21 C.F.R. § 1.644

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

Last amended: 2016Year: 2026Length: 76 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 1.644 (2026)

A third-party certification body seeking accreditation must demonstrate that it has: (a) Implemented a written program for monitoring and evaluating the performance of its officers, employees, and other agents involved in auditing and certification activities, including procedures to: (1) Identify deficiencies in its auditing and certification program or performance; and (2) Quickly execute corrective actions that effectively address any identified deficiencies; and (b) The capability to meet the quality assurance requirements of § 1.655, if accredited.
Cross-references to the CFR
1.655
21 C.F.R. § 1.644: What quality assurance procedures must a third-party certification body have to qualify for accreditation? | Justis AI