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

EE-RM-90-201 COMMENT OOE3

National 

Voluntary 

Laboratory 

Accreditation 

Program 

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

EE-RM-90-201 COMMENT OOE3

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 
PREFACE

NIST Handbook 150 is intended for information and use by staff of accredited 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 of NVLAP

for use in accrediting calibration and testing laboratories.

This handbook contains Part 285 of Title 15 of the U.S. Code of Federal 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 of the material was adopted so that users of the

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 of calibration and testing laboratories."

A small black triangle appears in the left-hand margin ofselected lines of text 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 of ISO 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 of quality systems for the control of Measuring and Test Equipment (M & TE).

A brief review of the evolution of the current CFR Part 285 follows:

The NVLAP Procedures and General Requirements were first published in the Federal

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

notice stated: "The purpose of this 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.

December 10, 1984 Revision. A revision ofthe Procedures was published in the Federal

Register on 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 of each part into

one section reduces the total amount of text and makes the NVLAP Procedures easier to

read and follow. Third, the accreditation criteria need to be updated in light of the recent

developments by national and international bodies, particularly as reflected in the

International Organization for Standardization (ISO) document ISO Guide 25 (revised),

iii

EE-RM-90-201 COMMENT OOE3

PREFACE 

NIST Handbook 150 is intended for information and use by staff of accredited 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 of NVLAP 

for use in accrediting calibration and testing laboratories. 

This handbook contains Part 285 of Title 15 of the u.s. Code of Federal 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 of the material was adopted so that users of the 

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 of calibration and testing laboratories." 

A small black triangle appears in the left-hand margin of selected lines of text 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 of ISO 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 of quality systems for the control of Measuring and Test Equipment (M & TE). 

A brief review of the evolution of the current CFR Part 285 follows: 

The NVLAP Procedures and General Requirements were first published in the Federal 

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

notice stated: "The purpose of this 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. 

December 10, 1984 Revision. A revision of the Procedures was published in the Federal 

Register on 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 of each part into 

one section reduces the total amount of text and makes the NVLAP Procedures easier to 

read and follow. Third, the accreditation criteria need to be updated in light of the 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 of Testing and Inspection Agencies." Fourth,

since interaction with national laboratory accreditation systems of other countries is

becoming increasingly important in fostering international trade, reciprocal recognition

of accredited 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 of Standards and Technology (NIST). A subsequent reorganization of

NIST transferred certain responsibilities of the Office of Standards 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 of responsibilities.

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 Organization for 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 and promote acceptance of calibration 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 of Standards

and Technology/NVLAP, Building 411, Room A162, Gaithersburg, MD 20899; phone (301) 975-4016;

FAX (301) 926-2884.

iv

EE-RM-90-201 COMMENT OOE3

"General Requirements for the Technical Competence of Testing Laboratories," and 

ASTM E548, "Criteria for the Evaluation of Testing and Inspection Agencies." Fourth, 

since interaction with national laboratory accreditation systems of other countries is 

becoming increasingly important in fostering international trade, reciprocal recognition 

of accredited 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 of Standards and Technology (NIST). A subsequent reorganization of 

NIST transferred certain responsibilities of the Office of Standards 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 of responsibilities. 

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 Organization for 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 and promote acceptance of calibration 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 of Standards 

and Technology/NVLAP, Building 411, Room A162, Gaithersburg, MD 20899; phone (301) 975-4016; 

FAX (301) 926-2884. 

iv 
ACKNOWLEDGMENTS

The preparation of this docwnent has been a joint effort, with the input of representatives from other

government agencies, laboratories, and the private sector. Acknowledgment of their efforts is in order;

however, the listing of all of the individual names is impossible. The submissions by individuals and

companies of letters offering suggestions for improvement to this docwnent were also very welcome, as

were the contributions of those 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 of the NVLAP staff in the revisions to the NVLAP Code

of Federal Regulations and the augmenting material of this publication; their knowledge and judgement

were essential for the comprehensive scope achieved. Major contributions were made by Jon M.

Crickenberger and C. Douglas Faison, who coordinated the addition ofmaterial specific to the Calibration

Laboratory Accreditation Program (LAP).

Several NIST 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 Lisa Warfield of the 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

EE-RM-90-201 COMMENT OOE3

ACKNOWLEDGl\1ENTS 

The preparation of this docwnent has been a joint effort, with the input of representatives from other 

government agencies, laboratories, and the private sector. Acknowledgment of their efforts is in order; 

however, the listing of all of the individual names is impossible. The submissions by individuals and 

companies of letters offering suggestions for improvement to this docwnent were also very welcome, as 

were the contributions of those 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 of the NVLAP staff in the revisions to the NVLAP Code 

of Federal Regulations and the augmenting material of this publication; their knowledge and judgement 

were essential for the comprehensive scope achieved. Major contributions were made by Jon M. 

Crickenberger and C. Douglas Faison, who coordinated the addition of material specific to 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 Lisa Warfield of the 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

EE-RM-90-201 COMMENT OOE3

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 of procedures 1

Sec. 285.3 Description and goal of NVLAP " 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 of technical 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 of laboratory 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

EE-RM-90-201 COMMENT OOE3

TABLE OF CONTENTS 

PREFACE .. . ....... .................. .. . . . .. . . .. .. . . ... . .... . ... iii 

ACKNOWLEDGMENTS . . ................... .. ..... ... .. ...... . .... " v 

REVISIONS .... .. .. . ........... .. ... . . . .. . . . ....... ... ....... .. " vi 

SUBPART A - GENERAL INFORMATION .. ... ... . . .. ... ...... .. . ... .... .. 1 

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

Sec. 285.2 Organization of procedures .. .. ... . . ... ... . . . . ... . . . . . . . . . . .. 1 

Sec. 285.3 Description and goal of NVLAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 of technical 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 of calibration or testing 30

(m) Outside support services and supplies 30

(n) Complaints. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 31

(0) Measuring and test equipment (M & TE) . . . . . . .. 31

viii

EE-RM-90-201 COMMENT OOE3

(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 of calibration or testing .... .. .... . ............. 30 

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

(n) Complaints. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 

(0) Measuring and test equipment (M & TE) . . .. . . . . . . . . . . . . . . . . . .. 31 

viii 
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

Laboratory Accreditation Program (NVLAP) operates

as an unbiased third party 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 of procedures

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 of NVLAP

(a) NVLAP is a system for accrediting calibration

laboratories and testing laboratories found competent

to perform specific tests or calibrations. 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 test methods.

(b) NVLAP is a process which:

(1) provides the technical and administrative

mechanisms for national and international

NIST Handbook 150 1

recognition for competent laboratories based on

a comprehensive procedure for promoting

confidence in calibration and testing laboratories

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 and quality management

(see Section 285.4, References).

(2) provides laboratory management with

documentation for use in the development and

implementation of their quality systems;

(3) identifies competent laboratories for use 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 and product

information; and

(5) promotes the acceptance of calibration and

test results between countries, and facilitates

cooperation between laboratories and other

bodies to assist in the exchange of information

and experience, facilitating removal ofnon-tariff

barriers to trade and promoting the

harmonization of standards and procedures.

(c) NVLAP is comprised of a series of laboratory

accreditation programs (LAPs) which are established

on the basis of requests 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 of the 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

EE-RM-90-201 COMMENT OOE3

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 

Laboratory Accreditation Program (NVLAP) operates 

as an unbiased third party 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 of procedures 

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 of NVLAP 

(a) NVLAP is a system for accrediting calibration 

laboratories and testing laboratories found competent 

to perform specific tests or calibrations. 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 test methods. 

(b) NVLAP is a process which: 

(1) provides the technical and administrative 

mechanisms for national and international 

NIST Handbook 150 1 

recognition for competent laboratories based on 

a comprehensive procedure for promoting 

confidence in calibration and testing laboratories 

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 and quality management 

(see Section 285.4, References). 

(2) provides laboratory management with 

documentation for use in the development and 

implementation of their quality systems; 

(3) identifies competent laboratories for use 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 of improved engineering and product 

information; and 

(5) promotes the acceptance of calibration and 

test results between countries, and facilitates 

cooperation between laboratories and other 

bodies to assist in the exchange of information 

and experience, facilitating removal of non-tariff 

barriers to trade and promoting the 

harmonization of standards and procedures. 

