What competency and capacity must an accreditation body have to qualify for recognition?

21 C.F.R. § 1.612
in effectEffective: 2024-07-01
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An accreditation body seeking recognition must demonstrate that it has: (a) The resources required to adequately implement its accreditation program, including: (1) Adequate numbers of employees and other agents with relevant knowledge, skills, and experience to effectively evaluate the qualifications of third-party certification bodies seeking accreditation and to effectively monitor the performance of accredited third-party certification bodies; and (2) Adequate financial resources for its operations; and (b) The capability to meet the applicable assessment and monitoring requirements, the reporting and notification requirements, and the procedures of this subpart, if recognized.

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