21 CFR 1.1113 - What are the eligibility requirements for a recognized accreditation body?

Regulations last checked for updates: May 16, 2024

Title 21 - Food and Drugs last revised: May 06, 2024

View all text of Subpart R [§ 1.1101 - § 1.1200]

§ 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.

authority: 15 U.S.C. 1333,1453,1454,1455,4402; 19 U.S.C. 1490,1491; 21 U.S.C. 321,331,332,333,334,335a,342,343,350c,350d,350j,352,355,360b,360ccc,360ccc-1,360ccc-2,362,371,374,381,382,384a,387,387a,387c,393,and; 42 U.S.C. 216,241,243,262,264,271

source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

cite as: 21 CFR 1.1113