Audit Report Form

Audit template

Audit Report Form for medical device internal and supplier audits

Use this editable Audit to plan, execute and close audits with clear findings, conclusions and corrective actions.

Plan audits systematicallyDefine scope, criteria, schedule and auditor independence.

Document objective evidenceRecord findings with references to standards and procedures.

Drive CAPA closureTrack corrective actions from identification to effectiveness check.

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.

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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 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.

Template preview

Template preview: Audit

Review the key sections included in the Audit template before downloading it. This preview shows the structure and content you will receive in the editable file.

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Audit Report

[Audit Type]

Document Number: ARYYYY-XXX

Revision: XXXX

Date: DD Month YYYY

Approval

Auditor Approval

Approval
Name:	Date:
Title:	Signature:

[Company name] Approval when applicable (e.g. supplier audit)

Approval
Name:	Date:
Title:	Signature:
Approval
Name:	Date:
Title:	Signature:

Audit procedure

The [audit type] has been performed at the [Company Name] premise in accordance with ISO 19011:2018. The audit process comprises the verification of [audit criteria] for the Quality Management System (QMS) maintained by [Company Name]. The audit results are documented in the audit checklist that covers the applicable requirements in the scope of the audit. The audit consists of sampling of documents according to the scope of the audit; hence not all deficiencies may be identified during the audit. The conformity is evidence-based and all the information obtained during the audit are gathered on a process approach basis.

[Important audit detail]

The [audit type] will involve a review of [Company Name]’s QMS against the audit criteria. Any identified gaps will be classified as follows:

Non-Conformity (NC): failure to meet a specific requirement of a standard, regulation, procedure, or other applicable criterion. It indicates that a process, product, or service does not comply with established requirements.
- A major NC (M-NC) is a serious issue that indicates a significant failure to comply with regulatory requirements, standards, or internal processes. It shows that the system or process is either not implemented, not maintained, or ineffective, and it has or may have a significant impact on product safety, compliance, or quality management. Examples are:
  - a total absence of a required process, procedure, or system.
  - a failure to meet critical regulatory or standard requirements that could lead to serious consequences, such as product recalls or customer harm.
  - repeated minor non-conformities in the same area that indicate systemic issues.
  - direct impact on the effectiveness of the management system or the ability to ensure compliance.
- A minor NC (m-NC) refers to a less severe issue that represents a failure to meet a requirement, but it does not immediately compromise the overall effectiveness of the quality management system or compliance with regulations. While the requirement is not fully met, the deficiency is usually isolated or low risk, and it can typically be corrected without major changes to the system. Examples are:
  - isolated incidents of non-compliance that do not suggest a systemic problem.
  - a minor deviation from a procedure or requirement that does not affect product quality, safety, or compliance in a significant way.
  - corrective action is necessary, but the issue is not critical to the overall effectiveness of the system.
Opportunity for Improvement (OFI): an observation that highlights a potential area where processes, performance, or compliance could be enhanced. Unlike a non-conformity, an OFI does not indicate a breach of a standard or regulatory requirement but suggests a way to improve efficiency, effectiveness, or quality.

The audit has been performed according to the audit plan (Annex II: Audit Plan) with the results documented in the audit checklist (see Annex I: Audit Checklist)

Audit details

Audit objective
Audit scope
Audit criteria	[audit criteria]
Locations
Audit dates
Contact details
Lead auditor
Auditor

Attendees

Position	Opening	Closure



Lead auditor	X	X

Requirements excluded from the audit

The following requirements have been evaluated not applicable or excluded from the audit:

Findings status from the previous audit

Findings	Appropriate action plan	Effectiveness verified	Comments	Closure / Finding

Opened corrective and preventive actions in scope of the audit

CAPA	Appropriate action plan	Effectiveness verified	Comments	Closure / Finding

Summary of Findings

Non-conformity

Finding	M-NCXX	Requirements
Short description
Objective evidence
Description

Finding	m-NCXX	Requirements
Short description
Objective evidence
Description

Recommendations

Recommendation	OFIXX	Requirements
Short description
Objective evidence
Description

Recommendation	OFIXX	Requirements
Short description
Objective evidence
Description

Audit Conclusion

The [audit type] has been performed to verify the compliance of [Company Name] with requirements from [audit criteria].

[Optional: critical findings, important remarks]

The [audit type] has identified XX non-conformity (X Major / X minor) and XX recommendations. As a result, [Company Name] needs to prepare and implement an action plan to remove the gaps and observations identified.

The audit was based on a sampling of documents and records. Neiter the auditor nor LEXQARA can guarantee that all gaps have been identified. It is ultimately the responsibility of [Company Name] to comply with [audit criteria]. For external audits

Annex I: Audit Checklist

Include the relevant audit checklist

Process to be audit (optional)

Topic to be audited

Description:

Checklist of requirements

Requirements	Requirement Description	Yes/NC/OFI	Comment

Topic/ Process to be audited

Description:

Checklist of requirements

Requirements	Requirement Description	Yes/NC/OFI	Comment

Annex II: Audit Plan

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SKU FORM-AUD-003 rev.1 Category Quality documents

Audit Report Form