Accreditation for ISO 13485 Medical Device Quality Systems


ISO 13485: Medical Devices Quality Management Systems – Requirements for Regulatory Purposes

What Is Accreditation for ISO 13485 Medical Devices Quality Management Systems?

ISO 13485 specifies requirements for a quality management system for the design and development, production, installation, and servicing of medical devices, and the design, development, and provision of related services. The international standard details management responsibility and applies to organizations involved with one or more stages of the medical device life cycle. It can also be used to assess the organization’s ability to meet customer and regulatory requirements in the medical device industry. The quality management system requirements specified in ISO 13485 are complementary to technical requirements for products.

CBs applying for ISO 13485 accreditation must conform to ISO/IEC 17021-1. ISO 13485 is a base standard program in ANAB’s fee schedule.

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

You can view the ISO 13485 application 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.

ISO 13485 Medical Devices Management Accreditation Requirements

Available from IAF:

  • IAF MD 8:2020, Application of ISO/IEC 17011:2017 in the Field of Medical Device Quality Management Systems (ISO 13485)
  • IAF MD 9:2017, Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)

Featured Product

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Talk to an Expert

Brenda Bissell

Senior Manager of Accreditation, Management Systems Information and Cyber Security, Medical Device, Telecom, and Artificial Intelligence


Portrait of Brenda Bissell

Need Training To Support Your Accreditation Journey?

Learn at your own pace with online courses or choose an instructor led class offered online or in a convenient location.

Management Systems Accreditation Resources

This manual explains the operational activities and responsibilities of ANAB and accredited management systems certification bodies (CBs).

Who is Accredited?

Search the directory of accredited management systems certification bodies.