ISO 13485:2016 Checklists & Other Tools

13485:2016 Internal Audit Checklist
Don’t cut corners with audits – buy a complete solution!

13485:2016/FDA Internal Audit Checklist
Don’t cut corners with audits – buy a complete solution!

ISO 13485:2003 to 13485:2016 Transition Gap Analysis Checklist
Outlines areas of Quality Systems for transition from ISO 13485:2003 to ISO 13485:2016

ISO 13485:2016 Gap Analysis Checklist
Outlines areas of Quality Systems that need improvement to meet ISO 13485:2016.

ISO ISO 9001:2015 / ISO 13485:2016 Combined Gap Analysis Checklist
The gap analysis checklist is a very useful tool in evaluating your Quality Management System (QMS) as you transition from ISO 9001:2015 to include ISO 13485:2016.