21 CFR §1.622

1. (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. (1)The performance of its officers, employees, or other agents involved in accreditation activities and the degree of consistency in conducting accreditation activities;
   2. (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. (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.
2. (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).
3. (c)Based on the evaluations conducted under paragraphs (a) and (b) of this section, the recognized accreditation body must:
   1. (1)Identify any area(s) where deficiencies exist;
   2. (2)Quickly implement corrective action(s) that effectively address those deficiencies; and
   3. (3)Establish and maintain records of any such corrective action(s) under § 1.625.
4. (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. (1)A description of any corrective actions taken under paragraph (c) of this section;
   2. (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. (3)A statement attesting to the extent to which the recognized accreditation body complied with applicable requirements of this subpart.