Health and Human Services Department Docket FDA-2011-N-0146 Final Rule

2016-29278: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Guidance for Industry and Food and Drug Administration Staff; Availability

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Summary

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry and FDA staff entitled "Third- Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards." The guidance contains FDA recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by the FDA Food Safety Modernization Act (FSMA). The guidance is intended to describe the standards for accreditation of third-party certification bodies as required under the final rule entitled "Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications." In addition, this guidance discusses specific clauses of ISO/IEC 17021: 2015 and industry practice that are currently being used by third-party certification bodies and that FDA recommends accreditation bodies consider as a model when making accreditation decisions.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

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