Code of Federal Regulations · Section

§ 1.1113 — What Are The Eligibility Requirements For A Recognized Accreditation Body?

21 C.F.R. § 1.1113

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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.

21 C.F.R. § 1.1110 21 C.F.R. § 1.1114

Authorizing Statute

General orders
19 U.S.C. § 1490
Definitions; generally
21 U.S.C. § 321
Labeling
15 U.S.C. § 1333
Regulations
42 U.S.C. § 216