# National Voluntary Laboratory Accreditation 

# Program



# Procedures and General Requirements

NIST HANDBOOK 150 (Prepublication Issue, March 1994) U.S. Department of Commerce Technology Administration National Institute of Standards and Technology 

# N National Voluntary Laboratory Accreditation 

# Prog ram



# Procedures and General Requirements

NlST HANDBOOK 150 (Prepublication Issue, March 1994) U.S. Department of Commerce Technoiogy Administration National Institute of Standards and Technology 

# N

### NIST HANDBOOK 150 (Prepublication Issue - March 1994) 

# National Voluntary Laboratory Accreditation Program


# Procedures and General Requirements

James 

### L. Cigler and Yanda R. White, Editors

March 1994



# u.s. Department of Commerce Ronald H. Brown, Secretary Technology Administration Mary 

### L. Good, Under Secretary for Technology National Institute of Standards and Technology Arati Prabhakar, Director 

### NIST HANDBOOK 150 (Pr epublication Issue - March 1994) 

# National Voluntary Laboratory Accreditation Program


# Procedures and General Requirements

James 

### L. Cigler and Yanda R. White, Editors

March 1994



# u.s. Department of Commerce Ronald H. Brown, Secretary Technology Administration Mary 

### L. Good, Under Secretary for Technology National Institute of Standards and Technology Arati Prabhakar, Director

## PREFACE

NIST Handbook 150 is intended for information and use by staffofaccredited laboratories, those seeking accreditation, other laboratory accreditation systems, users of laboratory services, and others needing information on the requirements for accreditation under the National Voluntary Laboratory Accreditation Program (NVLAP). It presents the basic procedures and general accreditation requirements ofNVLAP for use in accrediting calibration and testing laboratories.
This handbook contains Part 285 ofTitle 15 ofthe U.S. Code ofFederal Regulations (CFR), "National Voluntary Laboratory Accreditation Program Procedures and General Requirements," plus all general procedures, criteria, and policies formerly contained in the individual NVLAP technical handbooks and separately published NVLAP policies. This organization ofthe material was adopted so that users ofthe handbook can readily access all general accreditation requirements for a given subject in one place. Subpart D, Sections 285.33(a) through (n), is essentially identical to the language of ISO Guide 25, "General requirements for the competence ofcalibration and testing laboratories."
A small black triangle appears in the left-hand margin ofselected lines oftext throughout this handbook; the marked text applies only to the Calibration Laboratory Accreditation Program (LAP). In Sections 285.33(a) through (n), the marked text additions result from NVLAP interpretation ofISO Guide 25 via ANSIINCSL Z540-1-1994 (draft). Section 285.33(0), based in large part on the requirements of MIL-STD-45662A, was added in its entirety as contained in ANSI/NCSL Z540-1-1994 (draft) for assessment ofquality systems for the control ofMeasuring and Test Equipment (M & 

### TE).
A brief review of the evolution ofthe current CFR Part 285 follows:
The NVLAP Procedures and General Requirements were first published in the 

### Federal Registeron February 25, 1976, and became effective on that date. The 

### Federal Register notice stated: "The purpose ofthis part (

...ofthe CFR.

..) is to establish procedures under which a National Voluntary Laboratory Accreditation Program will function."
The Procedures were revised on December 10, 1984 and again on September 12, 1990, and a notice of proposed revisions was published in the 

### Federal Register on July 27, 1993. 

### December10, 

### 1984Revision. A revision ofthe Procedures was published in the 

### Federal Registeron November 8, 1984 to become effective on December 10, 1984. The 

### Federal Register notice cited four major reasons for revising the NVLAP Procedures: "First, the steps involved in establishing a laboratory accreditation program (LAP) and operating NVLAP needed to be streamlined to increase efficiency and to reduce costs. Budget constraints made this streamlining imperative. Second, large portions of Parts 7a, 7b, and 7c were repetitious. Consolidating the comparable sections ofeach part into one section reduces the total amount oftext and makes the NVLAP Procedures easier to read and follow. Third, the accreditation criteria need to be updated in light ofthe recent developments by national and international bodies, particularly as reflected in the International Organization for Standardization (ISO) document ISO Guide 25 (revised),

iii 

## PREFACE

NIST Handbook 150 is intended for information anduse by staffofaccredited laboratories, those seeking accreditation, other laboratory accreditation systems, users of laboratory services, and others needing inf ormation on the requirements for accreditation underthe National Voluntary Laboratory Accreditation Program (NVLAP). It presents the basic procedures and general accreditation requirements ofNVLAP for use in accrediting calibration and testing laboratories.
This handbook contains Part 285 ofTitle 15 ofthe 

## u.s. Code ofFederal Regulations (CFR), "National Voluntary Laboratory Accreditation Program Procedures and General Requirements," plus all general procedures, criteria, and policies formerly contained in the individual NVLAP technical handbooks and separately published NVLAPpolicies. This organization ofthe material was adopted so that users ofthe handbook can readily access all general accreditation requirements for a given subject in one place. Subpart D, Sections 285.33(a) through (n), is essentially identical to the language of ISO Guide 25, "General requirements for the competence ofcalibration and testing laboratories."
A small blacktriangle appears inthe left-handmargin ofselected lines oftext throughout this handbook; the marked text applies only to the Calibration Laboratory Accreditation Program (LAP). In Sections 285.33(a) through (n), the marked text additions result from NVLAP interpretation ofISO Guide 25 via ANSIINCSL Z540-1-1994 (draft). Section 285.33(0), based in large part on the requirements of MIL-STD-45662A, was added in its entirety as contained in 

### ANSI/NCSL Z540-1-1994 (draft) for assessment ofquality systems for the control ofMeasuring and Test Equipment (M & 

### TE).
A brief review of the evolution ofthe current CFR Part 285 follows:
The NVLAP Procedures and General Requirements were first published in the 

### Federal RegisteronFebruary 25, 1976, and became effective onthat date. The

### FederalRegister notice stated: "Thepurposeofthispart (

...oftheCFR

.. .) is to establishproceduresunder which a National Voluntary Laboratory Accreditation Program will function."
The Procedures were revised on December 10, 1984 and again on September 12, 1990, and a notice of proposed revisions was published in the 

### Federal Register on July 27, 1993. 

### December10, 

### 1984Revision. A revisionofthe Procedures was published in the

### Federal RegisteronNovember 8, 1984 to become effective onDecember 10, 1984. The

### Federal Register notice cited four major reasons for revising the NVLAP Procedures: "First, the steps involved in establishing a laboratory accreditation program (LAP) and operating NVLAP needed to be streamlined to increase efficiency and to reduce costs. Budget constraints made this streamlining imperative. Second, large portions of Parts 7a, 7b, and 7c were repetitious. Consolidating the comparable sections ofeachpart into one section reduces the total amount oftext and makes the NVLAP Procedures easier to read and follow

. Third, the accreditation criterianeed to beupdated in lightofthe recent developments by national and international bodies, particularly as reflected in the International Organization for Standardization (ISO) document ISO Guide 25 (revised),

iii

### "General Requirements for the Technical Competence of Testing Laboratories," and ASTM E548, "Criteria for the Evaluation ofTesting and Inspection Agencies." Fourth, since interaction with national laboratory accreditation systems of other countries is becoming increasingly important in fostering international trade, reciprocal recognition ofaccredited laboratories requires similar criteria and procedures." 

### September 12, 1990 Revision. The Omnibus Trade and Competitiveness Act of 1988 (Public Law No. 100-418) renamed the National Bureau of Standards (NBS) as the National Institute ofStandards and Technology (NIST). A subsequent reorganization of NIST transferred certain responsibilities ofthe Office ofStandards Services (OSS) to the National Voluntary Laboratory Accreditation Program (NVLAP). On September 12, 1990, authority was granted to amend the NVLAP Procedures to reflect the name change and the transfer ofresponsibilities. 

### March 1994 

### Revision. This revision was made for the following reasons: 1. To expand the procedures to include accreditation of calibration laboratories following establishment of the Calibration LAP 

### (Federal Register notice Monday, May 18, 1992). 2. To update the Procedures to ensure compatibility with generally accepted conformity assurance and conformity assessment concepts. 3. To incorporate international changes, especially to be consonant with relevant International Organizationfor Standardization (ISO) documents (e.g., ISO Guides 25,38, 43, and 58, and the ISO 9000 series of standards). NVLAP accreditation actions conform to ISO Guide 58, and laboratories accredited by NVLAP fulfill the ISO 25 guidelines. 4. To facilitate andpromote acceptance ofcalibration and test results between countries to avoid barriers to trade. Provisions in this regard will facilitate cooperation between laboratories and other bodies to assist in the exchange of information and experience, harmonize standards and procedures, and establish the basis for bilateral and multilateral agreements. Any questions or comments on this handbook should be submitted to the National Institute ofStandards and Technology/NVLAP, Building 411, Room A162, Gaithersburg, MD 

### 20899; phone (301) 975-4016; FAX (301) 926-2884.

iv "General Requirements for the Technical Competence of Testing Laboratories," and ASTM E548, "Criteria for the Evaluation ofTesting and Inspection Agencies." Fourth, since interaction with national laboratory accreditation systems of other countries is becoming increasingly important in fostering international trade, reciprocal recognition ofaccredited laboratories requires similar criteria and procedures." September 

### 12, 1990 Revision. 

### The Omnibus Trade and Competitiveness Act of 1988 (Public Law No. 100-418) renamed the National Bureau of Standards (NBS) as the National Institute ofStandards and Technology (NIST). A subsequent reorganization of NIST transferred certain responsibilities ofthe Office ofStandards Services (OSS) 

### to the National Voluntary Laboratory Accreditation Program (NVLAP). On September 12, 1990, authority was granted to amend the NVLAP Procedures to reflect the name change and the transfer ofresponsibilities. March 

### 1994Revision. 

### This revision was made for the following reasons: 1. To expand the procedures to include accreditation of calibration laboratories following establishment of the Calibration LAP (Federal Register 

### notice Monday, May 18, 1992). 2. Toupdate theProcedures to ensurecompatibility with generally accepted conformity assurance and conformity assessment concepts. 3

. To incorporate international changes, especially to be consonant with relevant International Organizationfor Standardization (ISO) documents (e.g

.,ISO Guides 25,38, 43, and 58, and the ISO 9000 series of standards). NVLAP accreditation actions conform to ISO Guide 58, and laboratories accredited by NVLAP fulfill the ISO 25 guidelines. 4. To facilitate andpromote acceptance ofcalibrationand test results between countries to avoid barriers to trade. Provisions in this regard will facilitate cooperation between laboratories and other bodies to assist in the exchange of information and experience, harmonize standards and procedures, and establish the basis for bilateral and multilateral agreements

. Any questions or comments on this handbook should be submitted to the National Institute ofStandards and Technology/NVLAP, Building 411, Room A162, Gaithersburg, MD 20899; phone (301) 975-4016; FAX (301) 926-2884.

iv

## ACKNOWLEDGMENTS

The preparation ofthis docwnent has been ajoint effort, with the input of representatives from other government agencies, laboratories, and the private sector. Acknowledgment oftheir efforts is in order; however, the listing of all ofthe individual names is impossible. The submissions by individuals and companies ofletters offering suggestions for improvement to this docwnent were also very welcome, as were the contributions ofthose who attended the public workshops. Special recognition is made of the considerable contributions of David F. Alderman, Jeffrey Horlick, Lawrence S. Galowin, and S. Wayne Stiefel ofthe NVLAP staffin the revisions to the NVLAP Code ofFederal Regulations and the augmenting material ofthis publication; their knowledge andjudgement were essential for the comprehensive scope achieved. Major contributions were made by Jon M. Crickenberger and C. Douglas Faison, who coordinatedthe additionofmaterial specific to the Calibration Laboratory Accreditation Program (LAP). Several NIST measurement divisions, members ofthe National Conference of Standards Laboratories (NCSL) Total Quality Management (TQM) Committee and its chairman, Gary Davidson, are recognized for their tireless efforts. Special thanks are given to Joe D. Simmons, Chief of the NIST Calibration Program, and Norman B. Belecki, Group Leader in the NIST Electricity Division, for their contributions to broadening the NVLAP procedures to embrace the special features required for a comprehensive Calibration LAP. Sincere appreciation for prepublication support is extended to Sherrie L. 

### Abrecht, Leslie T. King, Maria A. Lancaster, Channing L. 

### Monti, Margaret G. Musick, and Lisa Warfield ofthe NVLAP administrative staff.

James L. 

### Cigler and Yanda R. 

### White, Editors National Voluntary Laboratory Accreditation Program National Institute of Standards and Technology Building 411, Room A162 Gaithersburg, MD 20899

v 

## ACKNOWLEDGl\1ENTS

The preparation ofthis docwnent has been ajoint effort, with the input of representatives from other government agencies, laboratories, and the private sector. Acknowledgment oftheir efforts is in order; however, the listing of all ofthe individual names is impossible. The submissions by individuals and companies ofletters offering suggestions for improvement to this docwnent were also very welcome, as were the contributions ofthose who attended the public workshops. Special recognition is made ofthe considerable contributions of David F. Alderman, Jeffrey Horlick, Lawrence S. Galowin, and S . Wayne Stiefel ofthe NVLAP staffin the revisions to the NVLAP Code ofFederal Regulations and the augmenting material ofthis publication; their knowledge andjudgement were essential for the comprehensive scope achieved. Major contributions were made by Jon M. Crickenberger and C. Douglas Faison, who coordinatedthe additionofmaterial specificto the Calibration Laboratory Accreditation Program (LAP). Several NlST measurement divisions, members of the National Conference of Standards Laboratories (NCSL) Total Quality Management (TQM) Committee and its chairman, Gary Davidson, are recognized for their tireless efforts. Special thanks are given to Joe D

. Simmons, Chief of the NIST Calibration Program, and Norman B. Belecki, Group Leader in the NIST Electricity Division, for their contributions to broadening the NVLAP procedures to embrace the special features required for a comprehensive Calibration LAP. Sincere appreciation for prepublication support is extended to Sherrie L. 

### Abrecht, Leslie T. King, Maria A

.Lancaster, Channing L. 

### Monti, Margaret G

. Musick, and LisaWarfield ofthe NVLAP administrative staff.

James L. 

### Cigler and Yanda R. 

### White, Editors National Voluntary Laboratory Accreditation Program National Institute of Standards and Technology Building 411, Room A162 Gaithersburg, MD 20899

v

## REVISIONS

APPROVAL DATE PAGE PAR. COMMENTS NO. 

### NO. NAME INITIALS

vi 

## REVISIONS

APPROVAL DATE PAGE PAR. COMMENTS NO. 

### NO

. NAME INITIALS



### vi

## TABLE OF CONTENTS

PREFACE iii ACKNOWLEDGMENTS " v REVISIONS ., " vi SUBPART A - GENERAL INFORMATION 1 Sec. 285.1 Purpose 1 Sec. 285.2 Organization ofprocedures 1 Sec. 285.3 Description and goal ofNVLAP " 1 Sec. 285.4 References 2 Sec. 285.5 Definitions 2 Sec. 285.6 NVLAP documentation 7 Sec. 285.7 Confidentiality

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8 Sec. 285.8 Referencing NVLAP accreditation.

. . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8 Sec. 285.9 Information collection requirements

. . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8 SUBPART B

- ESTABLISHING A LAP " 8 

### Sec. 285.11 Requesting a LAP

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8 Sec. 285.12 LAP development decision

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 9 Sec. 285.13 Request from a government agency 10 Sec. 285.14 Request from a private sector organization

. . . . . . . . . . . . . . . . . . . . . .. 10 Sec. 285.15 Development oftechnical requirements

. . . . . . . . . . . . . . . . . . . . . . . .. 11 Sec. 285.16 Coordination with federal agencies.

. . . . . . . . . . . . . . . . . . . . . . . . . .. 11 Sec. 285.17 Announcing the establishment ofa LAP 11 Sec. 285.18 Adding to or modifying an established LAP

. . . . . . . . . . . . . . . . . . . . .. 11 Sec. 285.19 Termination ofa LAP 12 SUBPART C - ACCREDITING A LABORATORY

. . . . . . . . . . . . . . . . . . . . . . . . . . .. 12 Sec. 285.21 Applying for accreditation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 12 Sec. 285.22 Assessing and evaluating a laboratory.

. . . . . . . . . . . . . . . . . . . . . . . .. 14 Sec. 285.23 Granting and renewing accreditation.

. . . . . . . . . . . . . . . . . . . . . . . . .. 18 Sec. 285.24 Denying, suspending, and revoking accreditation.

. . . . . . . . . . . . . . . . .. 18 Sec. 285.25 Voluntary termination ofaccreditation 19 Sec. 285.26 Change in status oflaboratory 19 SUBPART D - CONDITIONS AND CRITERIA FOR ACCREDITATION 19 Sec. 285.31 Application ofaccreditation conditions and criteria.

. . . . . . . . . . . . . . . .. 19 Sec. 285.32 Conditions for accreditation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 19 Sec. 285.33 Criteria for accreditation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 20 (a) Scope.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 20 (b) Organization and management

. . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 21 (c) Quality system, audit and review 21 (d) Personnel.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 23

vii 

## TABLE OF CONTENTS

PREFACE

.. . ....... .................. .. . . . .. . . .. .. . . ... . .... . ... iii ACKNOWLEDGMENTS

. . ................... .. ..... ... .. ...... . .... " v REVISIONS

.... .. .. . ........... .. ... . . . .. . . . ....... ... ....... .. " vi SUBPART A

- GENERAL INFORMATION

.. ... ... . . .. ... ...... .. . ... .... .. 1 Sec. 285.1 Purpose

. . ............... ... ........ ..... . ... . . . ...... 1 Sec. 285 .2 Organization ofprocedures

.. .. ... . . ... ... . . . . ... . . . . . . . . . . .. 1 Sec

. 285.3 Description and goal ofNVLAP

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Sec. 285.4 References

.... ... .... . . . ............ . .. ... . ..... . . . .. . 2 Sec. 285

.5 DefInitions

.. .. ........ . . . .............. . ......... ... .. 2 Sec

. 285

.6 NVLAP documentation

. . . . ... .. ... .. .......... . .... . .. . ... 7 Sec. 285.7 ConfIdentiality

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8 Sec. 285.8 Referencing NVLAP accreditation.

. . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8 Sec. 285.9 Infonnation collection requirements

. . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8 SUBPART B

- ESTABLISHING A LAP

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8 Sec

. 285.11 Requesting a LAP

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8 Sec

. 285.12 LAP development decision.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 9 Sec. 285

.13 Request from a government agency ..... .. . .. ... . ....... . ..... 10 Sec. 285

.14 Request from a private sector organization

. . . . . . . . . . . . . . . . . . . . . .. 10 Sec. 285.15 Development oftechnical requirements

. . . . . . . . . . . . . . . . . . . . . . . .. 11 Sec. 285.16 Coordination with federal agencies

. . . . . . . . . . . . . . . . . . . . . . . . . . .. 11 Sec

. 285.17 Announcing the establishment of a LAP

.. . .... .. ........... .... 11 Sec. 285.18 Adding to or modifying an established LAP

..................... , 11 Sec. 285.19 Termination of a LAP

... .... . . ..... ... ... ... . ... ...... . . 12 SUBPART C

- ACCREDITING A LABORATORY

. . . . . . . . . . . . . . . . . . . . . . . . . . .. 12 Sec. 285.21 Applying for accreditation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 12 Sec

. 285.22 Assessing and evaluating a laboratory

. . . . . . . . . . . . . . . . . . . . . . . . .. 14 Sec. 285.23 Granting and renewing accreditation.

. . . . . . . . . . . . . . . . . . . . . . . . .. 18 Sec

. 285.24 Denying, suspending, and revoking accreditation.

. . . . . . . . . . . . . . . . .. 18 Sec. 285

.25 Voluntary termination of accreditation

... ..... .. .. ... . .. .. . . .. . 19 Sec. 285.26 Change in status oflaboratory

............. . ...... ... . . .. . .. 19 SUBPART D

- CONDITIONS AND CRITERIA FOR ACCREDITATION

. ... .... . . . .. 19 Sec. 285.31 Application of accreditation conditions and criteria

. . . . . . . . . . . . . . . . .. 19 Sec. 285.32 Conditions for accreditation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 19 Sec. 285.33 Criteria for accreditation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 20 (a) Scope.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 (b) Organization and management

. . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 21 (c) Quality system, audit and review

....... . . .... . .. ...... .. . ... 21 (d) Personnel

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

vii

### (e) Accommodation and environment

. . . . . . . . . . . . . . . . . . . . . . . . . . .. 23 (f) 

### Equipment and reference materials 24 (g) Measurement traceability and calibration 24 (h) 

### Calibration and test methods

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 26 (i) Handling of calibration and test items 27 (j) 

### Records.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 27 (k) Certificates and reports 28 (1) 

### Subcontracting ofcalibration or testing 30 (m) Outside support services and supplies 30 (n) Complaints.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 31 (0) 

### Measuring and test equipment (M 

### & 

### TE)

. . . . . . .. 31

viii 

### (e) Accommodation and environment

. . . . . . . . . . . . . . . . . . . . . . . . . . .. 23 (f) 

### Equipment and reference materials

... . .......... .... .. ... .... 24 (g) Measurement traceability and calibration

....... .... . . . .. . . . .. . . 24 (h) 

### Calibration and test methods

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 26 (i) Handling of calibration and test items

.................. . ...... 27 

## U) Records.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 27 (k) Certificates and reports

. . ....... . ..... . . ... ... . ... . . .. .. . 28 (1) 

### Subcontracting ofcalibration or testing

.... .. .... . ............. 30 (m) Outside support services and supplies

........ . ........ . ....... 30 (n) Complaints.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 (0) 

### Measuring and test equipment (M 

### & 

### TE)

. . .. . . . . . . . . . . . . . . . . . .. 31

viiiSUBPART A - GENERAL INFORMATION Sec. 285.1 Purpose The purpose of Part 285 of the Code of Federal Regulations is to set out procedures and general requirements under which the National Voluntary Laboratory AccreditationProgram(NVLAP)operates as an unbiased thirdparty to accredit both calibration laboratories and testing laboratories in response to: (a) mandates by the federal government through legislative or administrative action; (b) requests from a government agency (Section 285.13); and (c) requests from a private sector organization (Section 285.14). Supplementary technical and administrative requirements are provided in supporting handbooks and documents as needed depending on the criteria established for specific Laboratory Accreditation Programs (LAPs). Sec. 285.2 Organization ofprocedures Subpart A describes considerations which relate in general to all aspects of NVLAP. Subpart B describes how new LAPs are requested, developed, and announced, and how LAPs are terminated. Subpart C describes procedures for accrediting laboratories. Subpart D sets out the conditions and criteria for NVLAP accreditation. Sec. 285.3 Description and goal ofNVLAP (a) NVLAP is a system for accrediting calibration laboratories and testing laboratories found competent toperform specific tests orcalibrations. Competence is defmed as the ability of a laboratory to meet the NVLAP conditions (Section 285.32) and to conform to the criteria (Section 285.33) in NVLAP publications for specific calibration and testmethods. (b) NVLAP is a process which: (1) provides the technical and administrative mechanisms for national and international

NISTHandbook 150 1 recognition for competent laboratories based on a comprehensive procedure for promoting confidence incalibration andtestinglaboratories that show that they operate in accordance with NVLAP's requirements; NOTE: NVLAP operates under a Quality Management System to ensure that the NVLAP program meets the requirements of the U.S. Code of Federal Regulations (as augmented), and the various international standards for laboratory accreditation andqualitymanagement (see Section 285.4, References). (2) provides laboratory management with documentation for use in the development and implementation oftheir quality systems; (3) identifies competent laboratories foruse by regulatory agencies, purchasing authorities, and product certification systems; (4) provides laboratories with guidance from technical experts to aid them in reaching a higher level of performance, resulting in the generation ofimproved engineering andproduct information; and (5) promotes the acceptance ofcalibration and test results between countries, and facilitates cooperation between laboratories and other bodies to assist in the exchange ofinformation andexperience, facilitating removal ofnon-tariff barriers to trade and promoting the harmonization of standards and procedures. (c) NVLAP is comprised of a series oflaboratory accreditation programs (LAPs) which are established on the basis ofrequests and demonstrated need. The specific calibration and test methods, types of calibration and test methods, products, services, or standards to be included in a LAP are determined by an open process during the establishment ofthe LAP (see Section 285.11). The U.S. Department of Commerce, National Institute of Standards and Technology, formerly the National Bureau of Standards (NBS), administers NVLAP.

March 1994 SUBPART A - GENERAL INFORMATION Sec

. 285.1 Purpose The purpose of Part 285 of the Code of Federal Regulations is to set out procedures and general requirements under which the National Voluntary LaboratoryAccreditationProgram(NVLAP)operates as an unbiased thirdparty to accredit both calibration laboratories and testing laboratories in response to: (a) mandates by the federal government through legislative or administrative action; (b) requests from a government agency (Section 285.13); and (c) requests from a private sector organization (Section 285.14). Supplementary technical and administrative requirements are provided in supporting handbooks and documents as needed depending on the criteria established for specific Laboratory Accreditation Programs (LAPs)

. Sec. 285.2 Organization ofprocedures Subpart A describes considerations which relate in general to all aspects of NVLAP. Subpart B describes how new LAPs are requested, developed, and announced, and how LAPs are terminated. Subpart C describes procedures for accrediting laboratories. Subpart D sets out the conditions and criteria for NVLAP accreditation

. Sec. 285.3 Description and goal ofNVLAP (a) NVLAP is a system for accrediting calibration laboratories and testing laboratories found competent toperform specific tests orcalibrations. Competence is defmed as the ability of a laboratory to meet the NVLAP conditions (Section 285.32) and to conform to the criteria (Section 285.33) in NVLAP publications for specific calibration and testmethods. (b) NVLAP is a process which: (1) provides the technical and administrative mechanisms for national and international

NISTHandbook 150 1 recognition for competent laboratories based on a comprehensive procedure for promoting confidence incalibration andtestinglaboratories that show that they operate in accordance with NVLAP's requirements; NOTE: NVLAP operates under a Quality Management System to ensure that the NVLAP program meets the requirements of the U.S. Code of Federal Regulations (as augmented), and the various international standards for laboratoryaccreditation andqualitymanagement (see Section 285.4, References). (2) provides laboratory management with documentation for use in the development and implementation oftheir quality systems; (3) identifies competent laboratories foruseby regulatory agencies, purchasing authorities, and product certification systems; (4) provides laboratories with guidance from technical experts to aid them in reaching a higher level of performance, resulting in the generation ofimproved engineering andproduct information; and (5) promotes the acceptance ofcalibration and test results between countries, and facilitates cooperation between laboratories and other bodies to assist in the exchange ofinformation andexperience, facilitating removal ofnon-tariff barriers to trade and promoting the harmonization of standards and procedures. (c) NVLAP is comprised of a series oflaboratory accreditation programs (LAPs) which are established onthe basis ofrequests and demonstrated need. The specific calibration and test methods, types of calibration and test methods, products, services, or standards to be included in a LAP are determined by an open process during the establishment ofthe LAP (see Section 285.11). The u.S. Department of Commerce, National Institute of Standards and Technology, formerly the National Bureau of Standards (NBS), administers NVLAP.

