ISO 9001:2015

ISO 9001: 2015 brought a lot of changes with a comprehensive and almost radical revision. We can say that there are two main groups of changes that we can distinguish between “Conceptual” and “Application”. With this article, we take a look at some of the application changes that came mostly with ISO 9001: 2015.

The most important revision in ISO 9001: 2015 standard was brought with the “Leadership” item. As you already know, system installation and management works were carried out by assigning a “Quality Management Representative” or “Quality Management Officer” to any company that owns ISO 9001. . Generally, this was a serious “Lack of Awareness” problem, even if it was attempted to be carried out correctly.

I think the best change that came with the ISO 9001: 2015 revision is that every process creates its own quality management system with the leadership item. Thus, the leader (s) of each department (process) is now actively involved in the ISO 9001 quality management system. At the same time, each department is a team and the leader of each team has become the “Quality Management Officer” who has problems with its own process quality.

Corrective and Preventive Activities previously taking place in ISO 9001: 2008 were revised as Corrective Activity in ISO 9001: 2015, and were revised as “Preventive Actions” => “Risk-Oriented Approach” (Planning). In this change, ISO 9001: 2015 When a possible risk occurs, Corrective Action (the study for the repair of the results of the risk) is carried out according to the scope of the risk, and then the Preventive Activity (measures to be taken not to repeat the risk) was initiated.