The ANSI National Accreditation Board (ANAB) is a recognized accreditation body under the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA). Accreditation for FSMA is based on ISO/IEC 17065 and on ISO/IEC 17021-1.

ANAB accreditation supports those seeking FSMA compliance for both the Foreign Supplier Verification Program - which requires importers to verify that the food they import meets U.S. safety standards - and FDA's Accredited Third-Party Certification Program, a fee-based program that allows for expedited review and importation for those who achieve and maintain a safe and secure supply chain.

FSMA empowers FDA to take proactive steps to prevent the sale, distribution, and consumption of tainted food products by recognizing accreditation bodies - like ANAB - to assess the competence of third-part certification bodies according to the international standard, ISO/IEC 17021-1. The goal is to create a food safety system that focuses upon preventing contamination rather than reacting to problems that have already occurred.

Accreditation for Food Safety

ANAB applauds the FDA's recognition of the value of accredited food safety audits and certifications, which provides the best and fastest opportunity to bolster the safety of the food supply in the U.S., as private third-party food safety audits can reach beyond our borders.

 

 

Application for the ISO/IEC 17021-1 Based Program

You can view the FDA FSMA application in .pdf format to understand specific requirements but the application process must be completed online via ANAB's EQM database; first-time EQM users must register to create an account.

Please refer to information about the accreditation process at How to Become an ANAB-Accredited Certification Body.

Accreditation oversight can be combined with any of ANAB's existing accreditation programs.

Requirements

Accreditation Requirements for Management Systems CBs

ANAB Accreditation Rule 55

Code of Federal Regulations Title 21 (21 CFR) Part 1, Subpart M – Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications

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

FD&C Act and FDA regulations applicable to the scope of accreditation food safety requirements

CL 5316, FDA FSMA Supplemental Requirements Matrix

List of ANAB Accredited CBs

There are various FDA requirements for accreditation bodies to make information publicly available, including but not limited to accreditation status and information on the dates that accredited CB fees are paid. This page will be updated as CBs progress through the accreditation process with ANAB.

CB Fee Payments

LSQA, S.A. - 2022/07/29, 2022/06/02, 2021/11/30, 2021/11/01, 2021/09/30, 2021/05/01, 2021/01/19, 2020/11/30, 2020/06/01, 2020/05/04, 2020/01/20, 2019/12/19, 2019/10/03, 2019/04/15

CB Scope Reductions

None to report.

Foreign Supplier Verification Programs

The FDA FSMA rule on Foreign Supplier Verification Programs for Importers of Food for Humans and Animals requires importers to perform certain risk-based activities to verify that food imported into the United States was produced in a manner meeting applicable safety standards.

The use of on-site audits is an option when conducting supplier verification activities under the Foreign Supplier Verification Programs and Preventive Controls rules. These audits must be conducted by "qualified auditors." 

A certification body accredited by a recognized AB, such as ANAB, and listed on the FDA public registry, meets the definition of “qualified auditor” in 21 CFR 1.500, which lists the definitions applicable to the Foreign Supplier Verification Program.

Request a quote or for more information about FSMA accreditation, contact ANAB.

More Information

Key Facts About the Accredited Third-Party Certification Program

Industry Resources on Third-Party Audit Standards and FSMA Supplier Verification Requirements - Includes links to templates that can be used to help receiving facilities, importers, and other stakeholders (e.g., audit programs) compare the standards used in third-party audits to FDA food safety requirements.

VQIP Informational Webinar Link

Voluntary Qualified Importer Program webinar presented on September 20, 2018, provides information that CBs may find helpful for marketing.