What is ISO 9001? A simplified and structured explanation

what is ISO 9001?

What is ISO 9001?

ISO 9001 is a quality management system, QMS in short, that basically gives an outline or a foundation of how a company should operate to ensure that it meets customer requirements. Before going into more detail, let’s start by explaining what is quality. So quality is effectively meeting customer requirements. A quality management system is to have the systems required in place to consistently meet customer requirements.

Now, by having the right system in place, your business can ensure that a consistent product or service is given to clients every time they purchase from your business, irrespective of who the person serving the client is. Whether it’s someone who’s been working with the company for a very long time or someone who has recently joined the company, there should be no difference from the client’s experience as each and every client expects a pristine service and or product to be delivered each and every time.

So quality is the fact that customer requirements are met. A quality management system is to have the system needed in place to ensure that customer needs are consistently being met.

But what makes a quality management system?

And here I’d like to explain that a quality management system is effectively split into three main sections, three main pillars if you’d like. First of all, you have the key processes. Each and every company has four types of processes, sales process, purchasing process, operational processes and design and development process. Now, each company might have more than one process within the category for each of these key processes. For example, for the sales process, there might be sales by tenders, sales by quotes, direct clients, retail, and more. A business might have one or more of these processes and each of these would be mapped out following the steps required within the sales process.

The purchasing process relates to purchasing either from local or foreign suppliers. The key products or services needed by the company to operate. Here we’re not talking about trivial stuff, but about products or services that are either resold directly or indirectly to their clients. Else, we can also talk about services that are critical for the operation of the company, for example, IT services. So that relates to purchasing.

Operations vary from one company to the next. This relates to the main activities done by the company to meet the requirements of the clients. It might be installation, it might be software development, it might be the shift within a restaurant, or serving a client, or it might even be the installation of a gypsum board. It might be various things depending on the operation of the company.

And the design and development process is effectively that activity whereby we translate customer requirements into product specifications. In the first part of the quality management system, we have talked about the key processes of the company which are the sales, purchasing, operations and lastly, the design and development. For these, I do not like to create specific procedures. In fact, as a management system consultant, I despise bureaucracy, thus, I steer clear from using procedures for these processes. Instead, I make use of flowcharts. Flowcharts are designed in a shape and way as to make them easily understood by all people in the organisation.

That is essentially the first part of the answer to the question “What is ISO 9001?”

The second part to the question “What is ISO 9001?” relates to the supporting systems.

The supporting systems relate to activities that your client does not directly pay you to perform, but if you do not do them, you cannot achieve a consistent service provision. For example, you should have a training plan and training records in place, have regular equipment maintenance and supplier evaluation, complaint management, and customer feedback These systems must be in place, systems that are not necessary for the customer to receive a product. But with these supporting systems, such as the training plans, employees will be knowledgeable of what must be done and how they have to do it in order to provide a satisfactory product or service, hence meeting the requirements and expectations of the clients.

Other elements like for example getting feedback from customers is key because it allows the company to understand where it can improve. Equipment maintenance is critical since it will ensure that all equipment is available and running properly to render the product or service to the client. Evaluating the supplier is important because it will give you a good overview of which supplier better serves the company, helping the company to identify and weed out the weaker suppliers.

Complaint management and corrective and preventive actions are important as they form part of the 5 step system to continually learn and improve based on our mistakes. So the supporting system is vital since it provides the critical support that the main processes need to thrive, without ineffective supporting systems, the key processes will likely fail to work in a synchronized matter.

Lastly, we also have the third element of the quality management system, with the first two being the key processes and the supporting system. The third element of the question “What is ISO 9001?” relates to certain information regarding the QMS that we should give to ensure that we are headed in the correct direction. This relates to elements such as who the interested parties are within the organisation, such as employees, shareholders, clients, suppliers, or even the government – and the needs and expectations of these parties. This enables us to make sure that we are creating a management system that meets the requirements of all relevant interested parties.


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Also, we have to define elements like risk management, which is an exercise that we do during implementation and in subsequent years of running a quality management system for an ISO 9001 certified company, which is the exercise of identifying the strengths, weaknesses, opportunities and threats relating to your organisation and based on that, we come up with a list of risks and opportunities that might have a positive or negative impact on your organisation.

After all this has been completed, we will prioritise the lists of risks and opportunities, so as an organisation, all individuals involved will know of the risks and opportunities that must be focused on and give all he attention necessary to reap all the benefits by exercising the least possible amount of financial and time resources as possible.

Another extremely important element within this third pillar of the quality management system is to set up the quality objectives which act as the general pointer to everyone within the organisation to explain where we are headed as an organisation. By having this clear understanding of who are the people which have an interest in our organisation, which are the stakeholders, and what they need, by defining the risks and opportunities relating to our organisations and subsequent by setting up objectives aimed at continually improving the results of our key KPI (key performance indicators), then we are sure to have a  management system that is designed for continual improvement.

So by implementing a QMS based on these three pillars, key processes, supporting systems and other information that is typically placed within the quality manual then we are sure to have a created a strong foundation for continua improvement. it is foolish to think that any company that gets certified is perfect.

Rather, a company that gets ISO 9001 certified has a perfect mindset for continual improvement. Just like in my experience as a mechanical engineer, I did not know all the topics related to engineering as soon as I graduated, the same things happens for an organisation once it is certified. Once an organisation is ISO 9001 certified, it begins on the journey for constant and never ending improvement aimed but never reaching perfection.

That is all about the know how of what is ISO 9001 and what is required in becoming ISO 9001 certified.


Luke Desira is an ISO management system consultant who understands that taking the first step to achieve ISO certification is never easy. Make sure to listen to what Luke Desira has to say about Risk Management in ISO 9001:2015 and be sure to realise that mishaps are never far off. Read more about it here, where you can understand how things can go wrong when implementing any ISO Standard. Achieving consistency in quality is never an easy task.

All management systems based on ISO Standards that are implemented should pertain directly to the organization’s objectives, and ISO 9001 – Quality Management System  should be no different. Have a look at different ISO Certification specialised by Industry to understand in which category your organization falls.

Luke offers a variety of ISO certification services that puts him as the #1 ISO Certification consultant in Malta. He can help you become ISO 9001 certified efficiently. When ready, take the first step to success and call Luke Desira.

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