ISO 9001 certification is a long and detail-oriented process for any business owner who seeks the stamp of quality approval. However, this process proves to be worth it when it is all said and done. There are several clauses within ISO 9001 that provide general guidelines to company personnel while implementing the QMS standards.
How many clauses are in ISO 9001? When it comes to the ISO 9001 quality management standard, there are 10 individual clauses. All of these clauses include scope, application, references, general quality management system requirements, management responsibility, resource management, product realization, and measurement, analysis, and improvement: in that order.
Unlike the previous version of ISO 9001 which was updated in the year 2008, the current 2015 version contains a total of 10 clauses, with 7 of them being mandatory requirements (clauses 4-10). The first three clauses just provide general information, but are not any less important than the others.
The clauses in ISO 9001 serve the purpose of providing the business owner and company personnel with an organized breakdown of what is required of them. Being ISO 9001 certified means that everyone involved follows a set of specific procedures in order to maintain quality within all aspects of the business.
Each of these clauses contain individual requirements and procedures that must be followed to the T in order for the business to successfully hold on to their certification, as well as benefit from everything that comes from a properly executed quality management system. Keep reading to find out everything you need to know about all 10 clauses of ISO 9001.
When it comes to becoming certified with ISO 9001, there are a number of factors to consider, and regulations to get in line with.
While it is true that ISO 9001 standards make it much easier for businesses to run smoothly, they can also complicate things when they are not properly understood.
This is why the ISO 9001 standards are broken down and written out into their own separate clauses.
The clauses in ISO 9001 are essentially organized categories that will let you know what is included in each area of the business, how you can execute these tasks, and what kind of results are expected to come from them.
In the most recent and up to date version of the ISO 9001 standard, there are a total of 10 separate clauses, each containing helpful and valuable information about how a company can rise to the top with the implementation of their new quality management system.
Take a look at the list down below to learn the specific names of each ISO 9001 clause, and keep reading to get an idea of what each one is all about.
Let’s take a look at each one of these clauses, starting from number one all the way to ten. The lists throughout the rest of this section will give you all of the main ideas, and a general idea of what is included within each individual clause.
The first three clauses in ISO 9001:2015 are Scope, References, and Terms and Definitions. These are more so informational clauses, rather that clauses that outline any kind of actions or requirements. This is something we will get into in a later section, though.
For now, we will talk about what each of these processes include, and why they are important while implementing and maintaining an ISO 9001 QMS.
The first step of the process is Scope. The scope is something that is defined and written down by the company personnel, and essentially outlines the goals that they will go forth with during the ISO 9001 implementation process.
References provide a better understanding of the basic ISO terms through relatable comparisons, while the terms and definitions section highlights vocabulary words that are used in the ISO 9001 standard, along with exactly what they mean.
These first steps are very important in your journey to ISO 9001 certification, because they will help you to understand exactly what you are doing and go forth in the most calculated manner possible.
The fourth clause in ISO 9001 is General Quality Management System Requirements. This section outlines the general requirements for the entire quality management system as a whole.
This is essentially the beginning of the entire ISO 9001 standard, which we will discuss later on.
The general requirement section also highlights the other ISO 9001 requirements, and includes guidelines for creating essential components of the business.
A quality manual is something that every business with a QMS needs. It will clearly outline what is expected from each manager and employee in order to keep the business running smoothly at all times.
In addition, this section talks about how business owners can work to control documents and records, which is one of the most important aspects of staying organized and maintaining quality within a business.
Management responsibility has to do, mainly, with customer commitment requirements. This is basically the company’s commitment to serving the customer and building a more loyal following.
This section also establishes a general focus of the company, in terms of the customer. In other words, the company is pledging to always keep the customer happy, and do what they can to improve their products, services, and procedures accordingly.
Management responsibility also helps a company define a quality policy and objective guidelines, and provides help with QMS planning as a whole.
The definition of authority and responsibility in the workplace is another vital aspect of this ISO clause. This allows the company to define a clear separation between employees and managers, providing everyone with a basic breakdown of what they are expected to do and how they are expected to do it.
Finally, this clause ends with a mandatory review of the company’s management. This is a process that is repeated throughout several ISO 9001 certification procedures, beginning with this one.
These evaluations serve to assess how each employee in a management position is doing their job, making room for any necessary corrections or feedback.
Resource management involves a full assessment of the resources that are being provided by management, to both the employees underneath them and the customers that they serve on a daily basis.
