The ISO 9001 clause titled Control of Nonconforming Process Outputs, Products and Services is a mouthful to say the least. After reading through this section of the standards, I decided to get a better understanding of the requirements myself so that I could come up with a simpler explanation of the contents of this section.
What is ISO Control of Nonconforming Process Outputs, Products and Services? Control of Nonconforming Process Outputs, Products, and Services occurs when outputs from the business do not confirm with ISO 9001 guidelines. In this case, these products and outputs must be identified and corrected.
The ISO 9001 standards are very helpful to organizations that strive to stay organized and in full control of their business. With all of the specific clauses and requirements that exist within the system, some of the main ideas can get lost under all of the big words they are written with.
If you agree that some of the ISO 9001 guidelines are not as clear as you would like them to be, there is no need to worry. Keep reading this quick explanation of Control of Nonconforming Process Outputs, Products and Services to get a better understanding of some of the details that were left out.
|ISO 9001:2015||ISO 9001:2008||Summary of Changes|
|8.7||Control Of Nonconforming Process Outputs, Products And Services||8.3||Control Of Nonconforming Product||This clause now includes as a new requirement, the terms ‘process outputs’ and ‘services’ as well as products. It should be noted that there is no need to maintain a documented procedure but your organization may still chose to operate one.|
The term “nonconformity” when it comes to ISO 9001 guidelines refers to the event of one or more requirements being broken or ignored within an organization. There are several clauses with individual sections within ISO 9001 that highlight specific areas of a company in order to keep everything organized and running smoothly.
Some of these areas that are specified within the guidelines are process outputs, products, and services.
For the most straight forward and general explanation of what this clause means, it is basically the violation of rules and regulations within any of these specific categories.
From the moment that a nonconforming process or output is noticed within the company, there is a series of steps that must be followed in order to come up with a solution for the issue and prevent it from happening again.
This is where the Control part comes in within the Control of Nonconforming Process Outputs, Products, And Services clause.
While nonconformity cannot always be avoided because mistakes do happen within a company, the most important thing to keep in mind about this process is that the issue must be immediately handled when it presents itself.
In other words, the event of a nonconformity itself within an organization is not the end of the world, but it will have more dire consequences if the nonconformity is not properly identified, addressed, corrected, and prevented in the future.
Take a look at the list below to learn about the basics of ISO Control of Nonconformity.
ISO Control Of Nonconformity:
The three basic steps when it comes to Controlling nonconformity are identifying the problem or violation, recording it, and taking the appropriate action to put a stop to it.
In order to be able to properly deal with the issue that is at hand, the nonconformity must first be identified. This process will include determining which specific ISO 9001 requirement has been broken to move on to the next step of solving the problem.
Recording the nonconformity will be done by filling out a document called a Non-Conformance Report, or NCR. The NCR should be a very detailed report that clearly states what the violation was and how it can be fixed.
The control of the nonconformity must include a specific outline of the actions that will be taken in order to correct the nonconformity as well as control it during future business operations.
While the prompt correction of a nonconformity is needed within any organization, the maintenance of this process is key. Without following up on the specific issue after it has been handled, the nonconformity is more likely to happen again, which would defeat the entire purpose of correcting it in the first place.
When a product or output does not fit into the guidelines and requirements that are outlined by ISO 9001, it is considered to be a nonconforming product or output.
The term product refers to anything that is designed and developed by the organization for purchase and distribution to their customer base. Output, on the other hand, refers to the result of a process that does not fit into the requirements that are outlined by ISO 9001.
In either case, the issue of nonconformity must be quickly identified, corrected, and prevented in the future in order for the operations of the business to continue running smoothly.
Since the requirements of ISO must be strictly adhered to in order to maintain the quality standards of a business, any product or service that does not fit into these processes will need to be eliminated.
In the event that a product is not compliant with ISO 9001, it will not be able to be distributed to customers of the business, and must quickly be stopped before any mistakes of that nature occur.
Take a look at the list below to find an explanation of the process that goes into handling nonconforming products.
Handling Nonconforming Products:
When it comes to controlling and handling products that do not conform to ISO 9001 guidelines, there is a specific procedure that must be carefully followed to ensure that the wrong product is not given out to consumers.
First and foremost, the organization should already have a documented procedure that indicates the method they will use or plan of action that will be taken in order to control the products in question.
Following along with these guidelines that have already been put into place, the product that does not conform to the requirements must be immediately identified and separated from the other conforming products.
Upon the removal of the product that does not qualify under ISO 9001 guidelines, the organization will ensure that it does not get mixed up with the quality products that are on their way to be distributed to the masses.
Once the product has been effectively identified and removed from the others, it must be properly reviewed and approved before it can be released. The release of a nonconforming product can be made under concession by an authorized person. Any release of this kind should be properly documented after it has been completed.
The other details of the nonconformity must also be documented in detail. This should include the exact non-conforming characteristics that were identified, as well as the procedures that were followed in order to get rid of it and prevent it from happening in the future.
From the documentation of the nonconforming product, all company personnel should be able to understand the nature of the event, why the product did not conform to the specified standards, and what was done to eliminate the issue.
In the event that a nonconforming product is identified after it has already been distributed or delivered, there will be a separate set of actions that must be taken to solve the problem at hand. These actions will depend on the severity of the nonconformity, and will be determined by the discretion of the company leaders.
When a nonconforming product has been identified and a plan of action has been established to solve the problem, it can either be permanently removed or possibly altered in order to fit the guidelines and be considered a qualifying product.
When any nonconforming product is reprocessed, it must go through a revalidation process by someone of proper authority in order to be approved for release.
As you can see, the process of identifying and controlling products, services, and outputs, serves to keep an organization alert about what is coming and going from the business. With the help of these detailed standards, companies are able to ensure that they are meeting their goals without compromising quality.
John Walter is currently the head of the International Organization for Standardization, or ISO for short. From the years 2014 to 2016, he was the Vice-president of the ISO policy, until he was elected as the president of the organization in 2017.
An ISO certified company is defined as an organization that is complaint with the regulations of ISO 9001 standards. In addition to just following these guidelines, business that are certified with ISO go through an auditing and approval process to make sure that they are in line with the quality standards that have been put into place.
The abbreviation ISO stands for the International Organization for Standardization, which means that the standards are set for countries all around the world. In the current year, there are a total of 164 countries that are members of the ISO, certified and compliant with the quality guidelines that have been put into place.
ISO 9001 Clauses - DO
- 7.1 Monitoring and Measuring Resources for ISO 9001
- 7.2 Competence and Awareness - What is it?
- 7.5 What is Documented Information in ISO 9001
- 7.5.2 Creating and updating Documented Information for ISO 9001
- 7.5.3 Control of Documented Information Explained
- 8.2 What are the Requirements for Products and Services?
- 8.3 Design and Developent of Products and Services Explained
- 8.7 Control of Nonconforming Process outputs Products and Services
Written: 24th July 2019
Author: Richard Keen
Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
Learn more about Richard