which an accredited laboratory may refer to its accredited status, or both.

(c) Quality system. (1) An approved/ recognized accreditation body shall operate a quality system appropriate to the type, range and volume of work performed. This system shall be documented and the documentation shall be available for use by the accreditation body staff. The accreditation body shall designate a person having direct access to its highest executive level, to take responsibility for the quality system and the maintenance of the quality documentation.

(2) The quality system shall be documented in a quality manual and associated quality procedures, and the quality manual shall contain or refer to at least the following;

(i) A quality policy statement; (ii) The organizational structure of the accreditation body;

(iii) The operational and functional duties and services pertaining to quality, so that each person concerned will know the extent and the limits of their responsibility;

(iv) Administrative procedures including document control;

(v) Policies and procedures to implement the accreditation process;

(vi) Arrangements for feedback and corrective actions whenever discrepancies are detected;

(vii) The policy and procedures for dealing with appeals, complaints and disputes;

(viii) The policy and procedures for conducting internal audits;

(ix) The policy and the procedures for conducting quality system reviews;

(x) The policy and the procedures for the recruitment and training of assessors and monitoring their performance.

(3) An approved/recognized accreditation body shall audit its activities to verify that they comply with the requirements of the quality system. The quality system shall also be reviewed to ensure its continued effectiveness. Audits and reviews shall be carried out systematically and periodically and recorded together with details of any corrective actions taken.

(4) An approved/recognized accreditation body shall maintain records to demonstrate that accreditation procedures have been effectively fulfilled,

particularly with respect to application forms, assessment reports, and reports relating to granting, maintaining, extending, suspending or withdrawing accreditation. These accreditation documents shall form part of the record.

(5) An approved/recognized accreditation body shall have a policy and procedures for retaining records. The records shall be retained for a period of at least 5 years, and shall be available to NIST personnel and other persons considered by the accreditation body to have a right of access to these records.

(d) Granting, maintaining, extending, suspending, and withdrawing accreditation. (1) An approved/recognized accreditation body shall specify the conditions for granting, maintaining and extending accreditation and the conditions under which accreditation may be suspended or withdrawn, partially or in total for all or part of the laboratory's scope of accreditation.

(2) An approved/recognized accreditation body shall have arrangements to grant, maintain, suspend or withdraw accreditation, increase or reduce the scope of accreditation or require reassessment, in the event of changes affecting the laboratory's activity and operation, such as changes in personnel or equipment, or if analysis of a complaint or any other information indicates that the laboratory no longer complies with the requirements of the accreditation body.

(3) An approved/recognized accreditation body shall have arrangements relating to the transfer of accreditation when the legal status (e.g. ownership) of the accredited laboratory changes.

(e) Documentation. An approved/recognized accreditation body shall provide (through publications, electronic media or other means), update at adequate intervals, and make available on request:

(1) Information about the authority under which accreditation systems operated by the accreditation body were established and and specifying whether they are mandatory or voluntary; (2) A document containing its requirements for accreditation in accordance with this document;

(3) A document stating the arrangements for granting, maintaining, extending, suspending and withdrawing accreditation;

(4) Information about the assessment and accreditation process;

(5) General information on the fees charged to applicant and accredited laboratories;

(6) A description of the rights and duties of accredited laboratories as specified in § 280.504 of this part, including requirements, restrictions or limitations on the use of the accrediting body's logo and on the ways of referring to the accreditation granted.

§ 280.502 Laboratory assessors.

(a) Requirements for assessors. The assessor or assessment team appointed to assess a laboratory shall:

(1) Be familiar with the relevant legal regulations, accreditation procedures and accreditation requirements;

(2) Have a thorough knowledge of the relevant assessment method and assessment documents;

(3) Have appropriate technical knowledge of the specific tests or types of tests for which accreditation is sought and, where relevant, with the associated sampling procedures;

(4) Be able to communicate effectively, both in writing and orally;

(5) Be free of any commercial, financial or other pressures or conflicts of interest that might cause assessor(s) to act in other than an impartial or nondiscriminatory manner;

(6) Not have offered consultancies to laboratories which might compromise their impartiality in the accreditation process and decisions.

(b) Qualification procedures for assessors. An approved/recognized accreditation body shall have an adequate procedure for:

(1) Qualifying assessors, comprising an assessment of their competence and training, and attendance at one more actual assessments with a qualified assessor, and

or

(2) Monitoring the performance of as

sessors.

(c) Contracting of assessors. An approved/recognized accreditation body shall require the assessors to sign a contract or other document by which they commit themselves to comply

with the rules defined by the accreditation body, including those relating to confidentiality and those relating to independence from commercial and other interests, and any prior association with laboratories to be assessed.

(d) Assessor records. An approved/recognized accreditation body shall possess and maintain up-to-date records on assessors consisting of:

(1) Name and address;

(2) Organization affiliation and position held;

(3) Educational qualification and professional status;

(4) Work experience;

(5) Training in quality assurance, assessment and calibration and testing;

(6) Experience in laboratory assessment, together with field of competence;

(7) Date of most recent updating of record.

