Quality does not happen by chance; it must be designed to be reflected in our products and services. It is also incorrect to assume that testing what we produce can change the quality of products or services, as the true determining factor is the processes used for their production and delivery, which inherently contain the potential to create products and services of a certain quality.
Having a clear understanding of the factors that influence these processes’ ability to deliver expected results is crucial for consistently providing high-quality products and services over time. Section 4.4.1 of ISO 9001:2015 specifically requires that the processes necessary for the functioning of the quality system be determined. However, it goes beyond just identification, requiring several actions to be taken regarding these processes, which are outlined in eight points—although some contain more than one requirement.
In total, this section includes 15 requirements:
- Determine the necessary processes for the quality management system;
- Identify the required resources (this requirement is also mentioned in Section 7.1);
- Assign responsibilities and authorities for each process (this is also referenced in Section 5.3);
- Apply the quality system processes throughout the organization;
- Manage risks and opportunities (this requirement is reiterated in Section 6.1.1 of the standard);
- Define the necessary inputs;
- Identify the required and expected outputs;
- Evaluate processes and ensure they can achieve expected results (this requirement is also found in Section 9.1);
- Determine the sequence of processes;
- Improve processes and the quality system (this requirement is also covered in Section 10.1);
- Define interactions between processes;
- Keep documented information up to date (this requirement is also mentioned in Section 7.5.1);
- Retain documented information (this is also referenced in Section 7.5.3.2);
- Determine criteria and methodologies;
- Identify the necessary methodologies to ensure operational efficiency.
The standard does not require identifying all processes within the organization, but only those necessary for the quality system. So, what are these processes? How can they be identified? It is important to note that the activities forming the processes necessary for the quality system's operation are already being carried out by any organization—or at least planned for implementation.
These include business management processes—those capable of producing outputs that align with established business objectives. The key is to determine which of these processes contain elements that directly or indirectly impact the quality of products and/or services and can be adjusted, if necessary, to ensure the system delivers outputs that meet customer expectations. These groupings of activities form a value chain for customers and may include activities commonly referred to as “strategic planning,” “market research,” “new product or service development,” “sales promotion,” “procurement,” “production,” “delivery,” “after-sales service,” and more. The common thread among all these activities is that each contains elements and interconnections that positively influence the quality of outputs.
Thus, the processes necessary for the quality system are not just quality-related processes, but actual business processes that contain elements and connections capable of positively or negatively affecting the quality system's outputs. These are the processes that enable every organization to function. Why is it necessary to identify the processes required for quality management? Because we cannot manage what we do not understand, and to manage outputs, we need to know how they are produced. Since an output is the result of a process, we cannot manage it without knowing which process generates it.
How can we comply with this requirement? If our goal is to establish how people perform their work, we can easily identify processes that underpin tasks such as floor cleaning or conducting meetings. However, we cannot judge the importance of these processes at this level alone. We must consider the bigger picture and analyze how each process contributes to the system’s overall effectiveness.
Thus, if our goal is to determine the processes that lead to quality system results, we can, for example, identify a process aimed at maintaining a certain hygiene standard, in which one of the activities is floor cleaning. There are several ways to determine whether a process is essential to the quality system. Regardless of the methodology used, before deciding if a process is truly necessary, ask yourself the following question: “What impact does the outcome of this process have on customer satisfaction?”
Now, let’s explore different methodologies for identifying these processes:
- The Stakeholder Method – This approach is useful for aligning an organization’s mission, vision, and values with stakeholder needs and defining appropriate performance indicators. It involves a thorough analysis of all stakeholders using key questions to determine which process generates outputs that satisfy their requirements. This methodology helps align stakeholder needs with process activities, which, although time-consuming and challenging, is highly valuable.
- The Objective Method – Another method for identifying quality system processes is through objectives, which may relate to customer needs (overlapping with the stakeholder method), strategic goals, or general business objectives. Here, it is essential to remember that the purpose of any process is to achieve a goal, which must be strategically aligned with the organization's vision and mission or support a specific activity. Objectives, in this case, are simply outputs expressed differently. To identify a process, ask yourself:
- Which process delivers certain outputs or achieves certain objectives?
- Which activities produce these outputs?
- What factors influence our ability to produce these outputs?
- The Activity Method – Instead of starting with objectives, this approach involves analyzing the sequence of activities by asking the following questions:
- What is the output or goal of this activity?
- Where does this output go? (This question helps identify the next step in the process.)
- Once responses are gathered from different activities and business areas, analyze what commonalities exist among various output groupings to categorize related activities.
- Finally, assess how these activity groups contribute to the business.
To conclude, how can we practically demonstrate that the necessary quality system processes have been identified? Simply by:
- Providing evidence of stakeholder requirement analysis and linking it to the processes that generate outputs satisfying their needs;
- Presenting evidence of an analysis that connects objectives and processes, demonstrating that the chosen objectives best ensure customer satisfaction;
- Documenting the relationship between activities and the processes they belong to, showing how the objectives of these processes contribute to customer satisfaction;
- Providing a list of identified processes, specifying their objectives and outputs, and demonstrating how they contribute to achieving the expected quality system results.