March 1994The Director of the National Institute of Standards and Technology (NIST) does notunilaterally propose or decide the scope ofa LAP. Communication with other laboratory accreditation systems is fostered to encourage development of common criteria and approaches to accreditation and to promote the domestic, foreign, and international acceptance oftest data produced by the accredited laboratories. (d) NVLAP programs are established: (1) for public and private calibration and testing laboratories, including commercial laboratories, manufacturers' in-house laboratories, university laboratories, and federal, state, and local government laboratories; (2) to meet legal requirements, regulations or codes, and contract specifications, or to be recognized as demonstrably competent to meet the needs of its clients; and (3) as the basis for guidance to facilitate agreements on mutual recognition of accreditation of laboratories between NVLAP and other accreditation organizations. (e) NVLAP accreditation is: (1) based on evaluation of a laboratory's technical qualifications and competence for conducting specific testmethods, measurements and services in specified fields ofcalibration or testing; (2) granted only after thorough evaluation of the applicant has demonstrated that all NVLAP criteria have been met; (3) acknowledged by the issuance of two documents to attest to that compliance: (1) a Certificate ofAccreditation, and (2) a Scope of Accreditation which details the specific test methods, measurements and services for which a laboratory has been accredited; (4) administered in a nondiscriminatory manner;

NISTHandbook 150 2 (5) not conditional on the size of the laboratory or on its membership in any association or group; and (6) based on assessing the competence ofthe laboratory against all of the NVLAP requirements.
Sec. 285.4 References
NVLAP is designed to be compatible with domestic and foreign laboratory accreditation programs to ensure the universal acceptance oftest data produced by NVLAP-accredited laboratories. In this regard, these procedures are compatible with: (a) the most recent official publications of ISO Guides 2, 25, 30, 38, 43, 45,49, 58, and Standards 8402, 9001, 9002, 9003, and 9004; (b) International vocabulary ofbasic and general terms in metrology (VIM), and Guide to the expression ofuncenainty in measurement, issued by International Bureau of Weights and Measures (BIPM), International Electrotechnical Commission (IEC), International Federation ofClinical Chemistry (lFCC), International Organization for Standardization (ISO), International Union of Pure andAppliedChemistry (IUPAC), International Union of Pure and Applied Physics (IUPAP), and International Organization of Legal Metrology (OIML); (c) the most recent official publications of ISO Guidelines 10011-1 and 10011-2; (d) MIL-STD 45662A; Calibration System Requirement; 1988; (e) NIST Technical Note 1297; Guidelines for Evaluating and Expressing Uncenainty of NIST Measurement Results; 1993; and (I) NCSL Recommended Practice #7; Laboratory Design; July 25, 1993. Sec. 285.5 Definitions Accreditation (of a laboratory): A formal recognition that alaboratory is competent to carry out

March 1994 The Director of the National Institute of Standards and Technology (NIST) does notunilaterally propose ordecide the scope ofa LAP. Communication with other laboratory accreditation systems is fostered to encourage development of common criteria and approaches to accreditation and to promote the domestic, foreign, and international acceptance oftest data produced by the accredited laboratories. (d) NVLAP programs are established: (1) for public and private calibration and testing laboratories, including commercial laboratories, manufacturers' in-house laboratories, university laboratories, and federal, state, and local government laboratories; (2) to meet legal requirements, regulations or codes, and contract specifications, or to be recognized as demonstrably competent to meet the needs of its clients; and (3) as the basis for guidance to facilitate agreements on mutual recognition of accreditation of laboratories between NVLAP and other accreditation organizations. (e) NVLAP accreditation is: (1) based on evaluation of a laboratory's technical qualifications and competence for conducting specific testmethods, measurements and services in specified fields ofcalibration or testing; (2) granted only after thorough evaluation of the applicant has demonstrated that all NVLAP criteria have been met; (3) acknowledged by the issuance of two documents to attest to that compliance: (1) a Certificate ofAccreditation, and (2) a Scope of Accreditation which details the specific test methods, measurements and services for which a laboratory has been accredited; (4) administered in a nondiscriminatory manner;

NISTHandbook 150 2 (5) not conditional on the size of the laboratory or on its membership in any association or group; and (6) based on assessing the competence ofthe laboratory against all of the NVLAP requirements.
Sec. 285.4 References NVLAP is designed to be compatible with domestic and foreign laboratory accreditation programs to ensure the universal acceptance oftest data produced by NVLAP-accredited laboratories. In this regard, these procedures are compatible with: (a) the most recent official publications of ISO Guides 2, 25, 30, 38, 43, 45,49, 58, and Standards 8402,9001,9002, 9003, and 9004; (b) International vocabulary ofbasic and general terms in metrology (VIM), and Guide to the expression ofuncenainty in measurement, issued by International Bureau of Weights and Measures (BIPM), International Electrotechnical Commission (IEC), International Federation ofClinical Chemistry (IFCC), International Organization for Standardization (ISO), International Union of Pure andAppliedChemistry (IUPAC), International Union of Pure and Applied Physics (IUPAP), and International Organization of Legal Metrology (OIML); (c) the most recent official publications of ISO Guidelines 10011-1 and 10011-2; (d) MIL-STD 45662A; Calibration System Requirement; 1988; (e) NIST Technical Note 1297; Guidelines for Evaluating and Expressing Uncenainty of NIST Measurement Results; 1993; and (I) NCSL Recommended Practice #7; Laboratory Design; July 25, 1993. Sec. 285.5 DefInitions Accreditation (of a laboratory): A formal recognition that alaboratory is competent to carry out

March 1994specific tests or calibrations or types of tests or calibrations. Accreditation criteria: A set ofrequirements used by an accrediting body which alaboratory must meet in order to be accredited. Approved Signatory (ofanaccredited laboratory): An individual who is recognized by NVLAP as competent to signaccredited laboratory calibration or test reports. NOTE: The Approved Signatory is responsible for the technical content ofthe report and is the person to be contacted by NVLAP, 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 NVLAP upon request. Assessment (of a laboratory): The on-site examination of a testing or calibration laboratory to evaluate its compliance with the conditions and criteria for accreditation. Authorized Representative (of an accredited laboratory): An individual who is authorized by the laboratory or the parent organization to sign the NVLAP application form and commit the laboratory to fulfill the NVLAPrequirements. (The Authorized Representative may also be recommended by the laboratory as an Approved Signatory.) NOTE: The laboratory must designate an Authorized Representative who has authority to sign the NVLAP application and commit the laboratory to fulfill the NVLAP requirements. Only the Authorized Representative can authorize a change in the scope or nature of the laboratory's application. This person is listed in NVLAP directories and will receive all correspondence and inquiries from NVLAP. Calibration: A set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or

NISTHandbook 150 3 system, orvalues represented by a material measure, and the corresponding known values ofa measurand.

I!I- NOTES: (a) The result ofacalibration permits theestimation 10- of errors ofindication ofthe measuring instrument, I!I- measuring system, or the assignment of values to I» marks on arbitrary scales. (b) A calibration may also determine other I!I- metrological properties. (c) The result ofa calibration may be recorded in a document, sometimes called a calibration certificate or a calibration report.

I» (d) The result of a calibration is sometimes I» expressed as a calibration factor, or as a series of I» calibration factors in the form ofa calibration curve.

10> Calibration certificate or report: Document that 10> presents calibration results and other information I» relevant to a calibration. Calibration method: A defined technical procedure for performing a calibration. Certificate ofAccreditation: A document issued by NVLAP to a laboratory that has met the criteria and conditions for accreditation. The Certificate of Accreditation may be used as proof of accredited status. A Certificate of Accreditation is always accompanied with a Scope ofAccreditation. Client: Any person or organization that engages the services ofa testing or calibration laboratory. Competence: The ability ofa laboratory to meet the NVLAP conditions and to conform to the criteria in NVLAP publications for specific calibration and test methods. Deficiency: The non-fulfillment of NVLAP conditions and/or criteria for accreditation. Director of NIST: The Director of the National Institute of Standards and Technology or designate.

10> Error: The difference between the true and 10> measured value of a quantity.

March 1994 specific tests or calibrations or types of tests or calibrations. Accreditation criteria: A set ofrequirements used by an accrediting body which alaboratory must meet in order to be accredited

. Approved Signatory (ofanaccredited laboratory): An individual who is recognized by NVLAP as competent to signaccredited laboratory calibration or test reports. NOTE: The Approved Signatory is responsible for the technical content ofthe report and is the person to be contacted by NVLAP, laboratory clients, or others in case of questions or problems with the report. Approved Signatories shall be persons with responsibility, authority and technical capability withinthe 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 NVLAP upon request. Assessment (of a laboratory): The on-site examination of a testing or calibration laboratory to evaluate its compliance with the conditions and criteria for accreditation. Authorized Representative (of an accredited laboratory): An individual who is authorized by the laboratory or the parent organization to sign the NVLAP application form and commit the laboratory to fulfill the NVLAPrequirements. (The Authorized Representative may also be recommended by the laboratory as an Approved Signatory.) NOTE: The laboratory must designate an Authorized Representative who has authority to sign the NVLAP application and commit the laboratory to fulfill the NVLAP requirements. Only the Authorized Representative can authorize a change in the scope or nature of the laboratory's application. This person is listed in NVLAP directories and will receive all correspondence and inquiries from NVLAP. Calibration: A set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or

NISTHandbook 150 3 system, orvalues represented by a material measure, and the corresponding known values ofameasurand.**~** NOTES:**~** (a) Theresult ofacalibrationpermits theestimation**~** of errors ofindication ofthe measuring instrument,**~** measuring system, or the assignment of values to I» marks on arbitrary scales

.**~** (b) A calibration may also determine other**~** metrological properties.**~** (c) The result ofa calibration may be recorded in a**~** document, sometimes called a calibration certificate**~** or a calibration report.**~** (d) The result of a calibration is sometimes**~** expressed as a calibration factor, or as a series of**~** calibration factors in the form ofa calibration curve.**~** Calibration certificate or report: Document that**~** presents calibration results and other information**~** relevant to a calibration. Calibrationmethod: A defined technical procedure for performing a calibration. Certificate ofAccreditation: A document issued by NVLAP to a laboratory that has met the criteria and conditions for accreditation. The Certificate of Accreditation may be used as proof of accredited status. A Certificate of Accreditation is always accompanied with a Scope ofAccreditation. Client: Any person ororganization that engages the services ofa testing or calibration laboratory. Competence: The ability ofa laboratory to meet the NVLAP conditions and to conform to the criteria in NVLAPpublications for specific calibration and test methods. Deficiency: The non-fulfillment of NVLAP conditions and/or criteria for accreditation. Director of NIST: The Director of the National Institute of Standards and Technology or designate.**~** Error: The difference between the true and po measured value of a quantity.

March 1994Interlaboratory comparisons: Organization, performance and evaluation ofcalibrations ortests on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions.
Influence quantity: A quantity which is not the subject ofthe measurement but which influences the value of the measurand or the indication of the measuring instrument. Examples: ambient temperature; frequency of a measured alternating voltage. Laboratory: An organization that performs calibrations and/or tests. When a laboratory is part ofanorganizationthat carries outactivities 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. NOTE: NVLAP further defInes "laboratory" as being aphysical entity; that is, atesting orcalibration facility that is separate and apart physically from any other laboratory whether or not sharing common ownership, management, orquality systems with any other laboratory(s).
NVLAP previously differentiated between "main facilities" and

..sub-facilities." This distinction is no longer recognized. (Exception: As long as there is no break in accreditation, any laboratory previously accredited as a "sub-facility" may request to be "grandfathered" in its accreditation renewal underthe former classifIcation as a "sub-facility," including the unique conditions associated withthat classifIcation.) Any variation from this policy, other than the "grandfathering" exception, must be evaluated on its own merits. NVLAP reserves the right to decide whether or not to recognize variations. Laboratory accreditation body: Bodythatconducts and administers alaboratory accreditation system and grants accreditation. Laboratory accreditation system: System that has its own rules of procedure and management for carrying out laboratory accreditation.

NISTHandbook 150 4 LAP: Alaboratory accreditation programestablished and administered under NVLAP, consisting of test methods or calibrations relating to specifIc products or fIelds oftesting or calibration.
Limits of pennissible error (of a measuring instrument): The extreme values of an error permitted by specifIcations, regulations, etc. for a given measuring instrument. NOTE: This term is frequently referred to as "tolerance" in the United States. Measurand: A quantity subjected to measurement. NOTE: As appropriate, this may be the "measured quantity" or the "quantity to be measured."
Measurement: The set of operations having the object ofdetermining the value ofa measurand.
Measurement assurance: A process to ensure adequate measurement results that may include, but is not limited to: 1) use ofgood 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 knownor suspected influence factors, imported uncertainties, and the propagation of uncertainties throughout the measurement process; and 3)continuouslymonitoring the performance and state ofstatistical control ofthe measurement process with proven statistical process controltechniques includingthemeasurement ofwellcharacterized check standards along with the normal workload and the use of appropriate control charts. Measuring and test equipment: All of the measuring instruments, measurement standards, reference materials, auxiliary apparatus and instructions that are necessary to perform a measurement. This term includes measuring equipment used in the course of testing and inspection, as well as that used in calibration. NOTE: In the context of this handbook, the term "measuring and test equipment" is taken to encompass "measuring instruments" and "measurement standards." Moreover, a "reference

March 1994**~** Interlaboratory comparisons: Organization,**~** performance and evaluation ofcalibrations ortests on**~** the same or similar items or materials by two or**~** more laboratories in accordance with predetermined**~** conditions.**~** Influence quantity: A quantity which is not the**~** subject ofthe measurement but which influences the**~** value of the measurand or the indication of the**~** measuring instrument. Examples: ambient**~** temperature; frequency of a measured alternating**~** voltage. Laboratory: An organization that performs calibrations and/or tests

. When a laboratory is part ofanorganizationthat carries outactivities additional to calibration and testing, theterm "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

. NOTE: NVLAP further defInes "laboratory" as being aphysical entity; thatis, atesting orcalibration facility that is separate and apart physically from any other laboratory whether or not sharing common ownership, management, orquality systems with any other laboratory(s)

. NVLAP previously differentiated between "main facilities" and "sub-facilities." This distinction is no longer recognized. (Exception: As long as there is no break in accreditation, any laboratory previously accredited as a "sub-facility" may request to be "grandfathered" initsaccreditationrenewal underthe former classifIcation as a "sub-facility," includingthe uniqueconditions associated withthat classifIcation.) Any variation from this policy, other than the " grandfathering" exception, must be evaluated on its own merits. NVLAP reserves the right to decide whether or not to recognize variations. Laboratoryaccreditationbody: Bodythatconducts and administers alaboratory accreditation system and grants accreditation. Laboratory accreditation system: System that has its own rules of procedure and management for carrying out laboratory accreditation.

NISTHandbook 150 4 LAP: Alaboratory accreditation programestablished and administered under NVLAP, consisting of test methods or calibrations relating to specifIc products or fIelds oftesting or calibration.**~** Limits of permissible error (of a measuring**~** instrument): The extreme values of an error**~** permitted by specifIcations, regulations, etc. for a**~** given measuring instrument.**~** NOTE: This term is frequently referred to as**~** "tolerance" in the United States.**~** Measurand: A quantity subjected to measurement.**~** NOTE: As appropriate, this may be the "measured**~** quantity" or the "quantity to be measured."**~** Measurement: The set of operations having the**~** object ofdetermining the value ofa measurand.**~** Measurement assurance: A process to ensure**~** adequate measurement results that may include, but**~** is not limited to: 1) use ofgood 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 knownorsuspected**~** influence factors, imported uncertainties, and the**~** propagation of uncertamtles throughout the**~** measurement process; and 3)continuouslymonitoring**~** the performance and state ofstatistical control ofthe**~** measurement process with proven statistical process**~** controltechniques includingthemeasurement ofwell-**~** characterized check standards along withthe normal**~** workload and the use of appropriate control charts

.**~** Measuring and test equipment: All of the**~** measuring instruments, measurement standards,**~** reference materials, auxiliary apparatus and**~** instructions that are necessary to perform a**~** measurement. This term includes measuring**~** equipment used in the course of testing and**~** inspection, as well as that used in calibration.**~** NOTE: In the context of this handbook, the term**~** "measuring and test equipment" is taken to**~** encompass "measuring instruments" and**~** "measurement standards." Moreover, a "reference

March 1994material" is considered to be atype of "measurement standard." Measuring instrument: A device intended to make a measurement, alone or in conjunction with supplementary equipment. NIST: The National Institute of Standards and Technology. NVLAP: The National Voluntary Laboratory Accreditation Program. NVLAP is an Office within the National Institute of Standards and Technology. NVLAP Lab Code: A unique alphanumeric identifier assigned by NVLAP to each applicant laboratory; e.g., 1000 or 1000-00. It is used by NVLAP for identification, recordkeeping, and data base management. A laboratory uses its Lab Code in all correspondence with NVLAP. The Lab Code is cross-referenced with the laboratory's name, laboratory accreditation program (LAP), and geographic location in the NVLAP annual directory.
Person: Associations, companies, corporations, educational institutions, firms, government agencies at the federal, state and local level, partnerships, and societies-as well as divisions thereof-and individuals. Precision: The repeatability of measurement data; the similarity of successive independent measurements of a single magnitude generated by repeated applications of a process under specified conditions. Product: A type or a category of manufactured goods, constructions, installations, and natural and processed materials, or those associated services whose characterization, classification, or functional performance is specified by standards or test methods. Proficiency testing: The determination oflaboratory performance by means ofcomparing and evaluating calibrations or tests on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions. Quality audit: A systematic and independent examination to determine whether quality activities

NISTHandbook 150 5 andrelated results comply withplanned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. NOTE: The quality audit typically applies, but is not limited, to a quality system or elements thereof, to processes, to products, or to services. Such audits are often called "quality system audit," "process quality audit," "product quality audit," or "service quality audit." Quality manual: A document stating the quality policy, quality system, and quality practices of an organization. The quality manual may reference other laboratory documentation. Quality system: The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. Quality system review: A formal evaluation by management ofthe status and adequacy ofthe quality system in relation to quality policy and new objectives resulting from changing circumstances. Reference material: A material or substance one or more properties of which are sufficiently well established to be used for the calibration of an apparatus, for the assessment of a measurement method, or for assigning values to materials. A "certified reference material" means that one ormore ofthe property values of the reference material are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation which is issued by a certifying body. Reference standard: A standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived. Requirement: A translation ofthe needs into a set ofindividual quantified or descriptive specifications for the characteristics ofan entity in order to enable its realization and examination. Resolution: The smallest discrete or discernible change in a value that can be measured.

March 1994**~** ma ter ial n is considered tobe a type of "measurement**~** standard. "**~** Measuring instrument: A device intended to make**~** a measurement, alone or in conjunction with**~** supplementary equipment. NIST: The National Institute of Standards and Technology. NVLAP: The National Voluntary Laboratory Accreditation Program. NVLAP is an Office within the National Institute of Standards and Technology. NVLAP Lab Code: A unique alphanumeric identifier assigned by NVLAP to each applicant laboratory; e.g., 1000 or 1000-00. It is used by NVLAP for identification, recordkeeping, and data base management. A laboratory uses its Lab Code in all correspondence with NVLAP. The Lab Code is cross-referenced with the laboratory'S name, laboratory accreditation program (LAP), and geographic location in the NVLAP annual directory.
Person: Associations, companies, corporations, educational institutions, firms, government agencies at the federal, state and local level, partnerships, and societies-as well as divisions thereof-and individuals

.**~** Precision: The repeatability of measurement data;**~** the similarity of successive independent**~** measurements of a single magnitude generated by**~** repeated applications of a process under specified**~** conditions. Product: A type or a category of manufactured goods, constructions, installations, and natural and processed materials, or those associated services whose characterization, classification, or functional performance is specified by standards or test methods. Proficiency testing: The determination oflaboratory performance by means ofcomparing and evaluating calibrations or tests on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions

. Quality audit: A systematic and independent examination to determine whether quality activities

NISTHandbook 150 5 andrela ted resultscomply withplanned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. NOTE: The quality audit typically applies, butis not limited, to a quality system or elements thereof, to processes, to products, or to services

. Such audits are often called "quality system audit," "process quality audit," "product quality audit," or "service quality audit." Quality manual: A document stating the quality policy, quality system, and quality practices of an organization. The quality manual may reference other laboratory documentation

. Quality system: The organizational structure, responsibilities,procedures, processes, and resources for implementing quality management. Quality system review: A formal evaluation by management ofthe status and adequacy ofthe quality system in relation to quality policy and new objectives resulting from changing circumstances. Reference material: A material or substance one or more properties of which are sufficiently well established to be used for the calibration of an apparatus, for the assessment of a measurement method, or for assigning values to materials

. A "certified reference material" means that one ormore ofthe property values of the reference material are certified by a technically valid procedure, accompanied by ortraceable to a certificate orother documentation which is issued by a certifying body

. Reference standard: A standard, generally of the highest metrological quality available at a given location, from which measurements made at tha t location are derived

. Requirement: A translation ofthe needs into a set ofindividual quantified or descriptive specifications for the characteristics ofan entity in order to enable its realization and examination

.**~** Resolution: The smallest discrete or discernible**~** change in a value that can be measured

.

March 1994Revocation: Revocation is the removal of the accredited status ofa laboratory when it is found to have violated the terms of its accreditation. Scope of accreditation: A document issued by NVLAP which lists the test methods or services, or calibration services for which the laboratory is accredited. Stability: The ability of a measuring instrument to maintain constant its metrological characteristics. NOTE: It is usual to consider stability with respect to time. Where stability with respect to another quantity is considered, this should be stated explicitly. Standard, international (measurement): A standard recognized by an international agreement to serve internationally as the basis for assigning values to other standards ofthe quantity concerned. Standard, measurement: A material measure, measuring instrument, reference material or measuring system intended to define, realize, conserve or reproduce a unit or one or more values of a quantity to serve as a reference. Standard, mutual consent: An artifact or process that is used as a de facto standard by mutual consent of the supplier and customer when no recognized U.S. national or international standard is available. Standard, national (measurement): A standard, recognized by a national decision, to serve in a country as the basis for assigning values to standards ofthe quantity concerned. 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. Standard, reference: (See definition ofReference standard.) Standard, secondary: A standard whose value is assigned by comparison with a primary standard of the same quantity.

NISTHandbook 150 6 Standard, transport (ortransfer): A standard used as an intermediary to compare standards. Standard, working: A standard usually calibrated against a reference standard that is used routinely to calibrate or check material measures, measuring instruments or reference materials. Statistical Process Control (SPC): A systematic process for monitoring the validity ofa calibration or the value of a laboratory standard using statistical tools as a basis for decision. Sub-facility: A laboratory operating under the technical direction and quality system of a main facility that is accredited. Suspension: Suspension is a temporary removal of the accredited status ofa laboratory when it is found to be out of compliance with the terms of its accreditation.
Test: A technical operation that consists of the determination of one or more characteristics or performance ofagivenproduct, material, equipment, organism, physical phenomenon, process or service according to a specified procedure. Test method: A defined technical procedure for performing a test. Testing laboratory: A laboratory which measures, examines, tests, calibrates or otherwise determines the characteristics or performance of products or materials. Traceability: Property of the result of a measurement or the value of a standard whereby it canbe related to stated references, usually national or international standards, through anunbroken chain of comparisons all having stated uncertainties. Traceability of the accuracy of measuring instruments: A documented chain of comparison connecting the accuracy ofa measuring instrument to other measuring instruments ofhigher accuracy and ultimately to a primary standard. Uncertainty ofmeasurement: Parameter, associated with the result ofa measurement, that characterizes

March 1994 Revocation: Revocation is the removal of the accredited status ofa laboratory when it is found to have violated the tenns of its accreditation. Scope of accreditation: A document issued by NVLAP which lists the test methods or services, or calibration services for which the laboratory is accredited.**~** Stability: The ability of a measuring instrument to**~** maintain constant its metrological characteristics.**~** NOTE: It is usual to consider stability with respect**~** to time. Where stability with respect to another**~** quantity is considered, this should be stated**~** explicitly.**~** Standard, international (measurement): A**~** standard recognized by an international agreement to**~** serve internationally as the basis for assigning values**~** to other standards ofthe quantity concerned.**~** Standard, measurement: A material measure,**~** measuring instrument, reference material or**~** measuring system intended to defme, realize,**~** conserve or reproduce a unit or one or more values**~** of a quantity to serve as a reference.**~** Standard, mutual consent: An artifact orprocess**~** that is used as a de facto standard by mutual consent**~** of the supplier and customer when no recognized**~** U.S. national or international standard is available.**~** Standard, national (measurement): A standard,**~** recognized by a national decision, to serve in a**~** country as the basis for assigning values to standards**~** ofthe quantity concerned

.**~** 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

. Standard, reference: (See defmition ofReference standard.)**~** Standard, secondary: A standard whose value is**~** assigned by comparison with a primary standard of**~** the same quantity.

NISTHandbook 150 6**~** Standard, transport (ortransfer): A standard used**~** as an intermediary to compare standards.**~** Standard, working: A standard usually calibrated**~** against a reference standard that is used routinely to**~** calibrate or check material measures, measuring**~** instruments or reference materials.**~** Statistical Process Control (SPC): A systematic**~** process for monitoring the validity ofa calibration or**~** the value of a laboratory standard using statistical**~** tools as a basis for decision. Sub-facility: A laboratory operating under the technical direction and quality system of a main facility that is accredited. Suspension: Suspension is a temporary removal of the accredited status ofa laboratory when it is found to be out of compliance with the tenns of its accreditation.
Test: A technical operation that consists of the determination of one or more characteristics or performance ofagivenproduct, material, equipment, organism, physical phenomenon, process or service according to a specified procedure. Test method: A defined technical procedure for performing a test. Testing laboratory: A laboratory which measures, examines, tests, calibrates or otherwise determines the characteristics or performance of products or materials

.**~** Traceability: Property of the result of a**~** measurement or the value of a standard whereby it**~** canbe related to stated references, usually national or**~** international standards, through anunbrokenchain of**~** comparisons all having stated uncertainties. Traceability of the accuracy of measuring instruments: A documented chain of comparison connecting the accuracy ofa measuring instrument to other measuring instruments ofhigher accuracy and ultimately to a primary standard. Uncertaintyofmeasurement: Parameter, associated with the result ofa measurement, that characterizes

March 1994the dispersion ofthe values that could reasonably be attributed to the measurand. Uncertainty, Type A (evaluation of): Method of evaluation ofuncertainty by the statistical analysis of series ofobservations. Uncertainty, Type B (evaluation of): Method of evaluation of uncertainty by means other than the statistical analysis of series ofobservations. Verification: Confirmation by examination and provision of evidence that specified requirements have been met. NOTES: (a) In connection with the management of measuring equipment and/or processes, verification provides a means for checking that the deviations between values indicated by a measuring instrument and corresponding known values of a measured quantity are consistently smaller than the limits of permissible error defmed in a standard, regulation or specification peculiar to the management of the measuring equipment and/or processes. (b) The result of verification leads to a decision either to restore to service, or to perform adjustments, or to repair, or to downgrade, or to declare obsolete. In all cases documentation ofthe verification performed is kept on the measuring instrument's individual record. (c) The verification process is frequently referred to as "calibration" in the United States. Sec. 285.6 NVLAP documentation NVLAP publications are available for information and use by staff of accredited laboratories, those seeking accreditation, other laboratory accreditation systems, and others needing information on the requirements for accreditation under the NVLAP program. Accredited laboratories willbe sentrevised publications routinely. Publications include: (a) the Procedures and General Requirements, (15 CFR Part 285);

NISTHandbook 150 7 United States Code ofFederal Regulations (CFR) Theprimary document describing thelegal basis for NVLAP, including procedures for establishing accreditation activities and the criteria and general requirements for accreditation oflaboratories, is contained in the U.S. Code of Federal Regulations, Title 15

- Commerce and Foreign Trade, Subtitle B

- Regulations Relating to Commerce and Foreign Trade, Chapter II

- National Institute of Standards and Technology, Part 285

- "National Voluntary Laboratory Accreditation Program Procedures and General Requirements." CFR Part 285 is available as a reprint of the U.S. Code, and is incorporated in official NIST publications. (2) NIST Handbook 150 NIST Handbook 150 contains the U.S. Code [(1) above] plus additional material specifying NVLAP interpretation ofthe U.S. Code related to calibration and testing laboratory programs. (b) handbooks containing the administrative and operationalprocedures andtechnical requirements for specific LAPs; A series ofhandbooks in the 150 series (i.e.; 150-01

...... n) provides technical guidance, criteria and requirements for calibration and testing laboratories. A separate handbookispublishedfor each Laboratory Accreditation Program (LAP) or unique field of testing (e.g., anyone interested in the general and specific procedures and requirements for the Energy Efficient Lighting Products LAP needs NIST Handbook 150 plus NIST Handbook 150-01, Energy EfficientLighting Products, Lamps andLuminaires). Amplifying technical information related to specific fields of calibration is also published as part ofthe series (e.g., Calibration Laboratories Technical Guide). (c) adirectory ofaccredited laboratories, published annually and updated periodically; The annual directory contains the name and address, Authorized Representative, phone number, scope of accreditation, and the accreditation renewal date for

March 1994 the dispersion ofthe values that could reasonably be attributed to the measurand. Uncertainty, Type A (evaluation of): Method of evaluation ofuncertainty by the statistical analysis of series ofobservations. Uncertainty, Type B (evaluation of): Method of evaluation of uncertainty by means other than the statistical analysis of series ofobservations. Verification: Confirmation by examination and provision of evidence that specified requirements have been met. NOTES: (a) In connection with the management of measuring equipment and/or processes, verification provides a means for checking that the deviations between values indicated by a measuring instrument and corresponding known values of a measured quantity are consistently smaller than the limits of permissible error defmed in a standard, regulation or specification peculiar to the management of the measuring equipment and/or processes. (b) The result of verification leads to a decision either to restore to service, or to perform adjustments, or to repair, or to downgrade, or to declare obsolete. In all cases documentation ofthe verification performed is kept on the measuring instrument's individual record. (c) Theverificationprocess isfrequently referred to as "calibration" in the United States. Sec. 285.6 NVLAP documentation NVLAP publications are available for information and use by staff of accredited laboratories, those seeking accreditation, other laboratory accreditation systems, and others needing information on the requirements for accreditation under the NVLAP program. Accredited laboratories willbe sentrevised publications routinely. Publications include: (a) the Procedures and General Requirements, (15 CFR Part 285);

NISTHandbook 150 7 (1) United States Code ofFederal Regulations (CFR) Theprimary document describing thelegal basis for NVLAP, including procedures for establishing accreditation activities and the criteria and general requirements for accreditation oflaboratories, is contained inthe U.S. Code of Federal Regulations, Title 15

- Commerce and Foreign Trade, Subtitle B - Regulations Relating to Commerce and Foreign Trade, Chapter II

- National Institute of Standards and Technology, Part 285

- "National Voluntary Laboratory Accreditation Program Procedures and General Requirements." CFR Part 285 is available as a reprint of the U.S. Code, and is incorporated in official NIST publications. (2) NIST Handbook 150 NIST Handbook 150 contains the U.S. Code [(1) above] plus additional material specifying NVLAP interpretation ofthe U.S. Code related to calibration and testing laboratory programs. (b) handbooks containing the administrative and operationalprocedures andtechnical requirements for specific LAPs; A series ofhandbooks in the 150 series (Le.; 150-01

...... n) provides technical guidance, criteria and requirements for calibration and testing laboratories. Aseparate handbookispublishedfor each Laboratory Accreditation Program (LAP) or unique field of testing (e.g., anyone interested in the general and specific procedures and requirements for the Energy Efficient Lighting Products LAP needs NIST Handbook 150 plus NIST Handbook 150-01, Energy EfficientLighting Products, Lamps andLuminaires). Amplifying technical information related to specific fields of calibration is also published as part ofthe series (e.g., Calibration Laboratories Technical Guide). (c) adirectory ofaccredited laboratories, published annually and updated periodically; The annual directory contains the name and address, Authorized Representative, phone number, scope of accreditation, and the accreditation renewal date for

March 1994each accredited laboratory. The directory is distributed nationally and internationally to participating laboratories, manufacturers, suppliers, retailers, professional and trade associations, standards groups, and government agencies. (d) Policy Guides that provide changes to the Procedures andGeneral Requirements andHandbooks between formal revisions ofthose publications. Sec. 285.7 Confidentiality
To the extent permitted by applicable laws, NVLAP will seek to ensure confidentiality ofall information obtained relating to the application, on-site assessment, proficiency testing, evaluation, and accreditation oflaboratories. Sec. 285.8 Referencing NVLAP accreditation To become accredited and maintain accreditation, a laboratory shall agree in writing to: (a) Follow NVLAP guidance when advertising its accredited status (including the use of the NVLAP logo) on letterheads, brochures, test reports, and professional, technical, trade, or other laboratory services publications. (1) The term "NVLAP" and the NVLAP logo 

### (

## ~W~~@®) are federally registered trademarks ofltlhe National InstituteofStandards and Technology and the federal government, which retain exclusive rights to their use. (2) NIST reserves the right to control the quality ofthe use ofthe term

..NVLAP" and of the logo itself. (3) Use of the NVLAP logo on letterhead, brochures, and calibration or test reports, should be accompanied by the following: "Accredited by the National Voluntary Laboratory Accreditation Program for the specific scope ofaccreditation under Lab Code XXXX." (4) Permission for advertising NVLAP accreditation and use ofthe logo is conditional on and limited to those cases of calibration or

NISTHandbook 150 8 test reports that describe calibration or testing within the scope ofNVLAP accreditation. (5) The name of at least one Approved Signatory must appear on all calibration or test reports endorsed with the NVLAP logo or referencing NVLAP accreditation. Laboratory calibration or test reports carrying the NVLAP logo need not be signed individually by the Approved Signatory, except when required by legislation, or a client, or for otherlegal reasons. Computer-generated forms may have the signatory's name printed along with the calibration or test results, as long as there is evidence that there is a system in place to ensure that the calibration or test reports can not be generated without consent/review ofthe Approved Signatory. (6) Photographic and electronic copies ofthe logo are available from NVLAP upon request. (b) Inform its clients that the laboratory's accreditation or any ofits calibration or test reports in no way constitutes orimplies product certification, approval, or endorsement by NIST. Sec. 285.9 Infonnation collection requirements The information collection requirements contained in these procedures have been approved by the Office of Management and Budget under the Paperwork Reduction Act and have been assigned OMB control number 0693-0003.

