ISO 13485

ISO 13485:2003 - Medical Devices - Quality Management Systems
Requirements for Regulatory Purposes

ISO 13485:2003 is a Quality Management System for medical devices, specifically for regulatory purposes. It is based on ISO 9001:2000 with some modifications. The standard includes a process model similar to that of ISO 9001:2000 but requires more documented procedures that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The ISO 13485:2003 standard is an update and compilation of the older ISO 13485:1996 & ISO 13488:1996 standards. This update was in response to the publication of ISO 9001:2000.

The ISO 13485:2003 standard does not reference the requirements of ISO 9001 but does provide medical device manufacturers with a standalone standard for quality management systems that need to demonstrate compliance to regulatory requirements.

 

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