MEMORANDUM OF UNDERSTANDING

between
The National Institute of Standards and Technology
and
The National Cooperation for Laboratory Accreditation

Final Version
July 7, 2000

Preamble

The National Institute of Standards and Technology (NIST) of the U.S. Department of
Commerce and the National Cooperation for Laboratory Accreditation (NACLA) hereby
state their commitment to develop and maintain a system in the U.S. that will (a)
recognize competent laboratory accreditation bodies to accredit testing and calibration
laboratories when the services of such laboratories are required to demonstrate
compliance with procurement, regulatory, and other requirements of government at all
levels – Federal, State, and local – and to meet the needs of the private sector, (b)
encourage the use by government and the private sector of such accreditation bodies, and
(c) recognize competent laboratory accreditation bodies to carry out specific activities in
support of NIST in its role as a designating authority under government-to-government
mutual recognition agreements and arrangements.

1 Purpose

1.1 NIST and NACLA agree on the need for a coordinated national approach to the
accreditation of testing and calibration laboratories to eliminate unnecessary
duplication and complexity in the development and promulgation of laboratory
accreditation requirements and measures by government at all levels and by the
private sector.

1.2 NIST and NACLA agree on the need for a coordinated national approach to the
accreditation of testing and calibration laboratories to support government-to-
government trade agreements.

1.3 NIST and NACLA recognize the need for improved communication between and
within the private and public sectors on laboratory accreditation requirements and
practices and the need for affected U.S. government agencies at all levels to
contribute to the development, implementation, and use of a system that reduces
redundancy and complexity (to the maximum extent possible) while still meeting
procurement, regulatory, and other requirements.

1.4 NIST and NACLA agree on the need to monitor reductions in duplicative audits
and requirements, as well as savings in resources and improvements in efficiency,
that result from the NACLA recognition process and to share their respective
findings on an annual basis.

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2 NIST Responsibilities

2.1 In accordance with its responsibilities under the National Technology Transfer and
Advancement Act of 1995 (Public Law 104-113), NIST will continue to coordinate
laboratory accreditation activities of Federal, State, and local entities with those of
the private sector and will strive to eliminate unnecessary duplication and
complexity in the development and promulgation of such requirements and
measures. NIST will encourage government agencies at all levels to accept the use
of laboratory accreditation bodies recognized by NACLA when testing and
calibration services are required to demonstrate compliance with procurement,
regulatory, and other requirements of the U.S. Federal Government and of State
and local governments. NIST will work with other U.S. Federal agencies to ensure
that agency-unique accreditation requirements are understood by NACLA and
incorporated to the extent possible in targeted evaluations by NACLA to minimize
duplication and inefficiency in laboratory accreditation activities. NIST intends to
use the provisions of this Memorandum of Understanding (MOU) to ensure that
NACLA recognition fulfills the needs of agencies in this area, through the
verification process referred to in Article 3.1 of this MOU.

2.2 Under the provisions of Section 286.2(b)(3) of Title 15 of the U.S. Code of Federal
Regulations, NIST has determined after public consultation that recognition of
laboratory accreditation bodies by NACLA provides a suitable alternative to direct
NIST recognition under National Voluntary Conformity Assessment System
Evaluation (NVCASE) procedures, and thus NIST intends to use the provisions of
this MOU to ensure that NACLA recognition fulfills requirements of the
international agreements and arrangements set forth in Articles 2.3 and 2.4 below.
Appendix A1 of this MOU lists specific technical requirements for each of these
agreements and arrangements.

2.3 In furtherance of NIST’s role in carrying out its responsibilities as a designating

authority, NIST will accept NACLA recognition of the competence of laboratory
accreditation bodies located in the United States to accredit testing laboratories to
meet the technical requirements for their acceptance by European Community
Member State governments under the Electromagnetic Compatibility (EMC)
Annex of the Agreement on Mutual Recognition between the United States of
America and the European Community. Individual laboratories located in the
United States and accredited by a NACLA-recognized laboratory accreditation
body accepted by NIST may apply to NIST for designation as Conformity
Assessment Bodies (CABs) under the Agreement, subject to the terms and
conditions of the Agreement.