Work environment guidelines are also dealt with in this area of certification, as well as human resource training, awareness, competence, and more.
It is really important that a business has the proper resources for everyone who is involved, no matter if they make purchases with the company or go to work there every day. An organized and professional workplace is paramount to the successful implementation of a quality management system.
The product realization clause has to do with the general outputs of the company. More specifically, this is a set of guidelines for what the company produces and puts out to its customers.
This can either be a product that the customers can buy, or a service that the customers will experience. Either way, this clause is really important, because it helps the company to directly manage the quality standard that leaves the business.
The actual product realization steps include planning what the product or service will be and executing it.
After the product or service has been outlined and produced, an additional step will be required to maintain the quality. This includes measuring the products that are being produced or the resources that are needed, used, and wasted.
If the company does not produce a product, but provide a service instead, it will require consistent monitoring to make sure that everything is running smoothly throughout all areas of the business.
In the event that a company fails to complete these measurements and monitor their services, they can face a huge quality issue since nothing is being kept track of.
The measurement, analysis, and improvement clause allows the company personnel to step back after executing their product or service, and see how the customer has reacted to these positive changes.
Along with monitoring customer satisfaction, this clause includes guidelines for an internal audit, which also helps to assess the effectiveness of the new ISO quality management system.
Monitoring the execution of the product or service is vital, because it allows the upper management to make decisions on how to improve and what to avoid during future processes.
Every once in a while, there will be some product or service produced by the company that is not up to the standard protocol that is defined by the ISO 9001:2015 standard. This is also known as a non-conforming product/service, or a non-conformity.
When something does not conform to the ISO 9001 guidelines, it becomes a problem to the integrity and quality of the company. Therefore, any area that does not conform must be immediately identified and then resolved. All of these procedures are included within this particular clause.
Performance evaluation has to do with evaluating the company processes as a whole. As you might have been able to tell by now, the ISO 9001 standards all require a great deal of evaluation and assessment.
This is due to the fact that the goal of the entire QMS is to establish and maintain quality within a business.
Therefore, it will require management to constantly monitor and evaluate their processes, coming up with solutions to problems and ways to keep things running as smoothly as possible on a daily basis.
Overall, performance evaluation has to do with almost everything that is going on within the workplace. From company processes in general to the actual quality management system, and the procedures that are implemented every day, the performance of the company as a whole will be evaluated in this clause.
The final clause in the ISO 9001:2015 standard focuses mainly on improvement of the company. While it is true that you can go through the entire process of ISO certification to get the final stamp of approval from the organization, you won’t be able to keep it for long if you ignore the guidelines in this clause.
To be more specific, having an ISO certification is not just an achievement with a certificate that you can hang up on the wall and walk away from, but rather a constant effort that you must pay attention to at all times.
In other words, becoming ISO certified does not guarantee that your processes will maintain the quality that you have worked so hard to create. Instead, you will need to make sure that you are checking up on all company operations to guarantee that everything is exactly how you left it.
In addition to checking up on your daily processes through a continuous and diligent effort, you will need to work to improve on the existing quality management system that you have created.
A big part of being ISO 9001 certified is working to improve your company on a daily basis, as much as you can. You have already improved your old processes by becoming certified in the first place - so now, you will need to continue on the right track.
Improving your business will include assessing everything that is going on, deciding how you can make it better, and implementing those positive changes. This does not necessarily mean that anything is wrong with what you are doing, only that you want to get better every day.
You can think of your ISO 9001 quality management system like a flower in a pot. When you plant the seed and water it for a few weeks, a beautiful flower will sprout up from the soil.
However, if you are satisfied with what has grown and decide to stop watering and fertilizing it, you will find that it shrivels up and dies. To relate this back to your ISO 9001 certification, it is important to always nurture your quality management system, and improve in all areas that you can.
So, now that you have read through the names of all 10 ISO 9001 clauses, as well as a brief explanation of what each one entails, you might be wondering if the clauses are also requirements.
If you know anything about ISO 9001, then you probably understand how specific it can get.
When a business wants to become certified with ISO 9001, they are required to abide by a long list of very detailed processes that include defining the scope, performing surveillance and analysis, and going through internal audits before they can be considered ISO 9001 accredited.
With that being said, it is justified to assume that you must follow all of these standards line by line as a business owner, in order to gain and hold onto your ISO 9001 certification.
