21 CFR 1.615
§ 1.615 What records procedures must an accreditation body have to qualify for recognition?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 1.615, § 1.615 What records procedures must an accreditation body have to qualify for recognition?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/82825
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Full text
An accreditation body seeking recognition must demonstrate that it has:
(a) Implemented written procedures to establish, control, and retain records (including documents and data) for the period of time necessary to meet its contractual and legal obligations pertaining to this subpart and to provide an adequate basis for evaluating its program and performance; and
(b) The capability to meet the applicable reporting and notification requirements of this subpart, if recognized.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.