What are the eligibility requirements for a recognized accreditation body?

21 C.F.R. § 1.1113
in effectEffective: 2024-07-01
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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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