To clear this up, take a look at the list down below to find out the answer to the questions of whether or not all ISO 9001 clauses are requirements, and which ones are mandatory, if not.
First of all, not all 10 clauses of ISO 9001 are requirements for the business. The only mandatory clauses are everything between 4-10. Clauses 1, 2, and 3 are not requirements.
At this point, you might be wondering why the first three clauses are excluded from the certification requirements. If they are not required for certification, then what is the point of even reading them, right?
Clauses 1-3 are not requirements, only due to the fact that their purpose is to provide general information and terminology that will be used throughout the remainder of the standard.
In other words, clauses 1,2, and 3 of ISO 9001 do not outline any actionable requirements at all, making them non-mandatory for company personnel.
To recap on what was discussed in the previous section and provide a more clear distinction between the clauses, the list down below will highlight the mandatory clauses of ISO 9001.
ISO 9001 Mandatory Clauses (7):
After discussing the ISO 9001 clauses that are mandatory requirements, there is still the question of what a requirement necessarily means.
For all of the required clauses, must a business owner and company personnel follow everything line by line? Generally, the answer to this question is yes, but there is one small exception, which is contained in Clause number 7.
Let’s take a closer look at this clause, in particular. Refer to the list down below to get a detailed outline on the Product Realization section of the ISO 9001:2015 standard.
The product realization clause consists of a six-step process, beginning with planning. This is when the company personnel decides on what their product or service output will consist of.
During this time, the requirements for the product will be defined. This includes what it is supposed to do and how it will be executed. The same process goes for services as well, but in a slightly different manner.
Then, the product will be designed and developed before the products are purchased and everything is produced and supplied to customers.
Following these standard procedures, the company personnel must maintain control of the equipment, by measuring inventory and resources, along with closely monitoring everything else.
So, does this mean that companies can skip the product realization clause as a whole? Absolutely not. The entire Clause number 7 remains mandatory, all except for the third step: product design and development.
Let’s take a closer look at what exactly can be excluded from this particular clause.
The design requirements, or product design and development, can be emitted in one particular circumstance only. More specifically, this can occur when the company does not have a product at all, but is rather a service-based business.
Other than that, all companies that are compliant with ISO 9001 must follow all standards to the letter in order to obtain and maintain certification.
As you might have caught already, there are several different versions of the ISO 9001 standard, with two in particular.
This is due to the fact that the ISO 9001 quality management system is constantly changing and evolving to be more beneficial to everyone who is involved in a business, from the owner and employees to the regular customers.
While the years are steadily progressing, so is the ISO 9001 standard. Let’s take a look at what the two most recent versions of ISO 9001 are, before we get deeper into each one.
The two most recent versions of the ISO 9001 standard include ISO 9001:2008 and ISO 9001:2015. The older one was updated in the year 2008, while the most up to date came out in 2015.
With these changes going on, there were a lot of alterations in the amount of clauses between the two, as well as which clauses are considered to be requirements. Let’s start with ISO 9001:2008.
The 2008 version of ISO 9001 contained 8 total clauses, instead of the 10 that are contained in ISO 9001:2015.
Out of the total 8 clauses in ISO 9001:2008, there were only 5 required clauses, which were 4-8.
The 2015 version of ISO 9001, on the other hand, has 10 total clauses - meaning that two of them were recently added on to the standard in order to improve the system further.
Out of all 10, there are a total of 7 requirements, also meaning that the additional clauses became mandatory to ISO 9001 users.
ISO 9001:2015 has more individual clauses as well as more requirements than the older version from 2008.
So, now that you have learned everything there is to know about all 10 ISO 9001:2015 clauses, as well as which ones are required and how they have changed over the years, you might be wondering how you can benefit from gaining certification.
There are a multitude of benefits that come with ISO 9001 certification, for you as the business owner, as well as your employees and customers.
When a solid quality management system is in place and working exactly how it is supposed to, you will notice rewards coming from almost every avenue.
Whether you are most excited about gaining a loyal customer base and growing your following or establishing long-term employees who are enthusiastic about their positions, there is no doubt that both your business and revenue numbers will increase exponentially when you do it right.
With a good grasp on what the ISO 9001 clauses consist of, as well as what is expected from you within each section, you will be on your way to gaining an ISO 9001 certification and using the world-renowned quality management system in the favor of your growing business as you excel toward a more quality future.
Written: 27th 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