SUBPART B - ESTABLISmNG A LAP

Sec. 285.11 Requesting a LAP (a) A request to establish a LAP must be made to the Director ofNIST; (b) Each request must include: (1) the scope ofthe LAP interms ofproducts, calibration services, ortesting services proposed for inclusion;

March 1994 each accredited laboratory. The directory is distributed nationally and internationally to participating laboratories, manufacturers, suppliers, retailers, professional and trade asSOCIatIOns, standards groups, and government agencies. (d) Policy Guides that provide changes to the ProceduresandGeneral Requirements andHandbooks between formal revisions ofthose publications. Sec. 285.7 Confidentiality
To the extent permitted by applicable laws, NVLAP will seek to ensure confidentiality ofall information obtained relating to the application, on-site assessment, proficiency testing, evaluation, and accreditation oflaboratories. Sec. 285.8 Referencing NVLAP accreditation To become accredited and maintain accreditation, a laboratory shall agree in writing to: (a) Follow NVLAP guidance when advertising its accredited status (including the use of the NVLAP logo) on letterheads, brochures, test reports, and professional, technical, trade, or other laboratory services publications. (1) The term "NVLAP" and the NVLAP logo 

### (

## ~W~£@®) are federally registered trademarks ofltlhe National InstituteofStandards and Technology and the federal government, which retain exclusive rights to their use. (2) NIST reserves the right to control the quality ofthe use ofthe term "NVLAP" and of the logo itself. (3) Use of the NVLAP logo on letterhead, brochures, and calibration or test reports, should be accompanied by the following: "Accredited by the National Voluntary Laboratory Accreditation Program for the specific scope ofaccreditation under Lab Code XXXX." (4) Permission for advertising NVLAP accreditation and use ofthe logo is conditional on and limited to those cases of calibration or

NI STHandbook 150 8 t est reports that describe calibration or testing within the scope of NVLAP accreditation

. (5) The name of at least one Approved Signatory must appear on all calibration or test reports endorsed with the NVLAP logo or referencing NVLAP accreditation

. Laboratory calibration or test reports carrying the NVLAP logo need not be signed individually by the Approved Signatory, except when required by legislation, or a client, or for otherlegal reasons. Computer-generated forms may have the signatory's name printed along with the calibration or test results, as long as there is evidence that there is a system in place to ensure that the calibration ortest reports can not be generated without consent/review ofthe Approved Signatory. (6) Photographic and electronic copies ofthe logo are available from NVLAP upon request. (b) Inform its clients that the laboratory's accreditation or any ofits calibration or test reports inno way constitutes orimplies productcertification, approval, or endorsement by NIST. Sec. 285.9 Infonnation collection requirements The information collection requirements contained in these procedures have been approved by the Office of Management and Budget under the Paperwork Reduction Act and have been assigned OMB control number 0693-0003.

SUBPART B

- ESTABLISHING A LAP

Sec. 285.11 Requesting a LAP (a) A request to establish a LAP must be made to the Director ofNIST; (b) Each request must include: (1) the scope ofthe LAP interms ofproducts, calibration services, ortesting services proposed f or inclusion;

Marc h 1994(2) specific identification of the applicable standards and test methods, including appropriate designations, and the organizations orstandards-writingbodieshavingresponsibility for them; (3) a statement ofthe perceived need for the LAP including: (i) technical and economic reasons why the LAP would benefit the public interest; (ii) evidence of a national need to accredit calibration or testing laboratories for the specific scope beyond that served by an existing laboratory accreditation program in the public or private sector; (iii) an estimate of the number of laboratories that are likely to seek accreditation; and (iv) an estimate of the number and nature of the users of such laboratories; and (4) a statement of the extent to which the requestor is willing to support necessary developmental aspects ofthe LAP with funding and personnel. (c) NVLAP may request clarification of the information submitted according to paragraph (b) of this section. (d) Before determining whether a LAP should be established, the Director of NIST shall publish a Federal Register notice of the receipt of a LAP request if the request complies with Section 285.II(b). The notice will: (1) describe the scope ofthe requested LAP; (2) indicate how to obtain a copy of the request; and (3) state that anyone may submitcomments on the need for a LAP to NVLAP within 60 days ofthe date ofthe notice.

NISTHandbook 150 9 (e) Following receipt of the identification of a mandate for a LAP based on legislative or administrative action, the Director shall publish a Federal Register notice: (1) stating the purpose of the LAP including the national or international need; (2) describing the general scope ofthe LAP; (3) identifying government agencies having oversight; and (4) providing information to any interested party wishing to be on the NVLAP mailing list to receive routine information on the development ofthe LAP. ({) Consistent withapplicable laws andregulations, the Director may negotiate and conclude agreements with the governments ofother countries for NVLAP recognition offoreign laboratories. At a minimum, any agreement must provide that accredited foreign laboratories meet conditions for accreditation comparable to and consistent with those set out in these requirements. Sec. 285.12 LAP development decision (a) The Director of NIST shall establish all LAPs on the basis ofneed. (1) A mandate to develop a LAP by NVLAP will be interpreted as a de facto decision to develop the specified LAP, and a LAP will be developed (or existing LAPs modified, if practical) following these procedures. (2) Government agencies may document the needbyusing Section285.13, andprivate sector organizations by using Section 285.14. (b) After receipt of the request, the Director of NIST shall analyze itto determine ifthere is need for the requested LAP. Inmaking this determination, the Director ofNIST shall consider the following: (1) the needs and scope of the LAP initially requested; (2) the needs and scope ofthe userpopulation;

March 1994 (2) specific identification of the applicable standards and test methods, including appropriate designations, and the organizations orstandards-writingbodieshavingresponsibility for them; (3) a statement ofthe perceived need for the LAP including: (0 technical and economic reasons why the LAP would benefit the public interest; (ii) evidence of a national need to accredit calibration ortesting laboratories for the specific scope beyond that served by an existing laboratory accreditation program in the public or private sector; (iii) an estimate of the number of labora tories that are likely to seek accreditation; and (iv) an estimate of the number and nature of the users of such laboratories; and (4) a statement of the extent to which the requestor is willing to support necessary developmental aspects ofthe LAP with funding and personnel. (c) NVLAP may request clarification of the information submitted according to paragraph (b) of this section. (d) Before determining whether a LAP should be established, the Director of NIST shall publish a Federal Register notice of the receipt of a LAP request if the request complies with Section 285.11(b). The notice will: (1) describe the scope ofthe requested LAP; (2) indicate how to obtain a copy of the request; and (3) statethat anyone may submitcomments on the need for a LAP to NVLAP within 60 days ofthe date ofthe notice.

NISTHandbook 150 9 (e) Following receipt of the identification of a mandate for a LAP based on legislative or administrative action, the Director shall publish a Federal Register notice: (1) stating the purpose of the LAP including the national or international need; (2) describing the general scope ofthe LAP; (3) identifying government agencies having oversight; and (4) providing information to any interested party wishing to be on the NVLAP mailing list to receive routine information on the development ofthe LAP. (0 Consistent withapplicable laws andregulations, the Director may negotiate and conclude agreements with the governments ofother countries for NVLAP recognition offoreign laboratories. At a minimum, any agreement must provide that accredited foreign laboratories meet conditions for accreditation comparable to and consistent with those set out in these requirements. Sec. 285.12 LAP development decision (a) The Director of NIST shall establish all LAPs on the basis ofneed. (1) A mandate to develop a LAP by NVLAP will be interpreted as a de facto decision to develop the specified LAP, and a LAP will be developed (or existing LAPs modified, if practical) following these procedures. (2) Government agencies may document the needbyusing Section285.13, andprivate sector organizations by using Section 285.14

. (b) After receipt of the request, the Director of NIST shall analyze itto determine ifthere is need for the requested LAP. Inmakingthisdetermination, the Director ofNIST shall consider the following: (1) the needs and scope of the LAP initially requested; (2) the needs and scope ofthe userpopulation;

March 1994(3) the nature and content of other relevant public and private sector laboratory accreditation programs; (4) compatibility withthecriteriareferenced in Section 285.33; (5) the importance of the requested LAP to commerce, consumer well-being, or the public health and safety; (6) the economic and technical feasibility of accrediting laboratories for the calibration or test methods, types of calibration or test methods, products, services, or standards requested; and (7) recommendations from written comments for altering the scope ofthe requested LAP by adding or deleting test methods, types of test methods, products, services, or standards. (c) Ifthe Director ofNIST decides that a need has been demonstrated, and ifresources are available to develop a LAP, NVLAP shall notify interested persons ofthe decision to proceed with development of a LAP. (d) Ifthe Director of NIST concludes that there is a need for a LAP but that there are no resources for development, NVLAP shall notify the requestor and otherinterested persons ofthe decision notto proceed until resources become available. (e) Ifthe Director ofNIST decides that a need for a LAP has not been demonstrated, NVLAP shall notify the requestor and other interested persons of the decision and the reasons not to proceed with development ofa LAP. 

### Sec. 285.13 Request from a government agency (a) Any federal, state or local agency responsible for regulatory orpublic service programs established under statute or code, which has determined a need to accredit laboratories within the context of its programs, may request the Director of NIST to establish a LAP.

NISTHandbook 150 10 (b) Each request must be in wntmg and must include the infonnation required in Section 285.11 (b) and: (1) adescription ofthe procedures followed or a citation of the specific authority used to identify a need for a LAP; and (2) for state and local government agencies, a statement explaining why the LAP should be of national scope. (c) NVLAP may request clarification of the infonnation required by Section 285.11 (b)

. (d) Before deciding to proceed with development of a LAP, the Director ofNIST shall publish a 

### Federal Register notice ofthe receipt ofa LAP request. The notice will indicate how to obtain a copy of the request and will state that anyone may submit comments on the need for a LAP to the requesting government agency within 60 days ofthe date ofthe notice. (e) NVLAP shall notify interested persons of the decision to proceed or not to proceed with development ofa LAP. 

### Sec. 285.14 Request from a private sector organization (a) Any private sector organization which has determined aneed to accredit laboratories for specific products, calibrations, or testing services, may request the Director ofNIST to establish a LAP ifit uses procedures meeting the following conditions: (1) public notice of meetings and other activities including requests for LAPs is providedin atimely fashion and is distributed to reach the attention ofinterested persons; (2) meetings are open and participation in activities is available to interested persons; (3) decisions reached by the private sector organization inthe development ofarequest for a LAP represent substantial agreement of the interested persons;

March 1994 (3) the nature and content of other relevant public and private sector laboratory accreditation programs; (4) compatibility withthecriteriareferenced in Section 285.33 ; (5) the importance of the requested LAP to commerce, consumer well-being, or the public health and safety; (6) the economic and technical feasibility of accrediting laboratories for the calibration or test methods, types of calibration or test methods, products, services, or standards requested; and (7) recommendations from written comments for altering the scope ofthe requested LAP by adding or deleting test methods, types of test methods, products, services, or standards. (c) Ifthe Director ofNIST decides that a need has been demonstrated, and ifresources are available to develop a LAP, NVLAP shall notify interested persons ofthe decision to proceed with development of a LAP. (d) Ifthe Director of NIST concludes that there is a need for a LAP but that there are no resources for development, NVLAP shall notify the requestor and otherinterestedpersons ofthe decision notto proceed until resources become available. (e) Ifthe Director ofNIST decides that a need for a LAP has not been demonstrated, NVLAP shall notify the requestor and other interested persons of the decision and the reasons not to proceed with development ofa LAP. 

### Sec. 285.13 Request from a government agency (a) Any federal, state or local agency responsible forregulatory orpublic service programs established under statute or code, which has determined a need to accredit laboratories within the context of its programs, may request the Director of NIST to establish a LAP

.

NISTHandbook 150 10 (b) Each request m ust be in wntmg and m ust include the information required in Section 285.11(b) and: (1) adescription ofthe procedures followed or a citation of the specific authority used to identify a need for a LAP; and (2) for state and local government agencies, a statement explaining why the LAP should be of national scope. (c) NVLAP may request clarification of the information required by Section 285.11(b)

. (d) Before deciding to proceed withdevelopment of a LAP, the Director ofNIST shall publish a 

### Federal Register notice ofthe receipt ofa LAP request. The notice will indicate how to obtain a copy of the request and will state that anyone may submit comments on the need for a LAP to the requesting government agency within 60 days ofthe date ofthe notice. (e) NVLAP shall notify interested persons of the decision to proceed or not to proceed with development of a LAP. 

### Sec. 285.14 Request from a private sector organization (a) Any private sector organization which has determined aneed to accredit laboratories for specific products, calibrations, or testing services, may request the Director ofNIST to establish a LAP ifit uses procedures meeting the following conditions: (1) public notice of meetings and other activities including requests for LAPs is providedin atimely fashion and is distributed to reach the attention ofinterested persons; (2) meetings are open and participation in activities is available to interested persons; (3) decisions reached by the private sector organization inthe development ofarequest for a LAP represent substantial agreement of the interested persons;

March 1994(4) prompt consideration is given to the expressed views and concerns of interested persons; (5) adequate and impartial mechanisms for handling substantive and procedural complaints and appeals are in place; and (6) appropriate records of all meetings are maintained and the official procedures used by the private sector organization to make aformal request for a LAP are made available upon request to any interested person. (b) Each request must be in writing and must include the information required in Section 285.11 (b) and a description of the way in which the organization has met the conditions specified in paragraph (a) ofthis section. (c) NVLAP may request clarification of the information required by Section 285.1l(b). (d) Before deciding toproceed with development of a LAP, the Director ofNIST shall publish a Federal Register notice ofthe receipt ofa LAP request. The notice will indicate how to obtain a copy of the request and will state that anyone may submit comments on the need for a LAP to the requesting private sector organization within 60 days ofthe date ofthe notice. (c) NVLAP shall make every reasonable effort to ensure that the affected calibration or testing community within the scope ofthe LAP is informed ofany planned workshop. Summary minutes ofeach workshop will be prepared. A copy ofthe minutes will be made available for inspection and copying at the NIST Records Inspection Facility. Sec. 285.16 Coordination with federal agencies As a means of ensuring effective and meaningful cooperation, input, and participation by those federal agencies that may have an interest in and may be affected by established LAPs, NVLAP shall communicate and consult with appropriate officials within those agencies. Sec. 285.17 Announcing the establishment of a LAP (a) When NVLAP has completed the development of the technical requirements of the LAP and established a schedule of fees for accreditation, NVLAP shall publish anotice inthe FederalRegister announcing the establishment ofthe LAP. (b) The notice will: (1) identify the scope ofthe LAP; and (2) advise how to apply for accreditation. (e) NVLAP shall notify interested persons of the decision whether or not to proceed with development ofa LAP. Sec. 285.15 requirements Development of technical (c) NVLAP shall establish fees in amounts that will enable it to recover its full costs, and shall, from time to time as necessary, revise the fees for this purpose. Sec. 285.18 Addingto ormodifying an established LAP (a) Technical requirements for accreditation are specific for each LAP. The requirements tailor the criteriareferenced inSection285.33 tothecalibration or test methods, types ofcalibration or test methods, products, services, or standards covered by the LAP. (b) NVLAPshalldevelopthetechnical requirements based onexpert advice. This advice may be obtained through one or more informal public workshops or other suitable means.

NISTHandbook 150 11 (a) Established or developing LAPs may be added to, modified, or realigned based on either a written request from any person wishing to add or delete specific standards, calibration or test methods, or types of calibration or test methods or a need identified by NIST. (b) NVLAP may choose to make the additions or modifications available for accreditation under aLAP when:

March 1994 (4) prompt consideration is given to the expressed views and concerns of interested persons; (5) adequate and impartial mechanisms for handling substantive and procedural complaints and appeals are in place; and (6) appropriate records of all meetings are maintained and the official procedures used by the private sector organization to make aformal request for a LAP are made available upon request to any interested person. (b) Each request must be in writing and must include theinformationrequired in Section 285.11(b) and a description of the way in which the organization has met the conditions specified in paragraph (a) ofthis section. (c) NVLAP may request clarification of the information required by Section 285.1l(b). (d) Before deciding toproceed withdevelopment of a LAP, the Director ofNIST shall publish a Federal Register notice ofthe receipt ofa LAP request. The notice will indicate how to obtain a copy of the request and will state that anyone may submit comments on the need for a LAP to the requesting private sector organization within 60 days ofthe date ofthe notice. (e) NVLAP shall notify interested persons of the decision whether ornot to proceed with development ofa LAP. Sec. 285.15 requirements Development of technical

(a) Technical requirements for accreditation are specific for each LAP. The requirements tailor the criteriareferenced inSection285.33tothecalibration or test methods, types ofcalibration or test methods, products, services, or standards covered by the LAP. (b) NVLAPshalldevelopthetechnical requirements based onexpert advice. This advice may be obtained through one or more informal public workshops or other suitable means.

NISTHandbook 150 11 (c) NVLAP shall make every reasonable effort to ensure that the affected calibration or testing community within the scope ofthe LAP is informed ofany planned workshop. Summary minutes ofeach workshop will be prepared. A copy ofthe minutes will be made available for inspection and copying at the NIST Records Inspection Facility. Sec. 285.16 Coordination with federal agencies As a means of ensuring effective and meaningful cooperation, input, and participation by those federal agencies that may have an interest in and may be affected by established LAPs, NVLAP shall communicate and consult with appropriate officials within those agencies. Sec. 285.17 Announcing the establishment of a LAP (a) When NVLAP has completed the development of the technical requirements of the LAP and established a schedule of fees for accreditation, NVLAP shall publish anotice inthe FederalRegister announcing the establishment ofthe LAP. (b) The notice will: (1) identify the scope ofthe LAP; and (2) advise how to apply for accreditation. (c) NVLAP shall establish fees in amounts that will enable it to recover its full costs, and shall, from time to time as necessary, revise the fees for this purpose. Sec. 285.18 Addingtoormodifying anestablished LAP (a) Established or developing LAPs may be added to, modified, or realigned based on either a written request from any person wishing to add or delete specific standards, calibration or test methods, or types of calibration or test methods or a need identified by NIST. (b) NVLAP may choose to make the additions or modifications available foraccreditation under aLAP when:

March 1994(1) the additional standards, calibration ortest methods, or types ofcalibration or test methods requested are directly relevant to the LAP; (2) it is feasible and practical to accredit calibration or testing laboratories for the additional standards, calibration ortestmethods, or types ofcalibration or test methods; and (3) it is likely that laboratories will seek accreditation for the additional standards, calibration or test methods, or types of calibration or test methods. (c) A laboratory requesting the addition of calibration parameters, test methods or services to its Scope ofAccreditation must meet all NVLAP criteria forthe additional calibrationparameters, testmethods or services; e.g., technical requirements, proficiency testing, payment of fees, etc. The need for an additional on-site assessment and/or proficiency testing will be determined on a case-by-case basis. Sec. 285.19 Termination of a LAP (a) The Director of NIST may terminate a LAP when the Director ofNIST determines that a need no longer exists to accredit laboratories for the services covered under the scope of the LAP. In the event that the Director of NIST proposes to terminate a LAP, a notice will be published in the Federal Register setting forth the basis for thatdetermination. (b) The notice published under paragraph (a) ofthis section shall provide a 60-day period for submitting written comments on the proposal to terminate the LAP. All written comments will be made available for public inspection and copying at the NIST Records Inspection Facility. (c) Afterthe comment period, the Director ofNIST shall determine if public support exists for the continuation ofthe LAP. Ifpublic comments support the continuation of the LAP, the Director of NIST shall publishaFederalRegisternotice announcing the continuation of the LAP. In the absence of public support for continuation, the LAP will be terminated effective 90 days after the date of the published notice of intent to terminate the LAP.

NISTHandbook 150 I2 (d) If the LAP is terminated, NVLAP will no longer grant or renew accreditations following the effective date of termination. Accreditations previously granted shall remain effective until their expiration date unless terminated voluntarily by the laboratory or revoked by NVLAP.

SUBPART C - ACCREDITING A LABORATORY

Sec. 285.21 Applying for accreditation (a) A laboratory may complete and remit an application for accreditation in any ofthe established LAPs. (1) A NVLAP application package is sent to a laboratory on request. It includes the General Application, Program-Specific Application, NVLAPFee Schedule, theProgramHandbook, and all documents needed for understanding of the NVLAP program and requirements. This could include relevant Technical Guides in the fields ofcalibration for which a laboratory has requested accreditation. (2) The General Application must be completed and signed by the Authorized Representative of the laboratory. Before completing and signing the application, the Authorized Representative should review all documents and become familiar with NVLAP requirements. (b) Upon receipt of a laboratory's application, NVLAP shall: (1) acknowledge receipt ofthe application; (2) request further information, ifnecessary; (3) confirmpayment offees before proceeding with the accreditation process; and (4) specify the next step(s) inthe accreditation process. (c) Accreditation of laboratories outside of the United States may require:

March 1994 (1) the additional standards, calibration ortest methods, ortypes ofcalibration ortest methods requested are directly relevant to the LAP; (2) it is feasible and practical to accredit calibration or testing laboratories for the additional standards, calibrationortestmethods, or types ofcalibration or t est methods; and (3) it is likely that laboratories will seek accreditation for the additional standards, calibration or test methods, or types of calibration or test methods. (c) A laboratory requesting the addition of calibrationparameters, test methods orservices to its Scope ofAccreditation mustmeet all NVLAPcriteria forthe additional calibrationparameters, testmethods or services; e.g., technical requirements, proficiency testing, payment of fees, etc. The need for an additional on-site assessment and/or proficiency testing will be determined on a case-by-case basis

. Sec. 285.19 Termination of a LAP (a) The Director of NIST may terminate a LAP when the Director ofNIST determines that a need no longer exists to accredit laboratories for the services covered under the scope of the LAP. In the event that the Director of NIST proposes to terminate a LAP, a notice will be published in the Federal Register setting forththebasis forthatdetermination

. (b) Thenoticepublishedunder paragraph (a) ofthis section shall provide a 60-day period for submitting written comments on the proposal to terminate the LAP

. All written comments will be made available for public inspection and copying at the NIST Records Inspection Facility. (c) Afterthe comment period, the Director ofNIST shall determine if public support exists for the continuationofthe LAP. Ifpublic comments support the continuation of the LAP, the Director of NIST shallpublishaFederalRegisternotice announcingthe continuation of the LAP

. In the absence ofpublic support for continuation, the LAP will be terminated effective 90 days after the date of the published notice ofintent to terminate the LAP.

NISTHandbook 150 I2 (d) If the LAP is terminated, NVLAP will no longer grant or renew accreditations following the effective date of termination. Accreditations previously granted shall remain effective until their expiration date unless terminated voluntarily by the laboratory or revoked by NVLAP.

SUBPART C - ACCREDITING A LABORATORY

Sec. 285.21 Applying for accreditation (a) A laboratory may complete and remit an application for accreditation in any ofthe established LAPs. (1) ANVLAP application package is sent to a laboratory on request. It includes the General Application, Program-Specific Application, NVLAPFee Schedule, theProgramHandbook, and all documents needed for understanding of the NVLAP program and requirements. This could include relevant Technical Guides in the fields ofcalibration for which a laboratory has requested accreditation

. (2) The General Application must be completed and signed by the Authorized Representative of the laboratory. Before completing and signing the application, the Authorized Representative should review all documents and become familiar with NVLAP requirements. (b) Upon receipt of a laboratory's application, NVLAP shall: (1) acknowledge receipt ofthe application; (2) request further information, ifnecessary; (3) confirmpayment offeesbeforeproceeding with the accreditation process; and (4) specify the next step(s) inthe accreditation process. (c) Accreditation of laboratories outside of the United States may require:

March 1994(1) translation of laboratory documentation into English; NOTE: In cases where laboratory documents are not in English, or laboratory personnel do not speak English, it is the responsibility ofthe laboratory to provide a translator to assist the NVLAP assessor(s) during the on-site assessments. The translator will assist the assessor(s) in conversing directly with laboratory management and technical staff and in reviewing laboratory documentation. Documents such as quality assurance manuals, protocols, standards, and test reports sent to NVLAP prior to on-site assessments or reviewed during assessments need not be translated into English solely for NVLAP purposes. (2) payment of additional traveling expenses for on-site assessments and proficiency testing; NOTE: Some ofthe fees listed on the NVLAP Fee Schedule may be insufficient to cover the costs incurredby an applicant laboratory located outside the U.S. In such cases, the laboratory will be responsible for all additional costs incurred. Additional fees will be charged, if necessary, for travel by NVLAP assessor(s) outside ofthe U.S., for shipment ofproficiency testing materials to the laboratories and for any additional administrative expenses. To ensure that the initial or renewal application is processed without delay, payment (in U.S. currency) of the appropriate listed fees should accompany the application. When all the additional costs associated with the application have been identified, an invoice for any additional fee amount owed will be sent to the laboratory

. (3) export licenses. NOTE: For certain scientific and technical equipment to be exported from the United States, a license issued by the U.S. Department ofCommerce may be required. Ifa laboratory uses such equipment, NVLAP requires that the laboratory possess, and show upon request, an export license. For export license information, contact the U.S. Department of Commerce,

NISTHandbook 150 13 Export Administration, Exporter Assistance, P.O. Box 273, Washington, DC 20230, telephone (202) 482-4811 , FAX (202) 482- 3617. (d) NVLAP Fees NVLAP receives no appropriated public funds. NVLAP operates on a cost-reimbursable basis from fees paid by participating laboratories that apply for accreditation in specific NVLAP fields oftesting or calibration. For fee calculation purposes, a field is considered to be any area of accreditation that is a separate line item on the NVLAP Fee Schedule (for example, GOSIP is a separate field of testing even though it is part of the Computer/Electronics program). The fee structure incorporates five major fee categories: (1) The Initial Application Fee covers costs associated with processing an applicant for the first time. It is paid only one time per laboratory and is due with the initial application for accreditation. (2) TheAdministrativelTechnical Suppon Fee covers costs associated with NVLAP and other NIST staffconducting the program in all areas for which accreditation is offered and for providing these services to participating laboratories. This fee is due annually regardless of the accreditation status of a laboratory

. Laboratories which have been enrolled in a program for more than one year and are not yet accredited will be invoiced annually for the Administrative/Technical SupportFee, basedon the date the laboratory's initial application was accepted by NVLAP. (3) The On-Site Assessment Fee covers costs incurred for on-site assessment visits. On-site assessments are conducted prior to initial accreditation and every two years thereafter; therefore, this fee is due only for a renewal year in which an assessment is scheduled.