(c) NVLAP is comprised of a series of laboratory 

accreditation programs (LAPs) which are established 

on the basis of requests 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 of the 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 
The Director of the National Institute of Standards

and Technology (NIST) does not unilaterally propose

or decide the scope of a 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 test methods, measurements

and services in specified fields of calibration 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 of Accreditation, 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;

NIST Handbook 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 of the

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 of test 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 of basic and general

terms in metrology (VIM), and Guide to the

expression of uncenainty 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

and Applied Chemistry (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 a laboratory is competent to carry out

March 1994

EE-RM-90-201 COMMENT OOE3

The Director of the National Institute of Standards 

and Technology (NIST) does not unilaterally propose 

or decide the scope of a 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 of test 

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 test methods, measurements 

and services in specified fields of calibration 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 of Accreditation, 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; 

NIST Handbook 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 of the 

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 of test 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 of basic and general 

terms in metrology (VIM), and Guide to the 

expression of uncenainty in measurement, issued by 

International Bureau of Weights and Measures 

(BIPM), International Electrotechnical Commission 

(IEC), International Federation of Clinical Chemistry 

(IFCC), International Organization for 

Standardization (ISO), International Union of Pure 

and Applied Chemistry (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 a laboratory is competent to carry out 

March 1994 
specific tests or calibrations or types of tests or

calibrations.

Accreditation criteria: A set of requirements used

by an accrediting body which a laboratory must meet

in order to be accredited.

Approved Signatory (of an accredited laboratory):

An individual who is recognized by NVLAP as

competent to sign accredited laboratory calibration or

test reports.

NOTE: The Approved Signatory is responsible for

the technical content of the 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 NVLAP requirements. (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

NIST Handbook 150 3

system, or values represented by a material measure,

and the corresponding known values of a measurand.

I!I- NOTES:

(a) The result of a calibration permits the estimation

10- of errors of indication of the 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 of a 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 of a 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 of Accreditation: 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 of Accreditation.

Client: Any person or organization that engages the

services of a testing or calibration laboratory.

Competence: The ability of a 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

EE-RM-90-201 COMMENT OOE3

specific tests or calibrations or types of tests or 

calibrations. 

Accreditation criteria: A set of requirements used 

by an accrediting body which a laboratory must meet 

in order to be accredited. 

Approved Signatory (of an accredited laboratory): 

An individual who is recognized by NVLAP as 

competent to sign accredited laboratory calibration or 

test reports. 

NOTE: The Approved Signatory is responsible for 

the technical content of the 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 NVLAP requirements. (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 

NIST Handbook 150 3 

system, or values represented by a material measure, 

and the corresponding known values of a measurand. 

~ NOTES: 

~ (a) The result of a calibration permits the estimation 

~ of errors of indication of the 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 of a 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 of a calibration curve. 

~ Calibration certificate or report: Document that 

~ presents calibration results and other information 

~ relevant to a calibration. 

Calibration method: A defined technical procedure 

for performing a calibration. 

Certificate of Accreditation: 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 of Accreditation. 

Client: Any person or organization that engages the 

services of a testing or calibration laboratory. 

Competence: The ability of a 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. 

~ Error: The difference between the true and 

po measured value of a quantity. 

March 1994 
Interlaboratory comparisons: Organization,

performance and evaluation ofcalibrations or tests 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 of the 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

of an organization that carries out activities additional

to calibration and testing, the term "laboratory" refers

only to those parts of that organization that are

involved in the calibration and testing process. The

laboratory activities may be carried out at or from a

permanent location, at or from a temporary facility,

or in or from a mobile facility.

NOTE: NVLAP further defInes "laboratory" as

being a physical entity; that is, a testing or calibration

facility that is separate and apart physically from any

other laboratory whether or not sharing common

ownership, management, or quality 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 under the

former classifIcation as a "sub-facility," including the

unique conditions associated with that 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: Body that conducts

and administers a laboratory accreditation system and

grants accreditation.

Laboratory accreditation system: System that has

its own rules of procedure and management for

carrying out laboratory accreditation.

NIST Handbook 150 4

LAP: A laboratory accreditation program established

and administered under NVLAP, consisting of test

methods or calibrations relating to specifIc products

or fIelds of testing 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 of determining the value of a measurand.

Measurement assurance: A process to ensure

adequate measurement results that may include, but

is not limited to: 1) use of good experimental design

principles so that the entire measurement process, its

components, and relevant influence factors can be

well characterized, monitored, and controlled; 2)

complete experimental characterization of the

measurement process uncertainty including statistical

variations, contributions from all known or suspected

influence factors, imported uncertainties, and the

propagation of uncertainties throughout the

measurement process; and 3) continuously monitoring

the performance and state of statistical control of the

measurement process with proven statistical process

control techniques including the measurement 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

EE-RM-90-201 COMMENT OOE3

~ Interlaboratory comparisons: Organization, 

~ performance and evaluation of calibrations or tests on 

~ the same or similar items or materials by two or 

~ more laboratories in accordance with predetermined 

~ conditions. 

~ Influence quantity: A quantity which is not the 

~ subject of the 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 

of an organization that carries out activities additional 

to calibration and testing, the term "laboratory" refers 

only to those parts of that organization that are 

involved in the calibration and testing process. The 

laboratory activities may be carried out at or from a 

permanent location, at or from a temporary facility, 

or in or from a mobile facility. 

NOTE: NVLAP further defInes "laboratory" as 

being a physical entity; that is, a testing or calibration 

facility that is separate and apart physically from any 

other laboratory whether or not sharing common 

ownership, management, or quality 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 under the 

former classifIcation as a "sub-facility," including the 

unique conditions associated with that 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: Body that conducts 

and administers a laboratory accreditation system and 

grants accreditation. 

Laboratory accreditation system: System that has 

its own rules of procedure and management for 

carrying out laboratory accreditation. 

NIST Handbook 150 4 

LAP: A laboratory accreditation program established 

and administered under NVLAP, consisting of test 

methods or calibrations relating to specifIc products 

or fIelds of testing 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 of determining the value of a measurand. 

~ Measurement assurance: A process to ensure 

~ adequate measurement results that may include, but 

~ is not limited to: 1) use of good experimental design 

~ principles so that the entire measurement process, its 

~ components, and relevant influence factors can be 

~ well characterized, monitored, and controlled; 2) 

~ complete experimental characterization of the 

~ measurement process uncertainty including statistical 

~ variations, contributions from all known or suspected 

~ influence factors, imported uncertainties, and the 

~ propagation of uncertamtles throughout the 

~ measurement process; and 3) continuously monitoring 

~ the performance and state of statistical control of the 

~ measurement process with proven statistical process 

~ control techniques including the measurement of well-

~ characterized check standards along with the normal 

~ workload and the use of appropriate control charts. 

~ 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 
material" is considered to be 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 of comparing and evaluating

calibrations or tests on the same or similar items or

materials by two or more laboratories in accordance

with predetermined conditions.

Quality audit: A systematic and independent

examination to determine whether quality activities

NIST Handbook 150 5

and related results comply with planned 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 of the status and adequacy of the 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 or more

of the 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 of the needs into a set

of individual quantified or descriptive specifications

for the characteristics of an 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

EE-RM-90-201 COMMENT OOE3

~ material n is considered to be 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 of comparing and evaluating 

calibrations or tests on the same or similar items or 

materials by two or more laboratories in accordance 

with predetermined conditions. 

Quality audit: A systematic and independent 

examination to determine whether quality activities 

NIST Handbook 150 5 

and related results comply with planned 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 of the status and adequacy of the 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 or more 

of the 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 of the needs into a set 

of individual quantified or descriptive specifications 

for the characteristics of an 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 
Revocation: Revocation is the removal of the

accredited status of a 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 of the 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

of the 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 of Reference

standard.)

Standard, secondary: A standard whose value is

assigned by comparison with a primary standard of

the same quantity.

NIST Handbook 150 6

Standard, transport (or transfer): 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 of a 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 of a 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 of a given product, 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

can be related to stated references, usually national or

international standards, through an unbroken chain of

comparisons all having stated uncertainties.

Traceability of the accuracy of measuring

instruments: A documented chain of comparison

connecting the accuracy of a measuring instrument to

other measuring instruments of higher accuracy and

ultimately to a primary standard.

Uncertainty ofmeasurement: Parameter, associated

with the result of a measurement, that characterizes

March 1994

EE-RM-90-201 COMMENT OOE3

Revocation: Revocation is the removal of the 

accredited status of a 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 of the 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 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 

~ of the 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 of Reference 

standard.) 

~ Standard, secondary: A standard whose value is 

~ assigned by comparison with a primary standard of 

~ the same quantity. 

NIST Handbook 150 6 

~ Standard, transport (or transfer): 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 of a 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 of a 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 of a given product, 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 

~ can be related to stated references, usually national or 

~ international standards, through an unbroken chain of 

~ comparisons all having stated uncertainties. 

Traceability of the accuracy of measuring 

instruments: A documented chain of comparison 

connecting the accuracy of a measuring instrument to 

other measuring instruments of higher accuracy and 

ultimately to a primary standard. 

Uncertainty of measurement: Parameter, associated 

with the result of a measurement, that characterizes 

March 1994 
the dispersion of the values that could reasonably be

attributed to the measurand.

