About ISO 13485

The title of the ISO 13485:2003 standard is as follows:

ISO 13485:2003
Quality systems - Medical devices –Quality Management Systems - Requirements for regulatory purposes

This standard has been adopted by the Canadian Standards Association (CSA) and has been approved as a National Standards of Canada by the Standards Council of Canada, under the following reference number:

CAN/CSA-ISO 13485-2003
Medical devices – Quality Management Systems - Requirements for regulatory purposes

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What does each standard mean?
ISO 9001 is a generic quality system standard applicable to many industries. ISO 13485:2003 is the newest quality systems standard specific to medical devices. Developed by the International Organization for Standardization, ISO 13485 is a stand-alone standard that provides quality management systems requirements for manufacturers of medical devices. While many requirements of ISO 9001 are included, others are excluded, as they are not appropriate for medical device manufacturers. For this reason, manufacturers certified to ISO 13485 cannot claim to be ISO 9001 certified unless they meet all ISO 9001 requirements.

Is ISO 13485 applicable for European Requirements?
The current European medical device quality system standard is EN ISO 13485:2003 published July 24, 2003. This standard will replace current harmonized standards EN ISO 13485:2000 and EN ISO 13488:2000 with a three year transition period ending July 2006.

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