ISO 13485: 2003 Medical devices - Quality management systems - Requirements for regulatory purposes

The International Organization for Standardization (ISO). Second edition. 2003-07-15. This second edition cancels and replaces the first edition (ISO 13485:1996), which has been technically revised. It also cancels and replaces ISO 13488:1996. 64p. This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.