21 C.F.R. § 1.645

Current through July 31, 2024
Section 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.

21 C.F.R. §1.645