Understanding ISO 9001 Non-Conformities: Common Gaps and How to Fix Them

 

If your organization is working toward ISO 9001 Certification, or already holds the certificate, understanding ISO 9001 non-conformities is essential. These non-conformities reveal gaps in your quality management system (QMS) — and when handled properly, they become stepping stones for continuous improvement. This blog explores common non-conformities, root causes, and effective ways to resolve them.

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What Are ISO 9001 Non-Conformities?

A non-conformity under ISO 9001 is any deviation from a requirement in the standard, or a failure to follow your own documented processes and procedures. Non-conformities don’t always indicate failure; rather, they help identify areas where your system needs improvement.

These findings are generally categorized as major or minor, helping organizations decide what to prioritize.

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Major vs. Minor Non-Conformities

Major Non-Conformities

These indicate a serious breakdown in your QMS. Examples include:

• No internal audits being conducted
• Missing mandatory records
• Processes not being followed at all

Major non-conformities can delay or block ISO 9001 Certification, as they represent systemic issues affecting your ability to consistently meet customer and regulatory requirements.

Minor Non-Conformities

These are smaller deviations that don’t cripple your system but still need attention. Examples include:

• Outdated forms in use
• Slight variations in how processes are followed
• Missing minor details in records

Minor issues do not prevent certification but can accumulate over time if not addressed, eventually becoming major concerns.

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Common ISO 9001 Non-Conformities Found During Audits

Auditors frequently encounter similar patterns across industries when assessing  ISO 9001 non-conformities. Some of the most common include:

1. Poor Document Control

Documented procedures may not be updated, controlled versions may not be available, or employees may be using outdated documents.

2. Incomplete or Missing Records

Tasks may be performed but not properly recorded. Missing evidence creates compliance issues and weakens traceability.

3. Weak Management Reviews

Organizations sometimes fail to effectively review key areas such as risks, performance data, internal audit results, and customer feedback.

4. Lack of Clear Process Ownership

Processes may be running, but no single person or team is accountable for monitoring or improving them.

5. Ineffective Internal Audits

Internal audits may be shallow, skipping key areas, or performed only to “tick a box,” without evaluating process effectiveness.

6. Customer Complaints Closed Without Root Cause Analysis

Organizations may close complaints quickly without identifying the true cause, leading to repeat issues.

These non-conformities appear in both new applicants and certified companies undergoing surveillance audits.

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Why Do ISO 9001 Non-Conformities Happen?

Understanding the root causes of ISO 9001 non-conformities is crucial to preventing them from recurring. Common causes include:

Procedures Not Matching Actual Practices

Teams often adapt processes informally over time, leading to a mismatch between documented and actual practices.

Insufficient Training

Employees may not receive proper training on updated procedures, resulting in inconsistent employee behavior.

Siloed Departments

Poor communication between teams may lead to misaligned expectations and unclear handoff processes.

Quick Fixes

Organizations sometimes implement temporary fixes just to close a finding, instead of addressing underlying systemic issues.

Poor Communication

Responsibility gaps often arise because teams assume someone else will take ownership.

Using tools like the 5 Whys and Fishbone diagrams helps identify the true root causes.

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How Auditors Identify ISO 9001 Non-Conformities

Auditors follow a systematic approach to identify ISO 9001 non-conformities:

1. Reviewing Documentation
   They check whether documented processes align with ISO 9001 requirements.
2. Interviewing Employees
   Auditors verify whether employees understand and follow documented procedures.
3. Observing Activities
   They watch processes in real time to confirm consistency between practice and documentation.
4. Evaluating Records
   Records must be complete, accurate, and accessible as evidence.
5. Classifying Findings
   Based on risk and impact, auditors classify findings as major or minor.

This structured approach ensures findings are objective and evidence-based.

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How to Correct ISO 9001 Non-Conformities

Corrective action is a structured process designed to eliminate the root cause of a non-conformity and prevent recurrence. The steps include:

1. Clearly Define the Non-Conformity

Identify exactly what went wrong, where it happened, and which ISO 9001 requirement it relates to.

2. Conduct Root Cause Analysis

Use tools like 5 Whys or Fishbone to go beyond symptoms and uncover what actually caused the issue.

3. Create a Corrective Action Plan

The plan should include:

• Tasks to be completed
• Responsibility assigned
• Timeframes
• Expected results

4. Implement Corrective Actions

Actions may include retraining, updating documentation, redesigning processes, or improving communication channels.

5. Evaluate Effectiveness

Once the action is implemented, check whether the issue has been fully resolved. Only then should the non-conformity be closed.

Proper documentation at every stage ensures transparency and helps during future audits.

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Best Practices for Reducing ISO 9001 Non-Conformities

To minimize non-conformities and build a stronger QMS, organizations should:

Plan Audits Effectively

Prioritize high-risk areas, review previous findings, and schedule audits regularly.

Ask Better Questions

Encourage employees to explain processes in their own words. This exposes real issues, not just documented ones.

Focus on Both Paper and Practice

Ensure that documented processes match operational reality.

Promote Open Communication

Create a culture where employees feel comfortable reporting issues rather than hiding them.

Strengthen Process Ownership

Assign responsibilities clearly and ensure each process has a dedicated owner.

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Continuous Improvement: Beyond the Certificate

Addressing ISO 9001 non-conformities is not just about achieving or maintaining ISO 9001 Certification. It builds a foundation for continuous improvement. Every non-conformity — whether major or minor — is an opportunity to enhance processes, strengthen controls, and boost customer satisfaction.

Organizations that treat non-conformities as opportunities rather than threats experience long-term benefits, such as:

• Improved efficiency
• Reduced operational risks
• Better collaboration across teams
• Stronger customer trust
• A more robust and mature QMS

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Conclusion

Understanding, identifying, and addressing ISO 9001 non-conformities are essential steps in building an effective QMS and achieving long-term success with ISO 9001 Certification. Non-conformities provide valuable insights into gaps that may otherwise go unnoticed. By addressing them with structured root cause analysis and corrective actions, organizations build resilience, reduce risks, and ensure continuous improvement.