21 CFR 1.645
§ 1.645 What records procedures must a third-party certification body have to qualify for accreditation?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 1.645, § 1.645 What records procedures must a third-party certification body have to qualify for accreditation?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/82844
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Full text
A third-party certification body seeking accreditation must demonstrate that it:
(a) Implemented written procedures to establish, control, and retain records (including documents and data) for a period of time necessary to meet its contractual and legal obligations and to provide an adequate basis for evaluating its program and performance; and
(b) Is capable of meeting the reporting, notification, and records requirements of this subpart, if accredited.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.