Major vs Minor: Non-Conformance ISO


You may have heard of the terms minor non-conformance and major non-conformance when relating to businesses. But what do they actually mean and how do they impact your business and its activities? Well, we’ve put together this handy little blog post to break down the meaning of both, and what defines a minor non-conformance from a major one.

What are non-conformances?

Non-conformances are the areas where improvements can be made in relation to the business processes and procedures you’ve put in place. There are no definitive limitations where non-conformances are or aren’t occurring across a business. However, there are crucial differences between minor and major non-conformances, so being aware of them can be the key to continual improvement and ongoing certification.

Minor non-conformance

All non-conformances are very specific to your own business as well as to the ISO Standard that they relate to.

If a minor non-conformance occurs as a ‘one-off’, it won’t cause a breakdown in your business operations. But, if they begin to occur regularly and are not dealt with appropriately, they could result in a major non-conformance and the breakdown of your business procedures. If a minor non-conformance occurs, you should consider what to change in that specific area to ensure improvement.

It should also be used as a springboard for further investigation into your business systems to discover any other weaknesses, which can then be included in your plans for correction. A minor non-conformance will not necessarily affect your certification. If it’s flagged up in an audit, you’ll have an agreed amount of time to sort it out, which will be checked by your auditor at the next visit.

However, a minor non-conformance will always be a weakness in your business processes or procedures. This is where you should err on the side of caution, as this could lead to a major non-conformance if it’s not solved quickly. An example of a minor non-conformance would be a missed training record or a single invoice mistake.

Minor non-conformance examples

Some examples of minor non-conformance issues include the following:

  • A missing training record
  • An invoicing mistake
  • No separation of non-conforming products
  • Machines not calibrated properly

Major non-conformance

A major non-conformance is an occurrence that could negatively impact your business and its intended operations and objectives. It’s classified as a significant failure to meet the quality requirements, such as the ISO 9001 Standard.

It could be a failure to implement a key requirement within your respective ISO Standard, an absence of it altogether, or a failure to maintain conformance as a whole.

Major non-conformances are more serious by their nature as they may have a direct impact on your business. For instance, you could see a drop in customer satisfaction or a fall in your reputation. If the affected system relates to Health & Safety, it could be putting your staff at risk.

If a major issue is flagged up, this will also affect your certification as your procedures will not be meeting those set out by your Standard. This can cost you valuable time and money, as you’ll need to make improvements and then potentially have another audit.

Major non-conformance examples

Examples of major non-conformances include failure to carry out a vital process such as irregular backing up of data, or a culmination of multiple or significant errors (such as repeated invoice mistakes).

We understand that every business can benefit from a little helping hand now and again, so we spoke to our expert consultants to find out what the five most common major non-conformances are.

1. Issues with documentation

All Standards require that the records created by the implementation of business processes and procedures need to be kept – without it, you will be failing a key requirement.

2. Lack of management reviews

Management reviews show whether your processes are still fit for purpose, so it’s essential that they are carried out. It’s also crucial that they are run with an agenda and that minutes are taken, which can then be circulated. In your external audit, you’lll need to produce these minutes as part of your evidence.

3. Lack of internal audits

To keep your business processes shipshape you’ll need to keep a close eye on them. One way of doing this is to hold internal audits, which verify that processes and procedures are being effectively implemented in key areas of your business.

4. Training

Trained staff are key to a well-run business, which is why the ISO Standards place great emphasis on it. Training should be relevant to an individual’s job and could include documentation such as an induction handbook or staff handbook. All training should be recorded in a log, which can then be used as evidence during your audit with one of our consultants. ISO Training can help develop team skills and improve productivity and performance to ensure compliance with all ISO Standards and conformances.

5. Process for customer feedback

Many ISO Standards require businesses to be hands-on with their customer feedback as it can be a great indicator of areas where improvements can be made. By creating a process for customer feedback, you can check that their needs are being met, which will have the advantage of increasing the likelihood of repeat business.

Get ISO certification with Citation ISO Certification

So, if you need an experienced team of consultants and auditors, then we have just the solution for your business. We offer a simple and cost-effective approach to ISO certification, and we can helpyou get certified in as little as 45 days.

What’s more, you’ll get access to our sleek, interactive ISO management platform, Atlas, which simplifies all your ISO maintenance and ensures you remain on top of all essential tasks and compliant with conformances. For more information, check out our certification process and get your instant quote today.

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About the author

  • Name:

    Claire Price

  • Company:

    Content Marketing Executive

  • Bio:

    Claire worked for Citation ISO Certification between 2020 and 2022 writing creative and informative content on ISO certification and consultation to help businesses reach their potential.


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