Code · CFR · Title 21 — Food and Drugs · Part 1 — General Enforcement Regulations · § 1.644

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

76 words·~1 min read·/us/cfr/t21/s§ 1.644

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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.