March 1994 (1) translation of laboratory documentation into English; NOTE: In cases where laboratory documents are not in English, or laboratory personnel do not speak English, it is the responsibility ofthe laboratory to provide a translator to assist the NVLAP assessor(s) during the on-site assessments

. The translator will assist the assessor(s) in conversing directly with laboratory management and technical staff and in reviewing laboratory documentation. Documents such as quality assurance manuals, protocols, standards, and test reports sent to NVLAP prior to on-site assessments or reviewed during assessments need not be translated into English solely for NVLAP purposes. (2) payment of additional traveling expenses for on-site assessments and proficiency testing; NOTE: Some ofthe fees listed on the NVLAP Fee Schedule may be insufficient to cover the costs incurredby an applicant laboratory located outside the U.S. In such cases, the laboratory will be responsible for all additional costs incurred. Additional fees will be charged, if necessary, for travel by NVLAP assessor(s) outside ofthe U.S., for shipment ofproficiency testing materials to the laboratories and for any additional administrative expenses. To ensure that the initial or renewal application is processed without delay, payment (in U.S. currency) of the appropriate listed fees should accompany the application

. When all the additional costs associated with the application have been identified, an invoice for any additional fee amount owed will be sent to the laboratory

. (3) export licenses

. NOTE: For certain scientific and technical equipment to be exported from the United States, a license issued by the U.S. Department ofCommerce may be required. Ifa laboratory uses such equipment, NVLAP requires that the laboratory possess, and show upon request, an export license. For export license information, contact the U

.S. Department of Commerce,

N

I STHandbook 150 13 Export Administration, Exporter Assistance, P.O

. Box 273, Washington, DC 20230, telephone (202) 482-48 11, FAX (202) 482- 3617

. (d) NVLAP Fees NVLAP receives no appropriated public funds. NVLAP operates on a cost-reimbursable basis from fees paid by participating laboratories that apply for accreditation in specific NVLAP fields oftesting or calibration. For fee calculation purposes, a field is considered to be any area of accreditation that is a separate line item on the NVLAP Fee Schedule (for example, GOSIP is a separate field of testing even though it is part of the Computer/Electronics program)

. The fee structure incorporates five major fee categories: (1) The Initial Application Fee covers costs associated with processing an applicant for the first time. It is paid only one time per laboratory and is due withthe initial application for accreditation

. (2) TheAdministrativelTechnical SupponFee covers costs associated with NVLAP and other NIST staffconducting the program in all areas for which accreditation is offered and for providing these services to participating laboratories. This fee is due annually regardless of the accreditation status of a laboratory

. Laboratories which have been enrolled in a program for more than one year and are not yet accredited will be invoiced annually for the Administrative/Technical SupportFee, basedon the date the laboratory's initial application was accepted by NVLAP. (3) The On-Site Assessment Fee covers costs incurred for on-site assessment visits

. On-site assessments are conducted prior to initial accreditation and every two years thereafter; therefore, this fee isdue only for arenewal year in which an assessment is scheduled

.

March 1994NOTE: The optional use of a preassessment visit will be considered ifit is decided that such a visit would result in a better defInition ofthe scope ofaccreditation whichhas been requested by the laboratory. In such cases the preassessment costs will be charged to the laboratory in addition to the actual On-Site Assessment Fee. A laboratory will be charged for an additional assessment visit if required as the result of defIciencies in meeting NVLAP technical criteria. The fee for this additional assessment visit is the same as the On-Site Assessment Fee on the NVLAP Fee Schedule. (e) Fee Refund Policy This refund policy applies to laboratories that withdraw from the NVLAPprogram. It covers each ofthe fIve major fee categories as follows: (1) The Initial Application Fee is nonrefundable. (2) The a m 0 u n t 0 f the AdministrativelTechnical Support Fee and the Test Method Fee to be refunded depends upon the length oftime that has elapsed between the laboratory's renewal date and the date NVLAP was notifIed of the decision to withdraw. A laboratory will not be charged separately for a monitoring visit, which may be initiated by NVLAP at any time during the accreditation period for cause or on a random selection basis. (4) The Proficiency Testing Fee covers costs relating to the provision of profIciency test samples and artifacts, the collection andanalysis of laboratory results, and reports to NVLAP staff. Time ofwithdrawal (# ofmonths after renewal dater
Less than 3 months 3 months to less than 6 months 6 months to less than 9 months 9 months or greater Refund amount 3/4 1/2 1/4 No refund

The ProfIciency Testing Fee, which is paid with a laboratory's initial or renewal application, covers the rounds of profIciency testing scheduled for a given year. If a laboratory has participated in the scheduled rounds oftesting, but has not yet attained accreditation, it will be invoiced prior to each subsequent round of profIciency testing until it submits its fIrst renewal application. If profIciency testing is performed every other year, the fee is due only in the year that testing is scheduled to be performed. (5) The Test Method Fee covers incremental costs associated withtechnical supportrelated to the number and complexity of test methods selected by alaboratory withinagivenprogram. This fee is charged per test method; therefore, the total Test Method Fee depends on the total number oftest methods selected and varies from application to application within a program.

NISTHandbook 150 14 

## * Ifa laboratory is seeking initial accreditation (i.e., has never been accredited for a specifIc program), the time of withdrawal will be counted as the number ofmonths after the date the initial application was received.

(3) The On-SiteAssessment Fee is refundable only if no on-site related costs have been incurred. Otherwise, costs incurred will be deducted from the On-Site Assessment Fee. (4) The portion ofthe Proficiency Testing Fee for any profIciency testing planned but not sent to the laboratory, or for any profIciency testing that was not initiated, will be refunded. No refund will be given for artifacts sent but returned unmeasured by the laboratory. Sec. 285.22 Assessing and evaluating a laboratory (a) Information used to evaluate a laboratory's compliance with the conditions for accreditation set out in Section 285.32, the criteria for accreditation set out in Section 285.33, and the technical

March 1994 NOTE: The optional use of a preassessment visit will be considered ifit is decided that such a visit would result in a better definition ofthe scope ofaccreditation whichhas beenrequested by the laboratory. In such cases the preassessment costs will be charged to the laboratory in addition to the actual On-Site Assessment Fee.
A laboratory will be charged for an additional assessment visit if required as the result of deficiencies in meeting NVLAP technical criteria. The fee for this additional assessment visit is the same as the On-Site Assessment Fee on the NVLAP Fee Schedule.
A laboratory will not be charged separately for a monitoring visit, which may be initiated by NVLAP at any time during the accreditation period for cause oron a random selection basis. (4) The Proficiency Testing Fee covers costs relating to the provision of proficiency test samples and artifacts, thecollection andanalysis of laboratory results, and reports to NVLAP staff.
The Proficiency TestingFee, which is paid with a laboratory's initial or renewal application, covers the rounds of proficiency testing scheduled for a given year. Ifa laboratory has participated in the scheduled rounds oftesting, but has not yet attained accreditation, it willbe invoiced prior to each subsequent round of proficiency testing until it submits its first renewal application

. If proficiency testing is performed every other year, the fee is due only in the year that testing is scheduled to be performed. (5) The Test Method Fee covers incremental costs associated withtechnical supportrelated to the number and complexity of test methods selected byalaboratory withinagivenprogram. This fee is charged per test method; therefore, the total Test Method Fee depends on the total numberoftest methods selected andvaries from application to application within a program.

NISTH andbook 150 

### 14 (e) Fee Refund Policy This refund policy applies to laboratories that withdraw from the NVLAPprogram. Itcovers each ofthe five major fee categories as follows: (1) The Initial Application Fee is nonrefundable. (2) The a m 0 u n t 0 f the AdministrativelTechnical Support Fee and the Test Method Fee to be refunded depends upon the length oftime that has elapsed between the laboratory's renewal date and the date NVLAP was notified of the decision to withdraw.

Time ofwithdrawal (# ofmonths after r enewal date)" Refund amount Less than 3 months 3/4 3 months to less than 6 months 1/2 6 months to less than 9 months 1/4 9 months or greater No refund 

## * Ifa laboratory is seeking initial accreditation (i.e., has never been accredited for a specific program), the time of withdrawal will be counted as the number ofmonths after the date the initial application was received

.
(3) The On-SiteAssessment Fee is refundable only if no on-site related costs have been incurred

. Otherwise, costs incurred will be deducted from the On-Site Assessment Fee. (4) Theportion ofthe Proficiency Testing Fee for any proficiency testing planned but not sent to the laboratory, or for any proficiency testing that was not initiated, will be refunded. No refund will be given for artifacts sent but returned unmeasured by the laboratory. Sec. 285.22 Assessing andevaluatinga laboratory (a) Information used to evaluate a laboratory's compliance with the conditions for accreditation set out in Section 285.32, the criteria for accreditation set out in Section 285.33, and the technical

March 1994requirements established for each LAP will include (not necessarily in this order): (1) application andothermaterial submittedby the laboratory (Section 285.32(b»; (2) on-site assessment reports; (3) laboratory performance on proficiency tests; (4) laboratory responses to identified deficiencies; and (5) technical evaluation. (b) NVLAP shall arrange the assessment and evaluation ofapplicant laboratories in such a way as to minimize potential conflicts ofinterest. The laboratory will be contacted to schedule a mutually acceptable date for the on-site assessment afterpaymentofthe required fees and willbe notified ofany additional information whichmustbe supplied, andofany applicableproficiency testing requirements which must be completed, for the technical evaluation. (1) Technical Experts NVLAP uses Technical Experts (TEs) as assessors and evaluators. They may be engineers or scientists currently active in the field, consultants, college professors or retired persons. They are selected onthe basis oftheir professional and academic achievements, experience in the field oftesting or calibration, management experience, andtactindealing with people. Their services are generally contracted as required; they are normally not NVLAP staff members.
Assessors are TEs selected to conduct an on-site assessment of a particular laboratory on the basis of how well their individual experience matches the type oftesting or calibration to be assessed, as well as absence of conflict of interest. The laboratory has the right to appeal the assignment ofan assessor and may request an alternate.

NISTHandbook 150 15 Evaluators are TEs selected to review the record ofthe laboratory as a whole, including the application, assessment report, deficiencies, corrections to deficiencies, and proficiency test results. Based on the totality ofthe record, the evaluators recommend whether or not a laboratory shouldbe accredited. The evaluators are matched to the type oftesting or calibration being evaluated. Like assessors, evaluators are selected to avoid conflict ofinterest. (2) On-Site Assessment Before initial accreditation and every two years thereafter, an on-site assessment of each laboratory isconducted to determine compliance with the NVLAP criteria. NVLAP assigns an assessor or a team ofassessors and provides the laboratory with a short biographical sketch of the assessor(s). A lead assessor will be assigned ifneeded. The laboratory may request an alternate assessor if a conflict ofinterest or prior business relationship exists. Assessors use checklists providedby NVLAP so that each laboratory receives an assessment comparable to that received by others. However, assessors have some latitude to make judgments about a laboratory's compliance with the NVLAP criteria. An assessment normally takes one to five days depending on the scope of the laboratory's application. Every effort is made to conduct an assessment withas little disruptionas possibleto the normal operations ofthe laboratory. During the assessment, the assessor meets with management andlaboratorypersonnel, examines the quality system, reviews staff information, examines equipment and facilities, observes demonstrations of calibrations or testing, and examines calibration or test reports. The assessor reviews laboratory records including resumes, job descriptions of key personnel, training, andcompetency evaluations for all staffmembers who routinely perform, or affect the quality ofthe calibration ortesting for which accreditation is sought. The assessor need not be given information which violates individual privacy, such as salary, medical

March 1994 requirements established for each LAP will include ( not necessar ily in this order): (1) application andothermaterial submittedby the laboratory (Section 285

.32(b» ; (2) on-site assessment reports; (3) laboratory performance on proficiency tests; (4) laboratory responses to identified deficiencies; and (5) technical evaluation. (b) NVLAP shall arrange the assessment and evaluation ofapplicant laboratories in such a way as to minimize potential conflicts ofinterest. The laboratory will be contacted to schedule a mutually acceptable date for the on-site assessment afterpaymentofthe required fees and willbe notified ofany additional informationwhichmustbe supplied, andofany applicableproficiency testingrequirements w

hich must be completed, for the technical evaluation. (1) Technical Experts NVLAP uses Technical Experts (TEs) as assessors and evaluators. They may be engineers or scientists currently active in the field, consultants, college professors or retired persons. They are selected on the basis oftheir professional and academic achievements, experience in the field oftesting or calibration, management experience, andtactindealing with people. Their services are generally contracted as required; they are normally not NVLAP staff members.
Assessors are TEs selected to conduct an on-site assessment of a particular laboratory on the basis of how well their individual experience matches the type oftesting or cali bration to be assessed, as well as absence of conflict of interest. The laboratory has the right to appeal the assignment of an assessor and may request an alternate.

NI STHandbook 150 

### 15 Evaluators are TEs selected to review the record of the laboratory as a w hole, including the application, assessment report,deficiencies, corrections todeficiencies, and proficiency test results

. Based on the totality ofthe record, the evaluators recommend whether or not a laboratory shouldbe accredited. The evaluators are matched tothe type oftesting or calibra tion being evaluated. Like assessors, evaluators are selected to avoid conflict ofinterest. (2) On-Site Assessment Before initial accreditation and every two years thereafter, an on-site assessment of each laboratory isconducted todetermine compliance with the NVLAP criteria

. NVLAP assigns an assessor or a team ofassessors and provides the laboratory with a short biographical sketch of the assessor(s). A lead assessor will be assigned ifneeded

. The laboratory may request an alternate assessor if a conflict ofinterest or prior business relationship exists. Assessors use checklists providedby NVLAP so that each laboratory receives an assessment comparable to that received by others

. However, assessors have some latitude to make judgments about alaboratory'scompliance with the NVLAP criteria. An assessment normally takes one to five da ys depending on the scope of the laboratory's application. Every effort is made to conduct an assessment withas little disruptionas possibleto the normal operations ofthe laboratory. During the assessment, the assessor meets with management andlaboratorypersonnel, examines the quality system, reviews staff information, examines equipment and facilities, observes demonstrations of calibrations or testing, and examines calibration or test reports. The assessor reviews laboratory records including resumes, job descriptions of key personnel,training, andcompetency evalua tions for all staffmembers who routinely perf orm, or affect the quality ofthe calibration ortesting for which accreditation is sought. The assessor need not be given information which violates individual privacy, such as salary, medical

March 1994information, orperformance reviews outsidethe scope of the accreditation program. The staff information may be kept in the laboratory's official personnel folders or separate, official folders that contain only the information that the NVLAP assessor needs to review. At the conclusion of the assessment, the assessor conducts an exit briefing to discuss observations and any deficiencies with the AuthorizedRepresentative andotherresponsible laboratory staff. A written assessment report, signed by the Authorized Representative to acknowledge receipt ofthe report, will be left with the laboratory, and a copy forwarded to NVLAP. The [mal report submitted to the laboratory shall include as a minimum: (i) date(s) of assessment; (ii) the names of the person(s) responsible for the report; (iii) the names and addresses of all the laboratory sites assessed; (iv) the assessed scope of accreditation or reference thereto; and (v) comments and/or deficiencies cited by the assessor(s) onthe compliance ofthe laboratory with the accreditation requirements. (3) Deficiency Notification and Resolution
A deficiency is the failure of a laboratory to meet a NVLAP criterion. Deficiencies may be determined during on-site assessments, monitoring visits, proficiency testing, NVLAP staff review, and technical evaluation. Laboratories are informedofdeficiencies during the on-site assessment and through other correspondence. When a laboratory is notified ofdeficiencies, it must respond in writing to NVLAP within 30 days of the notification. The response must provide documentation, signed by the

NISTHandbook 150 16 Authorized Representative, that the specified deficiencies have either been corrected or include a plan of action to make corrections. The plan must include a list ofactions, dates of completion, and responsible persons. Acurrently accredited laboratory must submit a satisfactory response concerning resolution of deficiencies within 30 days of notification or face possible suspension or revocation of accreditation. Calibration of test equipment, materials, computer software, or measuring system implementations (whichhave acritical effect on the function accredited) that are identified as deficient (fail to meet the NVLAP criteria) should not be used for further NVLAPaccredited calibration ortesting until corrective action has been completed and documented. Evidence ofcorrection must be sent to NVLAP. If substantial deficiencies have been cited, NVLAP may require an additional on-site assessment, at additional cost to the laboratory, priorto granting accreditation. All deficiencies and resolutions will be subject to thorough review and corrective actions will be verified during subsequent assessments and technical evaluations. (4) Proficiency testing Proficiency testing is an integral part of the NVLAP accreditation process. The performance of calibrations or tests and reporting of results using proficiency testing prOVides NVLAP with a way to determine the overall effectiveness of the laboratory. Information obtained from proficiency testing helps to identify problems in a laboratory. When problems are found, NVLAP works with the laboratory staff to solve them. Each field of calibration or testing has proficiency testing requirements. Proficiency testing using interlaboratory comparisons may utilize randomly selected specimens from a batch of uniform material, selected specimens withknownproperties and results, artifacts with similar properties that have not been

March 1994 information, orperformance reviews outsidethe scope of the accreditation program. The staff information may be kept in the laboratory's official personnel folders or separate, official folders that contain onlythe informationthat the NVLAP assessor needs to review

. At the conclusion of the assessment, the assessor conducts an exit briefmg to discuss observations and any deficiencies with the AuthorizedRepresentative andotherresponsible laboratory staff

. A written assessment report, signed by the Authorized Representative to acknowledge receipt ofthe report, will be left with the laboratory, and a copy forwarded to NVLAP. The fmal report submitted to the laboratory shall include as a minimum: (i) date(s) of assessment; (ii) the names of the person(s) responsible for the report; (iii) the names and addresses of all the laboratory sites assessed; (iv) the assessed scope of accreditation or reference thereto; and (v) comments and/or deficiencies cited by the assessor(s) onthe compliance ofthe laboratory with the accreditation requirements. (3) Deficiency Notification and Resolution
A deficiency is the failure of a laboratory to meet a NVLAP criterion. Deficiencies may be determined during on-site assessments, monitoring visits, proficiency testing, NVLAP staff review, and technical evaluation. Laboratories are informedofdeficiencies during the on-site assessment and through other correspondence. When a laboratory is notified ofdeficiencies, it must respond in writing to NVLAP within 30 days of the notification. The response must provide documentation, signed by the

NISTHandbook 150 16 Authorized Representative, that the specified deficiencies have either been corrected or include a plan of action to make corrections

. The plan must include a list ofactions, dates of completion, and responsible persons. Acurrently accredited laboratory must submit a satisfactory response concerning resolution of deficiencies within 30 days of notification or face possible suspension or revocation of accreditation. Calibration of test equipment, materials, computer software, or measuring system implementations (whichhave acritical effect on the function accredited) that are identified as deficient (fail to meet the NVLAP criteria) should not be used for further NVLAP

accredited calibration ortesting until corrective action has been completed and documented. Evidence ofcorrection must be sent to NVLAP. If substantial deficiencies have been cited, NVLAP may require an additional on-site assessment, at additional cost to the laboratory, priorto granting accreditation. All deficiencies and resolutions will be subject to thorough review and corrective actions will be verified during subsequent assessments and technical evaluations

. (4) Proficiency testing Proficiency t esting is an integral part of the NVLAP accreditation process. The performance of calibrations or tests and reporting of results using proficiency testing provides NVLAP with a way to determine the overall effectiveness of the laboratory. Information obtained from proficiency testing helps to identify problems in a laboratory. When problems are found, NVLAP works with the laboratory staff to solve them. Each field of calibration or testing has proficiency testing requirements. Proficiency testing using interlaboratory comparisons may utilize randomly selected specimens from a batch of uniform material, selected specimens withknownproperties and results, artifacts with similar properties that have not been

March 1994characterized, and one-of-a-kind artifacts. Proficiency testing may use intralaboratory techniques such as comparisons of computer software implementations to reference implementations, use of standard reference materials, anduseoffundamental physical laws

. Proficiency testing for calibration laboratories may involve the comparison of calibration results obtained independently by thelaboratory and NIST/NVLAP on a selected instrument or artifact. Proficiency testing dataare analyzed by NVLAP and reports ofthe results are made known to the participants. Summary results are available upon request to other interested parties; e.g., professional societies and standards writing bodies. The identity and performance of individual laboratories are kept confidential. Unsatisfactory participation in any NVLAP proficiency testing program is a technical deficiency which must be resolved in order to obtain initial accreditation or maintain accreditation. Proficiency testing deficiencies are defined as, butnotlimited to, one or more ofthe following: (i) failure tomeet specifiedproficiency testing performance requirements prescribed by NVLAP; (ii) failure to participate in a regularly scheduled "round" of proficiency testing for which the laboratory has received instructions and/or materials; (iii) failure to submit laboratory control data as required; (iv) performance

### i as a statistically outlying laboratory in two successive rounds ofproficiency testing or showing a general pattern of outlying results over three or more rounds; and (v) failure to produce acceptable calibration ortest results when using NIST Standard Reference Materials or special artifacts whose properties are wellNISTHandbook 150 17 characterized and known to NIST/NVLAP. NVLAPwill notifythe laboratory ofproficiency testing deficiencies and actions to be taken to resolve the deficiencies. Denial or suspension of accreditation will result from failure to resolve deficiencies. (5) Technical Evaluation
A review panel is formed to determine if all technical requirements have been fulfilled. Each panel is composed of one or more NVLAPTechnical Experts (evaluators) who are matched to the type of calibration or testing being evaluated and are selected to avoid conflict ofinterest. The evaluation is based on a review of the record of the laboratory as a whole, including: (i) information provided on the application; (ii) results of quality system documentation review; (iii) on-site assessment reports; (iv) actions taken by the laboratory to correct deficiencies; (v) results ofproficiency testing; and (vi) information from any monitoring visits of the laboratory. Based onthis evaluation, the panel recommends whether or not a laboratory should be accredited. If the technical evaluation reveals additional deficiencies, written notification of the deficiencies will be made to the laboratory. The laboratory must respond as specified in the previous section, Deficiency Notification and Resolution. All deficiencies must be resolved before accreditation can be granted.

March 1994 characterized, and one-of -a-kind artifacts. Proficiency testing may use intralaboratory techniques such as comparisons of computer software implementations to reference implementations, use of standard reference materials, anduseoffundamental physical laws

. Proficiency testing for calibration laboratories may involve the comparison of calibration results obtained independently by the laboratory and NISTINVLAP on a selected instrument or artifact. Proficiency testingdataare analyzed by NVLAP and reports oftheresults are made known to the partICIpants. Summary results are available upon request to other interested parties; e.g., professional societies and standards writing bodies. The identity and performance of individual laboratories are kept confidential. Unsatisfactory participation in any NVLAP proficiency testing program is a technical deficiency which must be resolved in order to obtain initial accreditation or maintain accreditation. Proficiency testing deficiencies are defined as, butnotliInited to, one ormore ofthe following: (i) failure to meet specifiedproficiency testing performance requirements prescribed by NVLAP; (ti) failure to participate in a regularly scheduled "round" of proficiency testing for which the laboratory has received instructions andlor materials; (iii) failure to submit laboratory control data as required; (iv) performancei as a statistically outlying laboratory in two successive rounds ofproficiency testing or showing a general pattern of outlying results over three or more rounds; and (v) failure to produce acceptable calibration ortest results when using NIST Standard Reference Materials or special artifacts whose properties are wellNISTHandbook 150 17 characterized and known to NISTINVLAP. NVLAPwillnotifythelaboratory ofproficiency testing deficiencies and actions to be taken to resolve the deficiencies

. Denial or suspension of accreditation will result from failure to resolve deficiencies. (5) Technical Evaluation
A review panel is formed to determine if all technical requirements have been fulfilled. Each panel is composed of one or more NVLAPTechnical Experts (evaluators) who are matched to the type of calibration or testing being evaluated and are selected to avoid conflict ofinterest. The evaluation is based on a review of the record of the laboratory as a whole, including: (i) inf ormation provided on the application; (ii) results of quality system documentation review; (iii) on-site assessment reports; (iv) actions taken by the laboratory to correct deficiencies; (v) results ofproficiency testing; and (vi) information from any monitoring visits of the laboratory. Based onthis evaluation, the panel recommends whether or not a laboratory should be accredited. Ifthe technical evaluation reveals additional deficiencies, written notification of the deficiencies will be made to the laboratory

. The laboratory must respond as specified in the previous section, Deficiency Notification and Resolution. All deficiencies must be resolved before accreditation can be granted.

March 1994(6) Monitoring Visits
In addition to regularly scheduled assessments, monitoring visits may be conducted by assessors or by NIST staff at any time during the accreditation period. They may occur for cause or on a random selection basis. While most monitoring visits will be scheduled in advance with the laboratory, NVLAP may conduct unannounced monitoring visits. The scope ofa monitoring visit may range from checking a few designated items to a complete review. The assessors may review deficiency resolutions, verify reported changes in the laboratory's personnel, facilities, oroperations, or assist in resolving problems related to proficiency testing and other laboratory operations. (c) NVLAP shall inform each applicant laboratory of any additional action(s) that the laboratory must take to qualify for accreditation. Sec. 285.23 Granting and renewing accreditation Accreditation is granted for a specified period, usually one year. Initial accreditation is granted when a laboratory has met all NVLAP requirements. One of four renewal dates is assigned (January 1, April I, July I, or October I) and is usually retained as long as the laboratory remains in the program. Renewal dates may be reassigned to provide benefits to the laboratory and/or NVLAP. If a renewal date is changed, the laboratory will be notified in writing ofthe change and any related adjustment in fees. (a) NVLAP will take action to (1) grant initial accreditation, or (2) renew, suspend, or propose to deny or revoke accreditation of an applicant laboratory, based on the degree to which the laboratory complies with the specific NVLAP requirements. (b) Ifaccreditation is granted orrenewed, NVLAP shall:(1) provide a Certificate ofAccreditation and a Scope of Accreditation to the laboratory;

NISTHandbook 150 18 (2) provide guidance on referencing the laboratory's accredited status, and theuse ofthe NVLAP logo by the laboratory and its clients, as needed; and (3) remind the laboratory that accreditation does not relieve it from complying with applicable federal, state, and local laws and regulations. (c) NVLAP shall notify an accredited laboratory at least 30 days before its accreditation expires advising ofthe action(s) the laboratory must take to renew its accreditation. Each accredited laboratory will be sent a renewal application package before the expiration date ofits accreditation to allow sufficient time to complete the renewal process. Fees for renewal are charged according to services required as listed on the NVLAP Fee Schedule. The application and fees must be received by NIST prior to expiration of the laboratory's current accreditation to avoid a lapse in accreditation. Sec. 285.24 Denying, snspending, and revoking accreditation (a) If NVLAP proposes to deny or revoke accreditation of a laboratory, NVLAP shall inform the laboratory ofthe reasons for the proposed denial orrevocation and the procedure for appealing such a decision. (b) The laboratory will have 30 days from the date ofreceipt ofthe proposed denial or revocation letter to appeal the decision to the Director ofNIST. Ifthe laboratory appeals the decision to the Director of NIST, the proposed denial or revocation will be stayed pending the outcome of the appeal. The proposed denial or revocation will become fmal through the issuance of a written decision to the laboratory in the event that the laboratory does not appeal the proposed denial or revocation within the 30-day period. (c) If NVLAP finds that an accredited laboratory has violated the terms of its accreditation or the provisions of these procedures, NVLAP may, after consultation with the laboratory, suspend the

March 1994 (6) Monitoring Visits
In addition to regularly scheduled assessments, monitoringvisits may be conductedby assessors or by NIST staff at any time during the accreditation period. They may occur for cause or on a random selection basis. While most monitoring visits will be scheduled in advance with the laboratory, NVLAP may conduct unannounced monitoring visits. The scope ofa monitoring visit may range from checking a few designated items to a complete review. The assessors may review deficiency resolutions, verify reported changes in the laboratory's personnel, facilities, oroperations, or assist in resolving problems related to proficiency testing and other laboratory operations. (c) NVLAP shall inform each applicant laboratory of any additional action(s) that the laboratory must take to qualify for accreditation. Sec. 285.23 Granting andrenewing accreditation Accreditation is granted for a specified period, usually one year. Initial accreditation is granted when a laboratory has met all NVLAP requirements. One of four renewal dates is assigned (January 1, April 1, July 1, or October 1) and is usually retained as long as the laboratory remains in the program. Renewal dates may be reassigned to provide benefits to the laboratory and/or NVLAP. Ifa renewal date is changed, the laboratory will be notified in writing ofthe change and any related adjustment in fees

. (a) NVLAP will take action to (1) grant initial accreditation, or (2) renew, suspend, or propose to deny or revoke accreditation of an applicant laboratory, based on the degree to which the laboratory complies with the specific NVLAP requirements. (b) Ifaccreditation is granted orrenewed, NVLAP shall:(1) provide a Certificate ofAccreditation and a Scope of Accreditation to the laboratory;

NISTHandbook 150 18 (2) provide guidance on referencing the laboratory's accredited status, and theuse ofthe NVLAP logo by the laboratory and its clients, as needed; and (3) remind the laboratory that accreditation does not relieve it from complying with applicable federal, state, and local laws and regulations. (c) NVLAP shall notify an accredited laboratory at least 30 days before its accreditation expires advising ofthe action(s) the laboratory must take to renew its accreditation. Each accredited laboratory will be sent a renewal application package before the expiration date ofits accreditation to allow sufficient time to complete the renewal process. Fees for renewal are charged according to services required as listed on the NVLAP Fee Schedule. The application and fees must be received by NIST prior to expiration of the laboratory's current accreditation to avoid a lapse in accreditation. Sec. 285.24 Denying, suspending, and revoking accreditation (a) If NVLAP proposes to deny or revoke accreditation of a laboratory, NVLAP shall inform the laboratory ofthe reasons for the proposed denial orrevocation and the procedure for appealing such a decision. (b) The laboratory will have 30 days from the date ofreceipt ofthe proposed denial orrevocation letter to appeal the decision to the Director ofNIST. Ifthe laboratory appeals the decision to the Director of NIST, the proposed denial or revocation will be stayed pending the outcome of the appeal. The proposed denial or revocation will become [mal through the issuance of a written decision to the laboratory in the event that the laboratory does not appeal the proposed denial or revocation within the 30-day period. (c) If NVLAP finds that an accredited laboratory has violated the terms of its accreditation or the provisions of these procedures, NVLAP may, after consultation with the laboratory, suspend the

March 1994laboratory's accreditation, or advise of NVLAP's intent to revoke accreditation. If accreditation is suspended, NVLAP shall notify the laboratory ofthat action stating the reasons for and conditions of the suspension and specifying the action(s) the laboratory must take to have its accreditation reinstated. If accreditation is revoked, the laboratory may be given the option of voluntarily terminating the accreditation. (d) A laboratory whose accreditation has been denied, revoked, terminated, or expired, or which has withdrawn its application beforebeing accredited, may reapply and be accredited if the laboratory: (1) completes the assessment and evaluation process; and (2) meets the conditions and criteria for accreditation that are set out in Sections 285.32 and 285.33. (e) Conditions ofsuspensionwillincludeprohibiting the laboratory from using the NVLAP logo onits test or calibration reports during the suspension period. The determination ofNVLAP whether to suspend or to propose revocation ofa laboratory's accreditation will depend on the nature of the violation(s) of the terms ofits accreditation. Ifaccreditation is revoked, the laboratory must return its Certificate ofAccreditation and cease use ofthe NVLAP logo on any ofits reports, correspondence, or advertising. ownership, location, staffmg, facilities, and configuration. Changes in any ofthese conditions or criteria could result in loss ofaccreditation. NVLAP must be informed ifany ofthe conditions or criteria for accreditation are changed so that a determination canbemade concerning the status ofthe accreditation (see Section 285.32(a)(11».

