21 CFR § 1.614 General Enforcement Regulations

§ 1.614 What quality assurance procedures must an accreditation body have to qualify for recognition?

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

An accreditation body seeking recognition must demonstrate that it has:

(a) Implemented a written program for monitoring and evaluating the performance of its officers, employees, and other agents and its accreditation program, including procedures to:

(1) Identify areas in its accreditation program or performance where deficiencies exist; and

(2) Quickly execute corrective actions that effectively address deficiencies when identified; and

(b) The capability to meet the applicable quality assurance requirements of this subpart, if recognized.

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