EN ISO 13485:2016 is an International standard and specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development ,and provision of related services. This is the regulatory requirement for medical devices in European countries.

ISO 9001:2015 is an international standard and promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meting customer requirements.

The quality management system requirements specified in this international standard are complementary to requirement for products.