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Guidance Issuing OfficeOffice of the Commissioner, Office of Policy, Legislation, and International Affairs, Office of Global Policy and Strategy, Office of Gobal Operations, Latin America Office, DO NOT USE - Terms Set to be Removed, DO NOT USE - Office of Foods and Veterinary Medicine
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.
Individual Chapter Downloads
- Chapter 1: Introduction
- Chapter 2: Scope
- Chapter 3: Definitions
- Chapter 4: Legal Authority and Responsibility
- Chapter 5: Capacity and Competence
- Chapter 6: Conflicts of Interest
- Chapter 7: Quality Assurance
- Chapter 8: Records
- Chapter 9: Regulatory Audit Reports
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-N-0146.