YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes

Scope

This standard specifies the requirements for a quality management system for organizations that need to demonstrate their ability to continuously 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 the regulatory requirements of a coordinated quality management system. Therefore, this standard includes some specific requirements for medical devices and deletes some requirements in GB/T 19001 that are not suitable as regulatory requirements. Due to these deletions, organizations whose quality management systems comply with this standard cannot claim to comply with the GB/T 19001 standard unless their quality management systems also meet all the requirements of GB/T 19001 (see Appendix B).

Development Information

Replace the following standards

Superseded by the following standards

Referenced Standards

Adopt standards

Related Standards