A Process-based Approach to Quality
Management and ISO 9001:2015:
Why it makes sense


No matter the size of your organisation or the sector it operates in, it shares one common characteristic with other businesses around the world – it has processes.


These processes are a critical component of your organisation, guiding your people towards achieving business goals, so it is essential that they are coordinated efficiently.

One method often adopted is the process approach. Introduced in ISO 9001:2015, the standard outlines the process approach as establishing an organisation’s processes to operate as an integrated and complete system.


Despite this requirement, it is still common for organisations to continue to rely on their traditional text-based procedures which are proven to hinder process improvement.


The aim of this article is to emphasise the importance of the process approach to quality management, including the benefits it could bring to your organisation and the steps you can take towards implementation.

Benefits of the process approach

The benefits of the process approach to an organisation are substantial. In order to better explain and understand the benefits, it’s necessary to envision the organisation’s processes in a non-process-based manner.


The normal structure of an organisation comprises it being broken down into departments, people, and products. This leads to the question of:


How do these various entities efficiently interact with one another to benefit the business?


It is common for the workforce to prioritise their processes without considering how it affects other business areas or the final product delivered.


This can lead to inefficient working practices and failure to meet business objectives, ultimately costing the business both time and resources.


Reducing these inefficiencies and issues is one of the core benefits of the process approach. Combining organisational processes into one system allows the workforce to see the complete structure of each process from start to finish, regardless of the different departments involved.


They can then easily identify which part of the process they handle and how it achieves the required output.


This leads to more streamlined working practices and ensures that the organisation produces deliverables in a timely and efficient manner.


There are a number of additional benefits from becoming process-based, such as:


  • Verified processes – The validation exercise will provide a master document register which includes processes
  • Quick Access – Processes that are listed within a document management system can be difficult to find particularly if the user is unfamiliar with the application. The process approach uses end to end process overviews with business and delivery models helping users to find the right document quickly
  • Process Harmonisation – Where duplicated processes exist across the organisation, these can be harmonised into consistent, generic processes applicable to all sectors or regions

How to implement the process approach

Now that we have established that applying the process approach to your integrated management system will allow your organisation to consistently achieve and improve process performance, it’s time to discuss how you can begin implementation.


This can be broken down into different stages:

Identify your processes

In order to implement the process approach, you will need to identify your processes. Your management system is comprised of multiple processes which are entirely specific to your own business needs and objectives, for example:


This is just a small sample, but depending on your organisation’s functionality, this can be an exhaustive list. In order to make this step more manageable, it is recommended to create a graphical business model that represents how an organisation delivers its products/services.


Designed within a collaborative environment, it is essential that the workforce play a major part in this exercise.


On completion of the business model and end-to-end process views, the scene is set to map the processes using the swim-lane structure as this allows you to visualise the tasks, teams, and people involved in each process.

Determine process relationships

The next stage is determining the input-output relationships which exist between each process. Using a process mapping tool will make this step significantly easier, as it will allow your workforce to identify how your processes interact and are interrelated by these input-output relationships.


These interactions can subsequently ‌form the framework of an integrated process-based management system.

A swim lane process map showing the process flow, those involved and the actions they are responsible for
Swim-lane Process Map Example from the Agility System

Identify process responsibilities

Once your processes have been defined and the relationship between each one is established, the next stage of implementing the process approach is asserting who is responsible for each process.


By determining who is responsible and to what standard they should complete a business process, you will increase accountability while also encouraging collaboration with team members to engage in process improvement.

Highlight potential risks

While it is true that the process approach helps process improvement for your organisation, it is also essential that potential risks are identified within your processes and steps are put in place to mitigate these.


This involves ensuring risk-based thinking is applied throughout the process approach and that your processes, alongside your management system, are continuously monitored to ensure performance benchmarks are being achieved.

The next steps

The Agility System is both ISO compliant and process-based. Our business analysts can help your organisation transform from its text-based procedures or traditional system into an ISO 9001 integrated management system that provides improved operational performance and maintains compliance.


Simply book your free demo today, and a member of our team will be in touch to help you begin your journey to a process-based approach.

More insights

Peter Shields
Peter Shields
Peter is a Quality, Risk & Compliance expert with extensive experience working with process-based management systems in the Energy, Nuclear & Defence sectors since 1979.
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