---
kind: "section"
citation: "21 C.F.R. § 1.644"
title: "21"
number: "1.644"
heading: "What quality assurance procedures must a third-party certification body have to qualify for accreditation?"
url: "https://uscodex.org/cfr/21/1.644"
---

# §1.644. What quality assurance procedures must a third-party certification body have to qualify for accreditation?


A third-party certification body seeking accreditation must demonstrate that it has:

- (a) Implemented a written program for monitoring and evaluating the performance of its officers, employees, and other agents involved in auditing and certification activities, including procedures to:
  - (1) Identify deficiencies in its auditing and certification program or performance; and
  - (2) Quickly execute corrective actions that effectively address any identified deficiencies; and
- (b) The capability to meet the quality assurance requirements of [§ 1.655](/cfr/21/1.655.md), if accredited.

## 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.