Code of Federal Regulations · Section
§ 1.614 — What Quality Assurance Procedures Must An Accreditation Body Have To Qualify For Recognition?
21 C.F.R. § 1.614
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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.
Authorizing Statute
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General orders19 U.S.C. § 1490
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Definitions; generally21 U.S.C. § 321
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Labeling15 U.S.C. § 1333
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Regulations42 U.S.C. § 216