It may be a quite silly question. Still, I want to figure it out. In the Sub Cl. 6.3 Planning of changes "When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4)." Which kinds of changes can be considered as “changes to the quality management system”？ In my theory, it is safe to say that changes to the organizational structure, the COPs, SPs, MPs can be classified into this category. However, what about the changes to the manafacturing processes, such as the changes in 5M1E? They are just engineering changes? Has nothing to do with the changes to the quality management system? And is there other examples of changes to the QMS? PS: The answer may be just lying in the context of the Standards. Sadly, I didn`t get lucky to find it.