Written: 10th May 2019
Author: Richard Keen
While I was re-reading the current ISO 9001 guidelines this week, I noticed the term “nonconformity” within one of the clauses. I realized that a lot of people might not immediately know exactly what this means, so I decided to do some deeper research and come up with a detailed explanation if what nonconformity is.
What is nonconformity in ISO 9001? Nonconformity in ISO 9001 is defined as the failure to meet one or more requirements. When the functions of a business are not conforming to ISO 9001, there must be a solution where the problem is controlled or corrected before going forward.
|ISO 9001:2015||ISO 9001:2008||Summary of Changes|
|10.2||Non-Conformity And Corrective Action||8.3||Control Of Nonconforming Product||
This requirement is comparable to Clause 8.3 - Control of Non-conforming Product and Clause 8.5.2 - Corrective Action. There is an additional requirement for organizations to determine whether other similar non-conformances exist or have the potential to exist.
There is also a new requirement for an organisation to determine whether changes are required to the QMS in order to prevent a reoccurrence.
When a company is ISO 9001 certified, there is a specific set of regulations that must be followed in order to conform with the guidelines. In the event that one of these mandatory requirements are not being followed, the company or individual will be considered noncompliant.
Keep reading to find out what is considered to be nonconformity in ISO 9001, as well as what happens after the violation has been recognized.
Nonconformity in terms of ISO 9001 is defined as the failure to meet one or more requirements that are outlined throughout the mandatory clauses. To get more into detail on the topic, nonconformity can refer to the requirements of a regulatory body, the organization itself, or even the customers of the business.
ISO 9001 Nonconformity:
Nonconformity can be anything from the company’s individual procedures to the quality standards that must be upheld in order to satisfy the customer base. In the event that there are any violations of ISO 9001, there are a few actions that should be taken thereafter.
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There are two different types of nonconformity that can be identified, which are referred to as major and minor nonconformances.
A minor nonconformance is an event or action that is outside of the ISO 9001 requirements. However, this type of violation does not have any dire consequences to the way the business operates nor does it cause any major effects.
A major nonconformance, on the other hand, is identified when where is a huge violation of the business’ QMS, preventing the entire company from meeting the requirements outlined in ISO 9011 guidelines.
For example, if the company personnel failed to take corrective action on an area of the business that was not compliant with ISO regulations or just failed to implement the standards in the first place, this would be considered a major nonconformance.
What Happens After Nonconformity is Identified:
When nonconformity is identified in a business, there are a few things that will take place in order to get the company back on track. First of all, a non-conformance report (NCR) will be filled out by the supervising personnel.
Once the person who is being audited has been informed of the contents of the report, a plan of action is establishes and carried out in order to prevent future nonconformity.
The details of the processes that go into reporting and correcting ISO nonconformity will be described in detail within the next few sections. Keep reading to get a better idea of what this looks like within an ISO 9001 certified company.
When nonconformity occurs within a business, there is something called a non-conformance report (NCR) that is filled out to notify the violator of the issue at hand in explicit detail in order to begin to repair the problem.
The NCR is created in the form of a document, and is meant to be constructive, allowing the person who is being notified to be able to make changes and move into the right direction.
In order to create a detailed and effective nonconformance report, there are four main points that need to be addressed, as outlined in the ISO 9001 Nonconformity clause. These NCR requirements are outlined below, and explained more in detail throughout the rest of this section.
The first item that must be included in a nonconformance report is the specific requirement that is being violated by the nonconformance. Basically, the report must indicate which rule or regulation from ISO 9001 is being broken, which will be the reason why it is being written in the first place.
Along with the requirement that is being violated, the actual event or act that went wrong to cause the NCR to be written up must also be indicated in the report to notify the company personnel of what they have done incorrectly to cause the violation.
Next, and most importantly, a plan of action to prevent future problems of similar nature must be written on the report. Since Nonconformance reports are meant to be solution-oriented, there must be some kind of positive action recorded on the document.
To be more specific, nonconformance reports are not a notification of an employee being fired, put on suspension, or otherwise placed on any kind of punishment per say. They are meant to help the business improve as a whole, by assisting every member of the company in becoming fully compliant with the ISO 9001 regulations.
The NCR could be considered a warning to the non-complaint employee, that outlines a detailed process on how they can correct their actions and avoid making the same mistakes in the future. The plan of action must be accompanied by a more in-depth explanation of the steps that will be taken to fix the nonconformance.
Suggestions for Writing NCR:
When it comes to writing an effective NCR, there are a few tips that you will want to keep in mind to get your point across clearly and gain the best results afterward.
First of all, you will want to write clearly so that the auditee will be aware of the issue that has occurred. Along with addressing everything that is required in the report as mentioned in the list above, you will want to keep the nonconformance statement as general as possible.
Even though the report itself should be very detailed, you should write the most specific information in the area that is designated for the objective evidence.
The beginning of the report where you explain the regulation that has been violated should be written in generic terms in order to highlight the specific issue at hand, instead of confusing them with big words and distracting from the main idea of the report.
While it is important to avoid nonconformity in a business at all costs, there will be some instances where mistakes can happen and rules can be broken for whatever reason.
Instead of dwelling on the fact that an employee or certain area of the business is not currently conforming to ISO 9001 regulations, it is important to immediately come up with a plan and take action to fix the issue.
In this section, we will go over the process that should take place in the event that nonconformity occurs anywhere within a company.
As mentioned previously, a report must be written up in the event of any nonconformities within the business. In this report, there are detailed steps of how the problem will be solved.
While correcting the nonconformance, the efficiency of the corrective actions outlined in the report should be reviewed. Additionally, the auditees should be met with, observed, or followed up with to make sure the problem does not persist.
Throughout this entire process, everything should be documented for accuracy, effectiveness, and future reference.
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As you can see, nonconformity of ISO 9001 is something that occurs when regulations are not being followed, however there are plenty of actions to take in order to fix the problem and prevent any future ones.
Under ISO 9001 guidelines, there are requirements for almost everything that goes on within a business, including the products that are designed and developed. A nonconforming product is one that does not meet one or more of the ISO regulations. In this case, the product must be identified and stopped before distribution.
A minor nonconformance can include a misstep that broke a company policy or procedure, rather than directly failing to meet ISO requirements.
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Control of Non-conformity & Corrective Action Procedure
The purpose of this procedure is to establish the process for identifying, documenting and analyzing non-conformities and mitigating their impacts by implementing appropriate corrective actions. Your organization’s quality management system is geared toward the proactive elimination of actual and potential deficiencies.
Non-conformities in products, services, processes and our management system are investigated and action implemented to prevent their occurrence.
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