1) ISO13485:2003 is based on the process model of ISO9001:2000.

2) ISO13485:2003 is established based on the model of quality system requirements that comply with various global regulations.

3) Due to the change of emphasis to the mode of regulatory requirements, the author of ISO13485:2003 deleted the part of ISO9001:2000 that emphasized customer satisfaction.

4) ISO13485 has not been adopted by FDA, and FDA will continue to adhere to its independent Quality System Regulation (QSR). However, the FDA staff involved in the preparation of ISO 13485:2003 are confident that their standard and ISO 13485:2003 can run in parallel. Therefore, a company that complies with the requirements of ISO13485:2003 can easily meet the requirements of QSR.

5) TR14969 is a guideline for the use and implementation of ISO13485:2003.

6) ISO 13485:2003 is not established in accordance with the business model but as a tool to maintain the effectiveness of the process.

7) Different from ISO9001:2000, ISO13485:2003 does not allow manufacturers to reduce the documents reasonably. To ensure that companies comply with the rules, ISO 13485:2003 is more prescriptive and requires that certain process documents still need to be established.

8) Risk management is also a very critical factor in ISO13485:2003.

9) There is no significant connection between ISO13485:2003 and ISO9004:2000 (basic standards for quality management systems).

10) SO13485:2003 is compatible with other "non-quality" management systems such as ISO14001 and OHSAS18001.