Taiwan Provincial Standard of the People's Republic of China
Latest
CNS 15013-2006
Scope
Overview This standard specifies quality management system requirements for organizations that need to demonstrate their ability to supply medical devices and related services that continue to meet customer requirements and regulatory requirements applicable to medical devices and related services. The main purpose of this standard is to facilitate the implementation of harmonized regulatory requirements for quality management systems. Therefore, this standard contains some special requirements for medical devices, as well as deletions
CNS 15013-2006 history
2006CNS 15013-2006 Medical devices - Quality management systems - Requirements for regulatory purposes