Uncertainty, Type A (evaluation of): Method of

evaluation of uncertainty by the statistical analysis of

series of observations.

Uncertainty, Type B (evaluation of): Method of

evaluation of uncertainty by means other than the

statistical analysis of series of observations.

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 of the

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 will be sent revised

publications routinely. Publications include:

(a) the Procedures and General Requirements,

(15 CFR Part 285);

NIST Handbook 150 7

United States Code of Federal Regulations

(CFR)

The primary document describing the legal basis

for NVLAP, including procedures for

establishing accreditation activities and the

criteria and general requirements for

accreditation of laboratories, 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 of the U.S. Code related

to calibration and testing laboratory programs.

(b) handbooks containing the administrative and

operational procedures and technical requirements for

specific LAPs;

A series of handbooks in the 150 series (i.e.; 150-01

...... n) provides technical guidance, criteria and

requirements for calibration and testing laboratories.

A separate handbook is published for 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

Efficient Lighting Products, Lamps and Luminaires).

Amplifying technical information related to specific

fields of calibration is also published as part of the

series (e.g., Calibration Laboratories Technical

Guide).

(c) a directory of accredited 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

EE-RM-90-201 COMMENT OOE3

the dispersion of the values that could reasonably be 

attributed to the measurand. 

Uncertainty, Type A (evaluation of): Method of 

evaluation of uncertainty by the statistical analysis of 

series of observations. 

Uncertainty, Type B (evaluation of): Method of 

evaluation of uncertainty by means other than the 

statistical analysis of series of observations. 

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 of the 

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 will be sent revised 

publications routinely. Publications include: 

(a) the Procedures and General Requirements, 

(15 CFR Part 285); 

NIST Handbook 150 7 

(1) United States Code of Federal Regulations 

(CFR) 

The primary document describing the legal basis 

for NVLAP, including procedures for 

establishing accreditation activities and the 

criteria and general requirements for 

accreditation of laboratories, 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 of the U.S. Code related 

to calibration and testing laboratory programs. 

(b) handbooks containing the administrative and 

operational procedures and technical requirements for 

specific LAPs; 

A series of handbooks in the 150 series (Le.; 150-01 

...... n) provides technical guidance, criteria and 

requirements for calibration and testing laboratories. 

A separate handbook is published for 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 

Efficient Lighting Products, Lamps and Luminaires). 

Amplifying technical information related to specific 

fields of calibration is also published as part of the 

series (e.g., Calibration Laboratories Technical 

Guide). 

(c) a directory of accredited 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 
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

Procedures and General Requirements and Handbooks

between formal revisions of those publications.

Sec. 285.7 Confidentiality

To the extent permitted by applicable laws, NVLAP

will seek to ensure confidentiality of all information

obtained relating to the application, on-site

assessment, proficiency testing, evaluation, and

accreditation of laboratories.

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 Institute ofStandards

and Technology and the federal government,

which retain exclusive rights to their use.

(2) NIST reserves the right to control the

quality of the 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 of accreditation under Lab Code

XXXX."

(4) Permission for advertising NVLAP

accreditation and use of the logo is conditional

on and limited to those cases of calibration or

NIST Handbook 150 8

test 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

other legal 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 of the

Approved Signatory.

(6) Photographic and electronic copies of the

logo are available from NVLAP upon request.

(b) Inform its clients that the laboratory's

accreditation or any of its calibration or test reports

in no way constitutes or implies 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 of NIST;

(b) Each request must include:

(1) the scope of the LAP in terms of products,

calibration services, or testing services proposed

for inclusion;

March 1994

EE-RM-90-201 COMMENT OOE3

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 

Procedures and General Requirements and Handbooks 

between formal revisions of those publications. 

Sec. 285.7 Confidentiality 

To the extent permitted by applicable laws, NVLAP 

will seek to ensure confidentiality of all information 

obtained relating to the application, on-site 

assessment, proficiency testing, evaluation, and 

accreditation of laboratories. 

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 Institute of Standards 

and Technology and the federal government, 

which retain exclusive rights to their use. 

(2) NIST reserves the right to control the 

quality of the use of the 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 of accreditation under Lab Code 

XXXX." 

(4) Permission for advertising NVLAP 

accreditation and use of the logo is conditional 

on and limited to those cases of calibration or 

NIST Handbook 150 8 

test 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 

other legal 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 of the 

Approved Signatory. 

(6) Photographic and electronic copies of the 

logo are available from NVLAP upon request. 

(b) Inform its clients that the laboratory's 

accreditation or any of its calibration or test reports 

in no way constitutes or implies 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 - ESTABLISHING A LAP 

Sec. 285.11 Requesting a LAP 

(a) A request to establish a LAP must be made to 

the Director of NIST; 

(b) Each request must include: 

(1) the scope of the LAP in terms of products, 

calibration services, or testing services proposed 

for inclusion; 

March 1994 
(2) specific identification of the applicable

standards and test methods, including

appropriate designations, and the organizations

orstandards-writing bodies having responsibility

for them;

(3) a statement of the 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 of the 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 of the requested LAP;

(2) indicate how to obtain a copy of the

request; and

(3) state that anyone may submit comments on

the need for a LAP to NVLAP within 60 days

of the date of the notice.

NIST Handbook 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 of the 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 of the LAP.

({) Consistent with applicable laws and regulations,

the Director may negotiate and conclude agreements

with the governments of other countries for NVLAP

recognition of foreign 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 of need.

(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

need by using Section 285.13, and private sector

organizations by using Section 285.14.

(b) After receipt of the request, the Director of

NIST shall analyze it to determine if there is need for

the requested LAP. Inmaking this determination, the

Director of NIST shall consider the following:

(1) the needs and scope of the LAP initially

requested;

(2) the needs and scope ofthe user population;

March 1994

EE-RM-90-201 COMMENT OOE3

(2) specific identification of the applicable 

standards and test methods, including 

appropriate designations, and the organizations 

or standards-writing bodies having responsibility 

for them; 

(3) a statement of the 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 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 of the 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 of the requested LAP; 

(2) indicate how to obtain a copy of the 

request; and 

(3) state that anyone may submit comments on 

the need for a LAP to NVLAP within 60 days 

of the date of the notice. 

NIST Handbook 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 of the 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 of the LAP. 

(0 Consistent with applicable laws and regulations, 

the Director may negotiate and conclude agreements 

with the governments of other countries for NVLAP 

recognition of foreign 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 of need. 

(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 

need by using Section 285.13, and private sector 

organizations by using Section 285.14. 

(b) After receipt of the request, the Director of 

NIST shall analyze it to determine if there is need for 

the requested LAP. In making this determination, the 

Director of NIST shall consider the following: 

(1) the needs and scope of the LAP initially 

requested; 

(2) the needs and scope of the user population; 

March 1994 
(3) the nature and content of other relevant

public and private sector laboratory

accreditation programs;

(4) compatibility with the criteria referenced 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 of the requested LAP by

adding or deleting test methods, types of test

methods, products, services, or standards.

(c) If the Director of NIST decides that a need has

been demonstrated, and if resources are available to

develop a LAP, NVLAP shall notify interested

persons of the decision to proceed with development

of a LAP.

(d) If the 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

other interested persons ofthe decision not to proceed

until resources become available.

(e) If the Director of NIST 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 of a LAP.

Sec. 285.13 Request from a government agency

(a) Any federal, state or local agency responsible

for regulatory or public 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.

NIST Handbook 150 10

(b) Each request must be in wntmg and must

include the infonnation required in Section 285.11(b)

and:

(1) a description 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 of NIST shall publish a Federal

Register notice of the receipt of a 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 of the date of the

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 a need to accredit laboratories for specific

products, calibrations, or testing services, may

request the Director of NIST to establish a LAP if it

uses procedures meeting the following conditions:

(1) public notice of meetings and other

activities including requests for LAPs is

provided in a timely fashion and is distributed to

reach the attention of interested persons;

(2) meetings are open and participation in

activities is available to interested persons;

(3) decisions reached by the private sector

organization in the development of a request for

a LAP represent substantial agreement of the

interested persons;

March 1994

EE-RM-90-201 COMMENT OOE3

(3) the nature and content of other relevant 

public and private sector laboratory 

accreditation programs; 

(4) compatibility with the criteria referenced 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 of the requested LAP by 

adding or deleting test methods, types of test 

methods, products, services, or standards. 

(c) If the Director of NIST decides that a need has 

been demonstrated, and if resources are available to 

develop a LAP, NVLAP shall notify interested 

persons of the decision to proceed with development 

of a LAP. 

(d) If the 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 

other interested persons of the decision not to proceed 

until resources become available. 

(e) If the Director of NIST 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 of a LAP. 

Sec. 285.13 Request from a government agency 

(a) Any federal, state or local agency responsible 

for regulatory or public 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. 

