ISO 9001:2015 explained: What is the process approach?

Aaron Hoare Date published: Jul 25, 24

There are numerous ways to approach compliance with ISO 9001:2015, but what is the process approach? While this is by no means a new requirement, anecdotal evidence suggests that it is poorly understood.

The process approach was first introduced in ISO 9001:2000. And while the concept of a process-based quality management system has not changed, the requirements in the latest version of the standard, ISO 9001:2015, have become more specific and less ambiguous.

Of course, we expect some changes to the process approach to ISO 9001 when the next revision is published, currently expected in 2026. But for now, let’s look at common questions you might have about what the process approach is, why it’s important and crucially, how you can get your employees to apply it.

What is an ISO process approach?

The introduction of ISO 9001:2015 states that: “consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.”

An ISO 9001 process approach is a management strategy which incorporates the plan-do-check-act cycle and risk-based thinking. It means that processes are managed and controlled. It also means that we not only understand what the core processes are, but we also consider how they fit together. A process approach to ISO 9001 should, therefore, help accomplish the goal of more consistent, predictable outcomes.

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Key changes from ISO 9001:2008 - ISO 9001:2015

The requirement for a process-based quality management system is nothing new. The requirement to "establish, implement, maintain and continually improve" is familiar from both ISO 9001:2000 and ISO 9001:2008. The key changes that were made for ISO 9001:2015 are:

• For organizations that had already adopted ISO 9001:2008, a key factor in transitioning to ISO 9001:2015 was the extent to which the process approach has been adopted
• Clause 4.4 of ISO 9001:2015 sets out specific requirements for the adoption of a process approach, e.g. organizations must monitor, measure and use related performance indicators to determine effective operation and controls
• Top management must promote, engage and support employees to follow a process approach

We naturally expect that the ISO 9001 process approach will evolve further upon the publication of ISO 9001:2026. However, we can be relatively certain that the requirement for, and the effectiveness of, a process approach to ISO 9001 will remain when the standard is revised.

Why is the process approach so important?

Organizations are typically structured into departments which are managed by a department head. The head is responsible for what comes out of the department. Most departmental heads never interact with the external customer, only internal ones. As such, they are divorced from how the customer really feels. This is something the ISO 9001 process approach seeks to address.

If key performance indicators are set by individual departments, this compounds the problems. Heads try to maximize the performance of their departments to the possible detriment of other departments further down the line.

The ISO process approach introduces horizontal management, controlling processes which flow across departmental boundaries. Someone is accountable from start to finish. They see the whole picture from process initiation to process completion. They understand what the stakeholders in the process want and have delegated authority to act to realize this. An employee’s first loyalty is to their assigned projects, products or services – rather than their own departments.

Using an ISO 9001 process approach in a quality management system

There are a number of benefits to using an ISO 9001 process approach in your quality management system. It facilitates:

• Understanding and consistency in meeting requirements
• Viewing processes in terms of the value they add to your organization as a whole
• Achieving effective process performance
• Improving process performance based on analysis and evaluation of the data and information

Dedicated quality management software is by far the easiest way to implement a quality management system that will help you to seamlessly adopt an ISO 9001 process approach and achieve the above goals. Learn more about Ideagen’s quality management solutions today if you’re looking to comply with ISO 9001 with ease.

Implementing a process approach for ISO 9001 (step by step)

ISO 9001:2015 employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. You can read more about quality improvement methodologies like the PDCA cycle in a recent Ideagen whitepaper. But as part of the process approach, this means the organization needs to:

• Determine required process inputs and expected outputs
• Assign responsibilities and authorities for processes
• Identify risks and opportunities for processes, and plan to address these

As part of this, there are three core steps that need to be taken in order to properly adopt the process approach to ISO 9001.

1) Define your quality management system processes

ISO 9001 does not provide you with a list of core quality management system processes you need to include. Your organization must determine these for themselves. So, what should you include?

Some example processes as part of an ISO 9001 compliant quality management system include:

• Internal training, leadership and performance evaluation
• Manufacturing, design, distribution, development, service, delivery and assembly management
• revenue assurance / business process outsourcing
• new customer management
• equipment management
• supplier approval and re-evaluation
• risk identification and management
• contract change or revenue assurance management
• complaint handling
• information management
• audit and inspections
• other quality, health and safety and environmental (EHSQ) requirements

Ask yourself: how you are consistently providing products and services which meet customer and applicable statutory and regulatory requirements? In addition, how are you enhancing customer satisfaction?

These are the processes that need to be controlled. Your organization must then map out the inter-relationships between your core processes.

2) Assign responsibilities and authorities for processes

For the next step of the ISO 9001 process approach, your organization needs to work out who is responsible for what process. Rather than focusing on functions, focus on the process across the department, or even the whole organization. Pay particular attention to the interdependencies and the interactions. It can also help to:

• Involve employees in building the process-based quality management system
• Train individuals so they understand their roles and accountabilities in relation to the core processes to ensure they see their processes end-to-end
• Restructure the audit program around processes, not functions
• Train internal auditors to follow processes across departments, paying particular attention to interdependencies and interactions
• Provide documented information to support the operation of processes and ensure you have confidence that the processes are being carried out as planned
• Give procedures and work instructions another name

3) Identify risks and opportunities, and plan to address these

Risk-based thinking is an extension of preventive action. It requires organizations to determine risks and opportunities to processes, products and services, as well as the quality management system. The organization must take proportionate steps to address these actions. This means monitoring and measuring the performance of processes.

Adopt the ISO 9001 process approach with ease

By far the easiest way to implement a process approach to ISO 9001 is to use tried and trusted software. Ideagen offer software solutions for quality that will help you to establish unbreakable quality in your organization. In turn, compliance with ISO 9001 can turn from a laborious, box ticking task into something that happens as a simple matter of everyday process.

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