StacksVerified U.S. regulatory reference

21 CFR §1.1113

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
A recognized accreditation body or an accreditation body seeking recognition must meet all of the following requirements:
  1. (a)Demonstrates compliance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101).
  2. (b)Demonstrates that it is a full member of the International Laboratory Accreditation Cooperative (ILAC).
  3. (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.”
  4. (d)Will comply with all additional requirements for recognized accreditation bodies under this subpart while recognized.