NIST Handbook 150 10 

(b) Each request must be in wntmg and must 

include the information required in Section 285.11 (b) 

and: 

(1) a description of the 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 with development of 

a LAP, the Director of NIST shall publish a Federal 

Register notice of the receipt of a 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 of the date of the 

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 a need to accredit laboratories for specific 

products, calibrations, or testing services, may 

request the Director of NIST to establish a LAP if it 

uses procedures meeting the following conditions: 

(1) public notice of meetings and other 

activities including requests for LAPs is 

provided in a timely fashion and is distributed to 

reach the attention of interested persons; 

(2) meetings are open and participation in 

activities is available to interested persons; 

(3) decisions reached by the private sector 

organization in the development of a request 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 a formal

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) of this section.

(c) NVLAP may request clarification of the

information required by Section 285.1l(b).

(d) Before deciding to proceed with development of

a LAP, the Director of NIST shall publish a Federal

Register notice of the receipt of a 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 of the date

of the notice.

(c) NVLAP shall make every reasonable effort to

ensure that the affected calibration or testing

community within the scope of the LAP is informed

of any planned workshop. Summary minutes of each

workshop will be prepared. A copy of the 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 a notice in the Federal Register

announcing the establishment of the LAP.

(b) The notice will:

(1) identify the scope of the 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

of a 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 Adding to or modifying an established

LAP

(a) Technical requirements for accreditation are

specific for each LAP. The requirements tailor the

criteria referenced in Section 285.33 to the calibration

or test methods, types of calibration or test methods,

products, services, or standards covered by the LAP.

(b) NVLAP shall develop the technical requirements

based on expert advice. This advice may be obtained

through one or more informal public workshops or

other suitable means.

NIST Handbook 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 a LAP

when:

March 1994

EE-RM-90-201 COMMENT OOE3

(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 a formal 

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) of this section. 

(c) NVLAP may request clarification of the 

information required by Section 285.1l(b). 

(d) Before deciding to proceed with development of 

a LAP, the Director of NIST shall publish a Federal 

Register notice of the receipt of a 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 of the date 

of the notice. 

(e) NVLAP shall notify interested persons of the 

decision whether or not to proceed with development 

of a LAP. 

Sec. 285.15 

requirements 

Development of technical 

(a) Technical requirements for accreditation are 

specific for each LAP. The requirements tailor the 

criteria referenced in Section 285.33 to the calibration 

or test methods, types of calibration or test methods, 

products, services, or standards covered by the LAP. 

(b) NVLAP shall develop the technical requirements 

based on expert advice. This advice may be obtained 

through one or more informal public workshops or 

other suitable means. 

NIST Handbook 150 11 

(c) NVLAP shall make every reasonable effort to 

ensure that the affected calibration or testing 

community within the scope of the LAP is informed 

of any planned workshop. Summary minutes of each 

workshop will be prepared. A copy of the 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 a notice in the Federal Register 

announcing the establishment of the LAP. 

(b) The notice will: 

(1) identify the scope of the 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 Adding to or modifying an established 

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 for accreditation under a LAP 

when: 

March 1994 
(1) the additional standards, calibration or test

methods, or types of calibration 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 ortest methods,

or types of calibration 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 of Accreditation must meet all NVLAP criteria

for the additional calibration parameters, test methods

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 of NIST 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 that determination.

(b) The notice published under paragraph (a) of this

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) After the comment period, the Director ofNIST

shall determine if public support exists for the

continuation of the LAP. Ifpublic comments support

the continuation of the LAP, the Director of NIST

shall publish a Federal Register notice 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.

NIST Handbook 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,

NVLAP Fee Schedule, the Program Handbook,

and all documents needed for understanding of

the NVLAP program and requirements. This

could include relevant Technical Guides in the

fields of calibration 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 of the application;

(2) request further information, if necessary;

(3) confirm payment offees before proceeding

with the accreditation process; and

(4) specify the next step(s) in the accreditation

process.

(c) Accreditation of laboratories outside of the

United States may require:

March 1994

EE-RM-90-201 COMMENT OOE3

(1) the additional standards, calibration or test 

methods, or types of calibration 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 or test methods, 

or types of calibration 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 of Accreditation must meet all NVLAP criteria 

for the additional calibration parameters, test methods 

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 of NIST 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 that determination. 

(b) The notice published under paragraph (a) of this 

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) After the comment period, the Director ofNIST 

shall determine if public support exists for the 

continuation of the LAP. If public comments support 

the continuation of the LAP, the Director of NIST 

shall publish a Federal Register notice 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. 

NIST Handbook 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 of the established 

LAPs. 

(1) A NVLAP application package is sent to a 

laboratory on request. It includes the General 

Application, Program-Specific Application, 

NVLAP Fee Schedule, the Program Handbook, 

and all documents needed for understanding of 

the NVLAP program and requirements. This 

could include relevant Technical Guides in the 

fields of calibration 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 of the application; 

(2) request further information, if necessary; 

(3) confirm payment offees before proceeding 

with the accreditation process; and 

(4) specify the next step(s) in the 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 of the

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 of the fees listed on the NVLAP

Fee Schedule may be insufficient to cover the

costs incurred by 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 of the U.S., for shipment of proficiency

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

of Commerce may be required. If a 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,

NIST Handbook 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 of testing 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) The AdministrativelTechnical Suppon Fee

covers costs associated with NVLAP and other

NIST staff conducting 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 Support Fee, based on

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

EE-RM-90-201 COMMENT OOE3

(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 of the 

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 of the fees listed on the NVLAP 

Fee Schedule may be insufficient to cover the 

costs incurred by 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 of the U.S., for shipment of proficiency 

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 

of Commerce may be required. If a 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, 

NIST Handbook 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 of testing 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) The AdministrativelTechnical Suppon Fee 

covers costs associated with NVLAP and other 

NIST staff conducting 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 Support Fee, based on 

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 
NOTE: The optional use of a preassessment

visit will be considered if it is decided that such

a visit would result in a better defInition of the

scope of accreditation which has 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 NVLAP program. It covers each

of the 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 of time 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 and analysis

of laboratory results, and reports to NVLAP

staff.

Time of withdrawal

(# of months 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 of testing,

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 with technical support related to

the number and complexity of test methods

selected by a laboratory within a given program.

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.

NIST Handbook 150 14

* If a 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 of months after the date

the initial application was received.

(3) The On-Site Assessment 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 of the 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

EE-RM-90-201 COMMENT OOE3

NOTE: The optional use of a preassessment 

visit will be considered if it is decided that such 

a visit would result in a better definition of the 

scope of accreditation which has 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. 

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 and analysis 

of laboratory results, and reports to NVLAP 

staff. 

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 of testing, 

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 with technical support related to 

the number and complexity of test methods 

selected by a laboratory within a given program. 

This fee is charged per test method; therefore, 

the total Test Method Fee depends on the total 

number of test methods selected and varies from 

application to application within a program. 

NIST Handbook 150 14 

(e) Fee Refund Policy 

This refund policy applies to laboratories that 

withdraw from the NVLAP program. It covers each 

of the 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 of time that has elapsed between the 

laboratory's renewal date and the date NVLAP 

was notified of the decision to withdraw. 

Time of withdrawal 

(# of months after 

renewal 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 

* If a 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 of months after the date 

the initial application was received. 

(3) The On-Site Assessment 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 of the 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 
requirements established for each LAP will include

(not necessarily in this order):

(1) application and othermaterial submitted by

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 of applicant laboratories in such a way as

to minimize potential conflicts of interest.

The laboratory will be contacted to schedule a

mutually acceptable date for the on-site assessment

after payment ofthe required fees and will be notified

ofany additional information which must be supplied,

and ofany applicable proficiency 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 on the basis of their

professional and academic achievements,

experience in the field of testing or calibration,

management experience, and tact in dealing 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 of testing or calibration 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.

NIST Handbook 150 15

Evaluators are TEs selected to review the

record of the laboratory as a whole, including

the application, assessment report, deficiencies,

corrections to deficiencies, and proficiency test

results. Based on the totality of the record, the

evaluators recommend whether or not a

laboratory should be accredited. The evaluators

are matched to the type of testing or calibration

being evaluated. Like assessors, evaluators are

selected to avoid conflict of interest.

(2) On-Site Assessment

Before initial accreditation and every two years

thereafter, an on-site assessment of each

laboratory is conducted to determine compliance

with the NVLAP criteria. NVLAP assigns an

assessor or a team of assessors and provides the

laboratory with a short biographical sketch of

the assessor(s). A lead assessor will be

assigned if needed. The laboratory may request

an alternate assessor if a conflict of interest or

prior business relationship exists.