SUBPART D

- CONDmONS AND CRITERIA FOR ACCREDITATION

Sec. 285.31 Application of accreditation conditions and criteria
To become accredited and maintain accreditation, a laboratory must meet the conditions for accreditation set out in Section 285.32, the criteria set out in Section 285.33, and the guidance provided in the Handbooks for specific LAPs. Sec. 285.32 Conditions for accreditation (a) To become accredited and maintain accreditation, a laboratory shall agree in writing to: (1) be assessed and evaluated initially and on a periodic basis; (2) demonstrate, on request, that it is able to perform the calibrations or tests representative ofthose for which it is seeking accreditation; (3) pay all fees; Sec. 285.25 accreditation Voluntary termination of (4) partiCipate in proficiency testing as required; A laboratory may at any time terminate its participation and responsibilities as an accredited laboratory by advising NVLAP in writing of its desire to do so. NVLAP will terminate the laboratory's accreditation and notify the laboratory that its accreditation has been terminated in response to its request. Sec. 285.26 Change in status oflaboratory Accreditation of a laboratory is based on specific conditions and criteria, including the laboratory

NISTHandbook 150 19 (5) be capable ofperforming the calibrations or tests for which it is accredited according to the latest version of the calibration or test method within one year after its publication or within another time lilnit specified by NVLAP; (6) lilnit the representation ofthe scope ofits accreditation to only those calibrations, tests or services for which accreditation is granted; (7) resolve all deficiencies;

March 1994 laboratory's accreditation, or advise of NVLAP's intent to revoke accreditation

. If accreditation is suspended, NVLAP shall notify the laboratory ofthat action stating the reasons for and conditions of the suspension and specifying the action(s) thelaboratory must take to have its accreditation reinstated

. If accreditation is revoked, the laboratory may be given the option of voluntarily terminating the accreditation. (d) A laboratory whose accreditation has been denied, revoked, terminated, or expired, or which has withdrawnitsapplicationbeforebeing accredited, may reapply and be accredited ifthe laboratory: (1) completes the assessment and evaluation process; and (2) meets the conditions and criteria for accreditation that are set out in Sections 285.32 and 285

.33. (e) Conditionsofsuspensionwillincludeprohibiting the laboratory from using the NVLAP logo onits test or calibration reports during the suspension period. The determination ofNVLAP whether to suspend or to propose revocation ofa laboratory's accreditation will depend on the nature of the violation(s) ofthe terms ofits accreditation

. Ifaccreditation is revoked, thelaboratory must return its Certificate ofAccreditation and cease use ofthe NVLAP logo on any ofits reports, correspondence, or advertising. Sec. 285.25 accreditation Voluntary termination of

A laboratory may at any time terminate its participation and responsibilities as an accredited laboratory by advising NVLAP in writing of its desire to do so. NVLAP will terminate the laboratory's accreditation and notify the laboratory that its accreditation has been terminated in response to its request. Sec. 285.26 Change in status of laboratory Accreditation of a laboratory is based on specific conditions and criteria, including the laboratory

NISTHandbook 150 19 ownership, location, staffmg, facilities, and configuration. Changes in any ofthese conditions or criteria could result inloss ofaccreditation. NVLAP must be informed ifany ofthe conditions or criteria for accreditation are changed so that a determination canbemade concerning the status ofthe accreditation (see Section 285

.32(a)(11»

.

SUBPART D - CONDmONS AND CRITERIA FOR ACCREDITATION

Sec. 285.31 Application of accreditation conditions and criteria
To become accredited and maintain accreditation, a laboratory must meet the conditions for accreditation set out in Section 285.32, the criteria set out in Section 285.33, and the guidance provided in the Handbooks for specific LAPs

. Sec. 285.32 Conditions for accreditation (a) To become accredited and maintain accreditation, a laboratory shall agree in writing to: (1) be assessed and evaluated initially and on a periodic basis; (2) demonstrate, on request, that it is able to perform the calibrations or tests representative ofthose for which it is seeking accreditation; (3) pay all fees; (4) participate in proficiency testing as required; (5) be capable ofperforming the calibrations or tests for which it is accredited according to the latest version of the calibration or test method within one year after its publication or within another time limit specified by NVLAP; (6) limit the representation ofthe scope ofits accreditation to only those calibrations, tests or services for which accreditation is granted; (7) resolve all deficiencies;

March 1994(8) limit all its work or services for clients to those areas where competence and capacity are available; (9) maintain records of all actions taken in response to complaints for a minimum of one year; (10) maintain an independent decisional relationship between itself and its clients, affiliates, or other organizations so that the laboratory's capacity to render calibration or test reports objectively and without bias is not adversely affected; (11) report to NVLAP within 30 days any major changes involving the location, ownership, management structure, Authorized Representative, Approved Signatories, or facilities of the laboratory; and NOTE: In addition, a laboratory shall report to NVLAP within 30 days any major changes involving the following: deletion of a calibration parameter, test method or testing service for which it is accredited; or inability to perform calibrations, test methods or services for which it is accredited. (12) return to NVLAP the Certificate of Accreditation andthe Scope ofAccreditation for revision or other action should it: (i) be requested to do so by NVLAP; (ii) voluntarily terminate its accredited status; or (iii) become unable to conform to any of these conditions, the applicable criteria of Section 285.33, and related technical requirements. (b) To become accredited and maintain accreditation, alaboratory shall supply, uponrequest, the following information to NVLAPoritsdesignated contractor: (1) legal name and full address; (2) ownership ofthe laboratory;

NISTHandbook 150 20 (3) organization chart defining relationships that are relevant to performing testing and calibrations coveredinthe accreditation request; (4) general description of the laboratory, including its facilities and scope of operation; (5) name, address, and telephone and FAX number ofthe Authorized Representative ofthe laboratory; (6) names or titles and qualifications of laboratory staffnominated to serve as approved signatories of calibration or test reports that reference NVLAP accreditation; (7) the laboratory quality manual; and (8) otherinformation as may be needed for the specific LAP(s) inwhich accreditation is sought. Sec. 285.33 Criteria for accreditation (a) Scope (1) This section sets out the general requirements in accordance with which a laboratory has to demonstrate that it operates, if it is to be recognized as competent to carry out specific calibrations or tests. (2) Additional requirements and information which have to be disclosed for assessing competence orfor determining compliance with other criteria, may be specified by NVLAP, depending upon the specific character of the task ofthe laboratory. (3) This section is for use by calibration and testing laboratories in the development and implementation oftheir quality systems. Itmay also be used by accreditation bodies, certification bodies and others concerned with the competence oflaboratories. (4) A General Operations Checklist is used to verify compliance with the criteria of this section.

March 1994 (8) limit all its work or services for clients to those areas where competence and capacity are available; (9) maintain records of all actions taken in response to complaints for a minimum of one year; (10) maintain an independent decisional relationship between itself and its clients, affiliates, or other organizations so that the laboratory's capacity to render calibration or test reports objectively and without bias is not adversely affected; (11) report to NVLAP within 30 days any major changes involving the location, ownership, management structure, Authorized Representative, Approved Signatories, or facilities of the laboratory; and NOTE: Inaddition, a laboratory shall report to NVLAP within 30 days any major changes involving the following: deletion of a calibration parameter, test method or testing service for which it is accredited; orinability to perform calibrations, test methods or services for which it is accredited. (12) return to NVLAP the Certificate of Accreditation andthe Scope ofAccreditation for revision or other action should it: (i) be requested to do so by NVLAP; (ii) voluntarily terminate its accredited status; or (iii) become unable toconformto any of these conditions, the applicable criteria of Section 285.33, and related technical requirements. (b) To become accredited and maintain accreditation, alaboratory shall supply, uponrequest, the following information toNVLAPoritsdesignated contractor: (1) legal name and full address; (2) ownership ofthe laboratory;

NISTHandbook 150 20 (3) organization chart defining relationships that are relevant to performing testing and calibrations coveredinthe accreditation request; (4) general description of the laboratory, including its facilities and scope of operation; (5) name, address, and telephone and FAX number ofthe Authorized Representative ofthe laboratory; (6) names or titles and qualifications of laboratory staffnominated to serve as approved signatories of calibration or test reports that reference NVLAP accreditation; (7) the laboratory quality manual; and (8) otherinformation as may be needed for the specific LAP(s) inwhich accreditation is sought. Sec. 285.33 Criteria for accreditation (a) Scope (1) This section sets out the general requirements in accordance with which a laboratory has to demonstrate that it operates, if it is to be recognized as competent to carry out specific calibrations or tests. (2) Additional requirements and information which have to be disclosed for assessing competence orfor determining compliance with other criteria, may be specified by NVLAP, depending upon the specific character of the task ofthe laboratory. (3) This section is for use by calibration and testing laboratories in the development and implementation oftheir quality systems. Itmay also be used by accreditation bodies, certification bodies and others concerned with the competence oflaboratories. (4) A General Operations Checklist is used to verify compliance with the criteria of this section

.

March 1994(b) Organization and management (1) Thelaboratory shallbelegally identifiable. It shall be organized and shall operate in such a way that its permanent, temporary and mobile facilities meet these requirements. (2) The laboratory shall: (i) have managerial staff with the authority and resources needed to discharge their duties; (ii) have policies to ensure that its personnel are free from any commercial, financial and other pressures which might adversely affect the quality oftheir work; (iii) be organized in such a way that confidence in its independence of judgement andintegrity is maintained at all times; (iv) specify and document the responsibility, authority and interrelation of all personnel who manage, perform or verify work affecting the quality of calibrations and tests; (v) provide supervision by persons familiar with the calibration or test methods and procedures, the objective of the calibration or test and the assessment ofthe results. The ratio of supervisory to non-supervisory personnel shall be such as to ensure adequate supervision; (vi) have atechnical manager (however named) who has overall responsibility for the technical operations; (vii) have a quality manager (however named) who has responsibility for the quality system and its implementation. The quality manager shall have direct access to the highest level ofmanagement at which decisions are taken on laboratory policy or resources, and to the technical manager. In some laboratories, the quality manager may also be the technical manager or deputy technical manager;

NISTHandbook 150 (viii) nominate deputies in case of absence of the technical or quality manager; (ix) have documented policy and procedures to ensure the protection of clients' confidential information and proprietary rights; NOTE: It is recognized that this is not always a requirement for a laboratory. Where confidentiality and protection of proprietary rights are required by the customer, the laboratory policies and procedures shall be documented in the quality manual. (x) where appropriate, partIcIpate in interlaboratory comparisons and proficiency testing programs; (xi) have documented policy and procedures to ensure that its clients are served with impartiality and integrity. (c) Quality system, audit and review (1) The laboratory shall establish and maintain a quality system appropriate to the type, range and volume ofcalibration and testing activities it undertakes. The elements ofthis system shall be documented. The quality documentation shall be available for use by the laboratory personnel. The laboratory shall define and document its policies and objectives for, and its commitment to, good laboratory practice and quality of calibration or testing services. The laboratory management shall ensure that these policies and objectives are documented in a quality manual and communicated to, understood, and implemented by all laboratory personnel concerned. The quality manual shall bemaintained currentunderthe responsibility of the quality manager. (2) The quality manual, and related documentation, shall state the laboratory's policies and operational procedures established in order to meet the requirements of these procedures. The quality manual and related quality documentation shall also contain:

21 March 1994 (b) Organization and management (1) Thelaboratory shallbelegally identifiable. It shall be organized and shall operate in such a wa y that its permanent, temporary and mobile facilities meet these requirements. (2) The laboratory shall: (i) have managerial staff with the authority and resources needed to discharge their duties; (ii) have policies to ensure that its personnel are free from any commercial, financial and other pressures which might adversely affect the quality oftheir work; (iii) be organized in such a wa y that confidence in its independence of judgement andintegrity is maintained atall times; (iv) specify and document the responsibility, authority and interrelation of all personnel who manage, perform or verify work affecting the quality of calibrations and tests; (v) provide supervision by persons familiar with the calibration or test methods and procedures, the objective of the calibration or test and the assessment ofthe results

. The ratio of supervisory to non-supervisory personnel shall be such as to ensure adequate supervision; (vi) have atechnical manager (however named) who has overall responsibility for the technical operations; (vii) have a quality manager (however named) who has responsibility for the quality system and its implementation

. The quality manager shall have direct access to the highest level of management at which decisions are taken on laboratory policy or resources, and to the technical manager. Insome laboratories, the quality manager may also be the technical manager or deputy technical manager;

NI STHandbook 150 (viii) nomina te deputies in case of absence of the technical or quality manager; (ix) have documented policy and procedures to ensure the protection of clients' confidential information and proprietary rights; NOTE: It is recognized that this is not always a requirement for a laboratory. Where confidentiality and protection of proprietary rights are required by the customer, the laboratory policies and procedures shall be documented in the quality manual. (x) where appropriate, partICIpa te in interlaboratory comparisons and proficiency testing programs; (xi) have documented policy and procedures to ensure that its clients are served with impartiality and integrity. (c) Quality system, audit and review (1) Thelaboratory shall establish and maintain a quality system appropriate to the type, range and volume ofcalibration and testing activities it undertakes. The elements ofthis system shall be documented

. The quality documentation shall be available for use by the laboratory personnel. The laboratory shall define and document its policies and objectives for, and its commitment to, good laboratory practice and quality of calibration or testing services. The laboratory management shall ensure that these policies and objectives are documented in a quality manual and communicated to, understood, and implemented by all laboratory personnel concerned

. The quality manual shall bemaintained currentunderthe responsibility of the quality manager. (2) The quality manual, and related documentation, shall state the laboratory's policies and operational procedures established in order to meet the requirements of these procedures. The quality manual and related quality documentation shall also contain:

21 March 1994(i) aqualitypolicy statement, including objectives and commitments, by top management; (ii) the organization and management structure ofthe laboratory, its place in any parent organization and relevant organizational charts; (iii) the relations between management, technical operations, support services and the quality system; (iv) procedures for control and maintenance of documentation; (v) job descriptions of key staff and reference to the job descriptions of other staff; (vi) identification of the laboratory's approved signatories; (vii) the laboratory's procedures for achieving traceability ofmeasurements; (viii) the laboratory's scope of calibrations and/or tests; (ix) arrangements for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work; (x) reference to the calibration, verification and/or test procedures used; (xi) procedures for handling calibration and test items; (xii) reference to the major equipment andreference measurement standardsused; (xiii) reference to procedures for calibration, verification and maintenance of equipment; (xiv) reference to verification practices including interlaboratory comparisons, proficiency testing programs, use of

NISTHandbook 150 22 reference materials and internal quality control schemes; (xv) procedures to be followed for feedback and corrective action whenever discrepancies are detected, or departures from documented policies and procedures occur; (xvi) the laboratory management policies for departures from documented policies and procedures or from standard specifications; (xvii) procedures for dealing with complaints; (xviii) procedures for protecting confidentiality and proprietary rights; (xix) procedures for audit and review; (xx) a description of the laboratory's policy regarding the use of the NVLAP logo; (xxi) a statement of the laboratory's policy for establishing and changing calibration intervals for equipment it controls; and (xxii) a statement of the laboratory's policy concerning the technique(s) to be used for determining measurement uncertainty and calibration/verification adequacy. (3) The laboratory shall arrange for audits of its activities at appropriate intervals to verify that its operations continue to comply with the requirements ofthe quality system. Such audits shall be carried out by trained and qualified staff who are, wherever possible, independent ofthe activity to be audited. When the audit fmdings cast doubtonthe correctness orvalidity ofthe laboratory's calibration ortest results, the laboratory shalltakeimmediate corrective action and shall immediately notify, in writing, any client whose work may have been affected.

March 1994 (i) aqualitypolicystatement, including objectives and commitments, by top management; (ii) the organization and management structure ofthelaboratory, itsplace in any parent organization and relevant organizational charts; (iii) the relations between management, technical operations, support services and the quality system; (iv) procedures for control and maintenance of documentation; (v) job descriptions of key staff and reference to the job descriptions of other staff; (vi) identification of the laboratory's approved signatories; (vii) the laboratory's procedures for achieving traceability ofmeasurements; (viii) the laboratory's scope of calibrations and/or tests; (ix) arrangements for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work; ( x) reference to the calibration, verification and/or test procedures used; (xi) procedures for handling calibration and test items; (xii) reference to the major equipment andreference measurement standardsused; (xiii) reference to procedures for calibration, verification and maintenance of equipment; (xiv) reference to verification practices including interlaboratory comparisons, proficiency testing programs, use of

NI STHandbook 150 22 reference materials and internal quality control schemes; (xv) procedures to be followed for feedback and corrective action whenever discrepancies are detected, or departures from documented policies and procedures occur; ( xvi) the laboratory management policies for departures from documented policies and procedures or from standard specifications; (xvii) procedures for dealing with complaints; (xviii) procedures for protecting confidentiality and proprietary rights; (xix) procedures for audit and review; (xx) a description of the laboratory's policy regarding the use of the NVLAP logo; (xxi) a statement of the laboratory's policy for establishing and changing calibration intervals for equipment it controls; and (xxii) a statement of the laboratory's policy concerning the technique(s) to be used for determining measurement uncertainty and calibration/verification adequacy. (3) The laboratory shall arrange for audits of its activities at appropriate intervals to verify that its operations continue to comply with the requirements ofthe quality system

. Such audits shall be carried out by trained and qualified staff who are, wherever possible, independent of the activity to be audited. When the audit fmdings cast doubtonthe correctness orvalidity ofthe laboratory's calibration ortest results,the laboratoryshalltakeimmediate corrective action and shall immediately notify, in writing, any client whose work may have been affected

.

March 1994The audits shall be objective and be conducted internally or on contract. The audits shall include both general criteria (documents, records and policies) and technical compliance (test methods and practices and calibration procedures)

. (4) The quality system adopted to satisfy the requirements ofthis section shall be reviewed at least once each year by the management to ensureitscontinuing suitabilityandeffectiveness and to introduce any necessary changes or improvements. (5) All audit and review findings and any corrective actions that arise from them shall be documented. Thepersonresponsible for quality shall ensure that these actions are discharged within the agreed timescale. (6) Inaddition toperiodic audits the laboratory shall ensure the quality of results provided to clients by implementing checks. These checks shall be reviewed and shall include, as appropriate, but not be limited to: (i) internal quality control plans using whenever possible statistical techniques; NOTE: Measurement assurance techniques are acceptable means to control the measurement process and consistently produce the highest quality measurements. (ii) participation in proficiency testing or other interlaboratory comparisons; (iii) regular use of certified reference materials and/or in-house quality control using secondary reference materials; (iv) replicate testings using the same or different methods; (v) retesting ofretained items; (vi) correlation of results for different characteristics ofan item.

NISTHandbook 150 

### 23 (d) Personnel (1) The laboratory shall have sufficient personnel, having the necessary education, training, technical knowledge andexperience for their assigned functions. (2) The laboratory shall ensure that the training of its personnel is kept up-to-date. (3) Records on the relevant qualifications, training, skills and experience of the technical personnel shall be maintained by the laboratory

. (e) Accommodation and environment (1) Laboratory accommodation, calibration and test areas, energy sources, lighting, heating and ventilation shall be such as to facilitate proper performance of calibrations or tests. NOTE: Laboratory design will be, to the maximum extent practical, in accordance with the guidelines found in the NCSL Recommended Practice #7, LaboratoryDesign, July 25, 1993. (2) The environment in which these activities are undertaken shall not invalidate the results or adversely affect the required accuracy of measurement. Particular care shall be taken when such activities are undertaken at sites other than the permanent laboratory premises. NOTE: It is expected that environments which do not meet generally accepted norms, such as those found in NCSL Recommended Practice #7, yet which exhibit the stability required to apply necessary correction factors, will be specified by the laboratory for the purpose of assessment of compliance with its own procedures to achieve its stated uncertainties. (3) The laboratory shall provide facilities for the effective monitoring, control and recording of environmental conditions as appropriate. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic interference, humidity, voltage, temperature, and sound and vibration levels, as appropriate to the calibrations or tests concerned.

March 1994 The audits shall be objective and be conducted internally or on contract. The audits shall include both general criteria (documents, records and policies) and technical compliance (test methods and practices and calibration procedures)

. (4) The quality system adopted to satisfy the requirements ofthis section shall be reviewed at least once each year by the management to ensureitscontinuingsuitabilityandeffectiveness and to introduce any necessary changes or improvements. (5) All audit and review findings and any corrective actions that arise from them shall be documented. Thepersonresponsible for quality shall ensure that these actions are discharged within the agreed timescale. (6) Inadditiontoperiodicaudits the laboratory shall ensure the quality of results provided to clients by implementing checks

. These checks shall be reviewed and shall include, as appropriate, but not be limited to: (i) internal quality control plans using whenever possible statistical techniques; NOTE: Measurement assurance techniques are acceptable means to control the measurement process and consistently produce thehighest quality measurements. (ii) participation in proficiency testing or other interlaboratory comparisons; (iii) regular use of certified reference materials and/or in-house quality control using secondary reference materials; (iv) replicate testings using the same or different methods; (v) retesting ofretained items; (vi) correlation of results for different characteristics ofan item.

NISTHandbook 150 

### 23 (d) Personnel (1) The laboratory shall have sufficient personnel, having the necessary education, training, technical knowledgeandexperience for their assigned functions. (2) The laboratory shall ensure that the training of its personnel is kept up-to-date. (3) Records on the relevant qualifications, training, skills and experience of the technical personnel shall bemaintained by the laboratory. (e) Accommodation and environment (1) Laboratory accommodation, calibration and t est areas, energy sources, lighting, heating and ventilation shall be such as to facilitate proper performance of calibrations or tests. NOTE: Laboratory design will be, to the maximum extent practical, in accordance with the guidelines found in the NCSL Recommended Practice #7,LaboratoryDesign, July 25, 1993. (2) The environment in which these activities are undertaken shall not invalidate the results or adversely affect the required accuracy of measurement. Particular care shall be taken when such activities are undertaken at sites other than the permanent laboratory premises. NOTE: Itis expected that environments which do not meet generally accepted norms, such as those found in NCSL Recommended Practice #7, yet which exhibit the stability required to apply necessary correction factors, will be specified by the laboratory for the purpose of assessment of compliance with its own procedures to achieve its stated uncertainties. (3) The laboratory shall provide facilities for the effective monitoring, control and recording of environmental conditions as appropriate. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic interference, humidity, voltage, temperature, and sound and vibrationlevels, as appropriate to the calibrations or tests concerned.

March 1994(4) There shallbe effective separationbetween neighboring areas whenthe activities therein are incompatible. (5) Access to and use ofall areas affecting the quality of these activities shall be defmed and controlled. (6) Adequate measures shallbetaken to ensure good housekeeping in the laboratory. NOTE: It is the laboratory's responsibility to comply with relevant health, safety and environmental requirements. This aspect, however, is outside the scope ofthis handbook. 

### (0 Equipment and reference materials (1) The laboratory shall be furnished with all items of equipment (including reference materials) required for the correct performance ofcalibrations and tests. In those cases where the laboratory needs to use equipment outside its permanent control it shall ensure that the relevant requirements ofthis section are met. (2) All equipment shall be properly maintained. Maintenance procedures shall be documented. Any item ofequipment which has been subjected to overloading or mishandling, or which gives suspect results, or has been shown by verification or otherwise to be defective, shall be taken out of service, clearly identified and wherever possible stored at a specified place until it has been repaired and shown by calibration, verification or test to perform satisfactorily. The laboratory shall examine the effect of this defect on previous calibrations or tests. (3) Each item of equipment including reference materials shall, when appropriate, be labelled, marked or otherwise identified to indicate its calibration status. (4) Records shall be maintained ofeach item of equipment and all reference materials significantto the calibrations ortests performed. The records shall include: 0) the name ofthe item ofequipment; (ii) the manufacturer's name, type identification, and serial number or other unique identification; (iii) date received and date placed in service; NOTE: For initial accreditation, the date received and the date placed in service are notconsidered mandatory requirements for inclusion in laboratory records, although this is encouraged as good laboratory practice. (iv) currentlocation, whereappropriate; (v) condition when received (e.g. new, used, reconditioned); (vi) copy of the manufacturer's instructions, where available; (vii) dates and results of calibrations and/or verifications and date of next calibration and/or verification; (viii) details ofmaintenance carried outto date and planned for the future; (ix) historyofany damage, malfunction, modification or repair; and

I> (x) measured value observed for each I> parameter found to be out of tolerance I> during calibration/verification. 

### (g) Measurement traceability and calibration (1) All measuring and testing equipment having an effect on the accuracy or validity of calibrations or tests shall be calibrated and/or verified before being put into service. The laboratory shall have an established program for the calibration and verification ofits measuring and test equipment. The program will ensure the recall or removal from service of any standard or equipment which has exceeded its calibration interval or is otherwisejudged to be unreliable.

NISTHandbook 150 24 March 1994 (4) There shallbeeffective separationbetween neighboring areas whenthe activities therein are incompatible. (5) Access to anduse ofall areas affecting the quality of these activities shall be defmed and controlled. (6) Adequate measures shallbetaken toensure good housekeeping in the laboratory. NOTE: It is the laboratory's responsibility to comply with relevant health, safety and environmental requirements. This aspect, however, is outside the scope ofthis handbook

. 

