Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard. 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. While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. 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. The current ISO 13485 edition was published on 1 March 2016.
The latest version of this standard supersedes earlier documents such as EN 46001 (19) and EN 46002 (1996), the previously published ISO 13485 (19), and ISO 13488 (also 1996). ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