Assessors use checklists provided by 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 with as little disruption as possible to

the normal operations ofthe laboratory. During

the assessment, the assessor meets with

management and laboratory personnel, 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, and competency evaluations

for all staff members who routinely perform, or

affect the quality ofthe calibration or testing for

which accreditation is sought. The assessor

need not be given information which violates

individual privacy, such as salary, medical

March 1994

EE-RM-90-201 COMMENT OOE3

requirements established for each LAP will include 

(not necessarily in this order): 

(1) application and other material submitted by 

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 of applicant laboratories in such a way as 

to minimize potential conflicts of interest. 

The laboratory will be contacted to schedule a 

mutually acceptable date for the on-site assessment 

after payment of the required fees and will be notified 

of any additional information which must be supplied, 

and of any applicable proficiency 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 on the basis of their 

professional and academic achievements, 

experience in the field of testing or calibration, 

management experience, and tact in dealing 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 of testing or calibration 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. 

NIST Handbook 150 15 

Evaluators are TEs selected to review the 

record of the laboratory as a whole, including 

the application, assessment report, deficiencies, 

corrections to deficiencies, and proficiency test 

results. Based on the totality of the record, the 

evaluators recommend whether or not a 

laboratory should be accredited. The evaluators 

are matched to the type of testing or calibration 

being evaluated. Like assessors, evaluators are 

selected to avoid conflict of interest. 

(2) On-Site Assessment 

Before initial accreditation and every two years 

thereafter, an on-site assessment of each 

laboratory is conducted to determine compliance 

with the NVLAP criteria. NVLAP assigns an 

assessor or a team of assessors and provides the 

laboratory with a short biographical sketch of 

the assessor(s). A lead assessor will be 

assigned if needed. The laboratory may request 

an alternate assessor if a conflict of interest or 

prior business relationship exists. 

Assessors use checklists provided by 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 with as little disruption as possible to 

the normal operations of the laboratory. During 

the assessment, the assessor meets with 

management and laboratory personnel, 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, and competency evaluations 

for all staff members who routinely perform, or 

affect the quality of the calibration or testing for 

which accreditation is sought. The assessor 

need not be given information which violates 

individual privacy, such as salary, medical 

March 1994 
information, or performance reviews outside the

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

Authorized Representative and otherresponsible

laboratory staff. A written assessment report,

signed by the Authorized Representative to

acknowledge receipt of the 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) on the 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 informed ofdeficiencies during

the on-site assessment and through other

correspondence.

When a laboratory is notified of deficiencies, it

must respond in writing to NVLAP within 30

days of the notification. The response must

provide documentation, signed by the

NIST Handbook 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 of actions, dates of

completion, and responsible persons.

A currently 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 (which have a critical effect on

the function accredited) that are identified as

deficient (fail to meet the NVLAP criteria)

should not be used for further NVLAPaccredited calibration or testing until corrective

action has been completed and documented.

Evidence of correction 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,

prior to 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

with known properties and results, artifacts with

similar properties that have not been

March 1994

EE-RM-90-201 COMMENT OOE3

information, or performance reviews outside the 

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 briefmg to discuss 

observations and any deficiencies with the 

Authorized Representative and other responsible 

laboratory staff. A written assessment report, 

signed by the Authorized Representative to 

acknowledge receipt of the 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) on the compliance of the 

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 informed of deficiencies during 

the on-site assessment and through other 

correspondence. 

When a laboratory is notified of deficiencies, it 

must respond in writing to NVLAP within 30 

days of the notification. The response must 

provide documentation, signed by the 

NIST Handbook 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 of actions, dates of 

completion, and responsible persons. 

A currently 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 (which have a critical effect on 

the function accredited) that are identified as 

deficient (fail to meet the NVLAP criteria) 

should not be used for further NVLAPaccredited calibration or testing until corrective 

action has been completed and documented. 

Evidence of correction 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 , 

prior to 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 

with known properties and results, artifacts with 

similar properties that have not been 

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, and use offundamental physical laws.

Proficiency testing for calibration laboratories

may involve the comparison of calibration

results obtained independently by the laboratory

and NIST/NVLAP on a selected instrument or

artifact.

Proficiency testing data are 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,

but not limited to, one or more of the following:

(i) failure to meet specified proficiency

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) performancei

as a statistically

outlying laboratory in two successive

rounds of proficiency testing or showing a

general pattern of outlying results over

three or more rounds; and

(v) failure to produce acceptable

calibration or test results when using NIST

Standard Reference Materials or special

artifacts whose properties are wellNIST Handbook 150 17

characterized and known to

NIST/NVLAP.

NVLAP will notify the laboratory of proficiency

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

NVLAP Technical Experts (evaluators) who are

matched to the type of calibration or testing

being evaluated and are selected to avoid

conflict of interest. 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 of proficiency testing; and

(vi) information from any monitoring

visits of the laboratory.

Based on this 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

EE-RM-90-201 COMMENT OOE3

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, and use of fundamental physical laws . 

Proficiency testing for calibration laboratories 

may involve the comparison of calibration 

results obtained independently by the laboratory 

and NIST INVLAP on a selected instrument or 

artifact. 

Proficiency testing data are analyzed by NVLAP 

and reports of the 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, 

but not liInited to, one or more of the following: 

(i) failure to meet specified proficiency 

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 of proficiency testing or showing a 

general pattern of outlying results over 

three or more rounds; and 

(v) failure to produce acceptable 

calibration or test results when using NIST 

Standard Reference Materials or special 

artifacts whose properties are wellNIST Handbook 150 17 

characterized and know n to 

NIST INVLAP. 

NVLAP will notify the laboratory of proficiency 

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 

NVLAP Technical Experts (evaluators) who are 

matched to the type of calibration or testing 

being evaluated and are selected to avoid 

conflict of interest. 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 of proficiency testing; and 

(vi) information from any monitoring 

visits of the laboratory. 

Based on this 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 
(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 of a 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, or operations,

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

of the 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) If accreditation is granted or renewed, NVLAP

shall:

(1) provide a Certificate of Accreditation and

a Scope of Accreditation to the laboratory;

NIST Handbook 150 18

(2) provide guidance on referencing the

laboratory's accredited status, and the use of the

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

of the action(s) the laboratory must take to renew its

accreditation.

Each accredited laboratory will be sent a renewal

application package before the expiration date of its

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 of the reasons for the proposed denial

or revocation and the procedure for appealing such a

decision.

(b) The laboratory will have 30 days from the date

of receipt of the proposed denial or revocation letter

to appeal the decision to the Director of NIST. 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

EE-RM-90-201 COMMENT OOE3

(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 of a 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, or operations, 

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 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. If a renewal date 

is changed, the laboratory will be notified in writing 

of the 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) If accreditation is granted or renewed, NVLAP 

shall: 

(1) provide a Certificate of Accreditation and 

a Scope of Accreditation to the laboratory; 

NIST Handbook 150 18 

(2) provide guidance on referencing the 

laboratory's accredited status, and the use of the 

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 

of the action(s) the laboratory must take to renew its 

accreditation. 

Each accredited laboratory will be sent a renewal 

application package before the expiration date of its 

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 of the reasons for the proposed denial 

or revocation and the procedure for appealing such a 

decision. 

(b) The laboratory will have 30 days from the date 

of receipt of the proposed denial or revocation letter 

to appeal the decision to the Director of NIST. If the 

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 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) 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 before being 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 ofsuspensionwill include prohibiting

the laboratory from using the NVLAP logo on its test

or calibration reports during the suspension period.

The determination of NVLAP whether to suspend or

to propose revocation of a laboratory's accreditation

will depend on the nature of the violation(s) of the

terms of its accreditation.

Ifaccreditation is revoked, the laboratory must return

its Certificate of Accreditation and cease use of the

NVLAP logo on any of its reports, correspondence,

or advertising.

ownership, location, staffmg, facilities, and

configuration. Changes in any of these conditions or

criteria could result in loss of accreditation. NVLAP

must be informed if any of the conditions or criteria

for accreditation are changed so that a determination

can be made 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

of those 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 of laboratory

Accreditation of a laboratory is based on specific

conditions and criteria, including the laboratory

NIST Handbook 150 19

(5) be capable of performing 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 of the scope of its

accreditation to only those calibrations, tests or

services for which accreditation is granted;

(7) resolve all deficiencies;

March 1994

EE-RM-90-201 COMMENT OOE3

laboratory 's accreditation, or advise of NVLAP's 

intent to revoke accreditation. If accreditation is 

suspended, NVLAP shall notify the laboratory of that 

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 before being 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 of suspension will include prohibiting 

the laboratory from using the NVLAP logo on its test 

or calibration reports during the suspension period. 

The determination of NVLAP whether to suspend or 

to propose revocation of a laboratory's accreditation 

will depend on the nature of the violation(s) of the 

terms of its accreditation. 

