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6 Causes of non-conformance to ISO 9001

By Peter Hargittay on Fri, Jan 27, 2023 @ 12:25 PM

Non-conformance to ISO 9001 is when an organization fails to meet the standard requirements. 
As known, 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. And nonconformance occurs in your processes, products, or even in the actions of your personnel.
It is usually detected through internal and external audits and during routine inspections. 
Non-conformances can be anything from one-off errors that are easily amended to major mistakes that severely impact your conformance to ISO 9001, and they can be minor or major.

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

Minor conformance refers to an incident that does not comply with ISO 9001 requirements but doesn’t have a serious impact on your QMS and business operations.
Contrariwise, a major non-conformance 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. 
But you should know that, 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.

Common Causes of non-conformity to ISO 9001

1-    Failing to identify interested parties (Clause 4)
It’s a new requirement to identify and define interested parties. Many clients are failing to do this.
Also, many organizations are failing to meet the new requirement of monitoring and measuring processes.

2-    Failing to address change (Clause 6)
In ISO 9001:2015, organizations are required to plan and define actions when changes are being made to the quality management system (QMS). Auditors find that this isn’t effectively implemented.

ISO 9001:2015 requires a risk evaluation throughout an entire organization. Risk is often not properly evaluated in parts of an organization’s business, such as warehousing and external/internal issues.

3-    Lake of knowledge (Clause 7)
It’s mandatory to have accuracy with measuring devices. Some organizations aren’t using the appropriate tool/measuring device for a measurement taken, so the result is inaccurate.

A new requirement for ISO 9001:2015 is the need for an organization to improve its knowledge. It’s essential that this knowledge/training/education is captured, but auditors frequently find that it’s not. An example of this is training records that aren’t retained.

4-    Failing to control operations (Clause 8)
This section focuses on the control of operations, which should be carefully examined when an organization is preparing for an audit. Often, auditors find that first-piece inspections aren’t effective and not documented.

Receiving inspections is also cited as ineffective. The process for approving and disqualifying vendors that aren’t up to code is often not defined. Also, many organizations aren’t clearly defining the materials involved in their processes or manufacturing.

5-    Fail to meet requirements of internal audits (Clause 9)
The language may have changed from 2008 to 2015 but the requirements for internal audits remain the same. Many internal audit systems are ineffective, and organizations don’t meet the requirements for clause 9.

Common shortcomings include the lack of addressing the mitigation of risk or actions taken regarding the performance of the QMS.

6-    Fail to meet customer complaints (Clause 10)
This clause addresses nonconforming materials and corrective action. It’s virtually the same as in 2008, but 2015 adds customer complaints language.

Customer complaints are often recorded, but organizations don’t define or document corrective action, so they fail to meet the 2015 standard.

Impact of ISO 9001 nonconformance
Discovering non-conformances is not necessarily negative, it can be an opportunity to make improvements that lead to corrective actions. 
Discovering minor issues during an internal audit or management review can prevent long-term significant problems and barriers to ISO 9001:2015 certification.
The average number of minor non-conformances revealed during an audit is four to six. So, it’s worth investing time and energy to avoid both minor and major non-conformances to earn your certificate.

Bonus tip
It is not enough to discover non-conformances, how you deal with them is more important. After all, they can be corrected, but it is essential that you act quickly to control and amend the situation.  
The first step to do so is to fill out a Non-Conformance Report which will notify the person responsible for the non-conformance, outline the non-conformance, and 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.

Peter Hargittay

Written by Peter Hargittay

Peter Hargittay is the Chief Marketing Officer (CMO) and VP of Corporate Development at Intellect. Peter is responsible for rebranding the company as Intellect from Interneer and for positioning the company for significant growth. Peter joined Intellect in 2013, and is responsible for corporate, product, and online marketing, business development through the Intellect partner channel, demand generation, sales enablement, and go-to-market strategies. Peter has more than 15 years of experience in building successful software and services businesses. Prior to Intellect, Peter served as the VP of Marketing and Sales Operations at Arise Virtual Solutions, and previously held executive marketing roles at Aegis, PeopleSupport, Intersil, and FileNet. Peter received both his BA in Economics and MBA from California State University, Fullerton.