# Accreditation Bodies | Botable Glossary

https://www.botable.ai/glossary/accreditation-bodies

> Use as a glossary/reference definition and high-level primer.

## Summary

Defines an Accreditation Body as an entity (usually a private nonprofit or state agency) approved by a regulator (for example the FDA) to evaluate and certify facilities for compliance with quality or safety standards, describes the body’s main responsibilities, contrasts accreditation bodies with certification bodies, and explains the FDA/MQSA context for mammography accreditation.

## Audience

Quality, regulatory, and compliance teams in healthcare and life sciences (e.g., those involved in mammography, medical devices, pharmaceuticals)

## Prompts this page answers

- What is an Accreditation Body and what does it do?
- How does an Accreditation Body differ from a Certification Body?
- What role do Accreditation Bodies play under the FDA's MQSA for mammography facilities?

## Purpose

To provide a concise glossary definition and overview of what an Accreditation Body is, what it does, and how it differs from Certification Bodies, with specific references to ISO standards and the FDA/MQSA context.

## Highlights

- An Accreditation Body is usually a private nonprofit organization or a state agency officially approved by a regulatory authority (e.g., the FDA) to evaluate and certify facilities for compliance with established quality or safety standards.
- Primary responsibilities include setting standards, evaluation and auditing (including on-site visits and image review for mammography), conflict-of-interest mitigation, issuing accreditation decisions (grant/deny/suspend/revoke), and reporting serious risks to regulators.
- Accreditation Bodies authorize Certification Bodies (CBs) and operate under ISO/IEC 17011; Certification Bodies perform audits and issue ISO 9001 certificates to organizations.
- Under the MQSA, an FDA-approved Accreditation Body accredits mammography facilities; the FDA may annually evaluate Accreditation Bodies and withdraw approval for major deficiencies.
- The FDA also uses the term 'Issuing Agency' for organizations accredited to operate UDI issuance systems.

## How to cite

Link to the page: https://www.botable.ai/glossary/accreditation-bodies

## Publisher



## Topics

- accreditation body
- certification body
- ISO/IEC 17011
- ISO 9001
- FDA MQSA

## Key entities

- **Food and Drug Administration** (organization): Referenced regulatory authority (FDA) that approves Accreditation Bodies under MQSA. — https://www.fda.gov
- **Mammography Quality Standards Act (MQSA)** (other): U.S. regulatory context cited for FDA approval of Accreditation Bodies for mammography facilities.
- **ISO/IEC 17011** (other): International standard referenced as the standard under which Accreditation Bodies operate.
- **ISO 9001** (other): Example certification standard against which Certification Bodies audit organizations.
- **Botable** (organization): Site/brand hosting the glossary entry. — https://www.botable.ai

## Metadata

- Type: article