Clause 7.3.7 Design and Development Changes - Requirements Scope?

morteza

Trusted Information Resource
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.
 

Jim Wynne

Leader
Admin
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.

The note you refer to means that the requirements of 7.3.7 are applicable not only during the the initial pre-production design/development stage, but also for the life of the program.
I'm not sure how you arrived at the idea that design control requirements are applicable only after approval when the requirements clearly state that approvals are part of the necessary controls.

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.

Approvals may come in different shapes and sizes. If the organization is design-responsible, customer approval might not be an issue. The idea is that when changes are made they are approved by the appropriate authority.
 

morteza

Trusted Information Resource
Hi Jim,
Your replies are always very helpful.
What I can’t understand is that why for new design and development, approval is not necessary in ISO 9001, but for all changes it is necessary.
What is the difference between approval and validation? What does approval confirm?
 

Jim Wynne

Leader
Admin
Hi Jim,
Your replies are always very helpful.
What I can’t understand is that why for new design and development, approval is not necessary in ISO 9001, but for all changes it is necessary.
What is the difference between approval and validation? What does approval confirm?

The first sentence of 7.3.3, ISO 9001:2008:

The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release.
 
Top Bottom