ISO 13485

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ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. Compliance with ISO 13485 is often seen as the first step in achieving compliance with regulatory requirements.

This standard supersedes earlier documents such as ISO 46001 and ISO 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

While it remains a stand-alone document, ISO 13845 is aligned to ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organisation to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained.

[edit] External links

• ISO Organisation 13485 page
• Differences between ISO 13485:1996 and ISO 13485:2003