21 CFR § 1.644 General Enforcement Regulations

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

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

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.

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