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

Description

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.

Scope & Applicability

• 21CFR1.641§ 1.641 What legal authority must a third-party certification body have to qualify for accreditation?

  (a) A third-party certification body seeking accreditation from a recognized accreditation body or from FDA must demonstrate that it has the authority (as a governmental entity or as a legal entity with contractual rights) to perform such examinations of facilities, their process(es), and food(s) asRead full regulation →

• 21CFR1.642§ 1.642 What competency and capacity must a third-party certification body have to qualify for accreditation?

  A third-party certification body seeking accreditation must demonstrate that it has:Read full regulation →

• 21CFR1.650§ 1.650 How must an accredited third-party certification body ensure its audit agents are competent and objective?

  (a) An accredited third-party certification body that uses audit agents to conduct food safety audits must ensure that each such audit agent meets the following requirements with respect to the scope of its accreditation under this subpart. If the accredited third-party certification body is an indiRead full regulation →

• 21CFR1.643§ 1.643 What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?

  A third-party certification body must demonstrate that it has:Read full regulation →

• 21CFR1.657§ 1.657 How must an accredited third-party certification body protect against conflicts of interest?

  (a) An accredited third-party certification body must implement a written program to protect against conflicts of interest between the accredited third-party certification body (and its officers, employees, and other agents involved in auditing and certification activities) and an eligible entity seRead full regulation →

• 21CFR1.644§ 1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation?

  A third-party certification body seeking accreditation must demonstrate that it has:Read full regulation →

• 21CFR1.655§ 1.655 How must an accredited third-party certification body monitor its own performance?

  (a) An accredited third-party certification body must annually, upon FDA request made for cause, or as required under § 1.631(f)(1)(i) , § 1.634(d)(1)(i) , or § 1.635(c)(1)(i) , conduct a self-assessment that includes evaluation of compliance with this subpart, including:Read full regulation →

• 21CFR1.645§ 1.645 What records procedures must a third-party certification body have to qualify for accreditation?

  A third-party certification body seeking accreditation must demonstrate that it:Read full regulation →

• 21CFR1.658§ 1.658 What records requirements must a third-party certification body that has been accredited meet?

  (a) A third-party certification body that has been accredited must maintain electronically for 4 years records created during its period of accreditation (including documents and data) that document compliance with this subpart, including:Read full regulation →

• 21CFR1.652§ 1.652 What must an accredited third-party certification body include in food safety audit reports?

  (a) Consultative audits. An accredited third-party certification body must prepare a report of a consultative audit not later than 45 days after completing such audit and must provide a copy of such report to the eligible entity and must maintain such report under § 1.658 , subject to FDA access in Read full regulation →

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