If accreditation is revoked, the laboratory must return 

its Certificate of Accreditation and cease use of the 

NVLAP logo on any of its 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 

NIST Handbook 150 19 

ownership, location, staffmg, facilities, and 

configuration. Changes in any of these conditions or 

criteria could result in loss of accreditation. NVLAP 

must be informed if any of the conditions or criteria 

for accreditation are changed so that a determination 

can be made concerning the status of the 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 

of those for which it is seeking accreditation; 

(3) pay all fees; 

(4) participate in proficiency testing as 

required; 

(5) be capable of performing 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 of the scope of its 

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 and the 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, a laboratory shall supply, upon request,

the following information to NVLAP or its designated

contractor:

(1) legal name and full address;

(2) ownership of the laboratory;

NIST Handbook 150 20

(3) organization chart defining relationships

that are relevant to performing testing and

calibrations covered in the accreditation request;

(4) general description of the laboratory,

including its facilities and scope of operation;

(5) name, address, and telephone and FAX

number of the Authorized Representative of the

laboratory;

(6) names or titles and qualifications of

laboratory staff nominated to serve as approved

signatories of calibration or test reports that

reference NVLAP accreditation;

(7) the laboratory quality manual; and

(8) other information as may be needed for the

specific LAP(s) in which accreditation issought.

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 or for determining compliance with

other criteria, may be specified by NVLAP,

depending upon the specific character of the

task of the laboratory.

(3) This section is for use by calibration and

testing laboratories in the development and

implementation oftheir quality systems. It may

also be used by accreditation bodies, certification bodies and others concerned with the

competence of laboratories.

(4) A General Operations Checklist is used to

verify compliance with the criteria of this

section.

March 1994

EE-RM-90-201 COMMENT OOE3

(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 and the Scope of Accreditation 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, a laboratory shall supply, upon request, 

the following information to NVLAP or its designated 

contractor: 

(1) legal name and full address; 

(2) ownership of the laboratory; 

NIST Handbook 150 20 

(3) organization chart defining relationships 

that are relevant to performing testing and 

calibrations covered in the accreditation request; 

(4) general description of the laboratory, 

including its facilities and scope of operation; 

(5) name, address, and telephone and FAX 

number of the Authorized Representative of the 

laboratory ; 

(6) names or titles and qualifications of 

laboratory staff nominated to serve as approved 

signatories of calibration or test reports that 

reference NVLAP accreditation; 

(7) the laboratory quality manual; and 

(8) other information as may be needed for the 

specific LAP(s) in which 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 or for determining compliance with 

other criteria, may be specified by NVLAP, 

depending upon the specific character of the 

task of the laboratory. 

(3) This section is for use by calibration and 

testing laboratories in the development and 

implementation of their quality systems. It may 

also be used by accreditation bodies, certification bodies and others concerned with the 

competence of laboratories. 

(4) A General Operations Checklist is used to 

verify compliance with the criteria of this 

section. 

March 1994 
(b) Organization and management

(1) The laboratory shall be legally 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 of their work;

(iii) be organized in such a way that

confidence in its independence of

judgement and integrity 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

of the results. The ratio of supervisory to

non-supervisory personnel shall be such as

to ensure adequate supervision;

(vi) have a technical 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. In some laboratories, the quality

manager may also be the technical

manager or deputy technical manager;

NIST Handbook 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 of calibration and testing activities

it undertakes. The elements of this 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

be maintained current under the 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

EE-RM-90-201 COMMENT OOE3

(b) Organization and management 

(1) The laboratory shall be legally 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 of their work; 

(iii) be organized in such a way that 

confidence in its independence of 

judgement and integrity 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 

of the results. The ratio of supervisory to 

non-supervisory personnel shall be such as 

to ensure adequate supervision; 

(vi) have a technical 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. In some laboratories, the quality 

manager may also be the technical 

manager or deputy technical manager; 

NIST Handbook 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 

interl aboratory 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 of calibration and testing activities 

it undertakes. The elements of this 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 

be maintained current under the 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) aquality policy statement, including

objectives and commitments, by top

management;

(ii) the organization and management

structure of the 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 of measurements;

(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

and reference measurement standards used;

(xiii) reference to procedures for

calibration, verification and maintenance of

equipment;

(xiv) reference to verification practices

including interlaboratory comparisons,

proficiency testing programs, use of

NIST Handbook 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 doubt on the correctness or validity

ofthe laboratory's calibration or test results, the

laboratory shall take immediate corrective action

and shall immediately notify, in writing, any

client whose work may have been affected.

March 1994

EE-RM-90-201 COMMENT OOE3

(i) a quality policy statement, including 

objectives and commitments, by top 

management; 

(ii) the organization and management 

structure of the 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 of measurements; 

(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 

and reference measurement standards used; 

(xiii) reference to procedures for 

calibration, verification and maintenance of 

equipment; 

(xiv) reference to verification practices 

including interlaboratory comparisons, 

proficiency testing programs, use of 

NIST Handbook 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 of the 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 doubt on the correctness or validity 

of the laboratory's calibration or test results, the 

laboratory shall take immediate corrective action 

and shall immediately notify, in writing, any 

client whose work may have been affected. 

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

ensure its continuing suitability and effectiveness

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. The person responsible for quality

shall ensure that these actions are discharged

within the agreed timescale.

(6) In addition to periodic 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 of retained items;

(vi) correlation of results for different

characteristics of an item.

NIST Handbook 150 23

(d) Personnel

(1) The laboratory shall have sufficient

personnel, having the necessary education,

training, technical knowledge and experience 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, Laboratory Design,

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

EE-RM-90-201 COMMENT OOE3

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 of this section shall be reviewed at 

least once each year by the management to 

ensure its continuing suitability and effectiveness 

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. The person responsible for quality 

shall ensure that these actions are discharged 

within the agreed timescale. 

(6) In addition to periodic 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 of retained items; 

(vi) correlation of results for different 

characteristics of an item. 

NIST Handbook 150 23 

(d) Personnel 

(1) The laboratory shall have sufficient 

personnel, having the necessary education, 

training, technical knowledge and experience 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, Laboratory Design, 

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 
(4) There shall be effective separation between

neighboring areas when the activities therein are

incompatible.

(5) Access to and use of all areas affecting the

quality of these activities shall be defmed and

controlled.

(6) Adequate measures shall be taken 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

of calibrations and tests. In those cases where

the laboratory needs to use equipment outside its

permanent control it shall ensure that the

relevant requirements of this section are met.

(2) All equipment shall be properly

maintained. Maintenance procedures shall be

documented. Any item of equipment 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 of each item

of equipment and all reference materials

significant to the calibrations or tests performed.

The records shall include:

0) the name of the item of equipment;

(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

not considered mandatory requirements for

inclusion in laboratory records, although

this is encouraged as good laboratory

practice.

(iv) current location, where appropriate;

(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) history ofany 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 of its 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 otherwise judged to be

unreliable.

NIST Handbook 150 24 March 1994

EE-RM-90-201 COMMENT OOE3

(4) There shall be effective separation between 

neighboring areas when the activities therein are 

incompatible. 

(5) Access to and use of all areas affecting the 

quality of these activities shall be defmed and 

controlled. 

(6) Adequate measures shall be taken 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 Equipmeut and reference materials 

(1) The laboratory shall be furnished with all 

items of equipment (including reference 

materials) required for the correct performance 

of calibrations and tests. In those cases where 

the laboratory needs to use equipment outside its 

permanent control it shall ensure that the 

relevant requirements of this section are met. 

(2) All equipment shall be properly 

maintained. Maintenance procedures shall be 

documented. Any item of equipment 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 of each item 

of equipment and all reference materials 

significant to the calibrations or tests performed. 

The records shall include: 

0) the name of the item of equipment; 

NIST Handbook 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: For initial accreditation, the date 

received and the date placed in service are 

not considered mandatory requirements for 

inclusion in laboratory records, although 

this is encouraged as good laboratory 

practice. 

(iv) current location, where appropriate; 

(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 of maintenance carried outto 

date and planned for the future; 

(ix) history of any damage, 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 established program for 

the calibration and verification of its 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 otherwise judged to be 

unreliable. 

March 1994 
(2) The overall program of calibration 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 and shall provide the measurement

results and associated uncertainty of

measurement and/or a statement of compliance

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, the methodology ofthe Guide

to the expression ofuncertainty in measurement:

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

of NIST Measurement Results, is a practical

application document written around the Guide

to the expression ofuncertainty in measurement.

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

Standard and the Iodine-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

NIST Handbook 150 25

measurement assurance technique s,

interlaboratory comparisons, or other suitable

means, that its intrinsic standard measurement

results are correlated with those of national or

international standards.

