What is non-conformance in terms of ISO 9001?

If your organisation is ISO 9001 certified, it must adhere to a set of rules and regulations to conform to the requirements. Failure to meet these mandatory ISO 9001 guidelines means your organisation will be considered non-compliant. So, what exactly is ISO 9001 non-conformance? Read on to learn more about this type of non-conformance and what to do if your company is considered ISO 9001 non-conformant.

What is ISO 9001 non-conformance?

In its simplest definition, ISO 9001 non-conformance is when a company fails to follow the specifications of ISO 9001. As a standard developed by the International Organization for Standardization, ISO 9001 defines the quality management system (QMS) requirements to be implemented to ensure your products and services meet customer expectations and regulatory policies. Major or minor non-conformities can arise in your products, processes, or the actions of your employees.

These non-conformance issues are often discovered during regular inspections or internal and external audits. The issues range from minor errors to severe mistakes that significantly affect or fail your quality management system. They are divided into two categories: minor non-conformance issues and major non-conformance issues.

Minor non-conformance

This refers to an occurrence that doesn’t comply with ISO 9001 regulations but is less likely to have significant consequences. Simply put, this incident will not have a serious impact or lead to the failure of your QMS. Some examples of such incidents include not having the appropriate documentation for inspecting equipment, ineffective risk assessment, or a mistake made by personnel.

Major non-conformance

Major non-conformities can occur due to a repeated minor problem or a total breakdown in your QMS model, disrupting your entire ISO 9001 compliance efforts. Some examples of major non-conformances include failing to implement a section of the standard, failure to take a preventive measure, or failure to execute a procedure.

How to handle non-conformance

Non-conformance issues can have detrimental effects on your business if overlooked. For instance, repeated employee actions against ISO 9001 requirements could negatively affect your company’s morale. Similarly, failure to address a fall in the quality of your products or services may result in a tarnished reputation. However, the good part is that these non-conformities can be corrected.

Once you or the auditing team discovers a non-conformity within your QMS, you must act fast to combat the situation. This involves preparing a Non-conformance Report (NCR), which outlines the specific areas that don’t meet the quality requirements. The NCR is developed to let the auditee evaluate and explain the preventive or corrective action plans to be implemented.

Corrective action

According to ISO 9001:2015, organisations need to evaluate the effectiveness of any proposed actions and even identify possible opportunities and risks established during planning. Furthermore, assessing the effectiveness of the non-conformity corrective actions can help complement the existing corrective strategies. In a nutshell, corrective action aims to investigate the risk and eliminate it based on complexity.

Need assistance with ISO 9001 conformance? We can help

If you identify the significant causes of non-conformance in your QMS, you can implement a clear roadmap to mitigating them. Citation Certification will make your journey easier by providing effective training and coaching to facilitate ISO 9001 compliance and certification. Contact us online today to learn more about our services and discuss your organisation’s non-conformance management needs.