | h |                                                           |
|    |   |    | a |                                                           |
|    |   |    | l |                                                           |
|    |   |    | l |                                                           |
|    |   |    | o |                                                           |
|    |   |    | c |                                                           |
|    |   |    | c |                                                           |
|    |   |    | u |                                                           |
|    |   |    | r |                                                           |
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|    |   |    | d |                                                           |
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|    |   |    | v |                                                           |
|    |   |    | i |                                                           |
|    |   |    | a |                                                           |
|    |   |    | t |                                                           |
|    |   |    | i |                                                           |
|    |   |    | o |                                                           |
|    |   |    | n |                                                           |
|    |   |    | h |                                                           |
|    |   |    | a |                                                           |
|    |   |    | s |                                                           |
|    |   |    | b |                                                           |
|    |   |    | e |                                                           |
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|    |   |    | n |                                                           |
|    |   |    | d |                                                           |
|    |   |    | o |                                                           |
|    |   |    | c |                                                           |
|    |   |    | u |                                                           |
|    |   |    | m |                                                           |
|    |   |    | e |                                                           |
|    |   |    | n |                                                           |
|    |   |    | t |                                                           |
|    |   |    | e |                                                           |
|    |   |    | d |                                                           |
|    |   |    | , |                                                           |
|    |   |    | t |                                                           |
|    |   |    | e |                                                           |
|    |   |    | c |                                                           |
|    |   |    | h |                                                           |
|    |   |    | n |                                                           |
|    |   |    | i |                                                           |
|    |   |    | c |                                                           |
|    |   |    | a |                                                           |
|    |   |    | l |                                                           |
|    |   |    | l |                                                           |
|    |   |    | y |                                                           |
|    |   |    | j |                                                           |
|    |   |    | u |                                                           |
|    |   |    | s |                                                           |
|    |   |    | t |                                                           |
|    |   |    | i |                                                           |
|    |   |    | f |                                                           |
|    |   |    | i |                                                           |
|    |   |    | e |                                                           |
|    |   |    | d |                                                           |
|    |   |    | , |                                                           |
|    |   |    | a |                                                           |
|    |   |    | u |                                                           |
|    |   |    | t |                                                           |
|    |   |    | h |                                                           |
|    |   |    | o |                                                           |
|    |   |    | r |                                                           |
|    |   |    | i |                                                           |
|    |   |    | z |                                                           |
|    |   |    | e |                                                           |
|    |   |    | d |                                                           |
|    |   |    | , |                                                           |
|    |   |    | a |                                                           |
|    |   |    | n |                                                           |
|    |   |    | d |                                                           |
|    |   |    | a |                                                           |
|    |   |    | c |                                                           |
|    |   |    | c |                                                           |
|    |   |    | e |                                                           |
|    |   |    | p |                                                           |
|    |   |    | t |                                                           |
|    |   |    | e |                                                           |
|    |   |    | d |                                                           |
|    |   |    | b |                                                           |
|    |   |    | y |                                                           |
|    |   |    | t |                                                           |
|    |   |    | h |                                                           |
|    |   |    | e |                                                           |
|    |   |    | c |                                                           |
|    |   |    | l |                                                           |
|    |   |    | i |                                                           |
|    |   |    | e |                                                           |
|    |   |    | n |                                                           |
|    |   |    | t |                                                           |
|    |   |    | . |                                                           |
+----+---+----+---+-----------------------------------------------------------+

  ----- -----------------------------------------------------------------
        **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**         

                    

  \_\_\_\_    a\)   The laboratory shall use test and/or calibration methods,
                    including methods for sampling, which meet the needs of the
                    client 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.

                    

  \_\_\_     b\)   When necessary, the standard shall be supplemented with
                    additional details to ensure consistent application.

                    

  \_\_\_\_    c\)   When the client 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.

                    

  \_\_\_     d\)   The client shall be informed as to the method chosen.

