§ 280.501 - Accreditation bodies.

(a) General provisions. (1) The procedures under which an approved/recognized accreditation body operates shall be administered in a non-discriminatory manner. Access to an accreditation system operated by an approved/recognized accreditation body shall not be conditional upon the size of the laboratory or membership in any association or group, nor shall there be undue financial conditions to restrict participation.

(2) The competence of an applicant laboratory shall be assessed by an approved/recognized accreditation body against requirements consistent with the conditions set out in subpart C of this part.

(3) The requirements of § 280.501(a)(2) may have to be interpreted for a specific test or type of test by an approved/recognized accreditation body. These interpretations shall be formulated by relevant and impartial committees or persons possessing the necessary technical competence. They shall be published by the accreditation body.

(4) An approved/recognized accreditation body shall require accredited laboratories to maintain impartiality and integrity.

(5) An approved/recognized accreditation body shall confine its requirements, assessment and decision on accreditation to those matters specifically related to the scope of the accreditation being considered.

(b) Organization of an approved/recognized accreditation body. (1) An approved/recognized accreditation body shall:

(i) Be a legally identifiable, public or private entity;

(ii) Have rights and responsibilities relevant to its accreditation activities;

(iii) Have adequate arrangements to cover liabilities arising from its operations and/or activities;

(iv) Have the financial stability and resources required for the operation of an accreditation system;

(v) Have and make available on request a description of the means by which it receives its financial support;

(vi) Employ a sufficient number of personnel having the necessary education, training, technical knowledge and experience for handling the type, range and volume of work performed, under a senior executive who is responsible to the organization, body or board to which it reports;

(vii) Have a quality system including an organizational structure, that enables it to give confidence in its ability to operate a laboratory accreditation system satisfactorily;

(viii) Have documented policies and procedures for the operation of the quality system that include:

(A) Policies and decision-making procedures that distinguish between laboratory accreditation and any other activities in which the body is engaged;

(B) Policies and procedures for the resolution of complaints and appeals received from laboratories about the handling of accreditation matters, or from users of services about accredited laboratories or any other matters;

(ix) Together with its senior executive, and staff, be free from any commercial, financial and other pressures which might influence the results of the accreditation process;

(x) Have formal rules and structures for the appointment and operation of committees involved in the accreditation process; such committees shall be free from any commercial, financial and other pressures that might influence decisions or shall have a structure where members are chosen to provide impartiality through a balance of interest where no single interest predominates;

(xi) Establish one or more technical committees, each responsible, within its scope, for advising the accreditation body on the technical matters relating to the operation of its accreditation system;

(xii) Not offer consultancies or other services which may compromise the objectivity of its accreditation process and decisions;

(xiii) Have arrangements that are consistent with applicable laws, to safeguard, at all levels of its organization (including committees), confidentiality of the information obtained relating to applications, assessment and accreditation of laboratories;

(2) An approved/recognized accreditation body shall have arrangements for either controlling the ownership, use and display of the accreditation documents or controlling the manner in 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 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.