Description:
This Audit Report template documents audit results in a consistent, evidence-based format aligned to ISO 19011:2018.

• Control identifiers: ARYYYY-XXX, Revision, Date, Approval, and Change History.

• Confirm audit method: process approach, sampling limits, and evidence-based conformity.

• Define Audit objective, Audit scope, Audit criteria, locations, and audit dates.

• Record attendees for Opening and Closure meetings.

• Document exclusions as Requirements excluded from the audit with justification.

• Track prior findings and related CAPA status, action plans, and effectiveness.

• Classify outcomes as Major NC, Minor NC, and OFI with objective evidence.

Your needs:

• Audit report template

• Audit report template for ISO 13485, MDR compliance

• Reduce rework, standardize findings, and speed up CAPA follow-up.

Use this template after any internal or supplier audit to document what was checked, what was found, and what must be improved, with clear traceability from criteria to evidence.

It covers finding logic and closure readiness. A Major NC signals a significant system failure impacting compliance. A Minor NC is an isolated gap with lower immediate risk that still requires correction.

• Define objective, scope, and audit criteria.

• Record objective evidence for each finding.

• Classify findings as M-NC, m-NC, or OFI.

• Summarize conclusions and required action plans.

• Link findings to CAPA and effectiveness verification.

At Lexqara, we help you implement audit reporting workflows, grading consistency, and CAPA linkage for inspection-ready outcomes. Resource Center [https://lexqara.com/resource-center] and Audit & Inspection Support [https://lexqara.com/services/audit-and-inspection-support]. ISO 19011:2018 guidance [https://www.iso.org/standard/70017.html]. Download the template and request a short gap assessment.