Why Accredited Services Increase Business Opportunities And Contribute To The Harmonization Of Regulations

By Natalia Larrimer, Jacqueline Southee, Ph.D.
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October 31, 2017


• Categories: Food Safety Consortium, FSMA, GFSI, RC - FSMA Resource Center

Accreditation is an internationally accepted independent oversight process for maintaining operational standards and ensuring confidence. It is accepted by many governments and private industries, including at various levels of the global food supply.

Recognized within the food industry and endorsed by the Global Food Safety Initiative (GFSI), the process of accredited certification has become essential for business.

In the United States, the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), in its rule on accredited third-party certification, incorporates the accreditation process for oversight over third-party certification bodies certifying foreign food facilities manufacturing for import into the United States.

With accredited services increasingly becoming an integral part of business operations, many wonder how the processes of accreditation and certification work.

Accreditation is the process of ensuring that an organization has the necessary technical competence to perform a specific task, and has met and continues to meet a specific set of operational requirements. An accreditation body (AB) uses internationally established techniques and procedures to assess conformity assessment bodies (CABs) against recognized standards to ensure their impartiality, competence, and ability to produce consistently reliable, technically sound and impartial results.

Accreditation provides formal recognition that an organization is competent to carry out specific tasks, and provides an independent assessment of conformity assessment bodies (CABs)¹ against recognized standards to ensure their impartiality and competence. Accreditation provides assurance to a CAB’s customers and industry that the CAB continuously operates according to internationally accepted criteria applicable to CAB’s scope of accreditation.

Although there is flexibility for an AB to design its accreditation process within the constraints of ISO/IEC 17011, Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies, the standard to which all internationally recognized ABs must conform, some aspects are mandatory.

As part of the application process, the applicant for accreditation submits information about the desired scope of accreditation and its documented quality management system. The AB conducts a document review to verify that the applicant has documented all management system requirements specified in the relevant criteria and any other applicable requirements. Additional requirements could include, for example, those mandated by a specific regulatory authority or industry. During the assessment, through witnessing of the CAB conducting a conformity assessment activity, interviews of personnel, and review of records and other objective evidence, the AB’s assessment team verifies the CAB’s technical competence and implementation of the quality management system.

The applicant is required to provide corrective action for all identified deficiencies. Only after all identified issues have been addressed can the accreditation decision process begin. To ensure that the accreditation decision is impartial, members of the assessment team do not take part in the decision. The designated decision maker, which may be a group or an individual, is responsible for reviewing the assessment team’s recommendation and ensuring that all accreditation requirements have been met by the applicant and are properly documented before granting accreditation.

A certificate and scope of accreditation are issued only after a favorable accreditation decision.

Once accredited, the CAB is regularly re-assessed to ensure continued conformance to the accreditation requirements, and to confirm that the required standard of operation is being maintained.

To ensure transparency, the AB is required to make publicly available information on the status and scope of accreditation for each accredited CAB. Any changes occurring after initial accreditation, such as suspension for all or part of the scope of accreditation, are published on the AB’s website.

It is important to note while ABs provide oversight over CABs, internationally recognized ABs are themselves subject to regular oversight from organizations orchestrating the harmonization and recognition of the accreditation process internationally.

The International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF) provide this international oversight. ABs that are signatories of the ILAC and/or IAF mutual recognition agreements (MLAs or MRAs) must conform with the requirements of ISO/IEC 17011 as applicable program-specific requirements, and are admitted to the agreements for a specific capability, for example, as an accreditor for testing labs or for management systems certification bodies. Technical competence of the AB and conformance to the requirements is verified through rigorous on site evaluation by other member of the IAF or ILAC community.

Without international oversight, there would be no evidence or confirmation that an AB operates in accordance with international requirements when providing oversight of accredited CABs. This oversight provides assurance that the AB understands the CAB’s process and can attest to the CAB’s competence.

The IAF, MLA and ILAC agreements are internationally recognized forms of approval; signatories have demonstrated their compliance with specified standards and requirements. Accreditation by a signatory of the ILAC MRA and/or IAF MLA provides assurance that decisions are based on reliable results, thus minimizing risk.

This is of particular importance in the constantly evolving global food-supply network. Many specifiers, such as regulatory authorities, have acknowledged the importance of credible accreditation programs.

A number of government agencies in the United States and around the world, including the U.S. Consumer Product Safety Commission (CPSC), U.S. Environmental Protection Agency (EPA) and the Canadian Food Inspection Agency (CFIA), have mandated accreditation by an internationally recognized accrediting body for their programs.

Accreditation within the MLA/MRA process helps regulators meet their legislative responsibilities by providing assurance that testing, inspection and evaluation results are issued by organizations whose technical competence and compliance with specified criteria has been verified by an independent third party. It provides assurance to stakeholders, such as the regulatory authorities, that the accredited CAB operates in accordance with recognized and accepted criteria.

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The FDA is one of the latest government agencies to incorporate accreditation within FSMA. The FDA accredited third-party certification program is intended to facilitate entry of food to the United States from foreign producers.

