21 CFR § 1.645
What records procedures must a third-party certification body have to qualify for accreditation?
June 25, 2020
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.