ABSTRACT
Clause 4.1 refers to the concept of quality management in an organization. The standard requires denition of the main principles of the quality management system in the quality manual, denition of the scope of your quality management system by identifying the processes, and its support with activities described in the quality procedures. Next, the standard species…
The processes for product realization are the basis of a quality management system (QMS). But what are the processes? The processes need to be identied rst, in order to understand where to invest and control resources. Otherwise you may nd yourself documenting and controlling processes that have no relation to your medical device. It is advisable to rst draw the general £owchart of the process, describing how the product will be realized (Figure 4.1).