                    

  \_\_\_     e\)   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.

                    

  \_\_\_     f\)   The laboratory shall inform the client when the method
                    proposed by the client is considered to be inappropriate or
                    out of date.
  ----------- ----- -----------------------------------------------------------

  ---------------------- ----- -----------------------------------------------------------
  **5.4.3                      
  Laboratory-developed         
  methods**                    

                               

  \_\_\_                a\)   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.

                               

  \_\_\_                b\)   Plans shall be updated as development proceeds and
                               effective communication amongst all personnel involved
                               shall be ensured.
  ---------------------- ----- -----------------------------------------------------------

  -------------- ----- -----------------------------------------------------------
  **5.4.4              
  Non-standard         
  methods**            

                       

  \_\_\_\_       a\)   When it is necessary to use methods not covered by standard
                       methods, these shall be subject to agreement with the
                       client and shall include a clear specification of the
                       client\'s requirements and the purpose of the test and/or
                       calibration.

                       

  \_\_\_\_       b\)   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:   

                       

        a\)            appropriate identification;

                       

        b\)            scope;

                       

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

                       

        d\)            parameters or quantities and ranges to be determined;

                       

        e\)            apparatus and equipment, including technical performance
                       requirements;

                       

        f\)            reference standards and reference materials required;

                       

        g\)            environmental conditions required and any stabilization
                       period needed;

                       

        h\)            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;

        i\)   criteria and/or       
              requirements for      
              approval/rejection;   

                                    

        j\)   data to be recorded   
              and method of         
              analysis and          
              presentation;         

                                    

        k\)   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**         

                      

  \_\_\_\_      a\)   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.

                      

  \_\_\_       b\)   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 clients\' 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 client  
            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 client;

                      

        •             the existence of narrow limits on which decisions on
                      conformance 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 1.4).      

                             

             WMD Note:       
             ANSI/NCSL       
             Z540-2-1997 and 
             NIST Technical  
             Note 1297, 1994 
             edition, are    
             considered to   
             be equivalent   
             to the Guide to 
             the Expression  
             of Uncertainty  
             in Measurement  
             (GUM).          
  ---------- --------------- ----------------------------------------------------------

  ---------- ------------- ----------------------------------------------------------
  **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:
  ---------- ------------- ----------------------------------------------------------

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

                                                                                                       

  \_\_\_\_   b\)                           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;                                                 

                                                                                                       

  \_\_\_\_   c\)                           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**   

                                  

  \_\_\_\_      a\)               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).

                                  

  \_\_\_\_      b\)               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**         

                    

  \_\_\_\_    a\)   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.

                    

  \_\_\_\_    b\)   Calibration programs shall be established for key
                    quantities or values of the instruments where these
                    properties have a significant effect on the results.

                    

  \_\_\_\_    c\)   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:
  ---------- ----------- -----------------------------------------------------------

  ---------- ----- -----------------------------------------------------------
  \_\_\_\_   a\)   the identity of the item of equipment and its software;

                   

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

                   

  \_\_\_\_   c\)   checks that equipment complies with the specification (see
                   5.5.2);
  ---------- ----- -----------------------------------------------------------

  ---------- ----- -----------------------------------------------------------
                   

  \_\_\_\_   d\)   the current location, where appropriate;

                   

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

                   

                   

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

                   

  \_\_\_\_   g\)   the maintenance plan, where appropriate, and maintenance
                   carried out to date;

                   

  \_\_\_\_   h\)   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**                  

                             

  \_\_\_\_    a\)            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.

                             

  \_\_\_\_    b\)            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**

  -----------------------------------------------------------------------

  ---------- ----- -----------------------------------------------------------
  \_\_\_\_   a\)   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.

                   

  \_\_\_\_   b\)   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**   
  ---------------- --------------- ---------------------------------------------------------

  ---------- ----- -----------------------------------------------------------
  \_\_\_\_   a\)   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.
  ---------- ----- -----------------------------------------------------------

  ---------- ----- -----------------------------------------------------------
  \_\_\_\_   b\)   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.

