National Voluntary Laboratory Accreditation Program

Federal RegisterMay 3, 1994

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DEPARTMENT OF COMMERCE

Office of the Secretary

15 CFR Part 7

National Institute of Standards and Technology

15 CFR Part 285

[Docket No. 930103-4017]

RIN 0693-AB15

National Voluntary Laboratory Accreditation Program

AGENCY: National Institute of Standards and Technology, Commerce.

ACTION: Final rule.

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SUMMARY: The Director of the National Institute of Standards and

Technology, United States Department of Commerce, is today issuing a

final rule making changes to regulations previously found at 15 CFR

part 7 pertaining to the operation of the National Voluntary Laboratory

Accreditation Program (NVLAP). The NVLAP procedures are redesignated as

part 285 of title 15 of the Code of Federal Regulations, and are

revised to expand the procedures to include accreditation of

calibration laboratories; update the procedures for compatibility with

conformity assurance and assessment concepts; assure consistency with

relevant International Organization for Standardization (ISO) documents

(e.g., ISO Guides 25, 38, 43, 58, and 9000); and 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 bi-lateral and multi-lateral

agreements.

EFFECTIVE DATE: This rule is effective June 2, 1994.

ADDRESSES: Albert D. Tholen, Chief, National Voluntary Laboratory

Accreditation Program, National Institute of Standards and Technology,

Building 411, room A162, Gaithersburg, MD 20899, telephone number (301)

975-4016.

FOR FURTHER INFORMATION CONTACT:

Albert D. Tholen, Chief, National Voluntary Laboratory Accreditation

Program, (301) 975-4016.

SUPPLEMENTARY INFORMATION: The Director of the National Institute of

Standards and Technology, (NIST) is today issuing a final rule making

changes to regulations previously found at 15 CFR Part 7 pertaining to

the operation of the National Voluntary Laboratory Accreditation

Program (NVLAP). NVLAP provides an unbiased third party evaluation and

recognition of laboratory performance, as well as expert technical

assistance to upgrade that performance, by accrediting calibration

laboratories and testing laboratories found competent to perform

specific tests or calibrations.

Competence is defined as the ability of a laboratory to meet the

NVLAP conditions set out in the NVLAP regulations and to conform to the

criteria in NVLAP publications for particular calibration and test

methods. Specifically, NVLAP accreditation indicates that a

laboratory's quality system, staff, facilities and equipment,

calibration protocols, methods and procedures, records and reports have

been evaluated and found to meet NVLAP criteria.

Accreditation is granted following successful completion of a

process which includes submission of an application and payment of fees

by the laboratory, an on-site assessment, resolution of any

deficiencies identified during the on-site assessment, participation in

proficiency testing, technical evaluation, and administrative review.

The accreditation is formalized through issuance of a Certificate of

Accreditation and Scope of Accreditation and is publicized by

announcement in various government and private media. NVLAP

accreditation does not imply any guarantee or certification of

laboratory performance or test/calibration data; it is solely a finding

of laboratory competence.

NVLAP accreditation is available to commercial laboratories,

manufacturers' in-house laboratories, university laboratories, and

federal, state and local government laboratories. Foreign-based

laboratories may also be accredited if they meet the same requirements

as domestic laboratories and pay any additional fees required for

travel expenses.

NVLAP is comprised of a series of laboratory accreditation programs

(LAPs) which are established on the basis of requests and demonstrated

need. Each LAP includes specific calibration and/or test standards and

related methods and protocols assembled to satisfy the unique needs for

accreditation in a field of testing, field of calibration, product or

service.

Description of the Changes

The NVLAP procedures are redesignated as part 285 of title 15 of

the Code of Federal Regulations; expanded to include accreditation of

calibration laboratories; updated for compatibility with conformity

assurance and assessment concepts; made consistent with relevant

International Organization for Standardization (ISO) documents (e.g.,

ISO Guides 25, 38, 43, 58, and 9000); revised to facilitate and promote

acceptance of calibration and test results between countries to avoid

barriers to trade; and to eliminate references to the NVLAP advisory

committee. Section D has been replaced with language essentially

identical to ISO Guide 25. 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 bi-lateral and multi-lateral

agreements.

