§ 7.22 Assessing and evaluating a laboratory.

(a) Information used to evaluate a laboratory's compliance with the conditions for accreditation set out in § 7.32, the criteria for accreditation set out in §7.33, and the technical requirements established for each LAP will include:

(1) On-site assessment reports;

(2) Laboratory responses to identified deficiencies; and

(3) Laboratory performance on proficiency tests.

(b) The Director of OPSP shall arrange the assessment and evaluation of applicant laboratories by contract or other means in such a way as to minimize potential conflicts of interest.

(c) The Director of OPSP shall inform each applicant laboratory of any action(s) that the laboratory must take to complete the requirements for assessment and evaluation.

§7.23 Granting and renewing accreditation.

(a) The Director of OPSP, after reviewing an evaluation report, shall grant or renew, suspend, or propose to deny or revoke accreditation of an applicant laboratory, no later than 30 days following the date of submittal of the report. If accreditation action is not taken within this time limit, the Director of OPSP shall notify the laboratory stating the reasons for the delay.

(b) If accreditation is granted or renewed, the Director of OPSP shall:

(1) Provide a certificate of accreditation to the laboratory;

(2) Identify the scope and terms of the laboratory's accreditation;

(3) 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

(4) Remind the laboratory that accreditation does not relieve it from complying with applicable federal, state, and local laws and regulations.

(c) The Director of OPSP shall notify an accredited laboratory at least 30 days before its accreditation expires advising of the action(s) the laboratory must take to renew its accreditation.

(d) If an accredited laboratory fails to complete the assessment and evaluation process for renewal before its accreditation expires, the Director of OPSP shall notify the laboratory stating that its accreditation has expired and reiterating the action(s) the laboratory must take to renew its accreditation.

§ 7.24 Denying, suspending, and revoking accreditation.

(a) If the Director of OPSP proposes to deny or revoke accreditation of a laboratory, the Director of OPSP 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 request a hearing under the provisions of 5 U.S.C. 556. If the laboratory requests a hearing, the proposed denial or revocation will be stayed pending the outcome of the hearing held under provisions of 5 U.S.C. 556. 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.

(c) If the Director of OPSP finds that an accredited laboratory has violated the terms of its accreditation or the provisions of these procedures, the Director of OPSP may, after consultation with the laboratory, suspend the laboratory's accreditation, or advise of his/her intent to revoke its accreditation. If accreditation is suspended, the Director of OPSP 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. Conditions of suspension will include prohibiting the laboratory from using the NVLAP logo on its test reports during the suspension period. The determination of the Director of OPSP 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.

(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 Subpart D;

§ 7.25 Voluntary termination of accreditation.

A laboratory may at any time terminate its participation and responsibilities as an accredited laboratory by advising the Director of OPSP in writing of its desire to do so. The Director of OPSP shall terminate the laboratory's accreditation and shall notify the laboratory stating that its accreditation has been terminated in response to its request.

Subpart D-Conditions and Criteria for Accreditation

§ 7.31 Application of accreditation conditions and criteria.

(a) To become accredited and maintain accreditation, a laboratory must meet the conditions for accreditation set out in § 7.32 and the criteria set out in § 7.33 as tailored for specific LAPS.

(b) The conditions leading to accreditation include acceptance of the responsibilities of an accredited laboratory and requirements for information disclosure.

(c) The criteria are tailored and interpreted for the test methods, types of test methods, products, services or standards of the relevant LAP. These tailored criteria are the technical requirements for accreditation developed through the procedures of § 7.15. (d) In applying the conditions, criteria, and technical requirements for accreditation, the Director of OPSP shall not:

(1) Prohibit accreditation solely on the basis of a laboratory's affiliation or nonaffiliation with manufacturing, distributing, or vending organizations, or because the laboratory is a foreign firm; or

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(2) Develop, modify, or promulgate test methods, standards, or comparable administrative rules.

