Standard Title: 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.
Updates and additions/corrections welcomed by posting in this thread.
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.
Updates and additions/corrections welcomed by posting in this thread.