21 CFR § 1.614 - What quality assurance procedures must an accreditation body have to qualify for recognition?

---
identifier: "/us/cfr/t21/s1.614"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.614 - What quality assurance procedures must an accreditation body have to qualify for recognition?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.614"
section_name: "What quality assurance procedures must an accreditation body have to qualify for recognition?"
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"
---


# 1.614 What quality assurance procedures must an accreditation body have to qualify for recognition?

An accreditation body seeking recognition must demonstrate that it has:

(a) Implemented a written program for monitoring and evaluating the performance of its officers, employees, and other agents and its accreditation program, including procedures to:

(1) Identify areas in its accreditation program or performance where deficiencies exist; and

(2) Quickly execute corrective actions that effectively address deficiencies when identified; and

(b) The capability to meet the applicable quality assurance requirements of this subpart, if recognized.