ISO 13485 sets out requirements for a quality management system for the design and development, manufacturing, and servicing of medical devices. It can also be used to evaluate an organization’s ability to meet customer and regulatory requirements.

A Conformity Assessment Bodies applying for ISO 13485 accreditation must conform to ISO/IEC 17021, IAF MD9 and other additional International requirements as detailed in Specific Requirements for Accreditation for MDQMS Scheme.