What the checklist covers
The template includes clause area, audit question, evidence reviewed, observation notes, owner, due date, and follow-up status so teams can move from planning into closure without rebuilding the tracker.
The workbook ships with an Instructions tab and an audit sheet of 39 core clause prompts across ISO 13485:2016 clauses 4–8 — each with evidence-sampled, conformity-rating (dropdown), finding-ID, and notes columns. Prompts are paraphrased audit questions that reference the standard without reproducing its text; use the checklist alongside your controlled copy of ISO 13485:2016.
- Clause area and paraphrased audit question
- Evidence reviewed and observation notes
- Conformity rating (dropdown) and finding ID
- Owner and due date
- Follow-up status through to closure
How to use it effectively
Use the checklist to structure audit preparation, capture real evidence during the review, and assign action ownership immediately after the audit instead of pushing observations into a separate tracker later.
Where a governed eQMS helps
The spreadsheet is useful as a planning aid, but long term teams usually want audit observations, CAPA follow-up, and document links inside the same governed system.
