(a) A recognized accreditation body must annually, and as required under §1.664(g), conduct a self-assessment that includes evaluation of compliance with this subpart, including:

(1) The performance of its officers, employees, or other agents involved in accreditation activities and the degree of consistency in conducting accreditation activities;

(2) The compliance of the recognized accreditation body and its officers, employees, and other agents involved in accreditation activities, with the conflict of interest requirements of §1.624; and

(3) If requested by FDA, any other aspects of its performance relevant to a determination whether the recognized accreditation body is in compliance with this subpart.

(b) As a means to evaluate the recognized accreditation body's performance, the self-assessment must include onsite observation of regulatory audits of a representative sample of third-party certification bodies it accredited under this subpart. In meeting this requirement, the recognized accreditation body may use the results of onsite observations performed under §1.621(b).

(c) Based on the evaluations conducted under paragraphs (a) and (b) of this section, the recognized accreditation body must:

(1) Identify any area(s) where deficiencies exist;

(2) Quickly implement corrective action(s) that effectively address those deficiencies; and

(3) Establish and maintain records of any such corrective action(s) under §1.625.

(d) The recognized accreditation body must prepare, and as required by §1.623(b) submit, a written report of the results of its self-assessment that includes the following elements. Documentation of conformance to ISO/IEC 17011:2004 may be used, supplemented as necessary, in meeting the requirements of this paragraph.

(1) A description of any corrective actions taken under paragraph (c) of this section;

(2) A statement disclosing the extent to which the recognized accreditation body, and its officers, employees, and other agents involved in accreditation activities, complied with the conflict of interest requirements in §1.624; and

(3) A statement attesting to the extent to which the recognized accreditation body complied with applicable requirements of this subpart.