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

Aaron Hoare Date published: Jul 25, 24

In the context of ISO 9001, a non-conformance is when an organization 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 organization’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. Naturally, we expect there may be some development or evolution in ISO 9001 non-conformance with the planned 2026 revision to the standard, at which point we will update our ISO 9001 resources. But for now, let’s take a look at non-conformance in ISO 9001:2015.

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 organization 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.

ISO 9001 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 in ISO 9001?

A minor non-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 quality management system (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 and preventive actions which stop the non-conformance from happening again.

ISO 9001 non-conformance examples

To put ISO 9001 non-conformance into context, here are some examples of non-conformances you may find within your organization:

• 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 organization. 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 organization. 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 organization any favors when it comes to keeping stakeholders happy.

Ensuring you are complying with the demands of the ISO 9001 standard, 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, and it is often how you have handled your non-conformances that ISO 9001 auditors will be scrutinizing. 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 organization 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.

By adhering to this internationally recognized quality management standard, companies can improve operational efficiency through streamlined processes and reduced waste. It enhances customer satisfaction by ensuring consistent product and service quality, which builds trust and loyalty. Additionally, ISO 9001 certification can open up new market opportunities as many clients and partners prefer or require this standard. Finally, it promotes continuous improvement and risk management, fostering a culture of proactive problem solving and innovation within the organization.

There is no better way to achieve ISO 9001 compliance than to invest in the right QMS software. Ideagen provide quality management solutions that are trusted worldwide to uphold unbreakable standards of quality and to help organizations comply with ISO 9001.

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