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. § 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;

(c) A directory of accredited laboratories published annually and updated periodically; and

(d) Policy Guides that provide changes to the Procedures and General Requirements and Handbooks between formal revisions of those publications. § 285.7 Confidentiality.

To the extent permitted by applicable laws, NVLAP will seek to ensure confidentiality of all information obtained relating to the application, onsite assessment, proficiency testing, evaluation, and accreditation of laboratories.

§ 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.

[59 FR 22747, May 3, 1994]

Subpart B-Establishing a LAP

§ 285.11 Requesting a LAP.

(a) A request to establish a LAP must be made to the Director of NIST. (b) Each request must be in writing and must include:

(1) The scope of the LAP in terms of products, calibration services, or testing services proposed for inclusion;

(2) Specific identification of the applicable standards and test methods including appropiate designations, and the orgainizations or standards writing bodies having responsibility for them;

(3) A statement of need for the LAP including:

(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;

(ii) Evidence of a national need to accredit testing laboratories for the specific scope beyond that served by an existing laboriatory accreditation program in the public or private sector;

(iii) An estimate of the number of laboratories that may seek accreditation; and

(iv) An estimate of the number and nature of the users of such laboratories; and

(4) A stratement of the extent to which the requestor is willing to support necessary developmental aspects of the LAP with funding and personnel. (c) NVLAP may request clarification of the information submitted according to paragraph (b) of this section.

(d) Before determining the need for a LAP, the Director of NIST shall publish a FEDERAL REGISTER notice of the receipt of a LAP request if the request complies with §7.11(b). The notice will:

(1) Describe the scope of the requested LAP;

(2) Indicate how to obtain a copy of the request; and

(3) State that anyone may submit comments on the need for a LAP to NVLAP within 60 days of the date of the notice.

(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.

[49 FR 44623, Nov. 8, 1984, as amended at 55 FR 38314, Sept. 18, 1990. Redesignated and amended at 59 FR 22747, May 3, 1994]

§ 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 § 285.13, and private sector organizations by using § 285.14.

(b) After receipt of the request, the Director of NIST shall analyze it to determine if a need exists for the requested LAP. In making this determination, the Director of NIST shall consider the following:

(1) The needs and scope of the LAP initially requested;

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

(3) The nature and content of other relevant public and private sector laboratory accreditation programs;

(4) Compatibility with the criteria referenced in §7.33;

(5) The importance of the requested LAP to commerce, consumer wellbeing, or the public health and safety;

(6) The economic and technical feasibility of accrediting laboratories for the calibration or test methods, types of calibration or test methods, products, services, or standards requested; and

(7) Recommendations from written comments for altering the scope of the requested LAP by adding or deleting test methods, types of test methods, products, services, or standards.

(c) If the Director of NIST decides that a need has been demonstrated, and if resources are available to develop a LAP, NVLAP shall notify interested persons of the decision to proceed with development of a LAP.

(d) If the Director of NIST concludes that there is a need for a LAP but there are no resources for development, NVLAP shall notify the requestor and other interested persons of the decision not to proceed until resources become available.

(e) If the Director of NIST decides that a need for a LAP has not been demonstrated, NVLAP shall notify the requestor and other interested persons of the decision and the reasons not to proceed with development of a LAP.

[49 FR 44623, Nov. 8, 1984, as amended at 55 FR 38314, Sept. 18, 1990. Redesignated and amended at 59 FR 27748, May 3, 1994]

§ 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.

(b) Each request must be in writing and must include the information required in §7.11(b) and:

(1) A description of the procedures followed or a citation of the specific authority used to determine the need for a LAP; and

(2) For state and local government agencies, a statement of why the LAP should be of national scope.

(c) NVLAP may request clarification of the information required § 285.11(b).

by

(d) Before deciding to proceed with the development of a LAP, the Director of NIST shall publish a FEDERAL REGISTER notice of the receipt of a LAP request. The notice will indicate how to obtain a copy of the request and will state that anyone may submit comments on the need for a LAP to the requesting government agency within 60 days of the date of the notice.

(e) NVLAP shall notify interested persons of the decision to proceed or not to proceed with development of a LAP.

[49 FR 44623, Nov. 8, 1984, as amended at 55 FR 38314, Sept. 18, 1990. Redesignated and amended at 59 FR 27748, May 3, 1994]

§ 285.14 Request from a private sector organization.

(a) Any private sector organization which has determined a need to accredit laboratories for specific products, calibrations, or testing services, may request the Director of NIST to establish a LAP if it uses procedures meeting the following conditions:

(1) Public notice of meetings and other activities including requests for LAPS is provided in a timely fashion and is distributed to reach the attention of interested persons;

(2) Meetings are open and participation in activities is available to interested persons;

(3) Decisions reached by the private sector organization in the development of a request for a LAP represent substantial agreement of the interested persons;

(4) Prompt consideration is given to the expressed views and concerns of interested persons;

(5) Adequate and impartial mechanisms for handling substantive and procedural complaints and appeals are in place; and

(6) Appropriate records of all meetings are maintained and the official procedures used by the private sector organization to make a formal request for a LAP are made available upon request to any interested person.

