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Code · CFR · Title 21 — Food and Drugs · Part 1 — General Enforcement Regulations · § 1.1113

§ 1.1113. What are the eligibility requirements for a recognized accreditation body?

88 words·~1 min read·/us/cfr/t21/s§ 1.1113·

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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.
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