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Concept
ISO 13485
Summary
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard created by Steven Essery, 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. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
The current ISO 13485 edition was published on 1 March 2016.
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 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.
Other specific differences include:
the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S.
Official source
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