2.4 Section 5.3 of the Inter-American (CITEL) Mutual Recognition Agreement for
Conformity Assessment of Telecommunications Equipment and Section 5.3 of the
Asia-Pacific Economic Cooperation Mutual Recognition Arrangement for

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Appendices A, B and C are integral parts of this Memorandum of Understanding.

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 Conformity Assessment of Telecommunications Equipment empower NIST, as a
designating authority, to appoint accreditation bodies located in the United States to
accredit laboratories that may then be designated by NIST as Conformity
Assessment Bodies (CABs) for specified scopes of testing activity. Whenever a
laboratory accreditation body located in the United States obtains recognition by
NACLA in a technical area that permits the laboratory accreditation body to
accredit laboratories to conduct tests to assess conformance to specific legal,
regulatory, and administrative requirements covered under either the CITEL
Agreement or the APEC Arrangement, and upon application to NIST documenting
NACLA recognition, NIST will appoint that body to be an accreditation body
under the relevant framework. NIST shall promptly withdraw the appointment
should the laboratory accreditation body cease to be recognized by NACLA in the
relevant technical area. Individual laboratories located in the United States and
accredited by a laboratory accreditation body that has been appointed by NIST
under this section may apply to NIST for designation as CABs under the CITEL
Agreement and/or the APEC Arrangement, subject to the terms and conditions of
each.

2.5 NIST will encourage laboratory accreditation bodies, including those bodies whose
services are used by Federal, State, and local government for procurement,
regulatory, trade, and other support purposes, to seek NACLA recognition.

2.6 NIST will work with Federal, State, and local agencies to monitor reductions in
duplicative audits and requirements, as well as savings in resources and
improvements in efficiency, that result from the NACLA recognition process. NIST
will share these findings with NACLA on at least an annual basis.

2.7 NIST representatives will inform NACLA of developments and changes in Federal,
State, and local government policy with regard to laboratory accreditation, in a
reasonable timeframe whenever NIST becomes aware of such new developments
and changes.

2.8 NIST representatives will participate as appropriate in the activities of NACLA.

3 NACLA Responsibilities

3.1 NACLA has developed and implemented a program for recognizing competent
laboratory accreditation bodies through the use of accepted international standards
and guides and operates in compliance with relevant national and international
standards and guides. NACLA will continue to conduct this program and will
submit to periodic third party assessments as deemed necessary by the Director of
NIST Technology Services to verify that NACLA recognition of laboratory
accreditation bodies is carried out in conformance with the criteria in Appendix B
of this MOU. NIST will verify NACLA conformance using the process outlined in
Appendix C. NACLA will maintain integrity and impartiality in the way it applies
relevant standards and guides and judges conformity to them, and will not show

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 undue preference for one competent laboratory accreditation body versus another.
In addition, NACLA will, in consultation with and with the approval of the Director
of NIST Technology Services, establish impartial and objective procedures and
policies for the resolution of appeals made against NACLA recognition decisions.
These procedures may include the use of Alternative Dispute Resolution as
appropriate.

3.2 NACLA will encourage the private sector to specify the use of laboratory
accreditation bodies recognized by NACLA when testing and calibration services
are required to demonstrate compliance with procurement, regulatory, trade, and
other requirements. NACLA will also so encourage the public sector.

3.3 NACLA will encourage laboratory accreditation bodies, including those whose
services are used by the private sector to demonstrate compliance with
procurement, regulatory, trade, and other requirements, to seek NACLA
recognition.

3.4 Building on the existing NACLA program for recognizing competent laboratory
accreditation bodies through the use of accepted international standards and guides,
NACLA will evaluate the competence of laboratory accreditation bodies to accredit
testing and calibration laboratories to meet the legal, regulatory, and administrative
requirements necessary for their acceptance by foreign governments under the
provisions of those agreements and arrangements specified in Articles 2.3 and 2.4
of this MOU.

3.5 NACLA will work with the private sector to monitor reductions in duplicative
audits and requirements, as well as savings in resources and improvements in
efficiency, that result from the NACLA recognition process. NACLA will share
these findings with NIST on at least an annual basis.

4 Other Understandings, Agreements, and Arrangements

4.1 Nothing in this MOU precludes either NIST or NACLA from entering into other
MOUs, agreements, or arrangements related to laboratory accreditation.

