ISO 13485 – Medical

Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2016, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

Though it is tailored to the industry’s quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector’s ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration.

While it remains a stand-alone document, ISO 13485 is generally harmonized with (the 2008 revision) ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively
implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.

Also see ISO14971 as it is mandatory for 13485