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Clause 7.3.7 Design and Development Changes - Requirements Scope?

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7.3.7 - manage design and development changes, design and development, iso 9001 - quality management systems, validation (general), validation requirements
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  Post Number #1  
Old 27th April 2012, 02:31 PM
morteza

 
 
Total Posts: 122
Please Help! Clause 7.3.7 Design and Development Changes - Requirements Scope?

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/liveli...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.

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  Post Number #2  
Old 28th April 2012, 05:19 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 14,974
Re: Clause 7.3.7 Design and Development Changes - Requirements Scope?

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.
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  Post Number #3  
Old 28th April 2012, 08:23 AM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,142
Re: Clause 7.3.7 Design and Development Changes - Requirements Scope?

Quote:
In Reply to Parent Post by morteza View Post

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/liveli...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.

Quote:
In Reply to Parent Post by morteza View Post

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.
Thanks to Jim Wynne for your informative Post and/or Attachment!
  Post Number #4  
Old 28th April 2012, 01:10 PM
morteza

 
 
Total Posts: 122
Re: Clause 7.3.7 Design and Development Changes - Requirements Scope?

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?
  Post Number #5  
Old 28th April 2012, 01:41 PM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,142
Re: Clause 7.3.7 Design and Development Changes - Requirements Scope?

Quote:
In Reply to Parent Post by morteza View Post

Hi Jim,
Your replies are always very helpful.
What I canít 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.
Thanks to Jim Wynne for your informative Post and/or Attachment!
  Post Number #6  
Old 28th April 2012, 11:47 PM
Chennaiite's Avatar
Chennaiite

 
 
Total Posts: 568
Re: Clause 7.3.7 Design and Development Changes - Requirements Scope?

Quote:
In Reply to Parent Post by morteza View Post

Hi Jim,
.....
What is the difference between approval and validation? What does approval confirm?
Approval is just a green signal a stationed train receives. Validation is all the checks and balances that go into before providing the signal.
Thank You to Chennaiite for your informative Post and/or Attachment!
  Post Number #7  
Old 29th April 2012, 08:50 AM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,142
Re: Clause 7.3.7 Design and Development Changes - Requirements Scope?

Quote:
In Reply to Parent Post by Chennaiite View Post

Approval is just a green signal a stationed train receives. Validation is all the checks and balances that go into before providing the signal.
Exactly. Approval is what's done when validation is successfully completed.
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