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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. This standard supersedes earlier documents such as EN 46001 and |
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EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488. While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained. |
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Other specific differences include: |
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| The promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States. |
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- controls in the work environment to ensure product safety
- focus on risk management activities and design transfer activities during product development
- Specific requirements for documentation and validation of processes for sterile medical devices
- Specific requirements for verification of the effectiveness of corrective and preventive actions
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