Hi all
Again I faced with requirement scope problem!
According to ISO 9001 text, it seems that the clause 7.3.7 requirements scope starts after product validation or approval. My understanding can be supported by APG paper on design and development. (http://isotc.iso.org/livelink/livel...Development.doc?func=doc.Fetch&nodeid=5308362). See figure 1 in this paper.
But I believe that according to ISO/TS note under this clause, the requirement scope starts after product program approval. The requirement scope includes changes in product design inputs, changes in conceptual designs, changes in process design inputs/outputs, etc. which are occurred before product/process approval by customer.
Another question is that: what is the requirement for approval in the context of ISO 9001? Is not validation enough? I think approval is done by customer.
Thanks in advance for your help.
Again I faced with requirement scope problem!
According to ISO 9001 text, it seems that the clause 7.3.7 requirements scope starts after product validation or approval. My understanding can be supported by APG paper on design and development. (http://isotc.iso.org/livelink/livel...Development.doc?func=doc.Fetch&nodeid=5308362). See figure 1 in this paper.
But I believe that according to ISO/TS note under this clause, the requirement scope starts after product program approval. The requirement scope includes changes in product design inputs, changes in conceptual designs, changes in process design inputs/outputs, etc. which are occurred before product/process approval by customer.
Another question is that: what is the requirement for approval in the context of ISO 9001? Is not validation enough? I think approval is done by customer.
Thanks in advance for your help.