21 CFR § 1.645 General Enforcement Regulations

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

Current through Sep 8, 2026 · Read all of Part 1

⚠ 1 pending change to Part 1

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.

← § 1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation?§ 1.650 How must an accredited third-party certification body ensure its audit agents are competent and objective? →