21 CFR 1.1113
§ 1.1113 What are the eligibility requirements for a recognized accreditation body?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 1.1113, § 1.1113 What are the eligibility requirements for a recognized accreditation body?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/82909
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Full text
A recognized accreditation body or an accreditation body seeking recognition must meet all of the following requirements:
(a) Demonstrates compliance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101).
(b) Demonstrates that it is a full member of the International Laboratory Accreditation Cooperative (ILAC).
(c) Demonstrates that it is a signatory to the ILAC Mutual Recognition Arrangement (MRA) that has demonstrated competence to ISO/IEC 17011:2017(E) with a scope of “Testing: ISO/IEC 17025.”
(d) Will comply with all additional requirements for recognized accreditation bodies under this subpart while 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.