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

Contains Nonbinding Recommendations 

December 2016

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.

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance listed on the title page.


Page Last Updated: 03/26/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English