(3) Where traceability to national standards of

measurement is not applicable, the laboratory

shall provide satisfactory evidence ofcorrelation

of results, for example by participation in a

suitable program ofinterlaboratory 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 of measurement 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 of measurement 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

EE-RM-90-201 COMMENT OOE3

(2) The overall program of calibration and/or 

verification and validation of equipment 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 and shall provide the measurement 

results and associated uncertainty of 

measurement and/or a statement of compliance 

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, the methodology of the Guide 

to the expression of uncertainty in measurement: 

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 

of NIST Measurement Results, is a practical 

application document written around the Guide 

to the expression of uncertainty in measurement. 

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 

Standard and the Iodine-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 of physics, 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 

NIST Handbook 150 25 

measurement assu rance tec hniqu es, 

interlaboratory comparisons, or other suitable 

means, that its intrinsic standard measurement 

results are correlated with those of national or 

international standards. 

(3) Where traceability to national standards of 

measurement is not applicable, the laboratory 

shall provide satisfactory evidence of correlation 

of results, for example by participation in a 

suitable program of interlaboratory 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 of measurement 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 of measurement 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 of items 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 of the 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) Calibration procedures shall contain

the required range and tolerance or

uncertainty of each item or unit parameter

being calibrated or verified. In addition,

the procedures shall contain the generic

description of the 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

with any 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 not affected. Well-defmed

and documented measurement assurance

techniques or uncertainty analyses may be

NIST Handbook 150 26

used to verify the adequacy of a

measurement process. Ifsuch techniques

are not used, then the collective

uncertainty of the measurement standards

shall not exceed 25 % of the acceptable

tolerance (e. g., manufacturer's

specification) for each 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

publishedby reputable technical organizations or

in relevant scientific texts or journals.

(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

fully documented and validated, and be available

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 for protecting the integrity of

data; such procedures shall include, but

not be limited to, integrity of data entry or

capture, data storage, data transmission

and data processing;

March 1994

EE-RM-90-201 COMMENT OOE3

(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 of items 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 of the 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) Calibration procedures shall contain 

the required range and tolerance or 

uncertainty of each item or unit parameter 

being calibrated or verified. In addition, 

the procedures shall contain the generic 

description of the 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 

with any 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 not affected. Well-defmed 

and documented measurement assurance 

techniques or uncertainty analyses may be 

NIST Handbook 150 26 

used to verify the adequacy of a 

measurement process. If such techniques 

are not used, then the collective 

uncertainty of the measurement standards 

shall not exceed 25 % of the acceptable 

tolerance (e. g., manufacturer's 

specification) for each characteristic of the 

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 

published by reputable technical organizations or 

in relevant scientific texts or journals. 

(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 

fully documented and validated, and be available 

to the client and other recipients of the 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 for protecting the integrity of 

data; such procedures shall include, but 

not be limited to, integrity of data 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 of calibration and test data;

(v) it establishes and implements

appropriate procedures for the maintenance

ofsecurity ofdata including the prevention

of unauthorized access to, and the

unauthorized amendment of, computer

records.

(8) Documented procedures shall exist for the

purchase, reception and storage of consumable

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 or test, where the item

does not conform to the description provided, or

where the calibration or test required is not fully

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 or damage to the calibration or test

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 of an 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

of the laboratory.

(5) Tamper-resistant seals shall be affixed to

operator-accessible controls or adjustments on

measurement standards or measuring and test

equipment which, if moved, will invalidate the

calibration. The laboratory's calibration system

shall provide instructions for the use of such

seals and for the disposition of equipment 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 shall contain sufficient information to permit

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.

NIST Handbook 150 27 March 1994

EE-RM-90-201 COMMENT OOE3

(iv) computer and automated equipment 

is maintained to ensure proper functioning 

and provided with the environmental and 

operating conditions necessary to maintain 

the integrity of calibration and test data; 

(v) it establishes and implements 

appropriate procedures for the maintenance 

of security of data including the prevention 

of unauthorized access to, and the 

unauthorized amendment of, computer 

records. 

(8) Documented procedures shall exist for the 

purchase, reception and storage of consumable 

materials used for the technical operations of the 

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 or test, where the item 

does not conform to the description provided, or 

where the calibration or test required is not fully 

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 or damage to the calibration or test 

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 a calibration 

or test item or portion of an 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 

of the laboratory. 

(5) Tamper-resistant seals shall be affixed to 

operator-accessible controls or adjustments on 

measurement standards or measuring and test 

equipment which, if moved, will invalidate the 

calibration. The laboratory's calibration system 

shall provide instructions for the use of such 

seals and for the disposition of equipment 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 of the calibration certificate, 

test certificate or test report for an appropriate 

period. The records for each calibration and 

test shall contain sufficient information to permit 

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, 

Ii> although it is encouraged as good laboratory 

under specific environmental conditions, these ~ practice. 

conditions shall be maintained, monitored and 

NIST Handbook 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 of calibrations 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 or test results and all information

required by the method used.

NOTE: It is recognized that the results of each

calibration do not always result in the

production of a 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 of the laboratory;

(iii) unique identification of the

certificate or report (such as serial

number) and of each page, and the total

number of pages;

(iv) name and address of client, where

appropriate;

NIST Handbook 150 28

(v) description and unambiguous

identification of the item calibrated or

tested;

(vi) characterization and condition of the

calibration or test item;

(vii) date ofreceipt of calibration or test

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 of the 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

EE-RM-90-201 COMMENT OOE3

(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 of calibrations 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 or test results and all information 

required by the method used. 

NOTE: It is recognized that the results of each 

calibration do not always result in the 

production of a 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 to ; 

(ii) name and address of laboratory, 

and location where the calibration or test 

was carried out if different from the 

address of the laboratory; 

(iii) unique identification of the 

certificate or report (such as serial 

number) and of each page, and the total 

number of pages; 

(iv) name and address of client, where 

appropriate; 

NIST Handbook 150 28 

(v) description and unambiguous 

identification of the item calibrated or 

tested; 

(vi) characterization and condition of the 

calibration or test item; 

(vii) date of receipt of calibration or test 

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 of the 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 
(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 of use; 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 of the certificate or report,

especially with regard to presentation of the

calibration or test data and ease of assimilation

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 in the form of a further

document, or data transfer including the

statement "Supplement toCalibration Certificate

(or Test Report or Test Certificate), serial

number. .. [or as otherwise identified] ", or

equivalent form of wording. 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.

NIST Handbook 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 of calibration 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 a calibration or test 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

report prominently indicating, "Thisreport

contains data which are not covered by the

NVLAP accreditation"; and

(ii) a clear indication of which data are

not covered by the accreditation.

The laboratory must not misrepresent its

accreditation. When a client requires or

requests accredited services and any of the

requested services are not covered by the

March 1994

EE-RM-90-201 COMMENT OOE3

(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 of use; 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 of the certificate or report, 

especially with regard to presentation of the 

calibration or test data and ease of assimilation 

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 in the form of a further 

document, or data transfer including the 

statement "Supplement to Calibration Certificate 

(or Test Report or Test Certificate), serial 

number. . . [or as otherwise identified] , , or 

equivalent form of wording. 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. 

NIST Handbook 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 of calibration 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 a calibration or test 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 

report prominently indicating, "This report 

contains data which are not covered by the 

NVLAP accreditation"; and 

(ii) a clear indication of which data are 

not covered by the accreditation. 

The laboratory must not misrepresent its 

accreditation. When a client requires or 

requests accredited services and any of the 

requested services are not covered by the 

March 1994 
accreditation, the client must be so

advised.

(I) Subcontracting of calibration or testing

(1) Where a laboratory subcontracts any part

of the 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

work being 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 of its subcontractors and maintain a

register of all subcontracting.

(3) A NVLAP-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 shown by a current

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

manner consistent with and inconformance

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 NVLAPNIST Handbook 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. "

if not 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 of calibrations

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 of outside 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

EE-RM-90-201 COMMENT OOE3

accreditation, the client must be so 

advised. 

(I) Subcontracting of calibration or testing 

(1) Where a laboratory subcontracts any part 

of the 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 

work being 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 of its investigation of the competence and 

compliance of its subcontractors and maintain a 

register of all subcontracting. 

(3) A NVLAP-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 shown by a current 

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 

manner consistent with and in conformance 

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 NVLAPNIST Handbook 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. " 

if not 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 of calibrations 

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 of outside 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 of all

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 to the calibrations ortests

concerned.

(1) The laboratory shall have documented

policy and procedures for the resolution of

complaints received from clients or other parties

about the laboratory's activities. A record 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 other relevant 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 or procedures, or with the requirements

of this section or otherwise concerning the

quality of the laboratory's calibrations or tests,

the laboratory shall ensure that those areas of

activity and responsibility involved are promptly

audited in accordance with Section 285.33(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 of M & TE.

(i) Calibration systemdescription: The

supplier shall provide and maintain a

written description of the

calibration/verification system covering 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.

NIST Handbook 150 31 March 1994

EE-RM-90-201 COMMENT OOE3

consumable materials are not used until they 

have been inspected, calibrated or otherwise 

verified as complying with any standard 

specifications relevant to the calibrations or tests 

concerned. 

