FDA Issues Guidance for Industry about Model Accreditation Standards for Third-Party Certification Bodies

Constituent Update

December 6, 2016

The U.S. Food and Drug Administration today issued a guidance for industry entitled, “Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.” The final 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 the voluntary third-party certification program established under the FDA Food Safety Modernization Act (FSMA). The FDA issued a draft version of this guidance in July 2015.

In November 2015, the FDA announced the implementing final rule “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” that establishes a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements. This guidance serves as a companion document to the final rule and describes the standards for accreditation of third-party certification bodies as required by FSMA and the final rule.

In establishing the model standards, FDA looked to existing standards for certification bodies to avoid unnecessary duplication of efforts and costs. We refer specifically to International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) recommendations.

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