This standard provides guidance for the application of the medical device quality management system requirements contained in the YY/T 0287 standard. This standard does not add or change the requirements of YY/T 0287. This standard does not contain requirements for regulatory agency inspections or certification body assessment activities. This guide can be used to better understand the requirements of YY/T 0287 and to clarify some of the various available methods and approaches that can meet the requirements of YY/T 0287.
YY/T 0595-2006 Referenced Document
GB/T 19000-2000 Quality management systems-Fundamentals and vocabulary
YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
YY/T 0595-2006 history
2020YY/T 0595-2020 Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2003
2006YY/T 0595-2006 Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2003