21 CFR § 1.622 - How must a recognized accreditation body monitor its own performance?
---
identifier: "/us/cfr/t21/s1.622"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.622 - How must a recognized accreditation body monitor its own performance?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.622"
section_name: "How must a recognized accreditation body monitor its own performance?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "1"
part_name: "GENERAL ENFORCEMENT REGULATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271."
regulatory_source: "42 FR 15553, Mar. 22, 1977, unless otherwise noted."
cfr_part: "1"
---
# 1.622 How must a recognized accreditation body monitor its own performance?
(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.