Summary of Comments

On July 27, 1993, the National Institute of Standards and

Technology published a notice of proposed rulemaking in the Federal

associations, three manufacturers, one government agency, one

laboratory accrediting organization, one testing laboratory, and one

consultant commented. All eleven supported the proposal, especially the

changes in procedures that will result in achieving compatibility with

international standards and guides and broadening the scope of NVLAP to

include accreditation of calibration laboratories.

Other than recommendations to strengthen the national and

international recognition of NVLAP accredited laboratory data, the

comments covered a wide range of suggestions made by only one or two of

the respondents. Recommendations are addressed below with a summary

``Recommendation'' and a ``Response'' for each.

Comment. One accreditation organization and one consultant

suggested that NVLAP clarify Sec. 285.24 Denying, Suspending, and

revoking accreditation, to specify the conditions for making a

suspension decision vis-a-vis a revocation decision.

Response. Section 285.24 (e) clearly states that invoking

suspension or revocation ``will depend on the nature of the

violation(s)''. It is very difficult to be prescriptive because of the

vast possible combinations of laboratory operations and deficiencies.

Selecting suspension action implies the expectation that deficiencies

can be resolved before actual suspension is invoked; additionally, if

suspension is invoked, the expectation is that it will be rather short

lived. Revocation, in contrast, is clearly used in cases of more

serious deficiencies that are not likely to be resolved. The return of

the Certificate and Scope of Accreditation are required under

revocation; it is expected that suspension will be short lived,

therefore return of the Certificate and Scope are not required.

Comment. One manufacturer and one laboratory suggested that NVLAP

procedures should provide for an ``office of government liaison'' to

work toward reduction of redundant accreditation programs in the United

States to save laboratories the expense of paying for multiple

programs.

Response. Although redundant programs and multiple audits cause

confusion and added expense to accredited laboratories, NVLAP has no

authority to add a provision regarding redundant programs and/or

multiple audits. The NVLAP process is designed so that NVLAP itself

does not offer a LAP that duplicates one that exists or could be

offered by a public sector accreditor.

Comment. One consultant suggested that although a definition is

provided for the term ``Certificate of Accreditation'', a definition is

needed for the term ``Certificate'' as used in the definition of

``Reference material''.

Response. See NIST Special Publication 260, ``Standard Reference

Materials Catalog'', for definition and discussion of the term

``certificate'' as it applies to Standard Reference Materials. Defining

the term in the NVLAP procedures would be confusing and out of context

with its use.

Comment. One manufacturer suggested that part 285 should be

referenced in Sec. 285.6 NVLAP documentation.

Response. Section 285.6 (a) will be changed to include such a

reference.

Comment. One trade association suggested that NVLAP modify the

definition for Authorized Representative in Sec. 285.5 Definitions to

provide an organization with more flexibility in naming an Authorized

Representative.

Response. This section will be reworded to provide additional

flexibility by stating that the Authorized Representative of an

accredited laboratory may be an individual who is authorized by the

laboratory or the parent organization.

Comment. One manufacturer suggested adding a definition for

Competent to Sec. 285.5 Definitions.

Response. The definition of Competence will be added as ``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''.

Comment. One manufacturer suggested modifying the definition of

NVLAP in Sec. 285.5 Definitions to include its relationship to NIST.

Response. Agree. The definition for NVLAP will be changed to state

that NVLAP ``is an Office within the National Institute of Standards

and Technology''.

Comment. One trade association suggested changing the definition of

Traceability of the accuracy--in Sec. 285.5 Definitions by changing

``primary'' standard to ``reference'' standard.

Response. The definition is correct as written. Traceability

follows a path which may include the ``reference standard'' in the

laboratory but, as the definition states, must be traceable

``ultimately to a primary standard''.

Comment. One trade association suggested that Sec. 285.33 (k)

Certificates and reports identify the type of laboratory issuing the

certificate and report (e.g., independent, manufacturer's, etc.). It is

the belief of the writer of this comment that ``in-house'' laboratories

can not necessary produce ``unbiased'' results.

Response. No change is needed. Information describing the type of

laboratory accredited is provided by the laboratory in its application

and included in the NVLAP data base. However, the type of laboratory

has no bearing on the accreditation decision; rather, the accreditation

decision is based on the judgment (using results from on-site

assessments, proficiency testing, and monitoring visits) that the

laboratory meets all of the criteria established for a particular

Laboratory Accreditation Program (LAP), independent of the

``organizational'' association of the laboratory.

