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.