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
- 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 separate Confluence space backup. They can be merged into Instant 27001 using the provided instructions.
- ISO 13485 add-on
- ISO 9001 add-on (required)
Excluding applicable taxes (read more)