Comment: One consultant suggested revision of Sec. 285.23(a)

Granting and renewing accreditation to remove decisions based on

variations of compliance.

Response: Full compliance results in accreditation action. Less

than full compliance can result in accreditation or other actions

depending on variation from full compliance in terms of deficiencies

and the expectations of corrective action.

Comment: One consultant suggested that Sec. 285.23(b)(3) Granting

and renewing accreditation should contain a stronger statement than

``reminding'' laboratories of their legal obligations.

Response: NVLAP has no responsibility or authority to do more than

remind laboratories of this fact.

Comment: One trade association and one laboratory suggested that

Secs. 285.32(a)(10) and 285.33(b)(2)(ii) and (iii) be either deleted or

limited to ensure that the requirement for laboratories to avoid undue

or coercive commercial or financial pressures on staff are not applied

to the normal course of employer-employee and independent contractor

relationships of a manufacturer's in-house laboratory.

Response: These Sections clearly avoid undue interference by

limiting the requirement to ``pressures which might adversely affect

the quality of the work.'' Accreditation of a laboratory depends on

NVLAP's confidence that the laboratory will provide accurate test and

calibration services. These services must no be degraded by pressures

of any kind. NVLAP cannot deal with degrees or types of pressure, only

with the accuracy of data provided to customers.

Comment: One trade association suggested that NVLAP needs to

clarify its policy for addressing the recognition of foreign-based

laboratories based on accreditation by a foreign government or

accrediting organization.

Response: The policy will be clarified by adding to Sec. 285.11

Requesting a LAP a new paragraph (f) which states that ``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''.

Comment: One manufacturer suggested deleting the requirement in

Sec. 285.26 Change in status of laboratory for laboratories to advise

NVLAP of any change in location and/or configuration of its facilities.

Response: NVLAP must get this information prior to the laboratory

making any changes. The fact of moving or reconfiguration of a

laboratory could significantly affect the quality of its testing or

calibration activities.

Comment: One trade association suggested revising Sec. 285.32(a)(6)

Conditions for accreditation, to limit the services that a laboratory

offers to customers to NVLAP accredited areas.

Response: NVLAP accreditation does not limit the freedom of

laboratories to offer services outside the scope of accreditation.

NVLAP only limits laboratories from claiming accreditation for services

not included on their Scopes of Accreditation issued to the

laboratories.

Comment: One trade association asked that the regulation be made

more specific in defining the meaning of ``staffing'' in Sec. 285.26.,

stating that it is too broad.

Response: NVLAP believes that there are so many possibilities

regarding staffing changes that the reference needs to be general so

that an objective opinion can be made on the specific change proposed

or made. NVLAP focuses on staffing changes that could affect the

quality of the testing or calibration work.

Comment: One trade association suggested changing Sec. 285.33 (1)

Subcontracting of calibration or testing to limit subcontracting to

accredited laboratories only.

Response: This section is in full conformity with international

requirements which do not impose such a restriction. This is partly

based on the fact that no other accredited laboratory may be

geographically available or willing to provide the services needed.

NVLAP believes that its procedures for subcontracting will ensure that

the data provided by the subcontractor will meet the established

quality standards.

Comment. Two trade associations and one Government agency stated

that NVLAP procedures need to be more explicit regarding coordination

with the private and public sectors in defining the contents of a LAP,

especially when the LAP will be addressing regulatory responsibilities

of other agencies.

Response. NVLAP invites the participation of all interested parties

in the determination of need and in the design of a new accreditation

program (Secs. 285.15 and 285.16). The Federal Register, public

workshops, news releases, direct mailings to organizations and

associations, and participation in industry and professional meetings

are all mechanisms used in order to encourage such participation.

Comment. A trade association, a Government agency and an

accreditation organization commented that Sec. 285.12(b)(3) LAP

development decision does not adequately prevent a conflict of interest

for NIST in making LAP development decisions that could be in

competition with private sector accreditation programs.

Response. The conditions under which NVLAP establishes and operates

accreditation programs is explicit and addresses the conflict of

interest question. NVLAP believes that the requirements followed in

making a development decision are adequate and that NVLAP has guarded

against establishment of programs already existing or that could be

offered by private sector accreditors.