                   

  \_\_\_\_   c\)   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:

                                                

  \_\_\_\_   a\)             the use of         
                             certified          
                             reference          
                             materials provided 
                             by a competent     
                             supplier to give a 
                             reliable physical  
                             or chemical        
                             characterization   
                             of a material;     

                                                

  \_\_\_\_   b\)             the use of         
                             specified methods  
                             and/or consensus   
                             standards that are 
                             clearly described  
                             and agreed by all  
                             parties concerned. 

                                                

  \_\_\_\_   c\)             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**         

                      

  \_\_\_\_      a\)   The laboratory shall have a program and procedure for the
                      calibration of its reference standards.

                      

  \_\_\_\_      b\)   Reference standards shall be calibrated by a body that can
                      provide traceability as described in 5.6.2.1.

                      

  \_\_\_\_      c\)   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**          

                     

  \_\_\_\_     a\)   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.

                     

  \_\_\_      b\)   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 client 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 client.
  ------------- ----------- -----------------------------------------------------------

  ----------- ----- -----------------------------------------------------------
                    

  **5.8.2**         

                    

  \_\_\_\_    a\)   The laboratory shall have a system for identifying test
                    and/or calibration items.

                    

  \_\_\_     b\)   The identification shall be retained throughout the life of
                    the item in the laboratory.

                    

  \_\_\_\_    c\)   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.

                    

  \_\_\_     d\)   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**         

                    

  \_\_\_\_    a\)   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.

                    

  \_\_\_\_    b\)   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 client for further
                    instructions before proceeding and shall record the
                    discussion.
  ----------- ----- -----------------------------------------------------------

  ----------- ----- -----------------------------------------------------------
  **5.8.4**         

                    

  \_\_\_\_    a\)   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.

                    

  \_\_\_\_    b\)   Handling instructions provided with the item shall be
                    followed.

                    

  \_\_\_\_    c\)   When items have to be stored or conditioned under specified
                    environmental conditions, these conditions shall be
                    maintained, monitored and recorded.

                    

  \_\_\_\_    d\)   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**           

                      

  \_\_\_\_      a\)   The laboratory shall have quality control procedures for
                      monitoring the validity of tests and calibrations
                      undertaken.

                      

  \_\_\_\_      b\)   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.

                      

  \_\_\_\_      c\)   This monitoring shall be planned and reviewed and may
                      include, but 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.                            
  ----- ------------- ----- ----- ------------ ------------------------------------------------------

  ----------- --------------- ----------------------------------------------------------
  **5.10                      
  Reporting                   
  the                         
  results**                   

                              

  **5.10.1                    
  General**                   

                              

  \_\_\_\_    a\)             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.

                              

  \_\_\_\_    b\)             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 client 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.

                              

  \_\_\_\_    c\)             In the case of tests or calibrations performed for
                              internal clients, or in the case of a written agreement
                              with the client, 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 client 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.        
  ----------- --------------- ----------------------------------------------------------

+-----+----------------------------------------------------------------+
| **  |                                                                |
| 5.1 |                                                                |
| 0.2 |                                                                |
| T   |                                                                |
| est |                                                                |
| r   |                                                                |
| epo |                                                                |
| rts |                                                                |
| and |                                                                |
| ca  |                                                                |
| lib |                                                                |
| rat |                                                                |
| ion |                                                                |
| ce  |                                                                |
| rti |                                                                |
| fic |                                                                |
| ate |                                                                |
| s** |                                                                |
+-----+----------------------------------------------------------------+
|     |                                                                |
+-----+----------------------------------------------------------------+
|     | > Each test report or calibration certificate shall include at |
|     | > least the following information, unless the laboratory has   |
|     | > valid reasons for not doing so:                              |
+-----+----------------------------------------------------------------+

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

                   

