Facts About ISO 13485:-
ISO 13485:2003 was written as a model to meet the quality system requirements of various global regulations.
ISO 13485:2003 is compatible with other non-quality management systems, such as ISO 14001, or OHSAS 18001.
ISO 13485:2003 does not emphasize customer satisfaction as ISO 9001:2008 does because the standard was written as a model for regulatory requirements.
If a company meets ISO 13485:2003 requirements, it should easily be able to meet the FDA QSR requirements. Although ISO 13485:2003 has not been adopted by the FDA, the FDA participated in writing ISO 13485:2003 to ensure the requirements are aligned.
Risk management is a key element of ISO 13485:2003.
TR 14969 is a guidance document for the use and implementation of ISO 13485:2003.
ISO 13485:2003 was written as a tool for maintaining processes, not for a business improvement model.
Unlike ISO 9001:2008, ISO 13485:2003 will not allow manufacturers to rationalize documentation. In order to ensure companies meet regulatory requirements, ISO 13485:2003 is more prescriptive, and requires that certain procedures still need to be documented.
There is no significant relationship between ISO 13485:2003 and ISO 9004:2008.