§ 1.622. How must a recognized accreditation body monitor its own performance?

320 words·~1 min read·/us/cfr/t21/s§ 1.622

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(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.