Hi All, Interested to have you take on "the organisation shall consider" which appears all over the DIS. For example: " 4.3 Determining the scope of the quality management system. The organisation shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organisation shall consider: (a) The external and internal issues referred to in 4.1; (b) The requirements of relevant interested parties referred to in 4.2; (c) The products and services of the organisation." So when the auditor sits down with sharpened pencil, and says " show me how you considered the external and internal issues referred to in 4.1", what shall we be showing him? Initial thoughts would be that "to consider" would mean that we have addressed the item in a risk assessment perhaps?, so then I would be thinking that wherever we see shall consider in the standard, we should have a formal record of a risk assessment addressing the items noted in that clause for 'consideration'. (Or maybe I'm overdoing it on analysing the concept?) Whats your take?