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Process Approach and PDCA in ISO 9001:2015

ISO 9001:2015 Process Approach

The process approach, introduced by ISO in 2000, has been strengthened and made more explicit in ISO 9001:2015. Do you have the right controls in place to remain compliant?

“If you can't describe what you are doing as a process, you don't know what you're doing.” 

 -W. Edwards Deming

What is the "Process Approach?"

At a basic level, the process approach requires you to identify your processes, their inputs and intended outputs, and how these processes are interrelated and interact with each other.

Quality and manufacturing professionals use processes every single day. From approving a supplier or accepting a part, shipping a product or receiving feedback from customers, the list goes on and on. Almost everything you do in your organization can be defined as a process.

As one of ISO’s seven quality management principles, the process approach ensures organizations intentionally plan processes and their interactions to help them meet objectives. Identifying and managing interactions and linkages of processes ensures overall effectiveness of an organization.

Why is this important?

On the surface this may seem almost elementary, but there’s a reason ISO further emphasized the process approach in ISO 9001:2015. Understanding process interactions and dependencies is critical since the output of one quality management process is often the input for another.

Complaint management

For example, in a previous company I worked for, a new customer feedback/call center system was being installed. The system was set up for all calls to go directly into the complaint system. Once the system went live, the complaints department descended in chaos.

Why? Because now complaints was overwhelmed with responding to hundreds of customer issues that were not really complaints. The interactions between receiving the customer call and determining what calls were inputs into the complaints system were not established ahead of time.

Eventually, the system inputs into the complaint system were refined, but with proper planning the problems caused could have been completely avoided. Establishing individual processes and their interactions is a must.

How can I implement the Process Approach?

The process approach is simple when paired with the PDCA cycle. The cycle integrates processes and their interactions with risk-based thinking in every step. It also inherently supports continual improvement of your quality management system.

 

PDCA Cycle

 

What tools can help me determine process inputs and outputs?

Process maps are a powerful way to visualize the individual processes as well as their interactions to help you meet ISO 9001:2015 requirements. There are many tools available that depend on your objective and complexity of the process, but my personal favorite is the swim lane diagram because it tells you who does what and when.

  • SIPOC diagram gives you a high-level view of the process by outlining the supplier, input, process, output, and customer. This is a helpful start and gives you an overview of the internal and external process impacts. I would complement this with detailed flowcharts for complex processes.
  • Turtle diagram gives you a more detailed view of a process. This diagram type helps to define associated documentation, supporting processes, owners, equipment, and evaluation criteria for meeting objectives.
  • Swim Lane flowcharts are detailed process maps that show specific actions and ownership. Use this when there are multiple departments or participants involved.

Defining your processes and their interactions is critical for organizations to be effective and efficient. Ownership and responsibilities are better understood, risks and opportunities have been considered, and a process is in place that supports continual improvement of your quality management system helping you to meet ISO 9001:2015 requirements.

In the final post of this series, we will discuss ISO 9001:2015 expectations set for leadership responsibilities and performance evaluation of the QMS.

Have a quality filled day!

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