Comment. A trade association, a Government agency and an

accreditation organization commented that Sec. 285.18 Adding to or

modifying an established LAP should be strengthened to require NVLAP to

follow the same requirements for modifying a LAP as for establishing a

new LAP. NVLAP should not add test methods without going through a full

``need'' analysis.

Response. Every LAP is established after an exhaustive process that

includes the determination of need. Changes needed by a LAP sponsor,

caused by standards updated by standards bodies, or due to revisions in

regulatory requirements, must be made expeditiously so that the

accreditation program continues to meet the needs of its sponsor.

Comment. One manufacturer and one government agency suggested that

Sec. 285.13 Request from a government agency be revised to contain all

of the information required from a private sector organization

requesting a LAP (Sec. 285.14).

Response. The procedures to be followed by private sector

organizations and government agencies are, of necessity, different.

Regulatory and public service program authorities are specified in laws

and administrative procedures. Accreditation requirements established

by government agencies may contain the conditions noted in Sec. 285.14

and are automatically referenced in the specific authority establishing

a laboratory accreditation program.

NVLAP, however, agrees that the procedures do need to explicitly

address establishing or modifying NVLAP LAPs to meet the requirements

mandated by the Federal Government including legislative action and/or

intergovernmental understandings or agreements. Accordingly, section

285.1 is revised to state that NVLAP will operate 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

(Sec. 285.13); and (c) Requests from a private section organization

(Sec. 285.14)''.

In addition, Sec. 285.11, Requesting a LAP, is revised to provide

that following receipt of the identification of a mandate for a LAP

based on legislative or administrative action, the Director must

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. In addition, Sec. 285.12 is revised to

provide that the Director of NIST shall establish all LAPs on the basis

of need; and that a mandate to develop a LAP by NVLAP will be

interpreted as a defacto decision to develop the specified LAP, and a

LAP will be developed (or existing LAPs modified, if practical)

following these procedures.

Comment. In the context of the establishment of LAPs at the request

of Government agencies, one manufacturer stated that the proposed

change to the NVLAP procedures does not cover: (1) Requirements for

factory inspections as a part of certification; (2) certification

organizations; and (3) the need for a public review of the findings.

Further, the changes would allow the use of subcontractors who are not

independent of manufacturers, employers, and distributors.

Response. No changes are made. The comments reflect some of the

conditions of accreditation required by a government agency. These

kinds of conditions are normally addressed in gathering information

leading to a decision whether or not to develop a new LAP. The NVLAP

procedures can not be complete in anticipation of any and all possible

conditions required by a sponsor.

Comment. Three trade associations, two manufacturers, a Government

agency, an accreditation organization and a consultant each commented

on the need for more specifics regarding international trade,

international recognition of testing and calibration data, and

memoranda of understanding (MOUs) and mutual recognition agreements.

Most letters contained some reference to these issues, either pointing

out the need for explicit language recognizing international trade

interests such as ``reduction of non-tariff barriers''; working to

``make the program more acceptable nationally and internationally'';

stating that ``it is of great interest to U.S. manufacturers to have

U.S./EC recognized accreditation for testing to European

specifications''; and identifying the need to ``promote the acceptance

of calibration and testing results between countries to encourage

international trade''.

The comment was also made that the NVLAP revision should state that

inquiries from other countries regarding memoranda of understandings

(MOUs) and mutual recognition agreements (MRAs) will be referred to the

appropriate U.S. agency to participate in any detailed negotiations.

Response. Other than a general statement, the proposed regulation

did not specifically deal with these concerns.

Comment. One consultant suggested changing Sec. 285.22 Assessing

and evaluating a laboratory to eliminate the suggestion that NVLAP

provides consulting or legal services.

Response. Regarding consulting services, communications with

laboratories are in the context of these procedures, none of which

provide for consulting services. NVLAP identifies the deficiencies

noted; it is the responsibility of the laboratory, not NVLAP, to

determine how deficiencies will be rectified. Regarding legal services,

NVLAP provides guidance to the accredited laboratories on the

conditions for referencing accredited status; this is procedural, not

legal advice.

Comment. One consultant suggested that NVLAP expand and elaborate

Sec. 285.3 Description and goal of NVLAP to include additional

information explaining methods for achieving the various objectives and

goals in the section.

Response. The language in this section clearly defines the goals

and objectives of NVLAP. Methods for achieving these goals and

objectives are already contained in many other publications, including

NIST administrative procedures and various NVLAP programmatic

documents.

