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The three levels
| Level | Meaning | Example |
|---|---|---|
| Major nonconformity | A requirement is not met, and this threatens the system's ability to achieve intended results; also when there is significant doubt about effectiveness. | No internal audits take place; complaints are systematically not handled. |
| Minor nonconformity | A requirement is not met, but the system works in principle. | Two of twenty training records are missing; an instruction is outdated but no longer used. |
| Opportunity for improvement | Not a nonconformity but a note on where the system could be better. | Metrics could be evaluated earlier. |
Several minor nonconformities on the same topic can together be graded as a major one if they point to a systemic problem.
Consequences for the certificate
- Major nonconformity: a certificate is not granted or renewed until the correction and corrective action have been reviewed and accepted by the certification body. A follow-up audit is often needed.
- Minor nonconformity: you submit an action plan; implementation is usually checked at the next audit.
- Opportunity for improvement: no obligation to act, but auditors often pick it up again next time.
Deadlines are set by the certification body. Clarify them in the closing meeting so that your action plan is ready in time.
Responding correctly
- 1
Understand the finding
Ask in the closing meeting which requirement exactly is affected and which evidence was missing.
- 2
Correction
Fix the specific problem, such as providing missing records.
- 3
Analyse the cause
Clarify why it happened, for example with root cause analysis.
- 4
Corrective action and effectiveness
Remove the cause and check whether it worked.
Implementing it in docxpert
You create audit findings as deviations and handle them in CAPA management with root cause analysis, actions and an effectiveness check. The history is documented traceably and can be presented to the certification body as evidence.
Frequently asked questions
Do I get a certificate despite minor nonconformities?
Usually yes, if you submit an accepted action plan. Implementation is checked at the next audit.
Do I have to act on opportunities for improvement?
No. They are recommendations. A short decision on whether and how you handle them does make a good impression at the next audit.
Can I dispute a grading?
Yes. Raise it in the closing meeting; every certification body also has a process for appeals and complaints.
How do I avoid major nonconformities?
With a working internal audit, a real management review and consistently handled corrective actions. The [certification readiness checklist](content:checklist-certification-readiness) helps you prepare.