ISO 13485:2016 Checklists & Other Tools

13485:2016 Internal Audit Checklist
This complete Internal Audit Checklist Package provides everything you need to establish your ISO 13485:2016 Internal Audit Process.
13485:2016/FDA Internal Audit Checklist
This complete Internal Audit Checklist Package provides everything you need to establish your ISO 13485:2016 plus FDA QSR (21CFR-820) April 2016 requirements Internal Audit Process.
ISO 13485:2003 to 13485:2016 Transition Gap Analysis Checklist
This Gap checklist will help you understand what you need to do to migrate from ISO 13485:2003 to ISO 13485:2016.
ISO 13485:2016 Gap Analysis Checklist
This Gap checklist outlines what areas of your current Quality System need improvement to meet ISO 13485:2016.
ISO 9001:2015 / ISO 13485:2016 Combined Gap Analysis Checklist
This Gap checklist will help you understand what you need to do to migrate from ISO 9001:2008 to ISO 13485:2016.
ISO 9001:2015 to 13485:2016 Internal Audit Checklist
This complete Internal Audit Checklist Package provides everything you need to migrate from ISO 9001:2015 to ISO 13485 Internal Audit Process.