ISO 9001:15: Process approach and Risk-based thinking

Process approach: not a novelty, but the opportunity to understand its purely applicative nature, following the PDCA and improving thanks to the assessment of risks and opportunities

This International Standard uses the process approach , which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking . The process approach allows an organization to plan its processes and their interactions. The PDCA cycle enables the organization to ensure that its processes are properly resourced and managed, and that opportunities for improvement are determined and acted upon.
Risk -based thinking allows the organization to determine the factors that could cause its processes and quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and maximize opportunities, when they present themselves "
(ISO 9001:2015, Introduction)

The implementation of a quality management system, understood as the managerial tool for pursuing the objectives outlined and creating value, is based on the clear identification of one's own processes , which constitute the vital organs of every organization, with the uniqueness that characterizes it.

Grasping this essence of the process approach allows you to achieve results on two levels : outwards in the pursuit of business objectives and inwards in creating a collaborative and aware human environment.

The real turning point in understanding this tool is represented by the awareness of not having to create anything artifact , but rather to note that the organization lives and works in processes.

The added value will be represented by the clear identification of the interactions between processes , or between people: waste, disservices, non-conformities are essentially caused by unsatisfactory interactions.
A document passed late, a misunderstood communication, an incorrectly identified recipient are among the many examples that lead to non-compliance with the requirements of the product/service provided (loss of effectiveness of the process), as well as costs (loss of efficiency).

Wanting to define a process , looking beyond the classic definition that defines it as "the transformation of an input into an output", it could be very useful to focus our energy on people : "The process is how a group of people performs related activities, exchanging information, to achieve a specific result useful for the customer of the process" ( Leonardi, 2012).

From this point of view, which places the person and therefore the relationships between people at the forefront, the concept of "process indicators ", i.e. the measurement of the results obtained: times, correctness of data, costs, is also clear and concrete.

The implementation method refers to the well-known PDCA on which the quality approach is based:
  • PLAN: recognize and document processes;
  • DO: work for processes;
  • CHECK: measure effectiveness and efficiency;
  • ACT: react to the results of the measurements, implementing actions for improvement.
And here, one of the most significant principles underlined by the new version of the standard is inserted into this virtuous cycle, risk-based thinking as a strategic method for identifying the actions to be carried out at each process level , aimed at seizing opportunities and managing and/or containing risks.

The best synthesis could be the following: to constantly improve, thanks to a team effort represented by all the processes!

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