### (0 Equipmeut and reference materials (1) The laboratory shall be furnished with all items of equipment (including reference materials) required for the correct performance ofcalibrations and tests. In those cases where the laboratory needs touseequipment outsideits permanent control it shall ensure that the relevant requirements ofthis section are met. (2) All equipment shall be properly maintained. Maintenance procedures shall be documented. Any itemofequipment which has been subjected to overloading or mishandling, or which gives suspect results, or has been shown by verification or otherwise to be defective, shall be taken out of service, clearly identified and wherever possible stored at a specified place until it has been repaired and shown by calibration, verification or test to perform satisfactorily. The laboratory shall examine the effect of this defect on previous calibrations or tests. (3) Each item of equipment including reference materials shall, when appropriate, be labelled, marked or otherwise identified to indicate its calibration status. (4) Records shall be maintained ofeach item of equipment and all reference materials significantto thecalibrations ortestsperformed

. The records shall include: 0) the name ofthe item ofequipment;

NISTHandbook 150 24 (ii) the manufacturer's name, type identification, and serial number or other unique identification; (iii) date received and date placed in service; NOTE: Forinitial accreditation, the date received and the date placed in service are notconsidered mandatory requirements for inclusion in laboratory records, although this is encouraged as good laboratory practice. (iv) currentlocation, whereappropriate; (v) conditionwhenreceived (e.g. new, used, reconditioned); (vi) copy of the manufacturer's instructions, where available; (vii) dates and results of calibrations and/or verifications and date of next calibration and/or verification; (viii) details ofmaintenance carried outto date and planned for the future; (ix) historyofanydamage, malfunction, modification or repair; and (x) measured value observed for each parameter found to be out of tolerance during calibration/verification. 

### (g) Measurement traceability and calibration (1) All measuring and testing equipment having an effect on the accuracy or validity of calibrations or tests shall be calibrated and/or verified before being put into service. The laboratory shall have an establishedprogram for the calibration and verification ofits measuring and test equipment. The program will ensure the recall or removal from service of any standard or equipment which has exceeded its calibration interval oris otherwisejudged to be unreliable.

March 1994(2) The overall program ofcalibration and/or verification and validation ofequipment shall be designed and operated so as to ensure that, wherever applicable, measurements made by the laboratory are traceable to national standards of measurement where available. Calibration certificates shall, wherever available, indicate the traceability to national standards of measurement andshall providethe measurement results and associated uncertainty of measurement and/or a statement ofcompliance with an identified metrological specification.
NOTE: Traceability to national standards includes traceability to standards maintained or defined at national laboratories in foreign countries where applicable. In these cases, traceability is achieved via international standards. This includes intrinsic standards of measurement where available. Where applicable, themethodology ofthe Guide to the expression of uncertainty inmeasurement: 1993, shall be used as the basis for expression of uncertainty of the measurement. NIST Technical Note 1297; January 1993, Guidelines for Evaluating and Expressing the Uncertainty ofNIST Measurement Results, is a practical application document written around the Guide to the expression of uncertainty inmeasurement. Where detailed procedures are not used to quantify and combine uncertainties (i.e., use of test accuracy ratio concepts), the sources of uncertainty shall be tabulated and demonstrated to be acceptable for the measurement undertaken.
NOTE: A significant number of intrinsic standards, such as the Josephson Array Voltage StandardandtheIodine-Stabilized Helium-Neon Laser Length Standard, have been developed and are now being used by many national standards laboratories and some industrial laboratories. These standards are based on well-characterized laws ofphysics, fundamental constants of nature, or invariant properties of materials, and make ideal stable, precise, and accurate measurement standards if properly designed, characterized, operated, monitored and maintained. Where intrinsic standards are used, the laboratory should demonstrate by

NISTHandbook 150 

### 25 measurement assurance technique s, interlaboratory comparisons, or other suitable means, that its intrinsic standard measurement results are correlated with those ofnational or international standards. (3) Where traceability to national standards of measurement is not applicable, the laboratory shallprovide satisfactory evidence ofcorrelation of results, for example by participation in a suitableprogramofinterlaboratory comparisons or proficiency testing.
NOTE: Traceability requirements may also be satisfied by: (i) internationally accepted standards in the field concerned; (ii) suitable reference materials; (iii) ratio or reciprocity measurements; or (iv) mutual consent standards which are clearly specified and mutually agreed upon by all parties concerned. (4) Reference standards ofmeasurement held by the laboratory shall be used for calibration only and for no other purpose, unless it can be demonstrated that their performance as reference standards has not been invalidated. (5) Reference standards ofmeasurement shall be calibrated by a body that can provide traceability to a national standard of measurement. There shall be a program of calibration and verification for reference standards. (6) Where relevant, reference standards and measuring and testing equipment shall be subjected to in-service checks between calibrations and verifications. (7) Reference materials shall, where possible, be traceable to national or international standards of measurement, or to national or international standard reference materials.

March 1994 (2) The overall program ofcalibration and/or verification andvalidationofequipment shallbe designed and operated so as to ensure that, wherever applicable, measurements made by the laboratory are traceable to national standards of measurement where available. Calibration certificates shall, wherever available, indicate the traceability to national standards of measurement andshallprovidethe measurement results and associated uncertainty of measurement and/or a statement ofcompliance with an identified metrological specification. NOTE: Traceability to national standards includes traceability to standards maintained or defined at national laboratories in foreign countries where applicable. In these cases, traceability is achieved via international standards. This includes intrinsic standards of measurement where available. Where applicable, themethodology ofthe Guide to theexpression of uncertainty inmeasurement: 1993, shall be used as the basis for expression of uncertainty of the measurement. NIST Technical Note 1297; January 1993, Guidelines for Evaluating and Expressing the Uncertainty ofNIST Measurement Results, is a practical application document written around the Guide to theexpression of uncertainty inmeasurement. Where detailed procedures are not used to quantify and combine uncertainties (i.e

., use of test accuracy ratio concepts), the sources of uncertainty shall be tabulated and demonstrated to be acceptable for the measurement undertaken. NOTE: A significant number of intrinsic standards, such as the Josephson Array Voltage StandardandtheIodine-Stabilized Helium-Neon Laser Length Standard, have been developed and are now being used by many national standards laboratories and some industrial laboratories. These standards are based on well-characterized laws ofphysics, fundamental constants of nature, or invariant properties of materials, and make ideal stable, precise, and accurate measurement standards if properly designed, characterized, operated, monitored and maintained. Where intrinsic standards are used, the laboratory should demonstrate by

N

ISTHandbook 150 25 measurement assurance techniques , interlaboratory comparisons, or other suitable means, that its intrinsic standard measurement results are correlated with those ofnational or international standards. (3) Where traceability to national standards of measurement is not applicable, the laboratory shallprovide satisfactory evidence ofcorrelation of results, for example by participation in a suitableprogramofinterlaboratory comparisons or proficiency testing.
NOTE: Traceability requirements may also be satisfied by: (i) internationally accepted standards in the field concerned; (ii) suitable reference materials; (iii) ratio or reciprocity measurements; or (iv) mutual consent standards which are clearly specified and mutually agreed upon by all parties concerned. (4) Reference standards ofmeasurement held by the laboratory shall be used for calibration only and for no other purpose, unless it can be demonstrated that their performance as reference standards has not been invalidated. (5) Reference standards ofmeasurement shall be calibrated by a body that can provide traceability to a national standard of measurement. There shall be a program of calibration and verification for reference standards. (6) Where relevant, reference standards and measuring and testing equipment shall be subjected to in-service checks between calibrations and verifications. (7) Reference materials shall, where possible, be traceable to national or international standards of measurement, or to national or international standard reference materials.

March 1994

### Calibration and test methods (1) The laboratory shall have documented instructions on the use and operation of all relevant equipment, on the handling and preparation ofitems and for calibration and/or testing, where the absence of such instructions could jeopardize the calibrations or tests. AU instructions, standards, manuals and reference data relevant to the work ofthe laboratory shall be maintained up-to-date and be readily available to the staff. (2) The laboratory shall use appropriate methods and procedures for all calibrations and tests and related activities within its responsibility (including sampling, handling, transport and storage, preparation of items, estimation of uncertainty of measurement and analysis of calibration and/or test data). They shall be consistent with the accuracy required, and with any standard specifications relevant to the calibrations or tests concerned. NOTES: (i) Calibrationprocedures shallcontain the required range and tolerance or uncertainty ofeach item orunit parameter being calibrated or verified. In addition, the procedures shall contain the generic description ofthe measurement standards and equipment needed with the required parameter, range, tolerances or uncertainties, and specifications for performing the measurement of the calibration or verification, and/or representative types (manufacturer, model, option) that are capable of meeting the generic description for the measurement standards. The procedures shall be consistent with the accuracy required, and withany standard specifications relevant to the calibrations/verifications concerned. (ii) The laboratory shall ensure that the calibration uncertainties are sufficiently small so that the adequacy of the measurement is notaffected. Well-defmed and documented measurement assurance techniques oruncertainty analyses may be

NISTHandbook 150 

### 26 used to verify the adequacy of a measurement process. If such techniques are not used, then the collective uncertainty ofthe measurement standards shall not exceed 25 % of the acceptable tolerance (e. g., manufacturer's specification) foreach characteristic ofthe measuring and test equipment being calibrated or verified. (3) Where methods are not specified, the laboratory shall, wherever possible, select methods that have been published in international or national standards, those publishedbyreputable technical organizations or in relevant scientific texts orjournals. (4) Where it is necessary to employ methods that have not been established as standard, this shall be subject to agreement with the client, be fullydocumented andvalidated, andbeavailable to the client and other recipients ofthe relevant reports. (5) Where sampling is carried out as part of the test method, the laboratory shall use documented procedures and appropriate statistical techniques to select samples. (6) Calculations and data transfers shall be subject to appropriate checks. (7) Where computers or automated equipment are used for the capture, processing, manipulation, recording, reporting, storage or retrieval of calibration or test data, the laboratory shall ensure that: (i) the requirements of these procedures are complied with; (ii) computer software is documented and adequate for use; (iii) procedures are established and implemented forprotecting the integrity of data; such procedures shall include, but notbe limited to, integrity ofdata entry or capture, data storage, data transmission and data processing;

March 1994 (h) Calibration and test methods (1) The laboratory shall have documented instructions on the use and operation of all relevant equipment, on the handling and preparation ofitems and for calibration and/or testing, where the absence of such instructions could jeopardize the calibrations or tests. All instructions, standards, manuals and reference data relevant to the work ofthe laboratory shall be maintained up-to-date and be readily available to the staff. (2) The laboratory shall use appropriate methods and procedures for all calibrations and tests and related actiVities within its responsibility (including sampling, handling, transport and storage, preparation of items, estimation of uncertainty of measurement and analysis of calibration and/or test data). They shall be consistent with the accuracy required, and with any standard speCifications relevant to the calibrations or tests concerned. NOTES: (i) Calibrationprocedures shallcontain the required range and tolerance or uncertainty ofeach item orunitparameter being calibrated or verified. In addition, the procedures shall contain the generic description ofthe measurement standards and equipment needed with the required parameter, range, tolerances or uncertainties, and specifications for performing the measurement of the calibration or verification, and/or representative types (manufacturer, model, option) that are capable of meeting the generic description for the measurement standards. The procedures shall be consistent with the accuracy required, and withany standard specifications relevant to the calibrations/verifications concerned. (ii) The laboratory shall ensure that the calibration uncertainties are sufficiently small so that the adequacy of the measurement isnotaffected. Well-defmed and documented measurement assurance techniques oruncertainty analyses may be

NISTHandbook 150 

### 26 used to verify the adequacy of a measurement process. Ifsuch techniques are not used, then the collective uncertainty ofthe measurement standards shall not exceed 25% of the acceptable tolerance (e.g., manufacturer's specification) foreach characteristic ofthe measuring and test equipment being calibrated or verified. (3) Where methods are not specified, the laboratory shall, wherever possible, select methods that have been published in international or national standards, those publishedbyreputabletechnical organizationsor in relevant scientific texts orjournals. (4) Where it is necessary to employ methods that have not been established as standard, this shall be subject to agreement with the client, be fullydocumented andvalidated, andbeavailable to the client and other recipients ofthe relevant reports. (5) Where sampling is carried out as part of the test method, the laboratory shall use documented procedures and appropriate statistical techniques to select samples. (6) Calculations and data transfers shall be subject to appropriate checks. (7) Where computers orautomated equipment are used for the capture, processing, manipulation, recording, reporting, storage or retrieval of calibration or test data, the laboratory shall ensure that: (i) the requirements of these procedures are complied with; (ii) computer software is documented and adequate for use; (iii) procedures are established and implemented forprotecting theintegrity of data; such procedures shall include, but notbe limited to, integrity ofdata entry or capture, data storage, data transmission and data processing;

March 1994(iv) computer and automated equipment is maintained to ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity ofcalibration and test data; (v) it establishes and implements appropriateprocedures forthemaintenance ofsecurity ofdataincluding theprevention of unauthorized access to, and the unauthorized amendment of, computer records. (8) Documented procedures shall exist for the purchase, reception and storage ofconsumable materials used for the technical operations ofthe laboratory

. (i) Handling of calibration and test items (1) The laboratory shall have a documented system for uniquely identifying the items to be calibrated or tested, to ensure that there can be no confusion regarding the identity of such items at any time. (2) Upon receipt, the condition of the calibration or test item, including any abnormalities or departures from standard condition as prescribed in the relevant calibration or test method, shall be recorded. Where there is any doubt as to the item's suitability for calibration ortest, where the item does notconform to the descriptionprovided, or where the calibration ortest required is notfully specified, the laboratory shall consult the client for further instruction before proceeding. The laboratory shall establish whether the item has received all necessary preparation, or whether the client requires preparation to be undertaken or arranged by the laboratory. (3) The laboratory shall have documented procedures and appropriate facilities to avoid deterioration ordamage to the calibration ortest item, during storage, handling, preparation, and calibration or test; any relevant instructions provided with the item shall be followed. Where items have to be stored or conditioned under specific environmental conditions, these conditions shall be maintained, monitored and recorded where necessary. Where a calibration or test item or portion ofan item is to be held secure (for example, for reasons of record, safety or value, or to enable check calibrations or tests to be performed later), the laboratory shall have storage and security arrangements that protect the condition and integrity of the secured items or portions concerned. (4) The laboratory shall have documented procedures for the receipt, retention or safe disposal of calibration or test items, including all provisions necessary to protect the integrity ofthe laboratory. (5) Tamper-resistant seals shall be affixed to operator-accessible controls or adjustments on measurement standards or measuring and test equipment which, ifmoved, will invalidate the calibration. The laboratory's calibration system shall provide instructions for the use of such seals and for the disposition ofequipment with damaged or broken seals. NOTE: Tamper-resistant seals are sometimes affixed to equipment to prevent unauthorized access to areas where adjustments or critical components are located. (j) Records (1) The laboratory shall maintain a record system to suit its particular circumstances and comply with any applicable regulations. It shall retain on record all original observations, calculations and derived data, calibration records and a copy ofthe calibration certificate, test certificate or test report for an appropriate period. The records for each calibration and test shallcontain sufficient informationtopermit their repetition. The records shall include the identity of personnel involved in sampling, preparation, calibration or testing. EXCEPTION: The retention of all original observations, calculations, and derived data in the calibration record system is not a mandatory requirement for calibration laboratories, although it is encouraged as good laboratory practice.

NISTHandbook 150 27 March 1994 (iv) computer and automated equipment is maintained to ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity ofcalibration and test data; (v) it establishes and implements appropriateprocedures forthemaintenance ofsecurity ofdataincluding theprevention of unauthorized access to, and the unauthorized amendment of, computer records. (8) Documented procedures shall exist forthe purchase, reception and storage ofconsumable materials used forthe technical operations ofthe laboratory

. (i) Handling of calibration and test items (1) The laboratory shall have a documented system for uniquely identifying the items to be calibrated or tested, to ensure that there can be no confusion regarding the identity of such items at any time. (2) Upon receipt, the condition of the calibration or test item, including any abnormalities or departures from standard condition as prescribed in the relevant calibration or test method, shall be recorded. Where there is any doubt as to the item's suitability for calibration ortest, where the item does notconform to the descriptionprovided, or where the calibration ortest required is notfully specified, the laboratory shall consult the client for further instruction before proceeding. The laboratory shall establish whether the item has received all necessary preparation, or whether the client requires preparation to be undertaken or arranged by the laboratory. (3) The laboratory shall have documented procedures and appropriate facilities to avoid deterioration ordamage to the calibration ortest item, during storage, handling, preparation, and calibration or test; any relevant instructions provided with the item shall be followed. Where items have to be stored or conditioned recorded where necessary. Where acalibration or test item orportion ofan item is to be held secure (for example, for reasons of record, safety or value, or to enable check calibrations or tests to be performed later), the laboratory shall have storage and security arrangements that protect the condition and integrity of the secured items or portions concerned. (4) The laboratory shall have documented procedures for the receipt, retention or safe disposal of calibration or test items, including all provisions necessary to protect the integrity ofthe laboratory. (5) Tamper-resistant seals shall be affixed to operator-accessible controls or adjustments on measurement standards or measuring and test equipment which, ifmoved, will invalidate the calibration. The laboratory's calibration system shall provide instructions for the use of such seals and for the disposition ofequipment with damaged or broken seals. NOTE: Tamper-resistant seals are sometimes affixed to equipment to prevent unauthorized access to areas where adjustments or critical components are located. (j) Records (1) The laboratory shall maintain a record system to suit its particular circumstances and comply with any applicable regulations. Itshall retain on record all original observations, calculations and derived data, calibration records and a copy ofthe calibration certificate, test certificate ortest report for an appropriate period. The records for each calibration and test shallcontain sufficientinformationtopermit their repetition. The records shall include the identity of personnel involved in sampling, preparation, calibration or testing.**~** EXCEPTION: The retention of all original**~** observations, calculations, and derived data in**~** the calibration record system is not amandatory**~** requirement for calibration laboratories, Ii> although it is encouraged as good laboratory under specific environmental conditions, these**~** practice. conditions shall be maintained, monitored and

NISTHandbook 150 27 March 1994(2) AU records (including those listed in 285.33(t)(4) pertaining to calibration and test equipment), certificates and reports shall be safely stored, held secure and in confidence to the client. NOTE: The period of retention shall be specified in the quality manual. 

### (k) Certificates and 

### reports (1) The results of each calibration, test, or series ofcalibrations or tests carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, in accordance with any instructions in the calibration or test methods. The results should normally be reported in a calibration certificate, test report or test certificate and should include all the information necessary for the interpretation of the calibration ortest results and all information required by the method used. NOTE: It is recognized that the results ofeach calibration do not always result in the production ofa calibration certificate or report. Whenever a certificate or report is produced, the above requirements shall be met. (2) Each certificate or report shall include at least the following information: (i) a title, e.g. "Calibration Certificate", "Test Report" or "Test Certificate" ; (ii) name and address of laboratory, and location where the calibration or test was carried out if different from the address ofthe laboratory; (iii) unique identification of the certificate or report (such as serial number) and of each page, and the total number ofpages; (iv) name and address ofclient, where appropriate;

NISTHandbook 150 

### 28 (v) description and unambiguous identification of the item calibrated or tested; (vi) characterization and condition ofthe calibration or test item; (vii) date ofreceipt ofcalibration ortest item and date(s) of performance of calibration or test, where appropriate; EXCEPTION: Although it is encouraged as good laboratory practice, the requirement for inclusion of the date received is not mandatory for calibration laboratories. (viii) identification of the calibration or test method used, or unambiguous description of any non-standard method used; (ix) reference to sampling procedure, where relevant; (x) any deviations from, additions to or exclusions from the calibration or test method, and any other information relevant to a specific calibration or test, such as environmental conditions; (xi) measurements, examinations and derived results, supported by tables, graphs, sketches and photographs as appropriate, and any failures identified; (xii) a statement of the estimated uncertainty ofthe calibration or test result (where relevant); (xiii) a signature and title, or an equivalent identification of the person(s) accepting responsibility for the content of the certificate or report (however produced), and date of issue; (xiv) where relevant, a statement to the effect that the results relate only to the items calibrated or tested;

March 1994 (2) All records (including those listed in 285.33(t)(4) pertaining to calibration and test equipment), certificates and reports shall be safely stored, held secure and in confidence to the client. NOTE: The period of retention shall be specified in the quality manual. 

### (k) Certificates and 

### reports (1) The results of each calibration, test, or series ofcalibrations or tests carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, in accordance with any instructions in the calibration or test methods. The results should normally be reported in a calibration certificate, test report or test certificate and should include all the information necessary for the interpretation of the calibration ortest results and all information required by the method used.
NOTE: It is recognized that the results ofeach calibration do not always result in the production ofa calibration certificate orreport. Whenever a certificate or report is produced, the above requirements shall be met. (2) Each certificate or report shall include at least the following information: (i) a title, e.g. "Calibration Certificate", "Test Report" or "Test Certificateto ; (ii) name and address of laboratory, and location where the calibration or test was carried out if different from the address ofthe laboratory; (iii) unique identification of the certificate or report (such as serial number) and of each page, and the total number ofpages; (iv) name and address ofclient, where appropriate;

NISTHandbook 150 

### 28 (v) description and unambiguous identification of the item calibrated or tested; (vi) characterization and condition ofthe calibration or test item; (vii) date ofreceipt ofcalibration ortest item and date(s) of performance of calibration or test, where appropriate; EXCEPTION: Although it is encouraged as good laboratory practice, the requirement for inclusion of the date received is not mandatory for calibration laboratories. (viii) identification of the calibration or test method used, or unambiguous description of any non-standard method used; (ix) reference to sampling procedure, where relevant; (x) any deviations from, additions to or exclusions from the calibration or test method, and any other information relevant to a specific calibration ortest, such as environmental conditions; (xi) measurements, examinations and derived results, supported by tables, graphs, sketches and photographs as appropriate, and any failures identified; (xii) a statement of the estimated uncertainty ofthe calibration ortest result (where relevant); (xiii) a signature and title, or an equivalent identification of the person(s) accepting responsibility for the content of the certificate or report (however produced), and date of issue; (xiv) where relevant, a statement to the effect that the results relate only to the items calibrated or tested;

March 1994(xv) a statement that the certificate or report shall not be reproduced except in full, without the written approval of the laboratory; (xvi) a statement that the report must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government; (xvii) the signature of an Approved Signatory for all test and calibration reports endorsed with the NVLAP logo; (xviii) special limitations ofuse; and (xix) traceability statement. (3) Where the certificate or report contains results of calibrations or tests performed by subcontractors, these results shall be clearly identified. (4) Particular care and attention shall be paid to the arrangement ofthe certificate or report, especially with regard to presentation of the calibration or test data and ease ofassimilation by the reader. The format shall be carefully and specifically designed for each type of calibration or test carried out, but the headings shall be standardized as far as possible. (5) Material amendments to a calibration certificate, test report or test certificate after issue shall be made only inthe form ofafurther document, or data transfer including the statement "SupplementtoCalibrationCertificate (or Test Report or Test Certificate), serial number.

.. [or as otherwise identified] ", or equivalent form ofwording. Such amendments shall meet all the relevant requirements of 285.33(j). (6) The laboratory shall notify clients promptly, in writing, of any event such as the identification of defective measuring or test equipment that casts doubt on the validity of results given in any calibration certificate, test report or test certificate or amendment to a report or certificate.

NISTHandbook 150 

### 29 NOTE: Such notification shall quantify the magnitude of error created in the calibration results. The laboratory shall notify customers promptly, in writing, of any customer's measuring and test equipment found significantly out of tolerance during the calibration/verification process. Measurement data shall be reported so that appropriate action can be taken. (7) The laboratory shall ensure that, where clients require transmission ofcalibration or test results by telephone, telex, facsimile or other electronic or electromagnetic means, staff will follow documented procedures that ensure that the requirements of these procedures are met and that confidentiality is preserved. (8) Whenever a laboratory accredited by NVLAP issues acalibration ortest report which contains data covered by the accreditation and also data not covered by the accreditation, it must clearly identify in its records, and in the report to the client, specifically which calibration or test method(s), or portion of a calibration or test method(s), was not covered by the accreditation. The laboratory must also inform the client, before the fact, when calibrations or tests requested are not covered by the accreditation. NVLAP policy regarding calibration and test reports issued by an accredited laboratory, which reference the laboratory's accredited status, requires that any calibration or test report containing data from calibrations or tests which are not covered by the accreditation include: (i) a statement at the beginning of the reportprominently indicating, "Thisreport contains data which are not covered by the NVLAP accreditation"; and (ii) a clear indication ofwhich data are not covered by the accreditation. The laboratory must not misrepresent its accreditation. When a client requires or requests accredited services and any ofthe requested services are not covered by the

March 1994 (xv) a statement that the certificate or report shall not be reproduced except in full, without the written approval of the laboratory; (xvi) a statement that the report must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government; (xvii) the signature of an Approved Signatory for all test and calibration reports endorsed with the NVLAP logo; (xviii) special limitations ofuse; and (xix) traceability statement. (3) Where the certificate or report contains results of cali brations or tests performed by subcontractors, these results shall be clearly identified. (4) Particular care and attention shall be paid to the arrangement ofthe certificate or report, especially with regard to presentation of the calibration ortest data and ease ofassimilation by the reader

. The format shall be carefully and specifically designed for each type of calibration ortest carried out, but the headings shall be standardized as far as possible. (5) Material amendments to a calibration certificate, test report or test certificate after issue shall be made only in the form ofafurther document, or data transfer including the statement "SupplementtoCalibrationCertificate (or Test Report or Test Certificate), serial number

... [or as otherwise identified],, or equivalent form ofwording. Such amendments shall meet all the relevant requirements of 285.33(j)

. (6) The laboratory shall notify clients promptly, in writing, of any event such as the identification of defective measuring or test equipment that casts doubt on the validity of results given in any calibration certificate, test report or test certificate or amendment to a report or certificate

.

NISTHandbook 150 

### 29 NOTE: Such notification shall quantify the magnitude of error created in the calibration results. The laboratory shall notify customers promptly, in writing, of any customer's measuring and test equipment found significantly out of tolerance during the calibration/verification process. Measurement data shall be reported so that appropriate action can be taken. (7) The laboratory shall ensure that, where clients require transmission ofcalibration ortest results by telephone, telex, facsimile or other electronic or electromagnetic means, staf f will follow documented procedures that ensure that the requirements of these procedures are met and that confidentiality is preserved. (8) Whenever a laboratory accredited by NVLAP issues acalibration ortest report which contains da ta covered by the accreditation and also data not covered by the accreditation, it must clearly identify in its records, and in the report to the client, specifically which calibration or test method(s), or portion of a calibration or test method(s), was not covered by the accreditation. The laboratory must also inform the client, before the f act, when calibrations or tests requested are not covered by the accreditation

. NVLAP policy regarding calibration and test reports issued by an accredited laboratory, which reference the laboratory's accredited status, requires that any calibration or test report containing data from calibrations ortests which are not covered by the accreditation include: (i) a statement at the beginning of the reportprominently indicating, "Thisreport contains data which are not covered by the NVLAP accreditation"; and (ii) a clear indication ofwhich data are not covered by the accreditation. The labora tory must not misrepresent its accreditation. When a client requires or requests accredited services and any ofthe requested services are not covered by the

March 1994accreditation, the client must be so advised. (I) Subcontracting of calibration or testing (1) Where a laboratory subcontracts any part ofthe calibration or testing, this work shall be placed with a laboratory complying with these requirements. The laboratory shall ensure and be able to demonstrate that its subcontractor is competent to perform the activities in question and complies with the same criteria of competence as the laboratory in respect of the workbeing subcontracted. The laboratory shall advise the client in writing of its intention to subcontract any portion of the calibration or testing to another party. (2) The laboratory shall record and retain details ofits investigation ofthe competence and compliance ofits subcontractors and maintain a register ofall subcontracting. (3) ANVLAP-accredited laboratory intending to subcontract testing or calibration work that will be performed and reported as meeting NVLAP procedures and criteria must: (i) have in its quality manual a subcontracting policy compatible with the NVLAP policy, with a description of the procedures for administering and implementing those actions to demonstrate the conformance and consistency of the subcontracted laboratory to perform according to NVLAP procedures; (ii) place the subcontracted work with a laboratory that maintains accreditation established by NVLAP shownby acurrent NVLAP Lab Code, or provide and maintain current records that demonstrate that the subcontracted laboratory is competent to perform the test(s) or calibration(s), and that it operates in a mannerconsistentwithandinconformance to NVLAP criteria for accreditation; (iii) clearly identify in its records, and in the report to the client, exactly which data were obtained by the NVLAPNISTHandbook 150 30 accredited laboratory and which data were obtained by the subcontractor, NVLAPaccredited or not; (iv) inform its client, before the fact, that it intends to subcontract for completion of all or a portion of the client's work; and (v) include at the beginning of the report the name, address, and contact person of the subcontracted laboratory(ies), and one of the following statements, as appropriate: 

### if

NVLAP-accredited, "This report contains data which were produced by a subcontracted laboratory ACCREDITED (NVLAP LAB CODE) for the calibration or test methods performed. " 

### ifnot NVLAP-accredited, "This report contains data which were produced by a subcontracted laboratory NOT ACCREDITED for the calibration or test methods performed." The requirements of this section do not supersede any regulation, law, contract specification, or other related conditions which require NVLAP accreditation. (m) Outside support services and supplies (1) Where the laboratory procures outside services and supplies in support ofcalibrations or tests, the laboratory shall use only those outside support services and supplies that are of adequate quality to sustain confidence in the laboratory's calibrations or tests. (2) Where no independent assurance of the quality ofoutside support services or supplies is available, the laboratory shall have procedures to ensure that purchased equipment, materials and services comply with specified requirements. The laboratory should, wherever possible, ensure that purchased equipment and

March 1994 accreditation, the client must be so advised. (I) Subcontracting of calibration or testing (1) Where a laboratory subcontracts any part ofthe calibration or testing, this wor k shall be placed with a laboratory complying with these requirements

. The laboratory shall ensure and be able to demonstrate that its subcontractor is competent to perform the activities in question and complies with the same criteria of competence as the laboratory in respect of the workbeing subcontracted. The laboratory shall advise the client in writing of its intention to subcontract any portion of the calibration or testing to another party

. (2) The laboratory shall record and retain details ofitsinvestigation ofthe competence and compliance ofits subcontractors and maintain a register ofall subcontracting

. (3) ANVLAP-accredited laboratory intending to subcontract testing or calibration work that will be performed and reported as meeting NVLAP procedures and criteria must: (i) have in its quality manual a subcontracting policy compatible with the NVLAP policy, with a description of the procedures for administering and implementing those actions to demonstrate the conformance and consistency of the subcontracted laboratory to perform according to NVLAP procedures; (ii) place the subcontracted work with a laboratory that maintains accreditation established by NVLAP shownby acurrent NVLAP Lab Code, or provide and maintain current records that demonstrate that the subcontracted laboratory is competent to perform the test(s) or calibration(s), and that it operates in a mannerconsistentwithandinconformance to NVLAP criteria for accreditation; (iii) clearly ident ify in its records, and in the report to the client, exa ctly which data were obtained by the NVLAPNISTHandbook 150 30 accredited laboratory and which data were obtained by the subcontractor, NVLAPaccredited or not; (iv) inform its client, before the fact, that it intends to subcontract for completion of all or a portion of the client's work; and (v) include at the beginning of the report the name, address, and contact person of the subcontracted laboratory(ies), and one of the f ollowing statements, as appropriate: 

### ifNVLAP-accredited,

"This report contains data which were produced by a subcontracted laboratory ACCREDITED (NVLAP LAB CODE) for the calibration or test methods performed." ifnot NVLAP-accredited, "This report contains data which were produced by a subcontracted laboratory NOT ACCREDITED for the calibration or test methods performed

." The requirements of this section do not supersede any regulation, law, contract specification, or other related conditions which require NVLAP accreditation. (m) Outside support services and supplies (1) Where the laboratory procures outside services and supplies in support ofcalibrations or tests, the laboratory shall use only those outside support services and supplies that are of adequate quality to sustain confidence in the laboratory's calibrations or tests

. (2) Where no independent assurance of the quality ofoutside support services or supplies is available, the laboratory shall have procedures to ensure that purchased equipment, materials and services comply with specified requirements. The laboratory should, wherever possible, ensure that purchased equipment and

March 1994(0) Complaints (3) The laboratory shall maintain records ofall suppliers from whom it obtains support services or supplies required for calibrations or tests. consumable materials are not used until they have been inspected, calibrated or otherwise verified as complying with any standard specifications relevant tothecalibrations ortests concerned.