Although accreditation to international standards is not mandatory, it is recognized under the FDA FSMA program. Many of the requirements of the FDA Accredited Third-Party Certification Program are aligned with the requirements of international standards such as ISO/IEC 17021-1, Conformity assessment– Requirements for bodies providing audit and certification of management systems or ISO/IEC 17011 Conformity assessment– General requirements for accreditation bodies accrediting conformity assessment bodies.

Meeting the FSMA requirements is likely to be smoother for ABs and CBs that already operate in accordance with existing international standards. The FSMA compliance requirements for manufacturing facilities include many of the elements in existing international certification schemes (programs), making the transition easier for those organizations that are already certified for these programs.

An example of an existing accredited certification program is FSSC 22000. Benchmarked by the GFSI, FSSC 22000 was developed to provide industry with an independent certification scheme based on ISO 22000, the international standard for food safety management systems. FSSC 22000 certification demonstrates that a company has a robust and effective food safety management system (FSMS) in place to meet the requirements of regulators, food business clients, and consumers.

According to the FSSC 22000 certification scheme, organizations are certified upon completion of a satisfactory audit by the certification body’s auditor(s), who in turn shall have been assessed and judged as competent by an AB. As described above, ABs must operate to a high standard of competence and probity; they must apply the standards in a consistent and equivalent manner, meet the requirements of ISO/IEC 17011, and be a member of IAF and a signatory of the IAF MLA. Certification bodies must be accredited to the requirements of ISO/IEC 17021-1 and additional program-specific requirements.

An early comparison of the audit requirements for FSSC 22000 (food manufacturing scope) by The Acheson Group (TAG) against the FSMA Preventive Controls for Human Food Rule (PCHF) suggested that for the most part the FSSC 22000 scheme requirements were “in large measure comparable to those of the FSMA Final Rule” (TAG, April 2016).

The FSMA requirements, like FSSC 22000, are based on a foundation of international standards through ISO 22000 and ISO 17021, and both FSSC 22000 and FSMA share the common goal of achieving food safety through preventive controls (PRPs) and a flexible management system approach. Both PCHF Rule and FSSC 22000 require the implementation of a written food safety plan developed and overseen by a trained individual. FSMA nominates this individual as the PCQI, while FSSC 22000 requires a food safety team leader with similar training and experience. The Preventive Controls (PC’s) of the PCHF rule are also very comparable to the Critical Control Points (CCPs) and operational Prerequisite programs (oPRPs) of FSSC 22000. The international standard requires the same attention to monitoring, documentation and verification as the legislation and in some cases has a stricter demand for validation.

The PCHF Rule, being a legally binding regulation as opposed to a voluntary assessment, includes some requirements that are identified as either “being different” to the requirements of FSSC 22000, or as being “more specific” in the way they need to be addressed to achieve compliance. Some of these differences include specific directions for documentation while others require specific attention to how certain hazards are controlled, monitored, and documented.

A detailed alignment of FSSC 22000 as a voluntary certification scheme with the regulatory requirements is available to clarify some of these elements and to help organizations use FSSC 22000 certification as a tool to meet the requirements of the FSMA regulations in FSSC 22000-FSMA Alignment – September 2017. In addition, a supplement that expands on those areas where FSMA demands more specific detail than is required by FSCC 22000 has also been produced. Together, the documents are intended to help FSSC 22000 certified organizations integrate the requirements of the FSMA PCHF Rule into their FSMS, thus avoiding the need for two separate food safety plans.

It will help facilities completing a self-assessment against the requirements of the PCHF Rule and could be used by U.S. importers to determine what FSSC 22000 certification means relative to the requirements of Foreign Supplier Verification Program (FSVP).

As business competition increases around the United States and globally, accreditation is not only a means for specifiers to assure work is conducted by a technically competent organization, but also allows for suppliers to distinguish their products and abilities by marketing internationally recognized accredited services.

ANAB is a multi-disciplinary accreditation body, a member of the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC), and a signatory of the ILAC and IAF multilateral recognition arrangements. ANAB provides accreditation for ISO/IEC 17021-1 management systems certification bodies, ISO/IEC 17020 inspection bodies and forensic inspection agencies, ISO/IEC 17025 testing and calibration laboratories and forensic testing agencies, ISO Guide 34 reference material producers, ISO/IEC 17043 proficiency test providers, ISO 15189 medical test laboratories, and industry-specific programs.

For more information, visit www.anab.org.

FSSC 22000 (Food Safety System Certification 22000) is an independent food safety certification program based on the internationally recognized standards: ISO 22000, ISO 22003 with sector specific technical specifications for Prerequisite Programs (PRPs) and additional scheme requirements to provide a framework for effectively managing food safety and quality responsibilities.
The independent Foundation FSSC 22000 manages the FSSC 22000 Certification Program.

It is recognized by the Global Food Safety Initiative (GFSI) and developed in response to the needs of the international food sector. FSSC 22000 is accepted by 35 ABs worldwide and only uses IAF MLA members for accreditation of its CB’s. For more information, visit www.fssc22000.com/.

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¹ A CAB could be a laboratory, an inspection body, or a certification body.