Accreditation Bodies

An Accreditation Body is an entity, usually a private nonprofit organization or a state agency, that is officially approved by a regulatory authority, such as the FDA, to evaluate and certify facilities or organizations for compliance with established quality or safety standards.

In simple terms, the Accreditation Body acts as an independent validator that determines if an organization's systems (like its processes, documentation, and quality controls) meet stringent regulatory or international requirements, allowing that organization to legally operate in certain specialized fields.

Primary Role and Responsibilities

The Accreditation Body (or "body") is responsible for ensuring the integrity and impartiality of its actions while carrying out its accreditation responsibilities.

For facilities performing specialized functions like mammography, the FDA approves an Accreditation Body to accredit those facilities, making them eligible to perform the services.

Key responsibilities of an Accreditation Body typically include:

• Setting Standards: They require the facilities they accredit to meet standards for quality performance that are substantially the same as those set by the overarching regulatory body (e.g., the FDA).
• Evaluation and Auditing: They conduct reviews, inspections, and image evaluations (such as clinical image review and phantom image review in mammography) to monitor and assess a facility’s compliance. They may conduct on-site visits to determine whether staffing, funding, and resources are adequate.
• Conflict of Interest Mitigation: They must establish measures to reduce the possibility of conflict of interest or bias on the part of individuals acting on the body's behalf.
• Issuing Decisions: They notify facilities of deficiencies, monitor corrections, and either grant, deny, suspend, or revoke accreditation. A facility must attempt to resolve an adverse accreditation decision through the body’s appeals process before appealing to the FDA.
• Reporting to Regulators: They must inform the regulatory agency (like the FDA) of any equipment or practices that pose a serious risk to human health, and submit annual reports summarizing serious complaints received.

Comparison to Certification Bodies

While the Accreditation Body sets the final framework and authorizes groups to ensure consistency, the distinction between an Accreditation Body and a Certification Body is often seen in the context of ISO standards:

Certification Bodies (CBs) / Registrars are organizations that audit and issue ISO 9001 compliance certificates to organizations. They audit against an extensive sample of a company's sites, functions, products, services, and processes.

Accreditation Bodies (ABs) authorize ("accredit") the Certification Bodies (CBs) themselves. Various accreditation bodies often have mutual agreements to ensure that certificates issued by one accredited CB are accepted worldwide. Accreditation Bodies operate under ISO/IEC 17011.

For example, when a company seeks ISO 9001 certification, it hires an external Certification Body to audit its quality management system (QMS). That Certification Body must, in turn, be accredited by a recognized Accreditation Body.

FDA Context

Under the Mammography Quality Standards Act (MQSA), an Accreditation Body is approved by the FDA to accredit mammography facilities. The Accreditation Body’s decision to accredit a facility is a prerequisite for the FDA to issue a facility a certificate (or provisional certificate) for lawful operation.

The FDA retains the authority to evaluate each Accreditation Body's performance annually and may withdraw approval if major deficiencies, willful disregard for public health, fraud, or material false statements are found.

Note: The FDA also uses the term "Issuing Agency" in the context of Unique Device Identifier (UDI) regulations, which is defined as an organization accredited by the FDA to operate a system for issuing unique device identifiers.

‍