Introduced by the International Organization for Standardization in July 2003, ISO 13485:2003 is a quality management system standard designed specifically for medical device manufacturers. It is based on the same basic principles as ISO 9001:2000.
ISO 13485:2003 is often seen as a crucial first step in ensuring manufacturing and design processes consistently produce quality products that meet regulatory requirements. ISO 13485:2003 is used to assist in the synchronization of quality management systems and medical device regulatory requirements.
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