21 CFR § 1.642 - What competency and capacity must a third-party certification body have to qualify for accreditation?

---
identifier: "/us/cfr/t21/s1.642"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.642 - What competency and capacity must a third-party certification body have to qualify for accreditation?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.642"
section_name: "What competency and capacity 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"
---


# 1.642 What competency and capacity must a third-party certification body have to qualify for accreditation?

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

(a) The resources necessary to fully implement its certification program, including:

(1) Adequate numbers of employees and other agents with relevant knowledge, skills, and experience to effectively examine for compliance with applicable FDA food safety requirements of the FD&C Act and FDA regulations, conformance with applicable industry standards and practices, and issuance of valid and reliable certifications; and

(2) Adequate financial resources for its operations; and

(b) The competency and capacity to meet the applicable requirements of this subpart, if accredited.