ISO 13485:2016 defines a Quality Management System (QMS) for Medical Devices, to ensure an organization sets their own quality standards, taking patient risk into account.
The ISO 13485 (CE) add-on is relevant for organizations who develop medical devices, apps or platforms
ISO 13485 combines the quality management aspects of ISO 9001 with the information security risk management aspect of ISO 27001, so it is possible to integrate three management systems in one!
- Contains instructions how to update an existing ISO 27001:2013 + ISO 9001:2015 implementation to comply to ISO 13485:2016
- Existing ISO 27001 / ISO 9001 clauses are reused where possible
- As the numbering of chapters in ISO 13485:2016 does not match that of the current high level structure, a useful mapping table is included
- 7 extra clauses unique to ISO 13485 (4.2.2, 4.2.3, 7.5.2 thru 7.5.5 and 7.5.7) are added
- For each of these, the impact is indicated as compared to ISO 27001:2013 or ISO 9001:2015
- Implementation instructions and sample documents are included
Add-ons are delivered as a package for Confluence or Microsoft 365. Instructions for activation and merging are provided.
- ISO 13485 add-on
- ISO 9001 add-on (required)
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