§ 280.504 - Relationship between approved/recognized accreditation body and laboratory.

(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;

(v) Personnel, equipment, facilities, working environment or other resources, 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.