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

---
identifier: "/us/cfr/t21/s1.1113"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.1113 - What are the eligibility requirements for a recognized accreditation body?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.1113"
section_name: "What are the eligibility requirements for a recognized accreditation body?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "1"
part_name: "GENERAL ENFORCEMENT REGULATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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."
regulatory_source: "42 FR 15553, Mar. 22, 1977, unless otherwise noted."
cfr_part: "1"
---


# 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.