I have a question on this statement. It seems to me IMHO that this thinking is backwards and it’s the base of a lot of confusion with trying to comply with the requirements. 4.3 Determining the scope of the quality management system 4.3q1 The organization shall determine the boundaries and applicability of the quality management system to establish its scope. How have the boundaries and applicability of the QMS been used to establish the scope of the organization? The scope of my organization should be the foundation and the driving force behind my QMS, not the other way around. I would like your thoughts on this, it seems that we are all trying to make our QMS more difficult than it needs to be.