Non-conformance in ISO 9001: What is it and how do you deal with it?

Bethan Foston 30 Aug 2022

In the context of ISO 9001, a non-conformance is when an organisation fails to meet the standard’s requirements. Knowing what non-conformances to ISO 9001 are, and how to deal with them, is essential if you want to ensure the quality of your organisation’s processes, services and products, and keep your stakeholders happy.

This blog will explain ISO 9001 non-conformance in further detail, including the different levels of non-conformance and examples. It also explores the implications of non-conformance and how you should deal with it.

So, what exactly is meant by ISO 9001 non-conformance?

The non-conformance meaning is relatively straight forward. It can be defined as any instance where your organisation fails to conform to the requirements of ISO 9001.

As you will know, ISO 9001 is a standard set by the International Organization for Standardization. It outlines quality management system requirements to ensure that your products and services meet the expectations and needs of customers, regulators and legislation. Non-conformances can therefore occur in your processes, products, or even in the actions of your personnel.

Non-conformances are usually discovered during internal and external audits, as well during routine inspections. They can be anything from one-off errors that are easily amended to major mistakes that severely impact your conformance to ISO 9001. These can be defined as minor non-conformances and major non-conformances.

What is the difference between minor and major non-conformances?

A minor-conformance refers to an incident that does not comply with ISO 9001 requirements, but is a one-off occurrence that is unlikely to have a serious impact on your QMS and business operations.

A major non-conformance, on the other hand, can be either a repeated minor incident or a more serious single incident that does not conform to ISO 9001 requirements. It would have a severe impact on your QMS, potentially disrupting entire business operations.

Under ISO 9001, all non-conformances – regardless of which category they fall under – will need to be dealt with through corrective actions which stop the non-conformance from happening again.

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ISO 9001 non-conformance examples

To put non-conformance into context, here are some examples of non-conformances you may find within your organisation:

• A failure to address a drop in quality
• Not properly monitoring and measuring processes and procedures
• A mistake made by personnel
• Product specifications, such as measurements, not meeting client requirements
• Ineffective risk assessment and management
• A failure to document corrective actions
• Not clearly defining materials involved in your processes
• Missing important documents, such as legal or training records

What are the implications of non-conformance?

Non-conformances, if they are not found and are left undealt with, can potentially have a severe impact on your organisation.

For example, not addressing a fall in the quality of your products may result in dissatisfied customers and a tarnished reputation. Repeated personnel actions that do not follow ISO 9001 requirements could also have a detrimental impact on the morale of your organisation. What’s more, producing products to incorrect specifications may lead to products having to be recalled or production processes restarted, which lowers productivity levels. This, too, will not do your organisation any favours when it comes to keeping stakeholders happy.

Ensuring you are complying with the standards of ISO 9001, and correcting any instances where you do not comply, is therefore essential. It will ensure that you maintain the satisfaction and trust of your stakeholders, the smooth running of your systems and processes, and the quality of your products and services.

How do you deal with a non-conformance?

Although non-conformances are less than ideal, how you respond to them is what is most important. They can, after all, be corrected. Once a non-conformance has been identified, either by yourself or an internal or external auditor, it is essential that you act quickly to control and amend the situation.

The first step when dealing with a non-conformance is to fill out a Non-Conformance Report (NCR). This is a document that:

• notifies the person responsible for the non-conformance
• outlines precisely what the non-conformance is
• explains how it will be corrected and prevented from happening in the future

After completing an NCR, you should follow the plan of action you have outlined to correct the non-conformance. It is also a good idea to assess how effective your corrective actions were at resolving the issue.

By taking these actions, you will be better placed to ensure that your organisation is compliant with the requirements of ISO 9001.

Why is conformance to ISO 9001 important?

Successful conformance to ISO 9001 can lead to increased efficiency by reducing the likelihood of errors and saving you time. It can also create better consistency within your processes and systems, and help continuously improve your QMS. These benefits will in turn contribute to happier staff and happier customers.

Now that you have a better understanding of what non-conformance is and how you should deal with it, register for our webinar: The cost of poor quality: How poor quality can influence your business

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