Comments. One trade association and one consultant suggested that

NVLAP reword Sec. 285.8 Referencing NVLAP accreditation, to remove the

implication that laboratories must advertise accredited status, etc.

Response. Section 285.8(a) has been revised to make clear that

advertising is voluntary.

Comment. One accreditation organization suggested that NVLAP should

not make any changes to Sec. 285.33 Criteria for accreditation in

response to comments received as a result of the Federal Register

notice because it is important that the NVLAP regulation remain

compatible with the ISO Guide 25. It was recommended that such changes

should be compiled for use in discussions at upcoming ISO meetings

related to changing ISO Guide 25.

Response. NVLAP agrees, and is doing this.

Comment. One accreditation organization suggested that ASTM

Standard E 1301 should be referenced instead of ISO Guide 38, which is

``no longer a viable standard''; ISO Guide 43 should not be referenced

because it is very general and being revised.

Response. Guides 38 and 43 served as reference to ensure that the

NVLAP procedures meet all current international requirements. In fact,

the NVLAP procedures are more robust than the procedures contained in

either Guide 38 or Guide 43. NVLAP is committed to meeting

international requirements for laboratory accreditation, therefore we

reference the ISO guides and standards. We also know that ISO

``equivalents'' are published by other standards bodies. However, we do

not plan to invest time in evaluating the equivalence of these

standards in order to reference them in our procedures.

Comment. One accreditation organization suggested that the

reference to ISO Series 9000 documents in Sec. 285.4 References might

imply that NVLAP accreditation also conveys ISO 9000 registration.

Response. Reference to the ISO Series 9000 does not imply that

NVLAP is an ISO 9000 registrar. However, NVLAP accepts the statement in

ISO Guide 25 that ``laboratories meeting the requirements of the Guide

comply with the relevant requirements of the ISO 9000 series of

standards including those of the model described in ISO 9002''.

Comment. One consultant suggested deleting reference to ISO 9004

because it is intended only as a guideline document for use by

operators of quality management systems and not for regulatory adoption

or referencing as being compatible.

Response. The entire ISO Series is referenced because of the strong

relationship of this series with the quality systems criteria of ISO

Guide 25.

Additional Information

Executive Order 12866

This final rule has been determined to be not significant for

purposes of Executive Order 12866.

Executive Order 12612

This rule does not contain policies with Federalism implications

sufficient to warrant preparation of a Federalism assessment under

Executive Order 12612.

Regulatory Flexibility Act

The General Counsel of the Department of Commerce has certified to

the Chief Counsel for Advocacy of the Small Business Administration

that this rule will not have a significant economic impact on a

substantial number of small entities because (1) participation in NVLAP

is entirely voluntary, and (2) the changes are primarily

administrative, affecting the management of the program rather than

laboratories seeking or holding accreditation. Further, the technical

components of NVLAP, that is, the specific technical criteria that

individual laboratories are accredited against, are not changed in any

significant way by this proposal.

Paperwork Reduction Act

The information collection requirements contained in this proposed

rule have been approved by the Office of Management and Budget under

the Paperwork Reduction Act and have been assigned OMB control number

0693-0003.

National Environmental Policy Act

This rule will not significantly affect the quality of the human

environment. Therefore, an environmental assessment or Environmental

Impact Statement is not required to be prepared under the National

Environment Policy Act of 1969.

List of Subjects in 15 CFR Part 285

Business and industry, Commerce, Laboratories, Measurement

standards.

Dated: April 25, 1994.

Mary Good,

Under Secretary for Technology, Department of Commerce.

Dated: April 19, 1994.

Samuel Kramer,

Associate Director, NIST.

For reasons set forth in the preamble, Title 15 of the Code of

Federal Regulations is amended as follows:

PART 7--[REDESIGNATED AS PART 285]

1. Part 7 is redesignated as part 285.

1a. The authority citation for part 285 is revised to read as

follows:

Authority: 15 U.S.C. 272 et seq.

PART 285--[AMENDED]

2. The Table of Contents for Part 285 is revised to read as

follows:

Subpart A--General Information

Sec.

