Please help me to clarify the exact meaning of the phrases. If a QM is not required, Should I add an updated to 10th Ed. Scope page to my Documented procedures? Does identifying "products covered" mean I make a page of a complete list of API parts on the scope page? I would have to sort these from our non API parts if so. Would bringing the DP's and forms up to 10th Ed. be a good place to start? I know I am way behind on this, thanks for any help!
Which phrases don't you understand?
Gap analysis is an review of the requirements in the standard (or the new requirements in the revised standard) and whether you meet each requirement. Any requirement that is not met is a gap that needs to be addressed.
You can still keep a quality manual if you want. If you get rid of it, then you need to write down your scope on some other controlled document (call it a procedure or call it "scope" or whatever you want).
Identifying "products covered" can be done broadly, i.e. the scope is "subsurface sucker rod pumps and their components for use in the petroleum and natural gas industry". It does not need to be a list of model numbers or anything else extremely specific. However, it should accurately describe whatever is in scope, and should allow you to clearly differentiate between in-scope and out-of-scope products (if you have any out-of-scope products; it is possible that all products are in-scope).
Would bringing the DP's and forms up to 10th Ed. be a good place to start?
Again, I recommend first determining which 10th Ed requirements you do not currently meet (you probably already meet most of them and don't need to revise all your forms) and then revising whatever is necessary to meet those requirements. Which order will make it easiest for you to plan and control all the changes?
