21 C.F.R. § 1.645

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

Last amended: 2016Year: 2026Length: 66 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 1.645 (2026)

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.
21 C.F.R. § 1.645: What records procedures must a third-party certification body have to qualify for accreditation? | Justis AI