What quality assurance procedures must a third-party certification body have to qualify for accreditation?
21 C.F.R. § 1.644
in effectEffective: 2024-07-01A 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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026