---
kind: "section"
citation: "21 C.F.R. § 1.1113"
title: "21"
number: "1.1113"
heading: "What are the eligibility requirements for a recognized accreditation body?"
url: "https://uscodex.org/cfr/21/1.1113"
---

# §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](/cfr/21/1.1101.md)).
- (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.

## Notes

### Source

Source: 86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, unless otherwise noted.

### Authority

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 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

### Source

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