285.1 Purpose.

285.2 Organization of procedures.

285.3 Description and goal of NVLAP.

285.4 References.

285.5 Definitions.

285.6 NVLAP Documentation.

285.7 Confidentiality.

285.8 Referencing NVLAP Accreditation.

Subpart B--Establishing a LAP

285.11 Requesting a LAP.

285.12 LAP development decision.

285.13 Request from a government agency.

285.14 Request from a private sector organization.

285.15 Development of technical requirements.

285.16 Coordination with federal agencies.

285.17 Announcing the establishment of a LAP.

285.18 Adding to or modifying an established LAP.

285.19 Termination of a LAP.

Subpart C--Accrediting a Laboratory

285.21 Applying for accreditation.

285.22 Assessing and evaluating a laboratory.

285.23 Granting and renewing accreditation.

285.24 Denying, suspending, and revoking accreditation.

285.25 Voluntary termination of accreditation.

285.26 Change in Status of Laboratory.

Subpart D--Conditions and Criteria For Accreditation

285.31 Application of accreditation conditions and criteria.

285.32 Conditions for accreditation.

285.33 Criteria for accreditation.

3. Section 285.1 is revised to read as follows:

Sec. 285.1 Purpose.

The purpose of part 285 is to set out procedures and general

requirements under which the National Voluntary Laboratory

Accreditation Program (NVLAP) operates 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 (Sec. 285.13); and

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).

4. Section 285.2 is revised to read as follows:

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.

5. Section 285.3 is revised to read as follows:

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 defined as the ability of a laboratory to

meet the NVLAP conditions (Sec. 285.32) and to conform to the criteria

(Sec. 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 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

NVLAPs requirements;

(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.

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 Sec. 285.11). 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.

6. Section 285.4 is revised to read as follows:

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 uncertainty 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).

7. Section 285.5 is revised to read as follows:

Sec. 285.5 Definitions.

Accreditation (of a laboratory): A formal recognition that a

laboratory is competent to carry out specific tests or calibrations or

types of test 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.

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).

Calibration: A set of operations which establish, under specified

conditions, the relationship between values indicated by a measuring

instrument or system, or values represented by a material measure, and

the corresponding known values of a measurand.

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.

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.

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.

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.

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.

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.

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 of laboratory performance by

means of comparing and evaluating calibrations or tests on the same or

similar items or materials by two or more laboratories in accordance

with predetermined conditions.

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.

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, 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.

Scope of accreditation: A document issued by NVLAP which lists the

test methods or services, or calibration services for which the

laboratory is accredited.

Sub-facility: A laboratory operating under the technical direction

and quality system of a main facility that is accredited.

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 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.

8. Section 285.6 is revised to read as follows:

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);

(b) Handbooks containing the administrative and operational

procedures and technical requirements of specific LAPs;

updated periodically; and

(d) Policy Guides that provide changes to the Procedures and

General Requirements and Handbooks between formal revisions of those

publications.

9. Section 285.7 is revised to read as follows:

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.

10. Section 285.8 is added to read as follows:

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.

(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.

11. Section 285.11 is amended by revising paragraphs (a), (b)(1),

(b)(3)(ii) and (c) and adding paragraphs (e) and (f) to read as

follows:

Sec. 285.11 Requesting a LAP.

(a) A request to establish a LAP must be made to the Director of

NIST.

(b) * * *

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

services, or testing services proposed for inclusion;

* * * * *

(3) * * *

(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;

* * * * *

according to paragraph (b) of this section.

* * * * *

(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.

(f) 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.

12. Section 285.12 is amended by revising paragraphs (a) and (b)(6)

to read as follows:

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 Sec. 285.13,

and private sector organizations by using Sec. 285.14.

(b) * * *

(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

* * * * *

13. Section 285.13 is amended by revising paragraphs (a) and (c) to

read as follows:

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.

* * * * *

Sec. 285.11(b).

* * * * *

14. Section 285.14 is amended by revising paragraphs (a)

introductory text and (c) to read as follows:

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:

* * * * *

Sec. 285.11(b).

* * * * *

15. Section 285.15 is amended by revising paragraphs (a) and (c) to

read as follows:

Sec. 285.15 Development of technical requirements.

(a) Technical requirements for accreditation are specific for each

LAP. The requirements tailor the criteria referenced in Sec. 285.33 to

the calibration or test methods, types of calibration or test methods,

products, services, or standards covered by the LAP.

* * * * *

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.

16. Section 285.17(c) is revised to read as follows:

Sec. 285.17 Announcing the establishment of a LAP.