(e) Procedures for assessors. Assessors shall be provided with an up-to-date set of procedures giving assessment instructions and all relevant information on accreditation arrangements.

§ 280.503 Accreditation process.

(a) Application for accreditation. (1) A detailed description of the assessment and accreditation procedure, the documents containing the requirements for accreditation and documents describing the rights and duties of accredited laboratories (including fees to be paid by applicant and accredited laboratories) shall be maintained up-to-date and given to applicant laboratories.

(2) Additional relevant information shall be provided to applicant laboratories on request.

(3) A duly authorized representative of the applicant laboratory shall be required to sign an official application form, in which or attached to which

(1) The scope of the desired accreditation is clearly defined;

(ii) The applicant's representative agrees to fulfill the accreditation procedure, especially to receive the assessment team, to pay the fees charged to the applicant laboratory whatever the result of the assessment may be, and to accept the charges of subsequent maintenance of the accreditation of the laboratory;

(iii) the applicant agrees to comply with the requirements for accreditation and to supply any information needed for the evaluation of the laboratory.

(4)(i) The following minimum information shall be provided by the applicant laboratory prior to the on-site assessment:

(A) The general features of the applicant laboratory (corporate entity: Name, address, legal status, hurnan and technical resources);

(B) General information concerning the laboratory covered by the application, such as primary function, relationship in a larger corporate entity and, If applicable, physical location of laboratories involved;

(C) A definition of the materials or products tested, the methods used and the tests performed;

(D) A copy of the laboratory's quality manual and, where required, the associated documentation.

(ii) The information gathered shall be used for the preparation of on-site assessment and shall be treated with appropriate confidentiality.

(b) Assessment. (1) An approved/recognized accreditation body shall appoint qualified assessor(s) to evaluate all material collected from the applicant and to conduct the assessment on its behalf at the laboratory and any other sites where activities to be covered by the accreditation are performed.

(2) To ensure that a comprehensive and correct assessment is carried out, each assessor shall be provided with the appropriate working documents.

(3) The date of assessment shall be mutually agreed with the applicant laboratory. The latter shall be informed of the name(s) of the qualified assessor(s) nominated to carry out the assessment, with sufficient notice so that the laboratory is given an opportunity to appeal against the appointment of any particular assessor.

(4) The assessor(s) shall be formally appointed. A lead assessor shall be appointed, if relevant. The mandate given to the assessor(s) shall be clearly defined and made known to the applicant laboratory.

(c) Sub-contracting of assessment. (1) If an approved/recognized accreditation body decides to delegate fully or par

tially the assessment of a laboratory to another body, then the accreditation body shall take full responsibility for such an assessment made on its behalf.

(2) An approved/recognized accreditation body shall ensure that the party to which assessment has been delegated is approved/recognized by NIST.

(d) Assessment report. (1) An approved/ recognized accreditation body may adopt reporting procedures that suit its needs but as a minimum these procedures shall ensure that:

(i) A meeting takes place between the assessor or assessment team and the laboratory management prior to leaving the laboratory at which the assessment team provides a written or oral report on the compliance of the applicant laboratory with the accreditation requirements;

(ii) The assessor or assessment team provides the accreditation body with a detailed assessment report containing all relevant information concerning the ability of the applicant laboratory to comply with all of the accreditation requirements, including any which may come about from the results of proficiency testing;

(iii) A report on the outcome of the assessment is promptly brought to the applicant laboratory's notice by the accreditation body, identifying any noncompliances that have to be discharged in order to comply with all of the accreditation requirements. The laboratory shall be invited to present its comments on this report and to describe the specific actions taken, or planned to be taken within a defined time, to remedy any non-compliances with the accreditation requirements identified during the assessment.

(2) The final report authorized by an approved/recognized accreditation body and submitted to the laboratory, if it is different, shall include as a minimum: (i) Date(s) of assessment(s);

(ii) The names of the person(s) responsible for the report;

(iii) The names and addresses of all the laboratory sites assessed;

(iv) The assessed scope of accreditation or reference thereto;

(v) comments of the assessor(s) or assessment team on the compliance of the applicant laboratory with the accreditation requirements.

(3) The reports shall take into consideration:

(i) The technical qualification, experience and authority of the staff encountered, especially the persons responsible for the technical validity of test reports or test certificates;

(ii) The adequacy of the internal organization and procedures adopted by the applicant laboratory to give confidence in the quality of its services, the physical facilities, i.e., the environment and the calibration/test equipment of the laboratory including maintenance and calibration having regard to the volume of work undertaken; (iii) Proficiency testing or other interlaboratory comparison performed by the applicant laboratory, the results of this proficiency testing, and the use of these results by the laboratory;

(iv) The actions taken to correct any non-compliances identified at previous assessments.

(e) Decision on accreditation. (1) The decision whether or not to accredit a laboratory shall be taken by an approved/recognized accreditation body on the basis of the information gathered during the accreditation process.

