Accreditation for ISO 13485 Medical Device Quality Systems

ISO 13485 contains the requirements of ISO 9001 plus additional medical device industry requirements. 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. It can also be used to assess the organization's ability to meet customer and regulatory requirements. The quality management system requirements specified in ISO 13485 are complementary to technical requirements for products.

A CB 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.

Application

You can view the ISO 13485 application in .pdf format 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.

Requirements

Accreditation Requirements for Management Systems CBs

ANAB Accreditation Rule 35

IAF MD 9 :2015, Application of ISO/IEC 17021 in Medical Device Quality Management Systems (ISO 13485) (available from IAF)

ISO 13485:2003 Medical devices - Quality management systems - Requirements regulatory purposes (available from ASQ and ANSI, both with member discounts)

For more information, contact anab@anab.org.