Quality Management - Related International Standards
The following non-harmonised international standards are related to Quality Management for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes | active | 1, 2, 3, 4, 5, 6, 7, 8 | Link |
| ISO 19011:2018 | Guidelines for auditing management systems | active | 1, 2 | Link |
| AAMI TIR75:2019 | Guidance on the application of ISO 13485 to organizations that provide servicing of medical devices | active | 1, 2 | Link |