Third Party Audit Guidance FDA

This guidance is intended to assist industry and the Food and Drug Administration (FDA) staff by recommending standards for accrediting third-party certification bodies for the voluntary third-party certification program established under the FDA Food Safety Modernization Act (FSMA). The guidance serves as a companion document to the implementing regulations in 21 CFR parts 1, 11, and 16 that establish the framework, procedures, and requirements for accreditation bodies and third-party certification bodies for this program.

On November 27, 2015, we finalized the implementing regulations establishing the framework, procedures, and requirements of the third-party certification program, including conflict of interest safeguards and other requirements necessary to ensure the competency and independence of recognized accreditation bodies and of accredited third-party certification bodies, which will help ensure the validity and reliability of certifications and other information resulting from the food safety audits conducted by accredited third-party certification bodies (80 FR 74569) (implementing regulations).

This final guidance document fulfills the statutory mandate under section 808(b)(2) of the FD&C Act that FDA must develop Model Accreditation Standards that recognized accreditation bodies shall use to qualify third-party certification bodies for accreditation. As part of these recommendations, we looked to voluntary consensus standards on accreditation that are widely used in determining the qualifications of third-party bodies that audit and certify the food industry. Specifically, we refer to International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC) recommendations contained in the ISO/IEC 17021:2011, ISO/IEC 17021: 2015, ISO/IEC 17065:2012, and/or ISO/IEC 17065:2015. In instances where recommendations that are contained in the ISO/IEC 17021:2011, ISO/IEC 17021: 2015, ISO/IEC 17065:2012, and/or ISO/IEC 17065:2015, conflict with the requirements in the statute or implementing regulations, the requirements in the statute and regulations apply.

Guidance for Industry and FDA Staff:Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards – December 2016