ISO 13485 Certification | Medical Devices System
ISO 13485 is the International Standard Organization issued in 2016, representing the requirements of a comprehensive quality management system for the design and manufacture of medical equipment. This standard replaces previous documents such as EN 46001 and EN 46002 (both 1997), previously issued ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
Although it is tailored to the expectations of the industry quality system and regulatory requirements, organizations do not need to actively manufacture medical devices or their components to seek certification for this standard, in contrast to the automotive sector of ISO / TS 16949, where only firms with active demand for quotes, or On the bid list, from international supply chain Automotive Task Force manufacturers can search for registration
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