Being this item under “Planning of product realization”, I would understand this “shall” applied to manufacturing process changes if it was under 7.3 (7.3.7 to be exact). It seems to me that the intent is that we must be prepared (have pre-defined actions to do) in case of “changes” that affect product realization. How can I apply this to an injection moulding process? The “changes” happen every time I do a new job (new lot of material, different machine, etc.); my opinion is that we must decide what is a “change” in our manufacturing process. Your thoughts are welcome.