(2) An approved/recognized accreditation body shall not delegate its responsibility for granting, maintaining, extending, suspending or withdrawing accreditation.

(f) Granting accreditation. (1) An approved/recognized accreditation body shall transmit to each accredited laboratory formal accreditation documents such as a letter or a certificate signed by an officer who has been assigned such responsibility. These formal accreditation documents shall permit identification of—

(i) The name and address of the laboratory that has been accredited;

(ii) The scope of the accreditation including:

(A) The tests or types of test for which accreditation has been granted;

(B) For tests, the materials or products tested, the methods used and the tests performed;

(C) For specific tests for which accreditation has been granted the methods used defined by written standards or reference documents that have been accepted by the accreditation body.

(iii) Where appropriate, the persons recognized by the accreditation body as being responsible for the test certificates or the test reports;

(iv) The term of accreditation which shall be valid for a period not to exceed three years;

(v) The accredited laboratory by a unique number.

(2) An approved/recognized accreditation body shall furnish notification to NIST required by Subpart B of this part.

(g) Surveillance and reassessment of accredited laboratories. (1) An approved/ recognized accreditation body shall have an established documented program consistent with the accreditation granted for carrying out periodic surveillance and reassessment at sufficiently close intervals to ensure that its accredited laboratories continue to comply with the accreditation requirements.

(2) Surveillance and reassessment procedures shall be consistent with those concerning the assessment of laboratories as described in this Subpart.

(h) Proficiency testing. (1) The approved/recognized accreditation body shall require each fastener testing laboratory it accredits, and each laboratory which has applied to it for accreditation to participate in proficiency testing comparable to that conducted under Subpart C of this part by NVLAP.

(2) Although an accreditation shall not be granted or maintained only on the basis of the results of proficiency testing, accreditation shall not be granted or maintained if required proficiency testing participation is unsatisfactory.

(i) Certificates or reports issued by accredited laboratories. (1) An approved/ recognized accreditation body shall normally allow an accredited laboratory to refer to its accreditation in test reports and test certificates that contain only the results of tests or types of test for which accreditation is held.

(2) An approved/recognized accreditation body shall have a policy that defines the circumstances in which accredited laboratories are permitted to

(a) An approved/recognized accreditation body shall have arrangements to ensure that the laboratory and its representatives afford such accommodation and co-operation as is necessary, to enable the accreditation body to verify compliance with the requirements for accreditation. These arrangements shall include provision for examination of documentation and access to all testing areas, records and personnel for the purposes of assessment, surveillance, reassessment and resolution of complaints.

(b) An approved/recognized accreditation body shall require that an accredited laboratory

(1) At all times complies with the relevant provisions of these regulations;

(2) Claims that it is accredited only in respect of services for which it has been granted accreditation and which are carried out in accordance with these conditions;

(3) Pays such fees as shall be determined by the accreditation body;

(4) Does not use its accreditation in such a manner as to bring the accreditation body into disrepute and does not make any statement relevant to its accreditation which the accreditation body may consider misleading or unauthorized;

(5) Upon suspension or withdrawal of its accreditation (however determined) forthwith discontinues its use of all advertising matter that contains any reference thereto and return any certificates of accreditation to the accreditation body;

(6) Does not use its accreditation to state or imply any product approval by the accreditation body or any agency of the United States Government;

(7) Endeavors to ensure that no certificate or report nor any part thereof is used in a misleading manner;

(8) In making reference to its accreditation status in communication media such as advertising, brochures or other

documents, complies with the requirements of the accreditation body.

(c) Notification of change. (1) An approved/recognized accreditation body shall have arrangements to ensure that an accredited laboratory informs it without delay of changes in any aspect of the laboratory's status or operation that affects the laboratory's:

(i) Legal, commercial or organizational status;

(ii) Organization and management, e.g., key managerial staff;

(iii) Policies or procedures, where appropriate;

(iv) Premises;

environment

or

re

(v) Personnel, equipment, facilities, working other sources, where significant; (vi) Authorized signatories; (vii) Or other such matters that may affect the laboratory's capability, or scope of accredited activities, or compliance with the requirements in this document or any other relevant criteria of competence specified by the accreditation body.

(2) Upon receipt of due notice of any intended changes relating to the requirements of this document, the relevant criteria of competence and any other requirements prescribed by the accreditation body, the accreditation body shall ensure that the laboratory carries out the necessary adjustments to its procedures within such time, as in the opinion of the body is reasonable. The laboratory shall notify the body when such adjustments have been made.

(d) Directory of accredited laboratories. An approved/recognized accreditation body shall produce periodically but at least annually a directory of accredited laboratories describing the accreditation granted.

Subpart G-Enforcement

§ 280.600 Scope.

Section 280.601 of this part lists definitions used in this part. Section 280.602 of this part specifies that failure to take any action required by or taking any action prohibited by this part constitutes a violation of this part. Section 280.603 describes the penalties that may be imposed for violations of this part. Sections 280.605 through