5 Reviews

5.1 Officials of NIST and NACLA will meet at least annually to review this MOU,
cooperative efforts of the previous year, and plans for the coming year.

6 Term

6.1 This MOU will remain in effect for a period of 5 (five) years from the date of the
last signature below. It may be extended for additional periods by mutual
agreement of the two parties. It may be amended by agreement of the two parties
or terminated with 30 (thirty) days written notice by either party.

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Original signed by: Original signed by:

Donald Heirman Richard F. Kayser

President Director, Technology Services
NACLA NIST

Date: Date:

MOU signed at the NACLA Board Meeting

Toronto, Canada, July 13, 2000

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 APPENDIX A

SPECIFIC TECHNICAL REQUIREMENTS

FOR INTERNATIONAL AGREEMENTS AND ARRANGEMENTS

1. Agreement on Mutual Recognition between the United States of America and the
European Community (U.S.-EU MRA) – EMC (Electromagnetic Compatibility)
Sectoral Annex

Introduction

In order to ensure conformance of a product with Council Directive 89/336/EEC (the

EMC Directive), Article 10.2, when a manufacturer has not applied any, or has applied
only part, of the standard(s) referred to in Article 7(1), the manufacturer must utilize the
services of a Competent Body. In such a situation the Competent Body will be required
to develop a Technical Construction File (TCF) that describes the apparatus, sets out the
procedures used to ensure conformity of the apparatus with the protection requirements
referred to in Article 4 and include a technical report or certificate obtained from the
Competent Body. Under the U.S.-EU MRA, EMC Annex, a U.S. body may be
designated as a Conformity Assessment Body (CAB) and will thus operate as the
equivalent of a Competent Body. ( EMC CAB Type 1)

U.S. CAB Requirements

EMC CAB Type 1: This type of CAB shall be accredited by an accreditor that has been
recognized by NIST to be in conformance with ISO/IEC Guide 58. The CAB must
operate in accordance with ISO/IEC International Standard 17025: General Requirements
for the Competence of Testing and Calibration Laboratories, or in the short term prior to
complete implementation of ISO/IEC International Standard 17025, with ISO/IEC Guide
25: General Requirements for the Competence of Calibration and Testing Laboratories.
A CAB may use any appropriate technical standard that it, or the manufacturer, chooses
to examine the product. The scope of accreditation must include test methods relevant to
the claimed scope of competence of the CAB.

The CAB must also demonstrate its capability to evaluate data relevant to assess the
conformity of products covered by the EMC directive, regardless of whether the
manufacturer has applied relevant harmonized standards. The body must be able to
demonstrate knowledge of the EMC Directive and, in particular, knowledge of how to
develop or evaluate a TCF. NIST will continue to be responsible for ensuring the
technical competence of CABs for these additional activities, which are not covered by
accreditation to ISO/IEC Guide 25 or ISO/IEC IS 17025.

CAB Restrictions

The United States can only designate a CAB located in the United States. During the
transition phase of the MRA, which extends through December 3, 2000 and provides for

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mutual acceptance of test data and reports by the MRA Parties, a U.S. CAB must send all
TCF evaluation reports and dossiers for type examination certificates to an EU competent
body for approval. This restriction will not apply after the MRA enters its operational
phase, at which time listed U.S. CABs can carry out all of the activities of an EU
Competent Body.

Subcontracting

A CAB may subcontract some evaluation activities to another body. However, the CAB
will be fully responsible for all subcontracted work, e.g., test data, review of dossier
results, etc.

2. Asia-Pacific Economic Cooperation (APEC) Mutual Recognition Arrangement for

Conformity Assessment of Telecommunications Equipment, Phase 1

Introduction

Under Phase 1 procedures of the APEC MRA, partner economy regulatory bodies agree
to mutually accept test data supplied with an application for equipment approval that
supports the claim that equipment complies with the regulations. At the current time
participating APEC partner economies are Australia, Canada, Japan, Korea, Singapore,
Taiwan, the United States and Hong Kong.

The specific technical requirements for each economy are different and varied. In some
cases a partner economy will accept test data produced using accepted international
standards/methods, other countries’ standards/methods, or other standards/methods that
are appropriate for the specific application. In some cases the partner requires that only
its own standards/methods be used.

