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ISO 9001: The importance of the process approach

Since the update of ISO 9001 in 2000, the process approach has been a very important principle behind the way a Quality Management System (QMS) functions. Using this approach, a company is tasked to identify the processes within the QMS, define how the processes function, and also identify how these individual processes interact with each other. By properly identifying the processes, and the expected results, it is easier to monitor and control how the processes are functioning.

Additionally, by focusing on the processes, it is easier for your organization to work on continual improvement. By breaking the overall QMS down into smaller processes, it is much easier to identify areas for improvement, assess the risk of implementing changes, and validate that the changes have resulted in improvements to the process. Because improvement is also one of the quality management principles, and one of the main reasons to implement a QMS, this is an important aspect of implementing the process approach.

For more information about the seven quality management principles behind ISO 9001:2015, see Seven Quality Management Principles behind ISO 9001 requirements.

What is involved in identifying the processes?

Start by walking through your QMS process for creating and delivering your product or service from the beginning (e.g., marketing or sales) and go through until the end (e.g., delivery or after delivery service). What are all of the sub-processes that are required to get from the beginning to the end? After these sub-processes are identified, make sure you also identify the supporting processes that allow this to happen (e.g., document and record control processes).

Next, look at each of these smaller processes as a standalone entity so that you can identify the inputs, what is done, who does it, how it is done, the results expected, and the process outputs. One tool for this is the “turtle diagram” pictured below, which is one way of thinking about how a process is structured. This is not the only process tool available, but it is commonly used and easily understood. It is also a good idea to have a process owner who understands the process and is responsible for the process outcomes.

When you have identified the process, you can then gain the benefits of control, monitoring, and improvement for each process as mentioned above. In this way, the process owner can tell if the process is functioning properly, and if any changes made have resulted in improvements.

Sample of Process Diagram

What often gets missed when implementing the process approach?

One of the most often forgotten, and extremely important, elements of the process approach is to pay close attention to the interactions between processes. Sometimes a process owner can become too focused on the maintenance and improvement of their own process, and they can forget to also pay attention to how their process interacts with other processes. In fact, a lot can be gained from taking a top-level look at how your processes interact in the QMS.

As was discussed in How links between processes can increase level of quality, there are two main benefits to putting some focus on the interactions between processes. First, making a change to improve one process may not be the best idea if it causes problems in other areas that outweigh the improvement. This can only be found if you look at how each process interacts with others.

Secondly, it is important to know how the outputs of your process are used. The main reason is that understanding how the outputs are used will allow you to focus on how you improve your outputs. Equally important is the ability to identify an output that is not required. For example, if you are creating a report as a process output, and this report is not used by you as process owner (such as a monitoring tool), not needed as a record of the process, and is not used by anyone else in the organization, then the effort to create this report is wasted and the resources can be used more efficiently elsewhere.

The process approach: To maintain and improve

By using the process approach to define, understand, and control your QMS processes, you will find that you can better monitor how the process is performing, identify and implement improvements in the processes, and know that you are maintaining those improvements after changes are made. This is the easiest way to do this, and because monitoring and improving your QMS is one of the main reasons you implement a QMS according to the ISO 9001 requirements, wouldn’t you want these processes to be as easy as possible?

For more information on creating a process flowchart, see this white paper on  How to create an ISO 9001 process flowchart.

Advisera Mark Hammar
Mark Hammar
Mark Hammar is a Certified Manager of Quality / Organizational Excellence through the American Society for Quality and has been a Quality Professional since 1994. Mark has experience in auditing, improving processes, and writing procedures for Quality, Environmental, and Occupational Health & Safety Management Systems, and is certified as a Lead Auditor for ISO 9001, AS9100, and ISO 14001.