Major and Minor Nonconformities: Understanding the Difference

This guide explains how audit findings are classified, what each category means, and what an organisation needs to do after receiving one.

The Three Types of Audit Findings

1. Major Nonconformity

A major nonconformity means an important requirement of the standard is not being met, and the issue can affect the effectiveness of the management system.

Certification cannot normally be granted or continued until the major finding is addressed and verified.

2. Minor Nonconformity

A minor nonconformity is usually a single or isolated failure that does not affect the overall effectiveness of the management system.

Certification can generally continue, but the organisation must take corrective action and close the finding within the agreed timeframe.

3. Opportunity for Improvement

An opportunity for improvement is not a nonconformity. It is simply an auditor's observation that something could be improved or made more effective.

No action is normally mandatory. However, repeatedly ignoring such observations can eventually lead to actual nonconformities.

When Does a Finding Become Major Instead of Minor?

Auditors generally consider several factors:

Missing requirement vs. one-time mistake:

If a required process or system element does not exist at all, it is more likely to be considered a major nonconformity. If the process exists but was not followed in one instance, it is more likely to be minor.

System-wide problem vs. isolated issue:

If one record is missing out of 20, it may be considered a minor issue. If 12 out of 20 records are missing, it may indicate that the process itself is not working effectively and could become a major finding.

Impact on results:

A failure that results in nonconforming products or services reaching a customer is generally treated more seriously than a failure that has no such impact.

Repeated findings:

If a minor finding from a previous audit has not been properly addressed, it can become a major finding during the next audit. This is one of the most common ways a minor issue becomes major.

What Do You Need to Do?

For a major nonconformity:

The organisation must correct the issue and provide evidence that the correction has been effectively implemented before certification can be granted or continued. A follow-up audit or verification may sometimes be required. The certification body will specify the deadline.

For a minor nonconformity:

The organisation normally needs to submit a corrective action plan within the specified timeframe and provide evidence that the issue has been addressed by the agreed deadline. Verification may often take place during the next scheduled audit.

For both major and minor findings:

The response should address the root cause, not just fix the immediate problem. This is where many corrective actions fall short.

Why Are Corrective Actions Sometimes Rejected?

One of the most common reasons is that the organisation fixes the immediate problem but does not address why it happened.

For example, if an auditor finds that a calibration record is missing, simply creating or replacing the record is a correction. It does not explain why the record was missing.

The organisation should investigate questions such as:

• Was the calibration schedule being monitored?

• Did the responsible person know about the requirement?

• Was there a change in the process?

• Was the schedule updated after the process changed?

A strong corrective action response normally has three parts:

1. Correction: What was done to fix the specific issue?

2. Root Cause: Why did the issue happen?

3. Corrective Action: What was changed to prevent the issue from happening again?

If the response only explains the correction, the auditor may ask for further action.

What Does a Major Finding Actually Mean?

A major finding does not necessarily mean that an organisation has permanently lost its certificate.

It generally means that certification cannot continue until the issue is properly addressed and verified.

There is also not necessarily a requirement for a complete re-audit. In many cases, verification focuses specifically on the finding, the corrective action, and its root cause.

How Can You Reduce Findings Before the Certification Audit?

Many issues identified during certification audits could have been identified earlier through effective internal audits.

That is one of the main purposes of an internal audit programme: to identify weaknesses before an external auditor does.

A finding identified internally usually requires corrective action.

The same finding identified by a certification body can involve additional corrective action, evidence submission, verification, and management discussions about why the issue was not identified internally.

An effective internal audit programme can therefore help organisations identify and address issues before they become certification audit findings.

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Verification Notes Before Publishing

Two points should be checked against current information before publishing:

1. ISO 9001 Revision:

The first news article discusses the ISO 9001 revision in general terms without mentioning a specific publication date, version number, or transition deadline. Before publishing, confirm the latest status with the certification body and add the relevant dates. If the revision has already been published, update the wording from future tense to present tense.

2. Audit Practice Trend:

The second news article describes a trend observed in audit practice. It is not presented as a formal change to ISO requirements. It should therefore remain clearly framed as commentary or industry observation rather than a new mandatory requirement.

The remaining content is based on the general structure of ISO 9001 and commonly followed audit practices.