21 CFR 1.612
§ 1.612 What competency and capacity 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 1.612, § 1.612 What competency and capacity must an accreditation body have to qualify for recognition?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/82822
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Full text
An accreditation body seeking recognition must demonstrate that it has:
(a) The resources required to adequately implement its accreditation program, including:
(1) Adequate numbers of employees and other agents with relevant knowledge, skills, and experience to effectively evaluate the qualifications of third-party certification bodies seeking accreditation and to effectively monitor the performance of accredited third-party certification bodies; and
(2) Adequate financial resources for its operations; and
(b) The capability to meet the applicable assessment and monitoring requirements, the reporting and notification requirements, and the procedures 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.