If you want to check how well your QMS complies with ISO 13485, you can use this Aligned Elements Extension in your Aligned Elements instance.
In an auditing situation, you might be required to demonstrate how you comply to this standard.
The Extension consists of:
- A new template called "Checklist Item" incl. a Word Template for this type
- 143 importable checklist items that cover chapter 4 to 8 in ISO 13485:2016
- Each item contains a control question, an assessment of the question and a placeholder for adding evidence for the assessment
Use this checklist to get a properly controlled and document proof of your compliance with ISO 13485.
How to use the Extension:
Download and unzip the extension file.
- Add the Checklist Item.rvt and Checklist Item.docx templates to your template set.
- Import the Internal Audit Checklist ISO 13485.xml file. Make sure that the import setting "Recreate Chapters" is active.
- Assess each Control question.
- If your QMS complies with the Control question answer Yes and provide the Evidence in the corresponding field
- If the QMS does not comply, set the answer to No or TBD.
- When completed, create a Word Document for the now filled out Checklist.
