Regulations last checked for updates: Oct 31, 2024

Title 21 - Food and Drugs last revised: Oct 28, 2024
§ 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.

source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.
cite as: 21 CFR 1.1113