Audit Conclusion Form
Audit template
Audit Conclusion Form for medical device internal and supplier audits
Use this editable Audit Conclusion to plan, execute and close audits with clear findings, conclusions and corrective actions.
- Best for: internal audits, supplier audits, MDR/ISO 13485 audit programmes and audit reporting.
- Includes: editable sections for audit programme, plan, report, findings and conclusion.
- Format: editable template available through the standard WooCommerce download flow.
Lexqara prepares manufacturers and suppliers for medical device audits with practical tools and hands-on support. Explore the Resource Center or review our Quality Management System Audit Services.
Description:
This template documents why an audit nonconformity does not require starting a new CAPA, while keeping a clear, reviewable rationale linked to the Audit Report.
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Record the audit report number and Date for traceability
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Maintain Revision control with Change History
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Identify each Non-conformity (NCXX) with Grading: Major/Minor
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Restate the NC Description exactly as in the audit report
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Provide a robust Justification for absence of CAPA (evidence-based)
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Select a documented Conclusion (existing CAPA ongoing / irrelevant / N/A due to incomplete info / other)
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Replicate the table for multiple NCs as needed
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Finalize with Approval (Name, Position, Date, Signature)
Your needs:
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audit conclusion form
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audit conclusion form for ISO 13485 compliance
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Reduce rework and improve audit defensibility for CAPA decisions
Use this audit conclusion form when an auditor raises an NC and you need to justify, in a controlled record, why a new CAPA is not initiated.
Key requirements covered include CAPA (systematic corrective/preventive actions to address root causes) and N/A determination (a documented decision that an NC does not apply due to incomplete or invalid audit evidence).
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Link conclusions to the Audit Report identifier
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Document Major/Minor grading per NC
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Preserve NC wording in the Description field
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Justify the absence of new CAPA with objective rationale
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Confirm whether an existing CAPA already addresses the issue
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Use standardized Conclusion options, including N/A
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Capture Approval signatures for accountability
At Lexqara, we help strengthen audit files, CAPA decision logic, and reviewer-ready QMS records through audits support and targeted training. Use our Resource Center [https://lexqara.com/resource-center] and Audits & Training [https://lexqara.com/services/audits-training], and align governance expectations with the European Commission medical devices sector overview [https://health.ec.europa.eu/medical-devices-sector_en]. Download the template and request a short gap assessment.
Template preview
Template preview: Audit Conclusion
Review the key sections included in the Audit Conclusion template before downloading it. This preview shows the structure and content you will receive in the editable file.
The complete template content is displayed above. The editable file is available after adding the product to cart.
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