21 C.F.R. § 1.1113

Current through September 30, 2024
Section 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.

21 C.F.R. §1.1113

86 FR 68728, 2/1/2022