U.S. CAB Requirements

A U.S. CAB must be accredited to ISO/IEC International Standard 17025: General

Requirements for the Competence of Testing and Calibration Laboratories, or in the
short term prior to complete implementation of ISO/IEC International Standard 17025, to
ISO/IEC Guide 25: General Requirements for the Competence of Calibration and Testing
Laboratories to perform the required testing, by a NIST-recognized accreditor that
complies to ISO/IEC Guide 58. The specific technical requirements can be found at the
individual websites as indicated below. In addition to being capable of carrying out
specific test methods, a CAB must understand each individual partner’s regulations and
the approval process for the equipment that they desire to be designated to test.

Website List

NIST Conformity Assessment: http://ts.nist.gov/mra

APEC MRA: http://apii.or.kr/telwg click: MRA Task Group, Task Group input
documents

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Australia: http://www.dcita.gov.au
Canada: http://strategis.ic.gc.ca
Hong Kong: http://www.ofta.gov.hk
Japan: http://mpt.go.jp
Korea: http://www.mic.gov.kr (Korean only)
Singapore: http://www.tas.gov.sg
Taiwan: EMC: http://www.bsmi.gov.tw
Telecom: http://www.dgt.gov.tw

CAB Restrictions

The United States can only designate a CAB located in the United States.

Subcontracting

A CAB may subcontract some evaluation activities to another body. However, the CAB
will be fully responsible for all subcontracted work, e.g., test data, review of dossier
results, etc.

3. Asia-Pacific Economic Cooperation (APEC) Mutual Recognition Arrangement for

Conformity Assessment of Telecommunications Equipment, Phase 1 – Bilateral
Implementing Agreement between the United States of America and Chinese Taipei

Telecommunication Equipment Requirements

Under the Taiwan Telecommunications Act, telecommunications equipment approval is

the responsibility of the Directorate General for Telecommunications (DGT). Under the
terms of Phase I procedures of the APEC MRA, DGT has agreed to accept test reports
issued by CABs designated by NIST to be used in the equipment approval process.

Article 42 of the Telecommunications Act stipulates that three basic principles must be
satisfied concerning technical standards and requirements for telecommunications
terminal equipment:

1. The connection shall cause neither damage to the telecommunications machinery

and line facilities of a Type I telecommunications enterprise nor faults in the
performance of such facilities.
2. Other users of the telecommunications machinery and line facilities of a Type I
telecommunications enterprise shall not be injured.
3. A clear division of duties in regards to the telecommunications machinery and
line facilities of a Type I telecommunications enterprise and the terminal
equipment connected by users shall be ensured.

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Laboratory Criteria for Designation by NIST

In order for a U.S. laboratory to be designated as a CAB to test covered

telecommunications equipment and issue test reports acceptable to the DGT, the
laboratory shall satisfy the following criteria:

1. The laboratory shall be accredited to conduct applicable test methods of its choice
according to its particular interest and demonstrated competence.
2. An accredited laboratory must be familiar with the DGT requirements applicable
to their scope of activity. The DGT requirements for all covered products can be
found at their website http://www.dgt.gov.tw.

Some of the DGT technical regulations have specified test methods that must be used,
others do not have such specification. The laboratory may select which test method(s)
that it will use according to the following:

A. When specified – the specified Chinese National Standard (CNS)

B. When not specified – any test method that it is accredited to perform which will
satisfy the specific DGT requirement:
1. Chinese National Standard (CNS)
2. International Telecommunications Union (ITU) standard
3. Other international standard, e.g. ISO/IEC
4. Local standard

Note: Additional requirements for EMC are contained in a separate supplement available
on request from NIST

4. Inter-American (CITEL) Mutual Recognition Agreement for Conformity

Assessment of Telecommunications Equipment, Phase I

The CITEL MRA has not progressed far enough to begin the Conformity Assessment
Body (CAB) designation process, but it will require accredited test laboratories under
Phase I procedures. Participating CITEL economies will most likely be at least
Argentina, Brazil, Chile, Mexico, and the United States.

