---
kind: "section"
citation: "21 C.F.R. § 1.645"
title: "21"
number: "1.645"
heading: "What records procedures must a third-party certification body have to qualify for accreditation?"
url: "https://uscodex.org/cfr/21/1.645"
---

# §1.645. What records procedures must a third-party certification body have to qualify for accreditation?


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

- (a) Implemented written procedures to establish, control, and retain records (including documents and data) for a period of time necessary to meet its contractual and legal obligations and to provide an adequate basis for evaluating its program and performance; and
- (b) Is capable of meeting the reporting, notification, and records requirements of this subpart, 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.