ISO 9001 Revision explained in simple terms
The Process Approach
In February, the Workgroup Meeting about the ISO Revision, which probably was the last one, was held in Lithuania. In the five days of this meeting, the final touch was given to the Final Draft International Standard, FDIS. This means that the revision continues to go ahead as scheduled so that a publication in September may be expected.
In a series of technical lectures, Quality Austria provides information on the revision of ISO 9001:2015. Each month, a key concept of the revision will be explained more profoundly. This month, Ing. Joseph B. Garscha explains the changes in one key element of ISO 9001, the process approach.
Extension of the process approach in the new ISO 9001:2015
Ing. Joseph B. Garscha
As for requirements established in terms of an effective quality management system, ISO 9001:2015 provides for a very strong focus on the word “relevant”. If, however, requirements are relevant, it can be seen that specifications are much more concrete than they used to be. One topic that obviously is intensively concerned by this approach is the topic of how to handle the process approach. In this respect, it particularly is about concretizing what information and specifications require comprehensive process modelling.
Concretization helps to make the Standard easier to understand and use. Quite obviously many experience reports have been fed into the present revision. This is why many a thing that can meanwhile be regarded as being state of the art, at any rate, can now be found as a requirement of the Standard.
In concrete terms, this means the following: For the processes that are needed for the quality management system and for which adaptations within the organization have been established, a bundle of detailed specifications is now required. Implementation might be done completely pragmatically by using a process template / data sheet correspondingly stating these criteria for process description:
- input & output (What does the process need so that it can take effect, and with what “initial event” does this process start to act? What is the intended process result and, in analogy, the “final result”, i.e. what follow-up activities can be allocated to a different process?);
- integration of the processes within the organization and the interactions with other processes (e.g. processes for which there is no direct or obvious internal supplier-customer relationship);
- process indicators (what, by whom, how often and how) with set values and specifications for the way to handle the actual values acquired (and thus, in analogy, the build-up of a control loop);
- establishing resources (human and tangible resources, e.g. business units involved and the required competence of the employees implementing the tasks and equipment, infrastructure and/or services that may be availed of as well as information and know-how necessary to achieve the process goals);
- establishing responsibility and authority. Besides nominating the Process Owner, this might also mean that the choice of the competent “interface partners providing resources” is put in more concrete terms. This “process team” will be responsible for achieving the process goals established as a collective. Authority needs to be determined just as much as responsibility. This might also be seen as a kind of “competence for implementation”. Example: What powers to act are necessary to make it possible to guarantee effective implementation of the process goals under the defined basic conditions?
- Moreover, it is required to identify the symmetrical terms of “risks and opportunities” seen in the course of planning and implementation. If no risks were seen, this would also mean that no opportunities are seen! A minimum in the modelling of processes and operations might consist in identifying possible “disturbing variables” and/or the need for change (e.g. due to additional information, new situations or non-fulfilment of previous services/deliveries) and in finding out how to handle these factors, as the case may be;
- As for monitoring and review, which have already been required up to now, it might be useful to define clear methods for process control (in what way are what characteristic variables and events acquired, and how are the results handled? - e.g. in the form of a process review);
- The output of the item mentioned above might be the input for the last new requirement that the Standard places in terms of the processes: What opportunities for improvement / further development of the processes of the management system are seen based on the lessons learned from process control?
- Another thing that such a process data sheet should include would be the definition of what documented information is relevant for effective implementation of this process.
A big advantage of such a management system definitely is the fact that understanding of interrelations and thus systemic thinking can be supported. Interactions identified can thus also be used as a control tool.
However, it is the respective organization that still needs to delimit what processes are needed for the quality management system and to define how to use these processes. Thus system design will have to be attached utmost importance to even in future.
If all the process identified are brought together in one process map, their sequences of operations will be represented graphically.
Ing. Joseph B. Garscha
Lead Auditor, Trainer
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