21 CFR § 1.644 - What quality assurance procedures must a third-party certification body have to qualify for accreditation?

---
identifier: "/us/cfr/t21/s1.644"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.644 - What quality assurance procedures must a third-party certification body have to qualify for accreditation?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.644"
section_name: "What quality assurance procedures must a third-party certification body have to qualify for accreditation?"
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"
---


# 1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation?

A third-party certification body seeking accreditation must demonstrate that it has:

(a) Implemented a written program for monitoring and evaluating the performance of its officers, employees, and other agents involved in auditing and certification activities, including procedures to:

(1) Identify deficiencies in its auditing and certification program or performance; and

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

(b) The capability to meet the quality assurance requirements of § 1.655, if accredited.