(3) The laboratory shall maintain records of all 

suppliers from whom it obtains 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 from clients or other parties 

about the laboratory's activities. A record 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 or procedures, or with the requirements 

of this section or otherwise concerning the 

quality of the laboratory's calibrations or tests, 

the laboratory shall ensure that those areas of 

activity and responsibility involved are promptly 

audited in accordance with Section 285 .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 customer requirements. It is based in large 

~ 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 of M & TE. 

NIST Handbook 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, or is 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 other relevant 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) Calibration system description: The 

supplier shall provide and maintain a 

written description of the 

calibration/verification system covering 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) of this handbook.

(iii) Environmental conditions: M &

TE shall be used in an environment

controlled to the extent necessary 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 or verified 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 system must

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

NIST Handbook 150 32

specified conditions that do not

unreasonably impair the satisfaction ofthe

customer's requirements.

(v) Calibration procedures: 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: If any

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

condition with the 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 of the calibration system and to

ensure compliance with the requirements

of this 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 of this

handbook shall be supported by records

documenting that established schedules and

procedures are followed to maintain the

adequacy of all M & TE. The records for

M & TE requiring 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 of the calibration

source, calibration results (data and/or

condition status) and calibration action

taken (adjusted, repaired, new value

assigned, derated, etc.).

March 1994

EE-RM-90-201 COMMENT OOE3

(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) of this handbook. 

(iii) Environmental conditions: M & 

TE shall be used in an environment 

controlled to the extent necessary 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 or verified 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 system must 

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 of the calibration due 

date for limited periods of time under 

NIST Handbook 150 32 

specified conditions that do not 

unreasonably impair the satisfaction of the 

customer's requirements. 

(v) Calibration procedures: 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: If any 

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 

condition with the 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 of the calibration system and to 

ensure compliance with the requirements 

of this 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 of this 

handbook shall be supported by records 

documenting that established schedules and 

procedures are followed to maintain the 

adequacy of all M & TE. The records for 

M & TE requiring 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 of the 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 or adjustments

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 handbook to the degree necessary to

assure compliance with contractual

requirements. NVLAP accreditation ofthe

subcontractor's laboratory can serve as the

basis for compliance with thisrequirement.

(xii) Storage and handling: M & TE

shall be handled, stored, and transported in

a manner which shall not adversely affect

the calibration or condition of the

equipment.

NIST Handbook 150 33 March 1994

EE-RM-90-201 COMMENT OOE3

(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 or adjustments 

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 subcontr acto r 

calibration: The supplier is responsible for 

assuring that the subcontractor's 

calibration system conforms to 285.33(1) 

of this handbook to the degree necessary to 

assure compliance with contractual 

requirements. NVLAP accreditation of the 

subcontractor's laboratory can serve as the 

basis for compliance with this requirement. 

(xii) Storage and handling: M & TE 

shall be handled, stored, and transported in 

a manner which shall not adversely affect 

the calibration or condition of the 

equipment. 

NIST Handbook 150 33 March 1994 
NATIONAL VOLUNTARY LABORATORY

ACCREDITATION PROGRAM

NA1-IONAL INSTITUTE OF

STANDARDS AND TECHNOLOGY

DEPARTMENT OF COMMERCE

EE-RM-90-201 COMMENT OOE3

NATIONAL VOLUNTARY LABORATORY 

ACCREDITATION PROGRAM 

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.

EE-RM-90-201 COMMENT OOE3

NATIONAL VOLUNTARY LABORATORY 

ACCREDITATION PROGRAM 

NVLAP: IS A SYSTEM FOR ACCREDITING LABORATORIES 

FOUND COMPETENT TO PERFORM TEST METHODS 

OR CALlBRAT10N SERVICES. 

THE PROCESS ASSURES TH IRD PARTY INDEPENDENT 

EVALUATIONS. 

SUPPORTS PROGRAMS FOR VERIFICATION , CERTIFICATION 

AND DECLARATION METHODS FOR CONFORMANCE TO 

STANDARDS AN D TEST METHODS. 
NVLAP CURRENTLY

CONDUCTS ACCREDITATION OF

LABORATORIES FOR THE ENERGY EFFICIENT

LIGHTING PROGRAM

DEVELOPING AN ACCREDITATION OF

LABORATORIES PROGRAM FOR ENERGY

EFFICIENT ELECTRIC MOTORS

EE-RM-90-201 COMMENT OOE3

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

EE-RM-90-201 COMMENT OOE3

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 REQUIREM ENTS 

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

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

EE-RM-90-201 COMMENT OOE3

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.

EE-RM-90-201 COMMENT OOE3

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

EE-RM-90-201 COMMENT OOE3

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 Manu facturers 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

EE-RM-90-201 COMMENT OOE3

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 proposa ls 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

EE-RM-90-201 COMMENT OOE3

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 accr editation 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 periodi cally to ensure that anticipated benefits are being rea lized. 

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

of checklists.

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

EE-RM-90-201 COMMENT OOE3

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 

of checklists. 

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

EE-RM-90-201 COMMENT OOE3

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 AccreditationLJ : ;

ISO/lEe GUIDE 25 $

~~

.s'1"4TES of

LABORATORY, INC.

ANYTOWN, MD

is recognized under the National Voluntary Laboratory Accreditation Program for satisfactory compliance with

criteria established in 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 of Accreditation for:

LABORATORY ACCREDITATION PROGRAM

.T~nn~rv 1_ 199X

Effective until For the National Institute of Standards and Technology

EE-RM-90-201 COMMENT OOE3

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 Laboratory Accreditation Program for satisfactory compliance with 

criteria established in Title IS, Part 285 Code of Federal Regulations. This criteria encompasses the requirements 

of ISOIIEC Guide 25 and the relevant requirements of ISO 9002 (ANSI/ASQC Q92-198 7) as suppliers of 

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

LABORATORY ACCREDITATION PROGRAM 

January 1, 199X 

Effective until For the National Institute of Standards 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 of calibration 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 of the 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 of testing, 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 of America; and

(b) by NIST, provides that laboratory with the status of an accredited testing

laboratory in Canada;

Page 1 of 5

EE-RM-90-201 COMMENT OOE3

MUTUAL RECOGNITION AGREEMENT 

BETWEEN THE 

STANDARDS COUNCIL OF CANADA 

AND THE 

NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, 

UNITED STATES OF AMERICA 

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 of Standards and Technology (NIST). This MRA 

does not cover the accreditation of calibration 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 of the 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 of testing, 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 of America; 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

of the signing of this MRA

V. Resolution of Complaints

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 of such complaints.

Page 2 of 5

EE-RM-90-201 COMMENT OOE3

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 

of the signing of this MRA. 

V. Resolution of Complaints 

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 of such 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 of Standards 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

EE-RM-90-201 COMMENT OOE3

VI. Duration and Termina tion 

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 

By M~ 13 M (c;:~'( Title: Executive Director 

Standards Council of Canada 

Date: -----'~'----. ___ --+-_Z_7--+-/--"{-ty'---__ 

Designated Liaison Officer: 

Manager, PALCAN 

STANDARDS COUNCIL OF CANADA 

OTT A W A, 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 of Standards 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 of Canada (SCC)

Program for Accreditation of Laboratories - Canada (PALCAN)

and the

National Institute of Standards 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) of the Standards Council of Canada 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 of Canada (NRC).

3. Methods of Test

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 of data 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 of the

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

EE-RM-90-201 COMMENT OOE3

COMPARISON OF REQUIREMENTS FOR 

EVALUATION OF LABORATORIES 

Between 

The Standards Council of Canada (SCC) 

Program for Accreditation of Laboratories - Canada (pALCAN) 

and the 

National Institute of Standards and Technology (NIST), U.SA. 

National Voluntary Laboratory Accreditation 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) of the Standards Council of Canada 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 of Canada (NRC). 

3. Methods of Test 

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 of data 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 of the 

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 
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 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 of an application, or within three months to withdrawal of

an accreditation. When the assessors agree on the resolution of deficiencies, a final report of the 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 of SCC signs and issues the certificate of accreditation.

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 behalf of the 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

EE-RM-90-201 COMMENT OOE3

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 of an application, or within three months to withdrawal of 

an accreditation. When the assessors agree on the resolution of deficiencies, a final report of the assessment 

is submitted to the Testing Accreditation Sub-Committee (T ASC). 

8. Accreditation Process 

SCC has a three stage process: 

(1) The Assessment Team approves the Evaluation Report and recommends accreditation to T ASC; (2) the 

T ASC 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 of SCC signs and issues the certificate of accreditation. 

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 behalf of the 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 qua lity 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. La nguage 

NIST operates its program in English only, while SCC operates in both English and French. 

13. Cooperation and Ha nnonization 

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