FDA Issues Guidance on Third-Party Audit Accreditation Standards

FDA has issued guidance for industry on 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 of the 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. The agency specifically referred to International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) recommendations.

For More Information, see:

• Federal Register Notice: Guidance: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
• Guidance for Industry: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
• FSMA Final Rule on Accredited Third-Party Certification