(1) The laboratory shall have documented policy and procedures for the resolution of complaints received fromclients orotherparties about the laboratory's activities. Arecord shall be maintained of all complaints and of the actions taken by the laboratory. (iv) All operations performed by the supplier in compliance with this handbook shall be subject to customer verification at unscheduled intervals. (iii) The supplier shall have a program to recall for calibration or verification, or remove from service, M & TE that has exceeded its calibration interval, has broken calibration seals, or is suspected to be malfunctioning due to mishandling, misuse, or unusual results. (ii) M & TE used to determine compliance with customer technical specifications shall be calibrated or verified in accordance with 285.33(b) through (n) of this handbook.

Based on the results of the audits and any otherrelevant factors, such as customer feedback, the supplier shall review and modify the system as necessary. (v) The supplier shall carry out, or arrange to have carried out, periodic quality auditing of the calibration and verification system in order to ensure its continuing effective implementation and compliance with the requirements of this handbook. 

# ..

(2) Where a complaint, or any other circumstance, raises doubt concerning the laboratory's compliance with the laboratory's policies orprocedures, orwiththe requirements of this section or otherwise concerning the quality ofthe laboratory's calibrations or tests, the laboratory shall ensure that those areas of activity andresponsibility involvedarepromptly auditedinaccordance withSection285.33(c)(3).

Plans and procedures for the audits shall be documented. The conduct of the audit and any subsequent corrective action shall also be documented. (2) Detailed requirements for M & TE



### (1) General requirements for M & TE (i) The supplier shall establish and document a system to control the calibration/verification ofM & TE. (i) Calibrationsystemdescription: The supplier shall provide and maintain a written description of the calibration/verification systemcovering M & TE and measurement standards. The description shall be sufficient to satisfy each requirement of 285.33(0) of this handbook and any deviations shall be submitted with supporting documentation to the customer for approval.

NISTHandbook 150 31 March 1994 consumable materials are not used until they have been inspected, calibrated or otherwise verified as complying with any standard specifications relevant tothecalibrations ortests concerned. (3) Thelaboratory shallmaintain records ofall suppliers from whom itobtains support services or supplies required for calibrations or tests. (n) Complaints (1) The laboratory shall have documented policy and procedures for the resolution of complaints received fromclients orotherparties about the laboratory's activities

. Arecord shall be maintained of all complaints and of the actions taken by the laboratory. (2) Where a complaint, or any other circumstance, raises doubt concerning the laboratory's compliance with the laboratory's policies orprocedures, orwiththe requirements of this section or otherwise concerning the quality ofthe laboratory's calibrations or tests, the laboratory shall ensure that those areas of activity andresponsibility involvedarepromptly auditedinaccordance withSection285.33(c)(3). NOTE: This is interpreted to mean that complaints in those areas of activity and responsibility involved must be promptly resolved.**~** (0) Measuring and test equipment (M & TE)**~ ~**  NOTE: This section applies to the control of**~** measuring and test equipment (M & TE) used to**~** assure that supplies and services comply with**~** prescribed customerrequirements. It is based inlarge**~** part on the requirements found in government audit**~** standards such as MIL-STD 45662A, and is found in**~** Part II of the ANSI/NCSL Z540-1-1994 (Draft)**~** standard.**~ ~**  (1) General requirements for M & TE**~** (i) The supplier shall establish and document a system to control the calibration/verification ofM & TE.

NISTHand book 150 31**~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~ ~** **~** (ii) M & TE used to detennine compliance with customer technical specifications shall be calibrated or verified in accordance with 285.33(b) through (n) of this handbook

. (iii) The supplier shall have a program to recall for calibration or verification, or remove from service, M & TE that has exceeded its calibration interval, has broken calibration seals, oris suspected to be malfunctioning due to mishandling, misuse, or unusual results. (iv) All operations performed by the supplier in compliance with this handbook shall be subject to customer verification at unscheduled intervals. (v) The supplier shall carry out, or arrange to have carried out, periodic quality auditing of the calibration and verification system in order to ensure its continuing effective implementation and compliance with the requirements of this handbook. Based on the results of the audits and any otherrelevant factors, such as customer feedback, the supplier shall review and modify the system as necessary. Plans and procedures for the audits shall be documented. The conduct of the audit and any subsequent corrective action shall also be documented. (2) Detailed requirements for M & TE (i) Calibrationsystemdescription: The supplier shall provide and maintain a written description of the calibration/verification systemcovering M & TE and measurement standards. The description shall be sufficient to satisfy each requirement of 285.33(0) of this handbook and any deviations shall be submitted with supporting documentation to the customer for approval

.

March 1994(ii) Adequacy of measurement standards: Measurement standards used by the supplier for calibrating M & TE and other measurement standards shall comply with the requirements of 285.33(f)(1), 285.33(g)(1), and 285.33(h)(2) ofthis handbook. (iii) Environmental conditions: M & TE shall be used in an environment controlled to the extentnecessary to ensure valid results. Due consideration shall be given to temperature, humidity, lighting, vibration, dust control, cleanliness, electromagnetic interference and any other factors affecting the results of measurements. Where pertinent, these factors shall be monitored and recorded and, when appropriate, correcting compensations shall be applied to measurement results. (iv) Intervals of calibration and verification: M & TE requiring calibration shall be calibrated orverified at periodic

. intervals established and maintained to assure acceptable reliability, where reliability is defined as the probability that M & TE will remain intolerance throughout the interval. Intervals shall be established for all M & TE requiring calibration unless the equipment is regularly monitored through the use of check standards in a documented measurement assurance process. Check standards must closely represent the item parameters normally tested in the process and the check standard must be verified periodically. Where intervals are used to ensure reliability, the interval setting systemmust be systematically applied and shall have stated reliability goals and a method of verifying that the goals are being attained. Intervals may be based on usage or time since last calibration or verification. All exemptions from periodic calibration or verification shall be documented. The recall system may provide for the temporary extension ofthe calibration due date for limited periods of time under

NISTHandbook 150 

### 32 specified conditions that do not unreasonably impair the satisfaction ofthe customer's requirements. (v) Calibrationprocedures: Procedures used to calibrate/verify the supplier's M & TE shall comply with the requirements of 285.33(h)(l) and 285.33(h)(2) of this handbook. (vi) Out-of-tolerance conditions: Ifany M & TE is found to be significantly out of tolerance during the calibration/verification process, the supplier's system shall provide for notification to the user and to the supplier's quality element, if appropriate, of the out-of-tolerance conditionwiththe associated measurement data so that appropriate action can be taken. (vii) Adequacy of calibration system: The supplier shall establish and maintain documented procedures to evaluate the adequacy ofthe calibration system and to ensure compliance with the requirements ofthis handbook. (viii) Calibration sources: M & TE requiring calibration shall be calibrated or verified by laboratories that comply with sections 285.33(b) through (n) of this handbook. (ix) Records: The requirements ofthis handbook shall be supported by records documenting thatestablished schedules and procedures are followed to maintain the adequacy ofall M & TE. The records for M & TErequiring calibration shall include an individual record of calibration or verification, or other means of control, providing a description or identification of the item, calibration interval, date calibrated, identification ofthe calibration source, calibration results (data and/or condition status) and calibration action taken (adjusted, repaired, new value assigned, derated, etc.).

March 1994 (ii) Adequacy of measurement standards: Measurement standards used by the supplier for calibrating M & TE and other measurement standards shall comply with the requirements of 285.33(f)(1), 285.33(g)(1), and 285.33(h)(2) ofthis handbook. (iii) Environmental conditions: M & TE shall be used in an environment controlledtotheextentnecessary toensure valid results. Due consideration shall be given to temperature, humidity, lighting, vibration, dust control, cleanliness, electromagnetic interference and any other factors affecting the results of measurements. Where pertinent, these factors shall be monitored and recorded and, when appropriate, correcting compensations shall be applied to measurement results. (iv) Intervals of calibration and verification: M & TE requiring calibration shall becalibrated orverified at periodic

. intervals established and maintained to assure acceptable reliability, where reliability is defined as the probability that M & TE will remain intolerance throughout the interval

. Intervals shall be established for all M & TE requiring calibration unless the equipment is regularly monitored through the use of check standards in a documented measurement assurance process. Check standards must closely represent the item parameters normally tested in the process and the check standard must be verified periodically. Where intervals are used to ensure reliability, theinterval setting systemmust be systematically applied and shall have stated reliability goals and a method of verifying that the goals are being attained. Intervals may be based on usage or time since last calibration or verification. All exemptions from periodic calibration or verification shall be documented. The recall system may provide for the temporary extension ofthe calibration due date for limited periods of time under

NISTHandbook 150 

### 32 specified conditions that do not unreasonably impair the satisfaction ofthe customer's requirements. (v) Calibrationprocedures: Procedures used to calibrate/verify the supplier's M & TE shall comply with the requirements of 285.33(h)(l) and 285.33(h)(2) of this handbook. (vi) Out-of-tolerance conditions: Ifany M & TE is found to be significantly out of tolerance during the calibration/verification process, the supplier's system shall provide for notification to the user and to the supplier's quality element, if appropriate, of the out-of-tolerance conditionwiththe associated measurement data so that appropriate action can be taken. (vii) Adequacy of calibration system: The supplier shall establish and maintain documented procedures to evaluate the adequacy ofthe calibration system and to ensure compliance with the requirements ofthis handbook. (viii) Calibration sources: M & TE requiring calibration shall be calibrated or verified by laboratories that comply with sections 285.33(b) through (n) of this handbook. (ix) Records: The requirements ofthis handbook shall be supported by records documentingthatestablished schedules and procedures are followed to maintain the adequacy ofall M & TE. The records for M &TErequiring calibration shall include an individual record of calibration or verification, or other means of control, providing adescription oridentification of the item, calibration interval, date calibrated, identification ofthe calibration source, calibration results (data and/or condition status) and calibration action taken (adjusted, repaired, new value assigned, derated, etc.).

March 1994(x) Calibration status: M & TE shall be labeled to indicate calibration or verification status. The label shall identify specific date calibrated (day, month, year, Julian date, or equivalent) and the specific calibration due date or usage equivalent. Items not calibrated to their full capability or which have other limitations of use, shall be labeled or otherwise identified as to the limitations. When it is impractical to apply a label directly to an item, the label may be affixed to the instrument container or some other suitable means may be used to reflect calibration status. Tamper-resistant seals are affixed to operator accessible controls oradjustments which if moved will invalidate the calibration. The quality system shall provide instructions for the disposition of equipment with broken tamper-resistant seals. (xi) Control of subcontractor calibration: The supplier is responsible for assuring that the subcontractor's calibration system conforms to 285.33(1) ofthis handbookto the degree necessary to assure compliance with contractual requirements. NVLAPaccreditation ofthe subcontractor's laboratory can serve as the basis forcompliance withthisrequirement. (xii) Storage and handling: M & TE shallbehandled, stored, and transported in a manner which shall not adversely affect the calibration or condition of the equipment.

NISTHandbook 150 33 March 1994 (x) Calibration status: M & TE shall be labeled to indicate calibration or verification status. The label shallidentify specific date calibrated (day, month, year, Julian date, orequivalent) and the specific calibration due date or usage equivalent. Items not calibrated to their full capability or which have other limitations of use, shall be labeled or otherwise identified as to the limitations. When it is impractical to apply a label directly to an item, the label may be affixed to the instrument container or some other suitable means may be used to reflect calibration status. Tamper-resistant seals are affixed to operator accessible controlsoradjustments which if moved will invalidate the calibration. The quality s ystem shall provide instructions for the disposition of equipment with broken tamper-resistant seals

. (xi) Control of subcontractor calibration: The supplier is responsible for assuring that the subcontractor's calibration system conforms to 285

.33(1) ofthis handbooktothe degree necessary to assure compliance with contractual requirements. NVLAPaccreditation ofthe subcontractor's laboratory can serve as the basis forcompliance withthisrequirement. (xii) Storage and handling: M & TE shallbehandled, stored, and transported in a manner which shall not adversely affect the calibration or condition of the equipment.

NI STHandbook 150 33 March 1994

# NATIONAL VOLUNTARY LABORATORY 

# ACCREDITATION PROGRAM

NA1-IONAL INSTITUTE OF 

# STANDARDS AND TECHNOLOGY
DEPARTMENT OF COMMERCE 

# NATIONAL VOLUNTARY LABORATORY 

# ACCRE DITATION PROG RAM

NA1-IONAL INSTITUTE OF 

# STANDARDS AND TECHNOLOGY
DEPARTMENT OF COM M RCE

# ROCESS ASSURES THIRD PARTY IND PEN VALUATIONS. SPROGRAMS FOR VERI ICATION, C RTI ICATIO AND D CLARATION M HO SFOR CON ORMA STANDARDS AND T ST METHODS. 

# NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM NVLAP: IS ASYSTEM FOR ACCREDITING LABORATORIES FOUND COM PETENT TO PERFORM TEST M ETHODS 

# OR CALlBRAT10N SERV ICES

. THE PROCESS ASSURES TH IRD PARTY INDEPENDENT EVALUATION S. SUPPORTS PROGRAMS FOR VERIFICATION ,CERTIFICATION AND DECLARATION METHODS FOR CONFORM ANCE TO 

# STA NDARDS ANDTEST METHODS.

# NVLAP CURRENTLY
CONDUCTS ACCREDITATION OF LABORATORIES FOR THE ENERGY EFFICIENT LIGHTING PROGRAM DEVELOPING AN ACCREDITATION OF LABORATORIES PROGRAM FOR ENERGY EFFICIENT ELECTRIC MOTORS 

# NVLAP CURRENTLY
CONDUCTS ACCREDITATION OF LABORATORIES FOR THE ENERGY EFFICIENT LIGHTING PROGRAM DEVELOPING AN ACCREDITATION OF LABORATORIE PROGRAM FOR ENERGY EFFICIENT ELECTRIC MOTORS

# NVLAP RECOMMENDS: 1. FLUORESCENT LIGHT BALLASTS DOE CITE SPECIFIC TEST METHODS FROM STANDARDS FOR TESTING BALLASTS REQUIRE EXISTING NVLAP "ENERGY EFFICIENT LIGHTING ACCREDITATION PROGRAM" FOR TESTING LABORATORIES FOR REPORTING DATA TO SHOW CONFORMANCE TO RULES DOE SET SAMPLING TEST REQUIREMENTS 

# 2. 

# ACCREDITATION OF TEST LABORATORIES REQUIRE NVLAP ACCREDITATION FOR ALL LABORATORIES FOR EQUIPMENT TEST DATA REPORTS (IN THE RULE) TO SHOW CONFORMANCE TO THE REQUIREMENTS 

# NVLAP RECOMMENDS: 1. FLUORESCENT LIGHT BALLASTS DOE CITE SPECI FIC TEST METHODS FROM STANDARDS FOR TESTING BALLASTS REQUIRE EXISTING NVLAP "ENERGY EFFICIENT LIGHTING ACCREDITATION PROG RAM " FOR TESTING LABORATORIES FOR REPORTING DATA TO SHOW CONFORMANCE TO RULES DOE SET SAMPLING TEST REQUIREM ENTS 

# 2. 

# ACCREDITATION OF TEST LABORATORIES REQUIRE NVLAP ACCREDITATION FOR ALL LABORATORI ES FOR EQUIPME NT TEST DATA REPORTS (IN THE RULE) TO SHOW CONFORMANCE TO THE REQUIREMENTS

# NVLAP PROVIDES INTERNATIONAL ACCEPTANCE SUPPORTS "NAFTAII AUTHORIZED SIGNATORY TO MUTUAL RECOGNITION AGREEMENTS (MRA's) NEW INTERLAP RUSSIAN MRA IN DEVELOPMENT AS SIGNED BY VICE-PRESIDENT GORE 

# ASSISTS IN STANDARDS HARMONIZATION PROMOTES FOREIGN TRADE 

# NVLAP PROVIDES INTERNATIONAL ACCEPTANCE SUPPORTS IINAFTAII AUTHORIZE SIGNATORY TO MUTUAL RECOGNITION AGREEMENTS (MRA's) NEW INTERLAP RUSSIAN MRA IN DEVELOPMENT AS SIGNED BY VICE-PRESIDENT GORE 

# ASSISTS IN TANDARDS HARMONIZATION PROMOTES FOREIGN TRADE

# MUI'UAL RECOGNITION**AGHJ~EMENl'** 

# BE/TWEEN I'HE STANDARDS COUNCIL OF CANADA AND THE NAl'IONAL INSTIl'u'rE OF STANDARDS AND l'ECHNOLOGY, lJNITED STAl'ES OF AMERICA

1. 

## Purpose The purpose of this Mutual Recognition Agreement (MRA) is to provide for the mutual recognition, by the Parties to this l\.1AA 

## of the testing laboratory accreditation systems administered by the Standards Council of Canada (SCC) and by the National Institute of Standards and Technology (NIST). This MRA does not cover the accreditation of calibration laboratories. 

# MUT'UAL RECOGNITION**AGH.F~EMEN1~** 

# BE/TWEEN T'RE STANDARDS COUNCIL OF CANADA AND THE 

# NAT'IONAL INSTIT'U'TE OF STANDARDS AND T'ECHNOLOGY, lJNITED STATES OF AMERICA

1. 

## Purpose The purpose of this Mutual Recognition Agreement (MRA) is to provide for the mutual recognition, by 

## the Parties to this MAA of the testing laboratory accreditation systems administered by the Standards Council of Canada (SCC) and by the National Institute of Stand::nds and Technology (NIST)

. This MRA does not cover the accreditation of calibration laboratories.

# Establishing a 

# Laboratory Accreditation Program Described in NVLAP PROCEDURES

Requests from Congress: Asbestos legislation Fastener legislation Requests from U.S. Government: U.S. Nuclear Regulatory Commision Defense:· Information Systems Agency, DoD Requests from organizations: National Conference of Standards Labs. National Electrical Manufacturers Assoc. Requests from laboratories: 5 electromagnetic compatibility labs Requests from entire industry: thermal insulation materials testing

NVLAP

- n7 

# Establishing a 

# Laboratory Accreditation Program 

# Described in NVLAP PROCEDURES

Requests from Congress: Asbestos legislation Fastener legislation Requests from U.S. Government: U.S. Nuclear Regulatory Commision Defense:· Information Systems Agency, DoD Requests from organizations: National Conference of Standards Labs

. National Electrical Manufacturers Assoc. Requests from laboratories: 5 electromagnetic compatibility labs Requests from entire industry: thermal insulation materials testing

NVLAP

- n7

### Draft Re..<;ource Document for Consideration and Development of Accreditation Pr0l:rams by 

### NVLAP in Support of DoE EPACT Requirements INTERAGENCY AGREEMENT (IAA)
Between the NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY and DEPARTMENT OF ENERGY Purpose and 

### Scope 

### The purpose of this Interagency Agreement is to provide for joint collaboration in the development and establishment of laboratory accreditation programs followed by their operations and continued maintenance for accreditation services, performance and functions for unlimited duration. The laboratory accreditation programs will be developed by the National Voluntary Laboratory Accreditation Program (NVLAP) acting in conformance with its Procedures in the US Code of Federal Regulations with uniform criteria and requirements designed to support the DoE in implementing national legislation (public Law 102-486).

I. Introduction u. The National Institute of Standards and Technology (NIST) and the Department of Energy (DoE), Office of Building Technologie..<;, pursuant to their re..<;pective authorities, mutually agree to the establishment of an Interagency Agreement for e..<;tablishment of laboratory accreditation testing program(s) and other related functions with support services by NVLAP as the nationally recognized accreditation body to fulfill the requirements for provisions of Public Law 102-486

- October 24, 1992, the "National Energy Policy Act". b. In cooperation and conjunction with DoE, NVLAP will develop the program in accordance with its latest Procedures in the U.S. Code of Federal Regulations. NVLAP agrees to provide services and functions to undertake the obligations set forth in this Agreement under the terms and conditions stated herein. c. NVLAP offers accreditation to applicant laboratorie..<; on fully cost reimbursable basis for operating the accreditation program. NVLAP may submit budgetary cost proposals for DoE evaluation and consideration for funding when necessary to support development of features not normal to NVLAP.

Duration 

# or Agreement a. The Agreement is of unlimited duration; it will begin upon exchange of signature copies with an effective date entered here, , 1994.

N:IHOMEILAWRENCE\WPDATAIDOEENER.BILIIlA-REV.DOE 

### Draft Re.<;ource Document for Consideration and Development of Accreditation Programs by NVLAP in Support of DoE EPACT Requirements INTERAGENCY AGREEMENT (IAA)
Between the NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY and DEPARTMENT OF ENERGY Purpose and 

### Scope 

### The purpose of this Interagency Agreement is to provide for joint collaboration in the development and establishment of laboratory accreditation programs followed by their operations and continued maintenance for accreditation services, performance and functions for unlimited duration. The laboratory accreditation programs will be developed by the National Voluntary Laboratory Accreditation Program (NVLAP) acting in conformance with its Procedures in the US Code of Federal Regulations with uniform criteria and requirements designed to support the DoE in implementing national legislation (public Law 102-486).

I. Introduction a. The National Institute of Standards and Technology (NIST) and the Department of Energy (DoE), Office of Building Technologie.<;, pursuant to their re.<;pective authorities, mutually agree to the establishment of an Interagency Agreement for e.<;tablishment of laboratory accreditation testing program(s) and other related functions with support services by NVLAP as the nationally recognized accreditation body to fulfill the requirements for provisions of Public Law 102-486

- October 24, 1992, the "National Energy Policy Act". b. In cooperation and conjunction with DoE, NVLAP will develop the program in accordance with its latest Procedures in the U.S. Code of Federal Regulations

. NVLAP agrees to provide services and functions to undertake the obligations set forth in this Agreement under the terms and conditions stated herein. c. NVLAP offers accreditation to applicant laboratorie.<; on fully cost reimbursable basis for operating the accreditation program. NVLAP may submit budgetary cost proposals for DoE evaluation and consideration for funding when necessary to support development of features not normal to NVLAP.

II. 

### Duration of Agreement a. The Agreement is of unlimited duration; it 

### will begin upon exchange of signature copies with an effective date entered here, , 1994.

N:IHOMEILAWRENCE\WPDATAIDOEENER.BIL\!!A-REV.DOE

### III. 

### Scope Activities This initial Agreement describes three phases of planning, development and implementation dating from the date of signature and running for three years. Beyond the expiration date additional phases will be defined in subsequent revisions and extensions of the Agreement. The programs to be established will be prepared in consultation with and as identified by DoE for the technical products/fields in the Public Law. The three phases consist of:

- planning and scheduling;

- development of handbooks/documents, checklists for on-sites and establishment of asse'lsor Technical Expert arrangements and proficiency test contractor(s);

- implementation of each LAP following distribution of applications. Each LAP will overlay others since different timeline schedules are specified for each product/technology sector in the Public Law.
The products/technologies sectors are to include laboratory te'lting accreditation programs for lighting, electric motors, transformers, windows, plumbing fixture'l, office equipment (automation) and others that are mutually agreed upon. The Agreement include'l DoE recognition or the existing NVLAP accreditation programs in the following:

Energy Efficient Lighting Products Performance (EEL) LAP

- Lamps and Luminaire<; Plumbing Fixtures

- in the Commercial Products (CPL) LAP Windows

- listed in the extension of Thermal Insulation Materials Program (TIM) to the Thermal Integrity of the Building Envelope (TIE) (requires negotiation with NFRC for transition of accreditation only to NVLAP)

IV. Activities conducted by DoE include: 1. 

### Issue appropriate documents that specify NVLAP accreditation of laboratories in applicable technology/product sectors. 2. Adopt procedures for acceptance and recognition of NVLAP accredited laboratory te'lt data reports from te'lt methods in standards for application to the requirements for DoE regulations. 3. Publish DoE interim test procedures and/or standards in lieu of inadequate or imprecise standards for reference by NVLAP for accreditation. Publish documents and/or announcements in the Federal Register of information needed by laboratories intere'lted in procuring knowledge for programs. 4. Assist in review of Proficiency Te'lting, artifacts selection and upgrading to achieve greater accuracy and precision from laboratory testing (accreditation actions require final decision by the Chief of NVLAP). Financial support for adequate quantitie<; of unusual procurement requirements of te'lt materials and/or conducting development and assuring availability of artifacts for upgrading levels of accuracy and precision from modified improved standard test methods will be made by DoE to assure participating laboratories from excessive cost factors beyond "normal" sample materials procurement for enrollment fee<; in proficiency te<;ting rounds. 5. Review the program periodically to ensure that anticipated benefits are being**re~lized.**

N:\HOMEiLAWRENCEiWPDATA\DOEENER.BIL\IIA-REV.DOE 

### III. 

### Scope and Activities This initial Agreement describes three phases of planning, development and implementation dating from the date of signature and running for three years. Beyond the expiration date additional phases win be defined in subsequent revisions and extensions of the Agreement. The programs to be established will be prepared in consultation with and as identified by DoE for the technical products/fields in the Public Law. The three phases consist of:

- planning and scheduling;

- development of handbooks/documents, checklists for on-sites and establishment of asse.<;sor Technical Expert arrangements and proficiency test contractor(s);

- implementation of each LAP following distribution of applications. Each 

### LAP will overlay others since different timeline schedules are specified for each product/technology sector in the Public Law.

The products/technologies sectors are to include laboratory te.<;ting accreditation programs for lighting, electric motors, transformers, windows, plumbing fixture.<; , office equipment (automation) and others that are mutually agreed upon. The Agreement include.<; DoE recognition of the existing NVLAP accreditation programs in the following:

Energy Efficient Lighting Products Performance (EEL) LAP

- Lamps and Luminaire." Plumbing Fixtures

- in the Commercial Products (CPL) LAP Windows

- listed in the extension of Thermal Insulation Materials Program (TIM) to the Thermal Integrity of the Building Envelope (TIE) (requires negotiation with NFRC for transition of accreditation only to NVLAP)

IV. Activities conducted by DoE include: 1. 

### Issue appropriate documents that specify NVLAP accreditation of laboratories in applicable technology/product sectors. 2. Adopt procedures for acceptance and recognition of NVLAP accredited laboratory te.5t data reports from te.<;t methods in standards for application to the requirements for DoE regulations. 3. Publish DoE interim test procedures and/or standards in lieu of inadequate or imprecise standards for reference by NVLAP for accreditation. Publish documents and/or announcements in the Federal Register of information needed by 

### laboratories intere.<;ted in procuring knowledge for programs. 4. Assist in review of Proficiency Testing, artifacts selection and upgrading to achieve greater accuracy and precision from laboratory testing (accreditation actions require final decision by the Chief of NVLAP). Financial support for adequate quantitie.'i of unusual procurement requirements of te.<;t materials and/or conducting development and assuring availability of artifacts for upgrading levels of accuracy and precision from modified improved standard test methods will be made by DoE to assure participating laboratorie.<; from excessive cost factors beyond "normal" sample materials procurement for enrollment fee." in proficiency te."ting rounds. 5. 

