Non-conformance in ISO 9001

Non-conformance is a common concept within ISO 9001 quality management systems, but what does it actually mean, and how should businesses handle it? Non-conformance relates to when a process, product, or service fails to meet regulatory guidelines and requirements.

Non-conformance can disrupt the quality and efficiency of an organisation’s operations if not addressed appropriately. This blog will explain the different types of non-conformance, provide examples, and discuss how organisations can manage non-conformance effectively.

What is a non-conformance in ISO 9001?

ISO 9001 defines non-conformance as the failure to comply with the criteria outlined in a company’s quality management system (QMS). This can include customer requirements, legal regulations, and internal policies.

Non-conformance could be the result of many factors, such as defective products, ineffective processes, or employee errors. If these issues are not resolved, they can lead to bigger problems, such as customer dissatisfaction or fines.

Types of non-conformance

Major non-conformance

What is a major non-conformity for ISO 9001? Well, a major non-conformance is a significant issue that has a big impact on the company’s ability to meet ISO 9001 requirements. For instance, a missing quality control process that leads to unsafe products could be classified as a major non-conformance. This type of non-conformance should be addressed immediately to prevent further consequences.

Minor non-conformance

A minor non-conformance is less severe but still requires corrective action. An example might be an employee failing to follow a documented procedure on one occasion. While it may not have a direct impact on quality, it still indicates a gap in compliance that needs attention.

For more information on the differences between the two, see our blog on major vs minor ISO non-conformances.

ISO 9001 non-conformance examples

To better understand the concept, here are some examples of non-conformance in ISO 9001:

• Failure to document procedures: If a company doesn’t maintain accurate records of its processes or fails to update documentation regularly, it may be flagged for non-conformance during an audit.
• Non-compliance with safety standards: A manufacturing company might face non-conformance if it fails to ensure that all equipment meets the required safety standards, potentially putting workers at risk. See our blog on ISO 9001 for manufacturing organisations for more.
• Customer complaints: If a business receives frequent complaints about product quality or service delivery, it may highlight a non-conformance in its quality control processes.

How to handle non-conformance in ISO 9001

Managing non-conformance effectively is important for maintaining compliance and continuously improving your operations. Here are the key steps to take when non-conformance is identified:

Identify the issue

The first step is to recognise the non-conformance. This could be noticed during an internal audit, external audit, or even as a result of customer feedback. Once the non-conformance is identified, it should be documented, outlining the nature of the issue and its potential impact on the business.

Root cause analysis

After identifying the non-conformance, it’s important to determine the root cause of the issue. Was the non-conformance due to a process flaw, a human error, or a missing control? Conducting a thorough analysis will help pinpoint the cause and stop this from happening again.

Corrective action

Once the root cause is found, a corrective action plan should be developed and implemented. This plan must address the root cause and ensure the non-conformance doesn’t happen again. For example, if a process wasn’t followed, additional training or process changes might be needed.

Follow-up and review

After the corrective action is in place, it’s essential to monitor the situation to make sure the action has resolved the issue. ISO 9001 audits are perfect for this, and can help your business address these non-conformances.

Continuous improvement

Non-conformance is an opportunity to improve. By resolving the issue, businesses can learn from their mistakes and strengthen their overall quality management system. It’s a win-win!

Why not also take a look at our complete guide to ISO non-conformance?

Why managing non-conformance is essential

Effectively managing non-conformance is key to maintaining a robust ISO 9001 QMS. Failure to address non-conformance can lead to negative outcomes, such as customer dissatisfaction, loss of business, and potential legal implications. But, resolving non-conformance and implementing corrective actions can improve a company’s overall processes and help maintain compliance.

Managing non-conformance aligns with one of the core principles of ISO 9001 which is continuous improvement. Each time a non-conformance is identified and corrected, it supports the organisation’s ongoing growth, boosting efficiency and customer satisfaction.

Avoid non-conformances with Citation ISO Certification

Non-conformance is an inevitable part of any business, but the way it’s handled can make a significant difference. ISO 9001 provides a structured approach to managing non-conformance, ensuring that businesses take the necessary steps to identify issues, correct them, and prevent them from returning.

If you’re looking for ISO certification, then why not do it with us? Our ISO consultants will be there for you every step of the way, making sure that the QMS created fits your business.

Contact us today if you have any questions on how ISO 9001 could work for you.