Applying the Process Approach to a Quality Management System

Applying the Process Approach to a Quality Management System

Many people when they encounter the term process approach struggle to grasp an understanding of the term, and without this, the approach cannot be adequately followed. This article written by our expert Tutor, Liam Regan defines and outlines 10 steps on how the process approach can be applied to a Quality Management System in line with ISO 9001:2015.

What is a Process?

A process is defined in ISO 9000 as a “set of interrelated or interacting activities that use inputs to deliver an intended result”. The intended result depending on the scope of the process can be an output, product, service.

A process typically consists of the following components: a process owner; inputs, outputs, resources, methods, controls, suppliers, and customers.

A process approach can be simplified as the interaction/interdependency between multiple processes to achieve an organisational objective. This can mean that the outputs of one process may be the input to a subsequent process. For example, the output of a design process may be input to the manufacturing process.

In 2012, ISO ruled that their future management system standards would follow a common clause structure, in accordance with Annex SL. As a result, there have been more explicit requirements mandating a process approach is followed in a number of these standards. These requirements are outlined in Clause 4.4 of management system standards. The most prominent example of this is ISO 9001:2015.

This standard believes that understanding and managing interrelated processes as a system contributes to an organisation’s effectiveness and efficiency in achieving its intended results. It continues by stating 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.

The following steps below out how the process approach can be applied to a QMS, while cross-referencing the relevant clauses of ISO 9001:2015:

1. Determining what it is you want to do from the needs and expectation of your relevant stakeholders (i.e., the objectives you want to achieve or the outputs you want to deliver) (4.4.1a & 6.2)
2. Determining criteria or the measures of success from the constraints imposed by your stakeholders (i.e., the factors that will indicate whether the objectives have met the stakeholders’ satisfaction, or the outputs meet requirements) (4.4.1c)
3. Determining methods i.e., the critical activities need to achieving these objectives, the sequence in which they are carried out, and the direction in which information flows among them (4.4.1c)
4. Defining the resources, information, and competencies required to deliver the required outputs (4.4.1d, 7.1, 7.2)
5. Identifying the risks and putting in place measures that eliminate, reduce or control these risks (4.4.1f and 6.1)
6. Determining how performance will be measured against the objectives and variation reduced. This can be in the form of key performance indicators (4.4.1c)
7. Executing the process(es) as previously planned (8.1)
8. Measuring what has been achieved and comparing it against the process objectives (4.4.1g and 9.1)
9. Finding better ways of achieving the process objectives and improving process efficiency (4.4.1h and 9.1)
10. Checking whether the processes objectives remain relevant to the needs of the stakeholders and if necessary, changing them. This is typically completed as part of the Management Review. (9.3 and 10.3)