How to Write Non-Conformities in Quality Management System (QMS) Audit Reports

How to Write Non-Conformities in Quality Management System (QMS) Audit Reports: A Practical Guide for Professionals

Learn how to write effective and professional non-conformities in Quality Management System (QMS) audit reports. Discover best practices, formats, examples, and common mistakes to avoid.

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Introduction

Writing non-conformities is a crucial part of any Quality Management System (QMS) audit. Whether you're auditing to ISO 9001 or your internal QMS standards, the way you report non-conformities can determine how effectively an organization corrects and improves its processes. Poorly written non-conformities can lead to confusion, ineffective corrective actions, and missed opportunities for continuous improvement.

In this detailed guide, CMA Knowledge explains how to write non-conformities clearly, professionally, and in compliance with ISO 9001:2015 or similar standards. You’ll learn:

• What a non-conformity is
• Why writing it properly matters
• The ideal structure and format
• Do’s and Don’ts
• Practical examples with ISO clause references

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What is a Non-Conformity in QMS Auditing?

A non-conformity (NC) is any deviation from a specified requirement. In the context of a QMS audit, it refers to a failure in complying with:

• ISO 9001 or other relevant standards
• Legal or regulatory requirements
• Internal documented procedures

Non-conformities can be:

1. Major Non-Conformity:

A serious failure or a complete absence of a system element. This affects the organization's ability to achieve intended outcomes.

2. Minor Non-Conformity:

A smaller issue that does not critically impact the effectiveness of the QMS but still needs correction.

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Why Writing Non-Conformities Properly Is Important

A non-conformity is not just a sentence in an audit report—it’s a call for improvement. If it is unclear, vague, or emotionally worded, it might:

• Lead to confusion and delays in corrective actions
• Cause disagreements with the auditee
• Result in ineffective audits
• Miss chances for performance improvement

Correctly written non-conformities support clear communication, faster resolution, and stronger QMS performance.

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Standard Structure of a Well-Written Non-Conformity

To write a non-conformity effectively, use this simple but powerful format:

1. Statement of Non-Conformity

Write a clear statement of what requirement was not met.

2. Evidence Observed

Mention what you actually saw, reviewed, or heard during the audit that proves the non-conformity.

3. Criteria/Clause Reference

Quote the relevant ISO clause or internal procedure that was not followed.

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Example Format

Non-Conformity Statement:
The organization has not maintained records of internal training as per its procedure.

Evidence Observed:
No training records were available for three employees who were trained in February 2025.

Criteria Reference:
ISO 9001:2015 Clause 7.2 – Competence
Internal Document: HR Policy QMS-HR-005, Section 4.2

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How to Write Non-Conformities: Best Practices

✅ 1. Be Objective and Fact-Based

Write only what you observed. Avoid assumptions or emotional language.

• ✔️ Do: “Micrometer ID# M-234 was past calibration due date.”
• ❌ Avoid: “Calibration system is not working properly.”

✅ 2. Stick to Evidence, Not Opinions

Provide measurable, visible, and recorded facts.

✅ 3. Link to a Requirement

Reference the ISO clause or internal policy that was violated.

✅ 4. Be Clear and Specific

Avoid vague statements like “some documents missing.” Instead, name the document, the location, and what exactly was missing.

✅ 5. Separate Each Non-Conformity

Don’t group unrelated issues together. Write each non-conformity individually.

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Common Mistakes to Avoid in Non-Conformity Writing

❌ Don’t Use Blaming Language

Use neutral terms. Avoid blaming people or departments.

❌ Don’t Suggest Solutions

As an auditor, your job is to report non-conformance, not prescribe corrective actions.

❌ Don’t Be Vague

A statement like “process not followed” is unclear. Describe what process and how it wasn’t followed.

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Examples of Non-Conformities in QMS Audits

🔎 Example 1: Calibration Issue

Statement:
Measurement equipment used in final product inspection is not calibrated.

Evidence:
Caliper ID# C-451 had an expired calibration sticker (due Jan 2025) and no calibration record available.

Criteria:
ISO 9001:2015 – Clause 7.1.5.2 (Measurement Traceability)

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🔎 Example 2: Internal Audit Non-Conformance

Statement:
Internal audits are not conducted as scheduled in the annual audit plan.

Evidence:
Audit records for Q3 2024 were missing, though the audit schedule indicated it was due in September 2024.

Criteria:
ISO 9001:2015 – Clause 9.2.2

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🔎 Example 3: Document Control

Statement:
Obsolete versions of procedures were found in use.

Evidence:
SOP-QA-012, Revision 01 (obsolete) was observed on the shop floor, even though Revision 03 was current.

Criteria:
ISO 9001:2015 – Clause 7.5.3.2

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Final Checklist Before Submitting Non-Conformities

Before you finalize your audit report, ask yourself:

• ✅ Is the non-conformity clearly stated?
• ✅ Is the evidence specific and objective?
• ✅ Is the clause number or reference correct?
• ✅ Is the language neutral and professional?
• ✅ Are non-conformities separated clearly?

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Do’s and Don’ts Summary

✅ Do:

• Reference the standard or procedure.
• Use clear, factual language.
• Keep each NC concise and evidence-based.
• Maintain a professional tone.

❌ Don’t:

• Assume the root cause.
• Use opinions or emotional phrases.
• Group multiple issues into one.
• Suggest solutions.

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FAQs – Non-Conformity Writing in QMS Audit Reports

Q1. Can I raise a non-conformity based on verbal statements?

No. Only objective, documented, or observed evidence should be used to raise a non-conformity.

Q2. Should I include recommendations for corrective actions?

No. The auditee is responsible for determining the corrective actions. Auditors must remain independent.

Q3. Can a minor non-conformity become major over time?

Yes. If a minor issue is repeated or ignored, it could reveal systemic failure, making it a major non-conformity.

Q4. What if the auditee disputes the non-conformity?

They can present their case during the closing meeting. However, if the auditor has clear evidence, the NC remains valid.

Q5. Can I raise more than one non-conformity for the same process?

Yes, as long as each NC is unique, factual, and independently verifiable.

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Conclusion

Writing non-conformities in a QMS audit report requires skill, clarity, and objectivity. Whether it's a major or minor deviation, each non-conformity should help the organization move towards continuous improvement. As a quality auditor or professional, your ability to write strong, evidence-based non-conformities directly impacts the effectiveness of corrective actions and the overall strength of the QMS.

At CMA Knowledge, we believe in raising the standard of audit reporting by empowering professionals with clarity, confidence, and actionable knowledge.

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