The QMS and its processes (Part 1)



In this post we will analyse the process approach that could be applied in quality management systems, as well as the clause entitled: the quality management system and its processes.


We will start with the concept that any organization is like a living and learning social organism. It is adaptive and consists of interactive systems, processes, and activities. As an open system, it must adapt its variable context, since each organization needs to develop its capacity for change. Organizations often innovate to make significant improvements.


We can find a great variety of organizations, in terms of structure, size, productive sector, processes, technology, competitiveness, among other factors. However, if we visualize them as a system, practically all of them can be identified with the following diagram:

The organization's standardized model of the quality management system recognizes that not all systems, not all processes, and not all activities can be predetermined; therefore it needs to be flexible and adaptable within the complexities of the organization's context.

The processes are interconnected in a total and sometimes complex network. The outputs of one process can be the inputs of another one. Although it often appears to consist of similar processes, each organization is unique and so is its QMS.

Organizations should establish and operate processes that can be defined, measured and improved. These processes would be interacting to provide results consistent with the objectives of the organization and crossing functional limits. Some processes may be critical, while others may not. The processes have interrelated activities with inputs that generate outputs. People collaborate in a process to carry out their daily activities. Some activities are prescribed and depend on the understanding of the organization's objectives, while others are not and react with external stimuli to determine their nature and execution.

The ISO 9001: 2015 standard encourages the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to increase customer satisfaction by meeting customer requirements.

Understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its intended results. This approach allows the organization to control the interrelationships and interdependencies between the processes of the system, so that the overall performance of the organization can be improved.

The process approach involves the definition and systematic management of processes and their interactions, in order to achieve the expected results in accordance with the quality policy and the strategic direction of the organization.

The application of the process approach in a quality management system allows:

a) understanding and consistency in meeting requirements;

b) the consideration of the processes in terms of added value;

c) achieving effective performance of the process;

d) the improvement of processes based on the evaluation of data and information.

The ISO 9001: 2015 standard uses the process approach, which incorporates the Plan-Do-Check-Act (PHVA) cycle. This process approach enables an organization to plan its processes and interactions.

The PHVA cycle enables an organization to ensure that its processes are well resourced and properly managed, and that the opportunities for improvement are identified and acted upon.

If we remember one of the principles of management:

— Process approach: 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 QMS consists of interrelated processes. Understanding how this system produces results enables an organization to optimize the system and its performance.

Among some potential key benefits of this process approach are the following:


a) Increased ability to focus efforts on key processes for improvement opportunities;

b) Consistent and predictable results through a system of aligned processes;

c) Optimization of performance through effective process management, efficient use of resources and reduction of interdisciplinary barriers;

d) Possibility for the organization to provide confidence to stakeholders regarding its consistency, effectiveness and efficiency.


Possible actions for an organization to apply this approach to processes include:


1. Define the objectives of the system and the processes necessary to achieve them;

2. Establish the authority, responsibility and accountability for the management of the processes;

3. Understand the capabilities of the organization and determine the resource restrictions before acting;

4. Determine the interdependencies of the process and analyze the effect of the modifications to the individual processes on the system as a whole.

5. Manage the processes and their interrelationships as a system to achieve the quality objectives of the organization in an effective and efficient way.

6. Ensure that the necessary information is available to operate and improve processes and to monitor, analyse and evaluate the performance of the global system;

7. Manage the risks that may affect the outputs of the processes and the overall results of the QMS. 

In order to conclude this first part of the process topic, let's remember the representation diagram of a process, as well as the definition of this term:

In accordance with ISO 9000, a Process is defined as the set of interrelated or interacting activities that use inputs to deliver an intended result.

In the second part of this topic, we will analyse the notes to entry that complement this definition and all the subclause 4.4 of the standard. 


Ernesto Palomares Hilton