U.S. CAB Requirements

A U.S. CAB must be accredited to ISO/IEC International Standard 17025: General

Requirements for the Competence of Testing and Calibration Laboratories, or in the
short term prior to complete implementation of ISO/IEC International Standard 17025, to
ISO/IEC Guide 25: General Requirements for the Competence of Calibration and Testing
Laboratories to perform the required testing, by a NIST-recognized accreditor that
complies to ISO/IEC Guide 58. In addition to being capable of performing specific test
methods, a CAB must understand each individual partner’s regulations and the approval
process for the equipment that they desire to be designated to test.

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 APPENDIX B

GENERIC REQUIREMENTS, PROCEDURES, AND CONDITIONS FOR

ACCREDITATION BODY RECOGNITION

1.0 INTRODUCTION

This document specifies the generic requirements, procedures, and conditions for
accreditation body recognition. This document was developed with reference to existing
international guides and standards and is not intended to supercede or contradict the
principles represented in those documents.

2.0 ACCREDITOR REQUIREMENTS

The basic generic criteria that an accreditor must satisfy are contained in ISO/IEC Guide
58: Calibration and Testing Laboratory Accreditation Systems - General requirements
for Operation and Recognition. An accreditor shall accredit laboratories against ISO/IEC
International Standard 17025: General Requirements for the Competence of Testing and
Calibration Laboratories, or in the short term prior to complete implementation of
ISO/IEC International Standard 17025, against ISO/IEC Guide 25: General Requirements
for the Competence of Calibration and Testing Laboratories. Other additional
requirements or specifications mandated by law or contract shall also be taken into
account where applicable.

3.0 ACCREDITATION BODY EVALUATION PROCESS

The process of evaluating an accreditation body for recognition consists of a number of

activities, which must take place prior to and after granting recognition. The process
consists in general of a review of the accreditation body’s quality system, on-site
evaluation/re-evaluation of the premises, witness audits of assessments performed by the
accreditation body’s assessors, writing an evaluation report, review of accreditation body
response to the evaluation report, and final evaluation and decision. Surveillance
activities and on-site reevaluation visits of recognized accreditors are conducted
periodically.

3.1 Quality System Review and Evaluation

An accreditation body seeking recognition must submit copies of its quality

documentation for review and evaluation. The documentation must show that the quality
system promotes an adequate level of performance and quality management. If the
accreditation body cannot submit documentation in advance, the quality system review
and evaluation can be performed during the on-site evaluation.

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3.2 On-site Evaluation

An on-site evaluation of an accreditation body’s facilities is conducted prior to initial

recognition and at regular intervals thereafter, as specified by relevant national or
international practice, unless the recognition is terminated. The evaluation encompasses
an on-site review of selected procedures and operations for all sites involved in the
accreditation activities that the recognition would cover. An accreditation body may
appeal the inclusion of any member of the evaluation team proposed for the on-site
evaluation. Such appeal must be received in writing no later than 20 working days after
notification of the accreditation body of the membership of the evaluation team and must
provide a substantive reason for a change to be made.

3.3 Witness Audits/Assessments

As part of the evaluation process, an accreditation body must allow members of the
evaluation team to witness the accreditation body’s auditors/assessors performing an
assessment/audit of a client’s facilities. The number and identity of the witness audits to
be performed will be determined in consultation with the accreditation body. As a
general practice, at least two witness audits will be performed.

3.4 Final Report

The evaluation team prepares a final report after the evaluation and forwards it to the
accreditation body. The final report usually will be essentially the same as the draft report
unless additional information has been uncovered or issues that require clarification have
arisen.

The final report normally presents the definitive findings of the evaluation. However, if
additional information surfaces with significant bearing on the evaluation, a
supplementary report may be necessary. Any supplementary report that requires action
will be promptly forwarded to the accreditation body.

3.5 Accreditation Body Response to Evaluation Report/Deficiency Notification

The accreditation body must respond in writing to all identified deficiencies. All
specific corrective actions taken, and proposed plans to resolve each deficiency, must be
described in writing. Plans must include specific actions, time frames, dates, etc. In
some cases, an additional on-site visit may be necessary to observe stated resolutions.

