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