---
kind: "section"
citation: "21 C.F.R. § 1.622"
title: "21"
number: "1.622"
heading: "How must a recognized accreditation body monitor its own performance?"
url: "https://uscodex.org/cfr/21/1.622"
---

# §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)](/cfr/21/1.664.md?p=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](/cfr/21/1.624.md); 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)](/cfr/21/1.621.md?p=b).
- (c) Based on the evaluations conducted under paragraphs [(a)](#a) and [(b)](#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](/cfr/21/1.625.md).
- (d) The recognized accreditation body must prepare, and as required by [§ 1.623(b)](/cfr/21/1.623.md?p=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)](#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](/cfr/21/1.624.md); and
  - (3) A statement attesting to the extent to which the recognized accreditation body complied with applicable requirements of this subpart.

## Notes

### Source

Source: 80 FR 74650, Nov. 27, 2015, unless otherwise noted.

### Authority

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.

### Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.