Accreditation bodies holding a current valid recognition must respond to any deficiencies
identified within 30 days of receipt of a notification and have an approved plan to
implement the corrective actions within 90 days of receipt or recognition may be
suspended until full conformance is demonstrated.

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3.6 Final Evaluation Decision

Upon completion of all evaluation activities, an evaluation panel will be convened to

review all information collected regarding an accreditation body and make a final
decision on the appropriate recognition action to take. The decision is based on the
review and evaluation of all materials submitted by the accreditation body, reports
covering the quality system review, on-site evaluation(s) report, witness audit reports,
and deficiency resolution information.

3.7 Surveillance

A full or partial on-site visit or other forms of surveillance of a recognized accreditor or

any accredited body may be conducted to observe or verify conformance with program
requirements. Any deficiencies noted as a result of surveillance must be responded to in
accordance with Paragraph 3.5 above.

4.0 PROGRAM ACTIONS

A program for recognition of accreditation bodies shall have in place procedures for
granting, denying, suspending or terminating recognition of an accreditor. Accreditors
subject to an adverse action shall be provided with at least the following options: appeal
of the decision, submission of additional information for further evaluation, or acceptance
of the decision. The appeals process shall be clearly defined and may include the use of
Alternative Dispute Resolution as appropriate.

5.0 OBLIGATIONS OF A RECOGNIZED ACCREDITOR

5.1 Continuous Conformance

It shall be incumbent upon a recognized accreditor to conform to all requirements

throughout the period of participation. Failure to maintain conformance is cause for
suspension or termination of recognition.

5.2 Proper Use of Recognized Status and Claims

A recognized accreditor shall not make any claim which:

a) constitutes or implies certification, approval, or endorsement of any product

manufactured or entered into commerce in the United States based on its
recognition;
b) constitutes or implies that the accreditor or an accredited body is recognized for
any activities other than those specifically stated in the recognition documents.

A recognized accreditor must follow documented guidance when advertising its

recognition status on letterheads and in brochures, reports, and professional, technical,
trade, and other publications.

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 APPENDIX C

NIST VERIFICATION PROCESS

This Appendix outlines the NIST process, referenced in Article 3.1 of the NIST-NACLA
Memorandum of Understanding (MOU), for verifying that (1) NACLA recognition of
laboratory accreditation bodies is carried out in conformance with the technical criteria
found in Appendix B of the MOU, and (2) NACLA recognition fulfills the requirements
of the international agreements and arrangements set forth in Article 2.3, Article 2.4, and
Appendix A of the MOU.

The NIST verification process will include the following elements:

1. NIST will compare the NACLA Recognition Procedures with Appendix B of the
MOU to determine that Appendix B criteria have been adequately addressed.
a. NIST will ensure that accreditation bodies and laboratories have copies and
understand the technical requirements set forth in intergovernmental agreements
(Appendix A) or U.S. government agency specifications. NIST will work with
other Federal agencies to define these specifications when requested to do so by
NACLA.
2. NIST will review NACLA's plan to build on the existing general NACLA recognition
program to take into account the supplemental technical criteria listed in Appendix A
of the MOU or contained in U.S. government agency specifications.
3. A NIST representative will participate as an observer or as an evaluation-team
member for all initial evaluations of laboratory accreditation bodies seeking
recognition for any activity or activities covered under the provisions of the NIST-
NACLA MOU.
4. A NIST representative will participate on NACLA acceptance panels considering
laboratory accreditation bodies for recognition for any activity or activities covered
under the provisions of the NIST-NACLA MOU.

It is understood that initial implementation of the NIST-NACLA MOU will necessitate

putting in place an interim process for those laboratory accreditation bodies that have
completed the NACLA evaluation process prior to the MOU being put in place, and that
are either candidates for NACLA recognition or have already obtained NACLA
recognition. In these cases, NIST representatives will review the NACLA evaluation
team reports on accreditation body evaluations to verify that written criteria have been
addressed by evaluation teams and to confirm that identified nonconformances have been
addressed by the accreditation body being evaluated. If necessary, in advance of the
completion of the NACLA plan referenced in Item 2 above, NIST and NACLA will
jointly develop an interim witness audit plan to evaluate conformance to supplemental
technical requirements outlined in Appendix A of the MOU or contained in U.S.
government agency specifications.

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