  \_\_\_\_   b\)   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;

                   

  \_\_\_\_   c\)   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;

                   

  \_\_\_\_   d\)   the name and address of the client;

                   

  \_\_\_\_   e\)   identification of the method used;

                   

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

                   

  \_\_\_\_   g\)   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;

                   
  ---------- ----- -----------------------------------------------------------

  ---------- ----- -----------------------------------------------------------
  \_\_\_\_   h\)   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;

                   

  \_\_\_\_   i\)   the test or calibration results with, where appropriate,
                   the units of measurement;

                   

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

                   

  \_\_\_\_   k\)   where relevant, a statement to the effect that the results
                   relate only to the items tested or calibrated.
  ---------- ----- -----------------------------------------------------------

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

                                            

                             **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.    

                                            

  **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:
  ----------- -------------- -------------- ---------------------------------------------------------

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

                   

  \_\_\_    b\)   where relevant, a statement of compliance/non-compliance
                   with requirements and/or specifications;

                   

  \_\_\_\_   c\)   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 client\'s
                   instruction so requires, or when the uncertainty affects
                   compliance to a specification limit;

                   

  \_\_\_    d\)   where appropriate and needed, opinions and interpretations
                   (see 5.10.5);

                   

  \_\_\_    e\)   additional information which may be required by specific
                   methods, clients or groups of clients.
  ---------- ----- -----------------------------------------------------------

  --------- -------------- ---------------- ---------------------------------------------------------
            **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:

                                            

  \_\_\_   a\)            the date of      
                           sampling;        

                                            

  \_\_\_   b\)            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); 

                                            

  \_\_\_   c\)            the location of  
                           sampling,        
                           including any    
                           diagrams,        
                           sketches or      
                           photographs;     

                                            

  \_\_\_   d\)            a reference to   
                           the sampling     
                           plan and         
                           procedures used; 

                                            
  --------- -------------- ---------------- ---------------------------------------------------------

  --------- ----- -----------------------------------------------------------
  \_\_\_   e\)   details of any environmental conditions during sampling
                  that may affect the interpretation of the test results;

                  

  \_\_\_   f\)   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:

                                                   

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

                                                   

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

                                                   

  \_\_\_\_         c\)            evidence that    
                                  the measurements 
                                  are traceable    
                                  (see note 2 in   
                                  5.6.2.1.1).      
  ---------------- -------------- ---------------- ---------------------------------------------------------

  -------------- ----- -----------------------------------------------------------
  **5.10.4.2**         

                       

  \_\_\_\_       a\)   The calibration certificate shall relate only to quantities
                       and the results of functional tests.

                       

  \_\_\_        b\)   If a statement of compliance with a specification is made,
                       this shall identify which clauses of the specification are
                       met or not met.

                       

  \_\_\_        c\)   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.

                       

  \_\_\_        d\)   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
                           client. 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 
        client. Such      
        dialogue should   
        be written down.  
  ----- ----------------- -----------------------------------------------------------

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

                           

  \_\_\_\_           a\)   When the test report contains results of tests performed by
                           subcontractors, these results shall be clearly identified.

                           

  \_\_\_            b\)   The subcontractor shall report the results in writing or
                           electronically.

                           

  \_\_\_            c\)   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**     

                                                        

  \_\_\_\_                           a\)                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.

                                                        

  \_\_\_\_         b\)                                  Such amendments shall meet all the requirements of this
                                                        Handbook.

