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.

• Record the audit report number and Date for traceability

• Maintain Revision control with Change History

• Identify each Non-conformity (NCXX) with Grading: Major/Minor

• Restate the NC Description exactly as in the audit report

• Provide a robust Justification for absence of CAPA (evidence-based)

• Select a documented Conclusion (existing CAPA ongoing / irrelevant / N/A due to incomplete info / other)

• Replicate the table for multiple NCs as needed

• Finalize with Approval (Name, Position, Date, Signature)

Your needs:

• audit conclusion form

• audit conclusion form for ISO 13485 compliance

• 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).

• Link conclusions to the Audit Report identifier

• Document Major/Minor grading per NC

• Preserve NC wording in the Description field

• Justify the absence of new CAPA with objective rationale

• Confirm whether an existing CAPA already addresses the issue

• Use standardized Conclusion options, including N/A

• 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.