---
kind: "range"
citation: "21 C.F.R. §§ 1.641–1.645"
title: "21"
from: "1.641"
to: "1.645"
count: 5
url: "https://uscodex.org/cfr/21/1.641..1.645"
---

# §1.641. What legal authority must a third-party certification body have to qualify for accreditation?

- (a) A third-party certification body seeking accreditation from a recognized accreditation body or from FDA must demonstrate that it has the authority (as a governmental entity or as a legal entity with contractual rights) to perform such examinations of facilities, their process(es), and food(s) as are necessary to determine compliance with the applicable food safety requirements of the FD&C Act and FDA regulations, and conformance with applicable industry standards and practices and to issue certifications where appropriate based on a review of the findings of such examinations. This includes authority to:
  - (1) Review any relevant records;
  - (2) Conduct onsite audits of an eligible entity; and
  - (3) **Suspend or withdraw certification for failure to comply with applicable requirements.**
- (b) A third-party certification body seeking accreditation must demonstrate that it is capable of exerting the authority (as a governmental entity or as legal entity with contractual rights) necessary to meet the applicable requirements of accreditation under this subpart if accredited.

# §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.**

# §1.643. What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?


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

- (a) Implemented written measures to protect against conflicts of interest between the third-party certification body (and its officers, employees, and other agents involved in auditing and certification activities) and clients seeking examinations or certification from, or audited or certified by, such third-party certification body; and
- (b) The capability to meet the conflict of interest requirements in [§ 1.657](/cfr/21/1.657.md), if accredited.

# §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](/cfr/21/1.655.md), if accredited.

# §1.645. What records procedures must a third-party certification body have to qualify for accreditation?


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

- (a) Implemented written procedures to establish, control, and retain records (including documents and data) for a period of time necessary to meet its contractual and legal obligations and to provide an adequate basis for evaluating its program and performance; and
- (b) Is capable of meeting the reporting, notification, and records requirements of this subpart, if accredited.