§ 7.32 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 tests representative of those for which it is seeking accreditation;

(3) Pay all relevant fees;

(4) Participate in proficiency testing as required:

(5) Be capable of performing the tests for which it is accredited according to the latest version of the test method within one year after its publication or within another time limit specified by the Director of OPSP;

(6) Limit the representation of the scope of its accreditation to only those tests or services for which accreditation is granted;

(7) Limit all its test work or services for clients to those areas where competence and capacity are available;

(8) Limit advertising of its accredited status to letterheads, brochures, test reports, and professional, technical, trade or other laboratory services publications, and use the NVLAP logo under guidance provided by the Director of OPSP;

(9) Inform its clients that the laboratory's accreditation or any of its test reports in no way constitutes or implies product certification, approval, or endorsement by NBS;

(10) Maintain records of all actions taken in response to testing complaints for a minimum of one year;

(11) Maintain an independent decisional relationship between itself and its clients, affiliates, or other organizations so that the laboratory's capacity to render test reports objectively and without bias is not adversely affected;

(12) Report to the Director of OPSP within 30 days any major changes involving the location, ownership, management structure, authorized representative, approved signatories, or facilities of the laboratory; and

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(13) Return to the Director of OPSP the certificate of accreditation for possible revision or other action should it: (i) Be requested to do so by the Director of OPSP;

(ii) Voluntarily terminate its accredited status; or

(iii) Become unable to conform to any of these conditions or the applicable criteria of § 7.33 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 covered in the accreditation request;

(4) General description of the laboEratory, including its facilities and

scope of operation; (5) Name and telephone number of the authorized representative of the laboratory;

(6) Names or titles and qualifications of laboratory staff nominated to serve as approved signatories of test reports that reference NVLAP accreditation; and

(7) Other information as may be needed for the specific LAP(s) in which accreditation is sought.

§7.33 Criteria for accreditation.

(a) Quality system. (1) The laboratory shall operate under an internal quality assurance program appropriate to the type, range, and volume of work performed. The quality assurance program must be designed to ensure the required degree of accuracy and precision of the laboratory's work and should include key elements of document control, sample control, data validation, and corrective action. The quality assurance program must be documented in a quality manual or equivalent (e.g., operations notebook) which is available for use by laboratory staff. A person(s) must be identified as having responsibility for maintaining the quality manual.

(2) The quality manual must include as appropriate:

(i) The laboratory's quality assurance policies including procedures for

corrective action for detected test discrepancies;

(ii) Quality assurance responsibilities for each fuction of the laboratory;

(iii) Specific quality assurance practices and procedures for each test, type of test, or other specifically delineated function performed;

(iv) Specific procedures for retesting, control charts, reference materials, and interlaboratory tests; and

(v) Procedures for dealing with testing complaints.

(3) The laboratory shall periodically review its quality assurance system by or on behalf of management to ensure it's continued effectiveness. These reviews must be recorded with details of any corrective action taken.

(b) Staff. (1) The laboratory shall:

(i) Be staffed by individuals having the necessary education, training, technical knowledge, and experience for their assigned functions; and

(ii) Have a job description for each professional, scientific, supervisory and technical position, including the necessary education, training, technical knowledge, and experience.

(2) The laboratory shall document the test methods each staff member has been assigned to perform.

(3) The laboratory shall have a description of its training program for ensuring that new or untrained staff are able to perform tests properly and uniformly to the requisite degree of precision and accuracy.

(4) The laboratory shall be organized:

(i) So that staff members are not subjected to undue pressure or inducement that might influence their judgment or results of their work; and

(ii) In such a way that staff memIbers are aware of both the extent and the limitation of their area of responsibility.

(5) The laboratory shall have a technical manager (or similar title) who has overall responsibility for the technical operations of the laboratory.

(6) The laboratory shall have one or more signatories approved by the Director of OPSP to sign test reports that reference NVLAP accreditation. Approved signatories shall:

(i) Be competent to make a critical evaluation of test results; and

(ii) Occupy positions within the laboratory's organization which makes them responsible for the adequacy of test results.

(c) Facilities and equipment. (1) The laboratory shall be furnished with all items of equipment and facilities for the correct performance of the tests and measurements for which accreditation is granted and shall have adequate space, lighting, and environmental control, and monitoring to ensure compliance with prescribed testing conditions.

