The Difference Between Major And Minor Non-Conformances In ISO Audits

ISO audits play a crucial role in ensuring that businesses adhere to internationally recognised management system standards. One of the key outcomes of these audits is identifying non-conformances—areas where a company’s processes do not fully meet the requirements of the standard. These non-conformances are categorised as either major or minor, and understanding the distinction between them is essential for organisations striving for compliance and continuous improvement.

What is a Non-Conformance?

A non-conformance occurs when an organisation fails to meet the requirements of an ISO standard, a documented process, or regulatory obligation. Non-conformances indicate gaps in compliance that must be addressed to maintain certification and improve the effectiveness of a management system.

Major vs. Minor Non-Conformances: Key Differences

Major Non-Conformances

A major non-conformance is a significant failure in the management system that impacts the organisation’s ability to meet the ISO standard’s requirements. This can include:

• Complete absence of a required process or system (e.g., an organisation lacking a documented procedure required by the standard).
• Systemic failure (e.g., a repeated issue occurring across multiple departments, indicating a breakdown in the management system).
• Non-compliance with legal or regulatory requirements (e.g., failure to adhere to health and safety laws within an ISO 45001-certified organisation).
• Significant risk to quality, safety, or the environment (e.g., a failure in ISO 14001 leading to uncontrolled environmental impacts).
• Failure to address a previous non-conformance (e.g., unresolved issues identified in past audits, indicating ineffective corrective actions).

A major non-conformance often results in immediate action, requiring urgent corrective measures. If left unaddressed, it could lead to suspension or withdrawal of ISO certification.

Minor Non-Conformances

A minor non-conformance is a less critical issue that does not significantly impact the overall effectiveness of the management system but still requires corrective action. Examples include:

• Inconsistencies in documentation (e.g., minor errors in procedure documents that do not affect compliance but need correction).
• Isolated incidents of non-compliance (e.g., one instance of a process not being followed correctly, rather than a systemic issue).
• Lack of employee awareness in certain areas (e.g., an employee being unaware of a specific procedure but overall processes are in place).
• Slight deviations from a procedure that do not impact quality or compliance (e.g., missing a required review in an internal audit but having an otherwise effective audit process).

While minor non-conformances do not pose an immediate threat to compliance, they must still be addressed to prevent them from escalating into major issues in the future.

How to Address Non-Conformances

1. Identifying Root Causes

For both major and minor non-conformances, it’s essential to conduct a root cause analysis to determine why the issue occurred. Common techniques include:

• The 5 Whys Method (asking “why” multiple times to drill down to the root cause).
• Fishbone diagrams (identifying multiple potential causes in a structured way).

2. Implementing Corrective Actions

Once the root cause is identified, organisations must develop corrective actions to eliminate the issue. These should be:

• Specific – Clearly define the actions to be taken.
• Measurable – Ensure there is a way to track progress.
• Achievable – Set realistic expectations.
• Relevant – Address the root cause, not just the symptoms.
• Time-bound – Establish deadlines for implementation.

3. Preventing Recurrence

To prevent the same issue from happening again, businesses should:

• Update policies and procedures as needed.
• Train employees on revised processes.
• Conduct internal audits to verify compliance.
• Monitor and review corrective actions over time.

Final Thoughts

Understanding the difference between major and minor non-conformances is crucial for organisations seeking ISO certification or maintaining compliance. While minor non-conformances highlight areas for improvement, major non-conformances demand urgent corrective action to prevent certification risks.

By proactively addressing both types of non-conformances through structured root cause analysis and corrective action, businesses can strengthen their management systems, improve operational efficiency, and ensure continued compliance with ISO standards.