21 CFR 1.645 - What records procedures must a third-party certification body have to qualify for accreditation?

Regulations last checked for updates: Oct 31, 2024

Title 21 - Food and Drugs last revised: Oct 28, 2024

View all text of Subpart M [§ 1.600 - § 1.725]

§ 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.

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; 42 U.S.C. 216,241,243,262,264,271

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

cite as: 21 CFR 1.645