### Review the program periodically to ensure that anticipated benefits are being realized.

N:\HOMEiLAWRENCEiWPDATA\DOEENER.BILiIIA-REV.DOE

### 6. Provide copies of appropriate regulations and regulatory guidance to NVLAP and inform NVLAP of proposed changes in a timely manner. 7. 

### Provide NVLAP/NIST with technical guidance and assistance as needed by NVLAP staff/NVLAP technical expert assessor contractors. 

### 8. Maintain periodic discussions and informal reviews not**l~<;s** 

### than quarterly.

V. Activities conducted by NISTINVLAP include: A. Planning and Scheduling Development and Preparation 1. 

### Undertake planning, prepare flow charts with development schedules for agreed upon programs. 

### 2. Carry out the development and coordination with industry, consistent with DoE regulatory measures, for potential test methods in the programs. 3. 

### Organize technical working groups to prepare requirements for Proficiency**t~<;ting** 

### and Critical Elements (test methods summaries from standards) for initial sets of test methods to be adopted in the programs. B. Development of Handbooks, Checklists, Assessor Technical Experts and Proficiency**T~"ting** 

### 1. Develop accreditation LAPS (Laboratory Accreditation Programs) following its Procedures in U.S. CFR. 2. Prepare detailed technical requirements for the programmatic sectors. Prepare Handbook based on listed test methods. Industry, trade and standards representatives, and Agency participants will be consulted. 3. Develop laboratory on-site technical checklist**ass~"sment** 

### forms and reporting**procedur~"** 

### that support DoE regulations. 4. Select test methods to be included in Proficiency Testing. Deficiencies in standards for**t~"t** 

### methods or inadequacies and shortcomings of standard reference materials for artifacts in proficiency testing may require origination of interim standards or specifications for improved accuracy. Both parties to this Agreement will identify and recommend needs for proposed actions. 5. Prepare and publish Handbooks for each programmatic sector following public workshops. 6. Recruit, select and train Technical Experts in NVLAP procedural requirements and utilization ofchecklists. 7. Establish Technical Expert contracts; initiate Proficiency**T~<;t** 

### contract for pre-accreditation and regularly scheduled rounds. 8. Develop quality assurance guidelines for evaluating the technical performance of the contractor(s). Implementation and Operation L Conduct all NVLAP administrative and technical support**activiti~<;** 

### including distribution of applications, collect fees; arrange pre-accreditation proficiency testing and on-site assessments for evaluations of conformance with technical competency criteria. 2. Evaluate proficiency testing results,**ass~<;sments** 

### and**r~"olution** 

### of**delicienci~"** 

### as**nec~"sary;** 

### organize evaluation panels for technical reviews and recommendations for accreditation.

N:\HOME\LAWRENCE\WPDATA\DOEENER.BlUIIA·REV.DOE 

### 6. Provide copies of appropriate regulations and regulatory guidance to NVLAP and inform NVLAP of proposed changes in a timely manner. 

### 7. Provide NVLAP/NIST with technical guidance and assistance as needed by NVLAP staff/NVLAP technical expert assessor contractors. 

### 8. Maintain periodic discussions and informal reviews not**I~<;s** 

### than quarterly.



### V. Activities conducted 

### by NISfINVLAP include: A. Planning and Scheduling Development and Preparation 

### 1

. Undertake planning, prepare flow charts with development schedules for agreed upon programs. 

### 2. Carry out the development and coordination with industry, consistent with DoE regulatory measures, for potential test methods in the programs. 

### 3. Organize technical working groups to prepare requirements for Proficiency**t~<;ting** 

### and Critical Elements (test methods summaries from standards) for initial sets of test methods to be adopted in the programs. B. Development of Handbooks, Checklists, Assessor Technical Experts and Proficiency**T~"ting** 

### 1. Develop accreditation LAPS (Laboratory Accreditation Programs) following its Procedures in U.S. CFR. 2. Prepare detailed technical requirements for the programmatic sectors. Prepare Handbook based on listed test methods. Industry, trade and standards representatives, and Agency participants will be consulted. 3. Develop laboratory on-site technical checklist**ass~"sment** 

### forms and reporting**procedur~"** 

### that support DoE regulations. 4. Select test methods to be included in Proficiency Testing. Deficiencies in standards for**t~"t** 

### methods or inadequacies and shortcomings of standard reference materials for artifacts in proficiency testing may require origination of interim standards or specifications for improved accuracy. Both parties to this Agreement will identify and recommend needs for proposed actions. 5. Prepare and publish Handbooks for each programmatic sector following public workshops. 6. Recruit, select and train Technical Experts in NVLAP procedural requirements and utilization ofchecklists. 7. Establish Technical Expert contracts; initiate Proficiency**T~<;t** 

### contract for pre-accreditation and regularly scheduled rounds. 8. Develop quality assurance guidelines for evaluating the technical performance of the contractor(s). Implementation and Operation L Conduct aU 

### NVLAP administrative and technical support**activiti~..,** 

### including distribution of applications, collect fees; arrange pre-accreditation proficiency testing and on-site assessments for evaluations of conformance with technical competency criteria. 2. Evaluate proficiency testing results,**ass~<;sments** 

### and**r~"olution** 

### of**delicienci~"** 

### as**nec~"sary;** 

### organize evaluation panels for technical reviews and recommendations for accreditation.

N:IHOMEILAWRENCEIWPDATA\DOEENER.BiUI!A·REV.DOE

### 3. Issue Certificates and Scopes of Accreditation and periodically update published Directory of 

### accredited laboratories. 4. 

### Prepare additional rounds of proficiency testing with appropriate contractors. Publish NVLAP Tech Briefs and distribute copies and inform standards organizations of the rounds results. Perform subsequent rounds of proficiency testing with various representative artifacts and/or standard reference materials. 

### 5. Monitor the performance of the JYf 

### contractor(s). 

### 6. Prepare Technical Briefs on completed test rouijds and provide copies (blind coded) to Laboratories, DoE and other interested standards organizations. 7. 

### Maintain liaison with designated DoE staff and implement published improved test methods as advised or announced by DoE.


### VI Modification or Agreement 1. 

### The conditions and obligations under this agreement may be modified upon the mutual written consent of the parties.



### VII Termination of

### Agreement 1. 

### Termination of this Agreement can be unilaterally made by either party upon 90 days notice, or mutually negotiated. Any NIST contractual expenses due directly to a unilateral termination of the Agreement shall be paid for by the party terminating the Agreement. 2. The laboratory accreditation programs implemented and operated by NVLAP will continue independent of this Agreement except for mandated authority that countervenes restrictions on termination or conclusion of this Agreement.


## vm PROJECT OFFICERS As designated for NVLAP Program NIST/NVLAP As designated for DoE**N:\HOME\LAWRENCE\\\~>[)ATA\[)OEENER.BIL\IIA·REV.[)OE** 

### 3. Issue Certificates and Scopes of Accreditation and periodically update published Directory of accredited laboratories. 4. Prepare additional rounds of proficiency testing with appropriate contractors. Publish NVLAP Tech Briefs and distribute copies and inform standards organizations of the rounds results. Perform subsequent rounds of proficiency testing with various representative artifacts and/or standard reference materials. 

### 5. Monitor the performance of the JYf 

### contractor(s). 

### 6. Prepare Technical Briefs on completed test rouijds and provide copies (blind coded) to Laboratories, DoE and other interested standards organizations. 7. Maintain liaison with designated DoE staff and implement published improved test methods as advised or announced by DoE.


### VI Modification or Agreement L The conditions and obligations under this agreement may be modified upon the mutual written consent of the parties.


### VII Termination of Agreement 1. Termination of this Agreement can be unilaterally made by either party upon 90 days notice, or mutually negotiated. Any NIST contractual expenses due directly to a unilateral termination of the Agreement shall be paid for by the party terminating the Agreement. 2. The laboratory accreditation programs implemented and operated by NVLAP will continue independent of this Agreement except for mandated authority that countervenes restrictions on termination or conclusion of this Agreement.


## vm PROJECT OFFICERS As designated for NVLAP Program NIST/NVLAP As designated for DoE**N:\HOME\LAWRENCE\\\~>[)ATA\DOEENER.BIL\IIA·REV.DOE**

## United States Department of Commerce National Institute of Standards and Technology**~~~'T** OF CO.ff.

### ~~**----'l.t~ ~O** 

# DI~ Certificate of Accreditation

# LJ : ;

ISO/lEe GUIDE 25 

# $**~~** .s'1"4TES 

### of 

# LABORATORY, INC. ANYTOWN, MD



### is recognized under the National Voluntary LaboratoryAccreditation Program for satisfactory compliance with criteria establishedin Title 

### 15, Part 

### 285 Code 

### of Federal Regulations. This criteria encompasses the requirements 

### of ISOIIEC Guide 

### 25 and the relevant requirements 

### of ISO 

### 9002 (ANSI!ASQC 

### Q92-1987) as suppliers 

### of calibration or test results. Accreditation is awarded for specific services, listed on the Scope 

### ofAccreditation for: 

# LABORATORY ACCREDITATION PROGRAM**.T~nn~rv** 

### 1_ 199X Effective until For the National Institute of Standards and Technology 

## United States Department of Commerce National Institute of Standards and Technology**~~~ 'T**  OF CO-ff.

### ~**~~ ---------~~** **~O** 

# Im1W Certificate of Accreditation : :

# ~ c

# ~ -;**~** ISO/lEe GUIDE 25**~ ~** **~~ ~~~** **~~--------------------------------------------------------- ~o** **~~** oS1"4TES 

### of

### ~ 

# LABORATORY, INC. ANYTOWN, MD



### is recognized under the National Voluntary LaboratoryAccreditation Program for satisfactory compliance with criteria establishedin Title 

### IS, Part 

### 285 Code 

### ofFederal Regulations. This criteria encompasses the requirements 

### of ISOIIEC Guide 

### 25 and the relevant requirements 

### of ISO 

### 9002 (ANSI/ASQC 

### Q92-1987) as suppliers 

### of calibration or test results. Accreditation is awarded for specific services, listed on the Scope 

### ofAccreditation for: 

# LABORATORY ACCREDITATION PROGRAM

January 1, 199X Effective until For the National Institute of Stand ards and Technology

## MUTUAL RECOGNITION AGREEMENT BETWEEN THE STANDARDS COUNCIL OF CANADA AND THE NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, UNITED STATES OF AMERICA

1. 

### Purpose The purpose of this Mutual Recognition Agreement (MRA) is to provide for the mutual recognition, by the Parties to this MRA, of the testing laboratory accreditation systems administered by the Standards Council of Canada (SCC) and by the National Institute of Standards and Technology (NIST). This MRA does not cover the accreditation ofcalibration laboratories.

II. Background 

### 1. Within their respective jurisdictions, SCC and NIST operate ongoing testing laboratory accreditation systems to grant formal recognition to testing laboratories that are found competent to carry out specific tests. 2. Rather than attempt to re-accredit testing laboratories, it seems appropriate to find a way for each Party to recognize the testing laboratory accreditation granted by the other's testing laboratory accreditation system. This MRA has been devised for this purpose. Such an MRA is in harmony with the provisions ofthe General Agreement on Tariffs and Trade (GAlT) Agreement on Technical Barriers to Trade and the U.S.-Canada Free Trade Agreement. 3. The testing laboratory accreditation system administered by each of the Parties is voluntary for general participation by the laboratories being accredited except where specifically mandated by law in either country. SCC and NIST base their decisions to accredit a testing laboratory on broadly similar requirements, but the implementation is somewhat different in the two countries. Staff members responsible for the administration of each system have analyzed the evaluation requirements and operating procedures used in each system and have participated in assessment visits to testing laboratories seeking accreditation under each other's system.



### HI. Understanding This MRA gives effect to decisions by the Parties to grant recognition to each other's testing laboratory accreditation systems. For all fields oftesting, each Party will: 1. recognize that the accreditation of a testing laboratory: (a) by SCC, provides that laboratory with the status of an accredited testing laboratory in the territorial United States ofAmerica; and (b) by NIST, provides that laboratory with the status of an accredited testing laboratory in Canada; Page 1 of 5 

## MUTUAL RECOGNITION AGREEMENT BETWEEN THE STANDARDS COUNCIL OF CANADA AND THE NATIONALINSTITUTE OF STANDARDS AND TECHNOLOGY, UNITED STATES OFAMERICA

L 

### Purpose The purpose of this Mutual Recognition Agreement (MRA) is to provide for the mutual recognition, by the Parties to this MRA, of the testing laboratory accreditation systems administered by the Standards Council of Canada (SCC) and by the National Institute ofStandards and Technology (NIST)

. This MRA does not cover the accreditation ofcalibration laboratories.



### II. Background 1. Within their respective jurisdictions, SCC and NIST operate ongoing testing laboratory accreditation systems to grant formal recognition to testing laboratories that are found competent to carry out specific tests. 2

. Rather than attempt to re-accredit testing laboratories, 

### it seems appropriate to find a way for each Party to recognize the testing laboratory accreditation granted by the other's testing laboratory accreditation system. This MRA has been devised for this purpose. Such an MRA is in harmony with the provisions ofthe General Agreement on Tariffs and Trade (GAlT) Agreement on Technical Barriers to Trade and the U.S.-Canada Free Trade Agreement. 3. The testing laboratory accreditation system administered by each of the Parties is voluntary for general participation by the laboratories being accredited except where specifically mandated by law in either country. SCC and NIST base their decisions to accredit a testing laboratory on broadly similar requirements, but the implementation is somewhat different in the two countries

. Staff members responsible for the administration of each system have analyzed the evaluation requirements and operating procedures used in each system and have participated in assessment visits to testing laboratories seeking accreditation under each other's system.



### III. Understanding
This MRA gives effect to decisions by the Parties to grant recognition to each other's testing laboratory accreditation systems. For all fields oftesting, each Party will:
1. 

### recognize that the accreditation of a testing laboratory: (a) by SCc, provides that laboratory with the status of an accredited testing laboratory in the territorial United States ofAmerica; and (b) 

### by NIST, provides that laboratory with the status of an accredited testing laboratory in Canada; Page 1 of 5

### 2. recognize that the accreditations granted by both organizations are comparable and will make the fact known to interested parties; 3. recognize that accreditation by either of the Parties does not imply acceptance of, or responsibility for, test results generated by an accredited testing laboratory; 4. recognize that acceptance of test results generated by a testing laboratory accredited by either Party remains a negotiable matter between the client of the testing laboratory, to whom the results were rendered, and any third party to whom the test results are submitted; 5. maintain records of the scope of accreditation of each testing laboratory that 

### it accredits and, on request, make that information available;
6. publish its own requirements used to accredit testing laboratories and maintain on file the accreditation requirements for the other party's system; 7. collaborate in the development and adoption of revised requirements for accreditation of testing laboratories to increase harmony between the two accreditation systems; 8. reassess and audit its own accredited testing laboratories on a regular basis; 9. collaborate in the development and adoption of testing laboratory assessment methods and cooperate in developing and operating proficiency testing programs; 10. cooperate in promoting the development and adoption of testing laboratory accreditation principles internationally and in the development of international standards relating to testing laboratory accreditation systems and use these documents as a basis for achieving harmony between the two systems.

IV. Harmonization The Parties will cooperate in eliminating or minimizing differences between the systems within five years ofthe signing ofthis MRA

V. 

### Resolution ofComplaints Notwithstanding that this MRA does not create obligations binding under international law, each Party will investigate complaints about its accredited testing laboratories that the other Party brings forward and the Parties will work together to seek satisfactory resolution ofsuch complaints.

Page 2 of 5 

### 2

. recognize that the accreditations granted by both organizations are comparable and will make the fact known to interested parties; 3

. recognize that accreditation by either of the Parties does not imply acceptance of, or responsibility for, test results generated by an accredited testing laboratory; 4. recognize that acceptance of test results generated by a testing laboratory accredited by either Party remains a negotiable matter between the client of the testing laboratory, to whom the results were rendered, and any third party to whom the test results are submitted; 5. maintain records of the scope of accreditation of each testing laboratory that 

### it accredits and, on request, make that information available;
6

. publish its own requirements used to accredit testing laboratories and maintain on file the accreditation requirements for the other party's system; 7. collaborate in the development and adoption of revised requirements for accreditation of testing laboratories to increase harmony between the two accreditation systems; 8

. reassess and audit its own accredited testing laboratories on a regularbasis; 9

. collaborate in the development and adoption of testing laboratory assessment methods and cooperate in developing and operating proficiency testing programs; 10

. cooperate in promoting the development and adoption of testing laboratory accreditation principles internationally and in the development of international standards relating to testing laboratory accreditation systems and use these documents as a basis for achieving harmony between the two systems.

IV. Harmonization The Parties will cooperate in eliminating or minimizing differences between the systems within five years ofthe signing ofthis MRA.

V

. Resolution ofComplaints Notwithstanding that this MRA does not create obligations binding under international law, each Party will investigate complaints about its accredited testing laboratories that the other Party brings forward and the Parties will work together to seek satisfactory resolution ofsuch complaints.

Page 2 of 5

### VI. Duration and Termination This MRA will become effective on the date of signature. It 

### will remain in effect for a period of five (5) years and may be extended by mutual consent. This MRA may be terminated at any time by either Party upon twelve (12) months written notice to the other Party.



### APPROVED AND ACCEPTED FOR THE STANDARDS COUNCIL OF CANADA APPROVED AND ACCEPTED FOR THE NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

Title: Director National Institute ofStandards and Technology 

### By

# M~ 13 

# M**(c;:~'(** Title: Executive Director Standards Council of Canada By:

# ~cd1-!~~ I

Date:

# --.....::~'-----. --+-_Z_7----+-/--'c{-ty'--

__ Designated Liaison Officer: 11anager,**PAJLC~** STANDARDS COUNCIL OF CANADA OTTAWA, Ontario KIP 6N7 CANADA

Telephone: (613) 238-3222 Facsimile: (613) 995-4564 Date:

# ~A_LI? 

# __ .._2_2-L(_.'_/ 

## 4_Cl_Ll-_ 

## 1

_ Designated Liaison Officer: Chief, t\TVLAP NATIONAJL INSTITUTE OF STANDARDS AND TECHNOLOGY GAITHERSBURG, 11D 20899 U.S.A Telephone: (301) 975-4017 Facsimile: (301) 926-2884

Page 3 of 5 

### VI. Duration andTermination This MRA will become effective on the date of signature. It 

### will remain in effect for a period of five (5) years and may be extended by mutual consent. This MRA may be terminated at any time by either Party upon twelve (12) months written notice to the other Party.



### APPROVED AND ACCEPTED FORTHE STANDARDS COUNCIL OF CANADA

By

# M~ 13 

# M**(c;:~'(** Title: Executive Director Standards Council of Canada

Date:

# -----'~'----. ___ 

## --+-_Z_7--+-/--"{-ty'---

__ Designated Liaison Officer: Manager, PALCAN STANDARDS COUNCILOF CANADA OTT A WA, Ontario KIP 6N7 CANADA

Telephone: (613) 238-3222 Facsimile: (613) 995-4564 

### APPROVED AND ACCEPTED FOR THE NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

By:
Title: Director National Institute ofStandards and Technology

Date:

# ~A_L!? 

# __ .._2_2-L(_.'_/ 

### 4_C?_Ll-_1

____ _ Designated Liaison Officer: Chief, t-..TVLAP NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY GAITHERSBURG, MD 20899 U.S.A. Telephone: (301) 975-4017 Facsimile: (301) 926-2884

Page 3 of 5

## COMPARISON OF REQUIREMENTS EVALUATION OF LABORATORIES Between The Standards Council ofCanada (SCC) Program for Accreditation ofLaboratories

- Canada (PALCAN) and the National Institute ofStandards and Technology (NIST), 

## V.SA. National Voluntary Laboratory Accreditation Program (NVLAP)

1. Eligibility NIST will accredit all laboratories, including foreign laboratories, which comply with the requirements for accreditation. SCC accredits only laboratories located in Canada and in a country designated by an order under section 4(4) ofthe Standards Council ofCanada Act.
2. Equipment Both NIST and SCC require certified traceability to national standards authorities, which in the United States of America is defined as the U.S. National Institute of Standards and Technology (NIST) but in Canada is open to international sources recognized by the National Research Council ofCanada (NRC).
3. Methods ofTest SCC accredits laboratories for specific test methods and strictly defined types of testing in any appropriate field of testing. NIST accredits laboratories only for specified test methods in fields of testing for which a need has been determined through NIST procedures. NIST offers accreditation for national, foreign and international consensus or governmental standards. SCC offers accreditation for the preceding and for established, technically satisfactory "in-house" test methods.
4. Laboratory Records NIST requires retention ofdata for at least three years with the option to extend this period. SCC does not specify a minimum retention period but recommends a minimum of three years. Both recognize that the Fasteners and Metals Program under the Fastener Quality Act, U.S. Public Law 101-592, requires a ten year minimum retention period.
5. Test Reports NIST requires designated "approved signatories" for each laboratory. SCC checks the qualifications ofthe staff members who issue test reports, interviews them, and requires notification of any changes in their status.
6. Proficiency Testing Proficiency testing programs are encouraged and supported, in practice, under the SCC program. Proficiency testing is obligatory in each laboratory accreditation program (LAP) operated by NIST. SCC requires laboratories accredited to perform testing to comply with the Fastener Quality Act, U.S. Public Law 101-592, and either the Energy Efficiency Act Canada June 1992 or the Energy Policy Act of 1992, U.S. Public Law 102-486, to participate in the relevant NVLAP proficiency testing programs.

Page 4 of 5 

## COMPARISON OFREQUIREMENTS FOR EVALUATION OFLABORATORIES Between The Standards Council ofCanada (SCC) Program for Accreditation ofLaboratories

- Canada (pALCAN) and the National Institute ofStandards andTechnology (NIST), U.SA. National Voluntary LaboratoryAccreditation Program (NVLAP)

1. Eligibility NIST will accredit aU laboratories, including foreign laboratories, which comply with the requirements for accreditation. SCC accredits only laboratories located in Canada and in a country designated by an order under section 4(4) ofthe Standards Council ofCanada Act.
2

. Equipment Both NIST and SCC require certified traceability to national standards authorities, which in the United States of America is defined as the U.S. National Institute of Standards and Technology (NIST) but in Canada is open to international sources recognized by the National Research Council ofCanada (NRC).
3. Methods ofTest SCC accredits laboratories for specific test methods and strictly defined types of testing in any appropriate field of testing. NIST accredits laboratories only for specified test methods in fields of testing for which a need has been determined through NIST procedures. NIST offers accreditation for national, foreign and international consensus or governmental standards

. SCC offers accreditation for the preceding and for established, technically satisfactory "in-house" test methods. 4

. Laboratory Records NIST requires retention ofdata for at least three years with the option to extend this period. SCC does not specify a minimum retention period but recommends a minimum of three years. Both recognize that the Fasteners and Metals Program under the Fastener Quality Act, U.S. Public Law 101-592, requires a ten year minimum retention period.
5. Test Reports NIST requires designated "approved signatories" for each laboratory. SCCchecks the qualifications ofthe staff members who issue test reports, interviews them, and requires notification of any changes in their status.
6. Proficiency Testing Proficiency testing programs are encouraged and supported, in practice, under the SCC program. Proficiency testing is obligatory in each laboratory accreditation program (LAP) operated by NIST. SCC requires laboratories accredited to perform testing to comply with the Fastener Quality Act, U.S. Public Law 101-592, and either the Energy Efficiency Act Canada June 1992 or the Energy Policy Act of 1992, U.S. Public Law 102-486, to participate in the relevant NVLAP proficiency testing programs.

Page 4 of 57. On-Site Visits NIST uses assessors who are expert in the fields of testing for which accreditation is to be granted; if more than one field is involved, the assessors act as a team. SCC uses a team approach, often with a staff member as leader-coordinator, and as many technical experts as are required for the scope of testing to be accredited. While a typical NIST assessment visit lasts two days and could take longer, SCC usually takes only one day to one and a half days. The NIST assessor leaves a signed copy of an on-site assessment report, while SCC may leave a copy of major required action items and then sends a written report which lists the items discussed at the exit interview. NIST fonually requests a response by the laboratory within 30 days as to the corrective actions/plans for each itemized deficiency; a lack of response is fullowed up and failure to act in a reasonable time leads to denial, revocation or lapse of accreditation. SCC requests that the laboratory submit within 30 days a schedule for follow-up actions to correct non-compliances and the staff member follows up; failure to comply within six months may lead to revocation ofan application, or within three months to withdrawal of an accreditation. When the assessors agree on the resolution ofdeficiencies, a final report ofthe assessment is submitted to the Testing Accreditation Sub-Committee (TASC).
8. Accreditation Process SCC has a three stage process: (1) The Assessment Team approves the Evaluation Report and recommends accreditation to TASC; (2) the TASC reviews the report, the application and any other relevant documents, informs the Advisory Committee on Certification and Testing (ACCT) of the TASC report and recommends accreditation to the Executive Committee (EC) of SCC; and (3) the EC makes the final decision to grant accreditation, and the President ofSCC signs and issues the certificate ofaccreditation.
NIST has a two stage process: (1) NIST technical experts and staff members review the application, on-site assessment report, response to deficiencies, results of proficiency testing and any other relevant documentation, and recommend appropriate accreditation action to the Chief, National Voluntary Laboratory Accreditation Program (NVLAP), who (2) grants accreditation on behalfofthe NIST Director.
9. Accreditation Certificates SCC certificates of accreditation are time-limited for a period of up to four years, whereas those of NIST are usually valid for only 12 months and are so dated.
10. Follow-Up Visits NIST requires reassessment every two years. The SCC requires one quality system audit and one full reassessment in each four-year period.
11. Publicizing Accredited Status For accredited tests, NIST penuits use of its logo on test reports that are issued by approved signatories. SCC penuits the laboratory to include a specifically-worded statement on any test report containing only results for tests which are registered with SCc.
12. Language NIST operates its program in English only, while SCC operates in both English and French.
13. Cooperation and Hannonization Both NIST and SCC will treat any future federal legislation enacted in their respective countries as falling within the bounds of this MR.A unless it specificaliy states otherwise.

Page 5 of 5 7

. On-Site Visits NIST uses assessors who are expert in the fields of testing for which accreditation is to be granted; if more than one field is involved, the assessors act as a team. SCC uses a team approach, often with a staff member as leader-coordinator, and as many technical experts as are required for the scope of testing to be accredited

. While a typical NIST assessment visit lasts two days and could take longer, SCC usually takes only one day to one and a half days. The NIST assessor leaves a signed copy of an on-site assessment report, while SCC may leave a copy of major required action items and then sends a written report which lists the items discussed at the exit interview. NIST formally requests a response by the laboratory within 30 days as to the corrective actions/plans for each itemized deficiency; a lack of response is fullowed up and failure to act in a reasonable time leads to denial, revocation or lapse of accreditation. SCC requests that the laboratory submit within 30 days a schedule for follow-up actions to correct non-compliances and the staff member follows up; failure to comply within six months may lead to revocation ofan application, or within three months to withdrawal of an accreditation. When the assessors agree on the resolution ofdeficiencies, a final report ofthe assessment is submitted to the Testing Accreditation Sub-Committee (TASC).
8

. Accreditation Process SCC has a three stage process: (1) The Assessment Team approves the Evaluation Report and recommends accreditation to TASC; (2) the TASC reviews the report, the application and any other relevant documents, informs the Advisory Committee on Certification and Testing (ACCT) of the TASC report and recommends accreditation to the Executive Committee (EC) of SCC; and (3) the EC makes the final decision to grant accreditation, and the President ofSCC signs and issues the certificate ofaccreditation.
NIST has a two stage process: (1) NIST technical experts and staff members review the application, on-site assessment report, response to deficiencies, results of proficiency testing and any other relevant documentation , and recommend appropriate accreditation action to the Chief, National Voluntary Laboratory Accreditation Program (NVLAP), who (2) grants accreditation on behalfofthe NIST Director.
9

. Accreditation Certificates SCC certificates of accreditation are time-limited for a period of up to four years, whereas those of NIST are usually valid for only 12 months and are so dated.
10

. Follow-Up Visits NIST requires reassessment every two years. The SCC requires one quality system audit and one full reassessment in each four-year period.
11. Publicizing Accredited Status For accredited tests, NIST permits use of its logo on test reports that are issued by approved signatories. SCC permits the laboratory to include a specifically-worded statement on any test report containing only results for tests which are registered with SCC.
12. Language NISToperates its program in English only, while SCC operates in both English and French

. 13

. Cooperation and Hannonization Both NIST and SCC will treat any future federal legislation enacted in their respective countries as falling within the bounds of this MR.A. unless it specificaUy states otherwise

.
Page 5 of 5