Quality doesn't happen by chance; it is designed through processes. Having a clear understanding of the factors that influence the capability of these processes is therefore fundamental in managing quality products and services.
ISO 9001:2015 requires not only to determine the processes necessary for the quality system, but also several actions to be taken regarding these processes. In total, there are fifteen requirements to be met:
- determine the processes necessary for the quality management system;
- apply the quality system processes throughout the organization;
- determine the required inputs;
- determine the expected outputs;
- determine the process sequence;
- determine the interaction of the processes;
- determine the criteria and methods;
- determine the methods needed to ensure effective operation;
- determine the necessary resources;
- assign responsibilities and authorities for the processes;
- address risks and opportunities;
- evaluate the processes and ensure that they achieve the desired results;
- improve the processes and the quality system;
- maintain documented information;
- retain documented information
Let's examine the first eight in detail, starting with the determination of the processes necessary for the quality management system. The standard does not require the determination of all the processes used in the organization, but only those processes necessary to build the quality system. And what are these processes? These are the processes that have a direct or indirect impact on the quality of the product or service or that, if modified, could determine a change in customer satisfaction.
There are several ways to understand which processes are necessary for a quality system. The first is to be guided by the stakeholders, that is, to align the company's mission, vision and values with the needs of the interested parties and define the appropriate performance indicators based on a stakeholder analysis, asking them some key questions. Those processes that will provide the outputs capable of satisfying the needs of the interested parties are those that will have to be part of the quality system.
Another method is to derive the processes from the strategic objectives by asking some simple questions:
- which processes provide the results that interest us?
- What activities produce these outputs?
- What influences our ability to provide these results?
If our operational definition of a quality system is that it should be a systemic view of an organization from the perspective of how it creates and retains its customers, a third way could also be followed by asking the following three questions:
- what are the activities that provide products and services capable of retaining customers?
- What are the activities that provide the resources necessary for the others?
- What are the activities that create a greater capacity to face the work in the right way and that favor an environment suitable for carrying it out in the best way? And which ones provide a direction to follow and keep the organization on the right track, allowing it to achieve its vision consistently with its mission?
Arriving at the second requirement, what does it mean to apply the quality system processes throughout the organization?
Having established that a process is necessary to achieve an objective, the next step is to ensure that these processes are equipped with resources and made operational. However, processes require an event that activates them in their functions and therefore it is only when this triggering event occurs that the processes become operational. Until then they are simple models. Unless the processes work, the organization will not produce any output. Outputs are often the result of a network of processes and, therefore, different processes may be operational only in series or in parallel. To ensure that a predetermined process is executed when the event that activates it occurs, the people who will respond to that event must be aware that, in response to that event, a specific process has been designed. This is the role of process maps that show relationships between processes, their inputs and their outputs.
The third point concerns the action relating to the determination of the required inputs. These inputs can be of various types:
- work instructions;
- controls;
- constraints;
- specific resources;
- feedback from other processes;
- tangible elements
The fourth point, the one relating to the expected outputs, refers to the direct effects produced by a process. Outputs could be tangible but also intangible results (for example, the atmosphere in a restaurant or the trust created to carry out a transaction). There will also be avoidable outputs (which may occur suddenly and be completely unexpected) and unavoidable outputs (which are created due to inefficiencies in the process).
The point (the fifth) regarding the determination of the process sequence is also fundamental. Objectives are achieved through processes, each of which provides an output that acts as input to other processes along a chain that ultimately translates into the achievement of the objective.
The sequence, in this context, therefore refers to the order in which processes are executed to achieve a certain result and which can be serial and / or parallel. The regulatory requirement refers specifically to the sequence of processes and not to the sequence of activities within the single process.
The sixth requirement concerns the interaction between processes. Those who participated in TC 176 did not define what was meant by the words "interaction between processes" but in the document that refers to the concept and use of the process approach for management systems, an example is shown in which there are lines with arrows indicating the direction of the flow that connects various forms.
The seventh requirement concerns the determination and application of criteria. The criteria for the effective functioning and control of processes are those factors that influence their success. Determining these criteria essentially means establishing two things:
- the characteristics with which a performance is judged
- the level of performance to be met
Applying the criteria that we have determined previously means putting them into practice. Perhaps the reason for strengthening the concept is to emphasize that determination alone is insufficient. A process that is operating effectively provides the required outputs in the required quality, punctually and in accordance with the economic constraints applicable to the process.
And we arrive at the determination of the methods necessary to ensure effective operation of the system processes, the last of the first eight requirements. Determining the methods means determining the series of actions necessary to define and provide the results and not simply to identify a means to do something. The methods are ways to accomplish a task or to do something, but they can also be a way of transmitting information, of preventing human error, of protecting data integrity, etc. and therefore difficult to frame only in procedural methodologies. The methods that guarantee effective operation of the processes are those regular and systematic actions that lead to having the required results.