YY/T 0287-2003
Medical devices-Quality management systems-Requirements for regulatory purposes (English Version)
- Standard No.
- YY/T 0287-2003
- Language
- Chinese, Available in English version
- Release Date
- 2003
- Published By
- Professional Standard - Medicine
- Status
- 2017-05
- Replace By
- YY/T 0287-2017
- Latest
- YY/T 0287-2017
- Replace
- YY/T 0287-1996
- Scope
- This standard specifies quality management system requirements for organizations that need to demonstrate their ability to provide 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 and deletes some requirements in GB/T 19001 that are not suitable as regulatory requirements. Due to these deletions, an organization whose quality management system complies with this standard cannot claim to comply with GB/T 19001 unless its quality management system also meets all requirements in GB/T 19001.
YY/T 0287-2003 history
- 2017 YY/T 0287-2017 Medical devices.Quality management systems.Requirements for regulatory purposes
- 2003 YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
- 0000 YY/T 0287-1996