(d) Before deciding to proceed with development of a LAP, the Director of NIST shall publish a FEDERAL REGISTER notice of the receipt of a LAP request. The notice will indicate how to obtain a copy of the request and will state that anyone may submit comments on the need for a LAP to the requesting private sector organization within 60 days of the date of the notice.

(e) NVLAP shall notify interested persons of the decision to proceed or not to proceed with development of a LAP.

[49 FR 44623, Nov. 8, 1984, as amended at 55 FR 38314, Sept. 18, 1990. Redesignated and amended at 59 FR 27748, May 3, 1994]

(a) Technical requirements for accreditation are specific for each LAP. The requirements tailor the criteria referenced in §285.33 to the calibration or test methods, types of calibration or test methods, products, services, or standards covered by the LAP.

(b) NVLAP shall develop the technical requirements based on expert advice. This advice may be obtained through one or more informal public workshops or other suitable means.

(c) NVLAP shall make every reasonable effort to ensure that the affected calibration or testing community within the scope of the LAP is informed of any planned workshop. Summary minutes of each workshop will be prepared. A copy of the minutes will be made available for inspection and copying at the NIST Records Inspection Facility. [49 FR 44623, Nov. 8, 1984, as amended at 55 FR 38315, Sept. 18, 1990. Redesignated and amended at 59 FR 27748, May 3, 1994]

§ 285.16 Coordination

agencies.

with

Federal

As a means of assuring effective and meaningful cooperation, input, and participation by those federal agencies

that may have an interest in and may be affected by established LAPs, NVLAP shall communicate and consult with appropriate officials within those agencies.

[49 FR 44623, Nov. 8, 1984, as amended at 55 FR 38315, Sept. 18, 1990. Redesignated at 59 FR 22745, May 3, 1994]

§ 285.17 Announcing the establishment of a LAP.

(a) When NVLAP has completed the development of the technical requirements of the LAP and established a schedule of fees for accreditation, NVLAP shall publish a notice in the FEDERAL REGISTER announcing the establishment of the LAP.

(b) The notice will:

(1) Identify the scope of the LAP; and (2) Advise how to apply for accreditation.

(c) NVLAP shall establish fees in amounts that will enable it to recover its full costs, and shall, from time to time as necessary, revise the fees for this purpose.

[49 FR 44623, Nov. 8, 1984, as amended at 55 FR 38315, Sept. 18, 1990. Redesignated and amended at 59 FR 22748, May 3, 1994]

§ 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. [59 FR 22748, May 3, 1994]

§ 285.19 Termination of a LAP.

(a) The Director of NIST may terminate a LAP when the Director of NIST determines that a need no longer exists to accredit laboratories for the services covered under the scope of the LAP. In the event that the Director of NIST proposes to terminate a LAP, a notice will be published in the FEDERAL REGISTER setting forth the basis for that determination.

(b) The notice published under paragraph (a) of this section will provide a 60-day period for submitting written comments on the proposal to terminate the LAP. All written comments will be made available for public inspection and copying at the NIST Records Inspection Facility.

(c) After the comment period, the Director of NIST shall determine if public support exists for the continuation of the LAP. If public comments support the continuation of the LAP, the Director of NIST shall publish a FEDERAL REGISTER notice announcing the continuation of the LAP. If public support does not exist for continuation, the LAP will be terminated effective 90 days after the date of the published notice of intent to terminate the LAP.

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

[49 FR 44623, Nov. 8, 1984, as amended at 55 FR 38315, Sept. 18, 1990. Redesignated and amended at 59 FR 27748, May 3, 1994]

Subpart C-Accrediting a
Laboratory

§ 285.21 Applying for accreditation.
(a) A laboratory may complete and
remit an application for accreditation
in any of the established LAPS.

(b) Upon receipt of a laboratory's application, NVLAP shall:

(1) Acknowledge receipt of the application;

(3) Confirm payment of fees before proceeding with the accreditation process; and

(4) Specify the next step(s) in the accreditation process.

(c) Accreditation of laboratories outside of the United States may require: (1) Translation of laboratory documentation into English; and

(2) Payment of additional traveling expenses for on-site assessments and proficiency testing.

[49 FR 44623, Nov. 8, 1984, as amended at 55 FR 38315, Sept. 18, 1990. Redesignated and amended at 59 FR 27748, May 3, 1994]

§ 285.22 Assessing and evaluating a laboratory.

(a) Information use to evaluate a laboratory's compliance with the conditions for accreditation set out in § 285.32, the criteria for accreditation set out in § 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

(§ 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.

(c) NVLAP shall inform each applicant laboratory of any additional action(s) that the laboratory must take to qualify for accreditation.

[59 FR 22748, May 3, 1994]

§ 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 Accredita

the laboratory;