Code of Federal Regulations · Section

§ 1.612 — What Competency And Capacity Must An Accreditation Body Have To Qualify For Recognition?

21 C.F.R. § 1.612

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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.

21 C.F.R. § 1.611 21 C.F.R. § 1.613

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