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ISO 13485:2016 Full Audit Report
Your complete gap analysis report including all sections, AI-generated findings, document references, and remediation tracker.
Executive summary with statistical breakdown
Detailed findings for all applicable clauses
Document reference tables per clause
AI-generated follow-up findings
Consolidated gap & remediation tracker
Word document · Compatible with Microsoft Word and Google Docs
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Recommended next steps
1
Review your gap summary — Start with the clauses marked as “No” in your report. These are your highest priority items before a certification audit.
2
Share the report with your team — The Word document is fully editable. Add your remediation plans, responsible owners, and target dates directly in the gap tracker table.
3
Re-run the audit in 3-6 months — After implementing corrective actions, use the tool again to verify your progress before your formal certification audit.

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