                                                        

  \_\_\_\_         c\)                                  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___Toc35565380
.anchor}![](media/image2.wmf){width="0.6916666666666667in"
height="7.291666666666667e-2in"}

########  State 

Recognition Period: \_\_\_\_\_\_\_\_\_\_

+--------------------------+---------------------+---------------------+
| Laboratory Staff &       | Address             | Communications      |
| Titles                   |                     |                     |
+--------------------------+---------------------+---------------------+
|                          |                     | Phone:              |
+--------------------------+---------------------+---------------------+
|                          |                     | Fax:                |
|                          |                     |                     |
|                          |                     | e-mail:             |
|                          |                     |                     |
|                          |                     | URL:                |
+--------------------------+---------------------+---------------------+

  ----------------------- ----------------------- -----------------------
  Services Available                              

  Parameter               Range                   Uncertainty\*

  Mass, I                                         

  Mass, II                                        

  Mass, III                                       

  Length, Tapes - Bench                           

  Length, Tapes - Tape                            

  Length, Rigid Rules                             

  Volume, Gravimetric                             

  Volume, Transfer                                

  Temperature, I                                  

  Temperature, II                                 

  Temperature, III                                

  Temperature, IV                                 

  Temperature, V                                  

  Tuning Forks                                    

  Hydrometers                                     

  Time                                            

  Moisture                                        
  ----------------------- ----------------------- -----------------------

**\*** Uncertainties Chart must be completed for *each* measurement
parameter listed.

**State**

  -----------------------------------------------------------------------
  Fees

  -----------------------------------------------------------------------

  ----------------------------------- -----------------------------------
  National Type Evaluation Program    
  (NTEP)                              

  Address                             Telephone Number

                                      

                                      

                                      

                                      

                                      
  ----------------------------------- -----------------------------------

  ----------------------------------- -----------------------------------
  Commercial Measuring Device Testing 
  (non-NTEP)                          

  Address                             Telephone Number

                                      

                                      

                                      

                                      

                                      
  ----------------------------------- -----------------------------------

**State**

  ----------------------------------- -----------------------------------
  Grain Moisture Testing              

  Address                             Telephone Number

                                      

                                      

                                      

                                      
  ----------------------------------- -----------------------------------

  ----------------------------------- -----------------------------------
  Petroleum Quality Testing           

  Address                             Telephone Number

                                      

                                      

                                      

                                      
  ----------------------------------- -----------------------------------

  ----------------------------------- -----------------------------------
                                      

                                      

                                      

                                      

                                      
  ----------------------------------- -----------------------------------

**Appendix E. Uncertainties Chart for Measurement
Parameter**[]{#__RefHeading___Toc35565381
.anchor}**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

####### Laboratory\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

+-----------+-------+---------+---------+------------+---------------+---+
| **Range** | *     | **Type  | **C     | **Expanded | **Comments**  |   |
|           | *Type | B**     | ombined | Standard   |               |   |
|           | A     |         | Uncert  | U          |               |   |
|           | Unc   | *       | ainty** | ncertainty |               |   |
|           | ertai | *Uncert |         | (k = 2 or  |               |   |
|           | nty** | ainty** |         | 3)**       |               |   |
+===========+=======+=========+=========+============+===============+===+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+
|           |       |         |         |            |               |   |
+-----------+-------+---------+---------+------------+---------------+---+

[^1]: Section 4 substantially references the text of ISO/IEC 17025:1999,
    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. NIST/WMD does not Accredit laboratories;
    however, WMD assesses State laboratories that participate in the
    measurement traceability program for conformance to these
    requirements.

[^2]: Section 5 substantially references the text of ISO/IEC 17025:1999,
    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. NIST/WMD does not Accredit laboratories;
    however, WMD assesses State laboratories that participate in the
    measurement traceability program for conformance to these
    requirements.

[^3]: This section is adapted from the NVLAP Calibration Laboratories
    Draft Technical Guide and is modified for WMD application.

[^4]: This section was originally developed by WMD for adoption in the
    NVLAP Calibration Laboratories Draft Technical Guide; 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; it is modified
    here for WMD application.

[^6]: This section is adapted from the NVLAP Calibration Laboratories
    Draft Technical Guide, and modified for WMD application.

[^7]: This section is adapted from the NVLAP Calibration Laboratories
    Draft Technical Guide, and modified for WMD application.

[^8]: This section was originally developed by WMD.