21 C.F.R. § 1.1113 — What are the eligibility requirements for a recognized accreditation body?
§ 1.1113 What are the eligibility requirements for a recognized accreditation body? 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.