(2) All equipment must be properly maintained to ensure protection from corrosion and other causes of deterioration. Instructions for a proper maintenance procedure for those items of equipment

which require periodic maintenance must be available. Any item of equipment or component thereof which has been subjected to overloading or mishandling, gives suspect results, or has been shown by calibration or otherwise to be defective, must be taken out of service and clearly labelled until it has been repaired. When placed back in service, this equipment must be shown by test or calibration to be performing its function satisfactorily.

(3) Records of each major item of equipment must be maintained. Each record must include:

(i) The name of the item of equipment;

(ii) The manufacturer's name and type, identification and serial number;

(iii) Date received and date placed in service;

(iv) Current location, where appropriate;

(v) Details of maintenance; and

(vi) Date of last calibration, next calibration due date, and calibration report references.

(d) Calibration. The laboratory shall:

(1) Calibrate new testing equipment before putting it into service;

(2) Recalibrate, at regular intervals, in-service testing equipment with the calibration status readily available to the operator;

(3) Perform checks of in-service testing equipment between the regular calibration intervals, where relevant;

(4) Maintain adequate records of all calibrations and recalibrations; and

(5) Provide traceability of all calibrations and reference standards of measurement where these standards exist. Where traceability of measurements to primary (national or international) standards is not applicable, the laboratory shall provide satisfactory evidence of the accuracy or reliability of test results (e.g., by participation in a suitable program of interlaboratory comparison).

(e) Test methods and procedures. The laboratory shall:

(1) Conform in all respects with the test methods and procedures required by the specifications against which the test item is to be tested, except that whenever a departure becomes necessary for technical reasons the departure must be acceptable to the client and recorded in the test report;

(2) Have data to prove that any departures from standard methods and/ or procedures due to apparatus design or for other reasons do not detract from the expected or required precision of the measurement;

(3) Maintain a test plan for implementing testing standards and procedures including adequate instructions on the use and operation of all relevant equipment, on the handling and preparation of test items (where applicable), and on standard testing techniques where the absence of such instructions could compromise the test. All instructions, testing standards, specifications, manuals, and reference data relevant to the work of the laboratory must be kept up-to-date and made readily available to the staff;

(4) Maintain measures for the detection and resolution of in-process testing discrepancies for manual and automatic test equipment and electronic data processing equipment, where applicable;

(5) Maintain a system for identifying samples or items to be tested, which remains in force from the date of receipt of the item to the date of its disposal, either through documents or through marking to ensure that there is no confusion regarding the identity of the samples or test items and the results of the measurements made; and

(2) Retain all original observations, calculations and derived data, and calibration records for one year unless a longer period is specified; and

(3) Hold records secure and in confidence, as required.

(g) Test reports. (1) The laboratory shall issue test reports of its work which accurately, clearly, and unambiguously present the specified test results and all required information. Each test report must include the following information as applicable:

(i) Name and address of the laboratory;

(ii) Identification of the test report by serial number, date, or other appropriate means;

(iii) Name and address of client; (iv) Description and identification of the test specimen, sample, or lot of material represented;

(v) Identification of the test specification, method, or procedure used;

(vi) Description of sampling procedure, if appropriate;

(vii) Any deviations, additions to, or exclusions from the test specifications; (viii) Measurements, examinations, and derived results supported by tables, graphs, sketches, and photographs, as appropriate, and any failures identified;

(ix) A statement of measurement uncertainty, where relevant;

(x) Identification of the organization and the person accepting technical responsibility for the test report and date of issue;

(xi) A statement that the report must not be reproduced except in full with the approval of the laboratory; and

(xii) A statement to the effect that the test report relates only to the items tested.

(2) The laboratory shall issue corrections or additions to a test report only by a further document suitably marked, e.g. "Supplement to test report serial number " which meets the relevant requirements of § 7.33(g)(1).

(3) The laboratory shall retain a copy of each test report issued for one year unless a longer period is specified by the Director of OPSP.

(4) The laboratory shall ensure that all test reports endorsed with the NVLAP logo are signed by an approved signatory.

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