* * * * *

recover its full costs, and shall, from time to time as necessary,

revise the fees for this purpose.

17. Section 285.18 is revised to read as follows:

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:

(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.

18. Section 285.19(a) is revised to read as follows:

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.

* * * * *

19. Section 285.21 is amended by revising paragraphs (a) and (c) to

read as follows:

Sec. 285.21 Applying for accreditation.

(a) A laboratory may complete and remit an application for

accreditation in any of the established LAPs.

* * * * *

require:

(1) Translation of laboratory documentation into English; and

(2) Payment of additional traveling expenses for on-site

assessments and proficiency testing.

20. Section 285.22 is revised to read as follows:

Sec. 285.22 Assessing and evaluating a laboratory.

(a) Information use to evaluate a laboratory's compliance with the

conditions for accreditation set out in Sec. 285.32, the criteria for

accreditation set out in Sec. 285.33, and the technical requirements

established for each LAP will include (not necessarily in this order):

(1) Application and other material submitted by the laboratory

(Sec. 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.

action(s) that the laboratory must take to qualify for accreditation.

21. Section 285.23 is amended by removing paragraph (d), and by

revising paragraphs (a) and (b) to read as follows:

Sec. 285.23 Granting and renewing accreditation.

(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;

(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.

* * * * *

22. Section 285.24 is revised to read as follows:

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 final 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 that 30-day period.

terms of its accreditation or the provisions of these procedures, NVLAP

may, after consultation with the laboratory, suspend the 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.

(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 Secs. 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.

23. Section 285.26 is added to read as follows:

Sec. 285.26 Change in status of laboratory.

Accreditation of a laboratory is based on specific conditions and

criteria including the laboratory ownership, location, staffing,

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.

24. Section 285.31 is revised to read as follows:

Sec. 285.32 Application of accreditation conditions and criteria.

To become accredited and maintain accreditation, a laboratory must

meet the conditions for accreditation set out in Sec. 285.32, the

criteria set out in Sec. 285.33, and the guidance provided in the

Handbooks for specific LAPs.

25. Section 285.32 is revised to read as follows:

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;

(8) Limit all its work or services of 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

(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 Sec. 285.33, and related technical requirements.

(b) To become accredited and maintain accreditation, a laboratory

shall supply, upon request, the following information:

(1) Legal name and full address;

(2) Ownership of the laboratory;

(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.

26. Section 285.33 is revised to read as follows:

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.

(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;

(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;

(x) Where appropriate, participate in interlaboratory comparisons

and proficiency testing programs.

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 quality documentation, shall

state the laboratory's policies and operational procedures established

in order to meet the requirements of procedures. The quality manual and

related quality documentation shall also contain:

(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 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.

(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. Where the audit findings

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.

(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 schemes using whenever possible

statistical techniques;

(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) Re-testing of retained items;

(vi) Correlation of results for different characteristics of an

item.

(d) Personnel. (1) The testing laboratory shall have sufficient

personnel, having the necessary education, training, technical

knowledge and experience for their assigned functions.

(2) The testing 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.

(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.

(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.

(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 defined and controlled.

(6) Adequate measures shall be taken to ensure good housekeeping in

the laboratory.

(f) 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:

(i) 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;

(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 out to date and planned for

the future;

(ix) History of any damage, malfunction, modification or repair.

(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.

(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 applicable 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.

(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.

(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.

(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.

(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, these 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 used 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;

(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 procedure 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. Were 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.

(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.

(2) All records (including those listed in Sec. 285.33(f)(4)

pertaining to calibration and test equipment), certificates and reports

shall be safely stored, held secure and in confidence to the client.

(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.

(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;

(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;

(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;

(xv) A statement that the certificate or report shall not be

reproduced except in full, without the written approval of the

laboratory.

(3) Where the certificate or report contains results of

calibrations or tests performed by sub-contractors, 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 for Test Report or Test Certificate), serial

number * * * for as otherwise identified]'', or equivalent form of

wording. Such amendments shall meet all the relevant requirements of

Sec. 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 of amendment

to a report or certificate.

(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.

(l) 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.

(m) Outside support services and supplies. (1) Where the laboratory

procures outside services and supplies, other than those referred to in

these procedures, 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 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 circumstances, 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 this section.

[FR Doc. 94-10449 Filed 5-2-94; 8:45 am]

BILLING CODE 3510-13-M

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.