BS EN ISO 13485:2016+A11:2021
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
- Standard No.
- BS EN ISO 13485:2016+A11:2021
- Published By
- British Standards Institution (BSI)
- Latest
- BS EN ISO 13485:2016+A11:2021
- Scope
- To be read in conjunction with BS EN ISO 9001:1994
BS EN ISO 13485:2016+A11:2021 history
- 1970 BS EN ISO 13485:2016+A11:2021 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
- 2017 BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes
- 2012 BS EN ISO 13485:2012 Medical devices. Quality management systems. Requirements for regulatory purposes
- 2003 BS EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
- 2001 BS EN ISO 13485:2001 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
- 1997 BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices
