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Notes

21 C.F.R. §§ 1.641–1.645

5 sections in range

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

21 C.F.R. § 1.641

(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.
Notes, amendments, and revision history

Source

Source: 80 FR 74650, Nov. 27, 2015, unless otherwise noted.

Authority

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.

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

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

21 C.F.R. § 1.642

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.
Notes, amendments, and revision history

Source

Source: 80 FR 74650, Nov. 27, 2015, unless otherwise noted.

Authority

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.

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

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

21 C.F.R. § 1.643

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, if accredited.
Notes, amendments, and revision history

Source

Source: 80 FR 74650, Nov. 27, 2015, unless otherwise noted.

Authority

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.

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

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

21 C.F.R. § 1.644

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.
Notes, amendments, and revision history

Source

Source: 80 FR 74650, Nov. 27, 2015, unless otherwise noted.

Authority

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.

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

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

21 C.F.R. § 1.645

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.
Notes, amendments, and revision history

Source

Source: 80 FR 74650, Nov. 27, 2015, unless otherwise noted.

Authority

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.

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.