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ISO 9001 2015 Exclusions - Product Design is purchased.
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ISO 9001 2015 Exclusions - Product Design is purchased.
ISO 9001 2015 Exclusions - Product Design is purchased.
ISO 9001 2015 Exclusions - Product Design is purchased.
ISO 9001 2015 Exclusions - Product Design is purchased.
ISO 9001 2015 Exclusions - Product Design is purchased.
ISO 9001 2015 Exclusions - Product Design is purchased.
ISO 9001 2015 Exclusions - Product Design is purchased.
ISO 9001 2015 Exclusions - Product Design is purchased.
ISO 9001 2015 Exclusions - Product Design is purchased.
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design and development, design exclusion, exclusions of clauses in a standard, iso 9001:2015
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  Post Number #1  
Old 18th January 2018, 02:43 AM
Karib1

 
 
Total Posts: 1
Let Me Help You ISO 9001 2015 Exclusions - Product Design is purchased.

We are going into manufacturing a product , however the design is purchased from external sources. The design will not be controlled by us except for giving customer feed-backs for design improvement as per contract with external sources.

How do we map this into our scope , can we map design and development as not applicable ?

Please help!

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  Post Number #2  
Old 18th January 2018, 03:12 AM
Big Jim

 
 
Total Posts: 2,902
re: ISO 9001 2015 Exclusions - Product Design is purchased.

That's a good question.

I'm joining the thread to follow the discussion.
  Post Number #3  
Old 18th January 2018, 05:55 AM
dsanabria

 
 
Total Posts: 1,338
re: ISO 9001 2015 Exclusions - Product Design is purchased.

Quote:
In Reply to Parent Post by Karib1 View Post

Hi !
I'm Kari new to this forum , following is my query :
We are going into manufacturing a product , however the design is purchased from external sources. The design will not be controlled by us except for giving customer feed-backs for design improvement as per contract with external sources.
How do we map this into our scope , can we map design and development as not applicable ?
Please help!
Q. So are you manufacturing to customers B/P?

Q. You manufacturing engineers gets involved for clarification and to understand the best way to manufacture the product?

If both are yes - then you can take an exclusion for 8.3 but if one of the q is a no then please clarify and provide additional information.
  Post Number #4  
Old 18th January 2018, 07:13 AM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,924
Let Me Help You re: ISO 9001 2015 Exclusions - Product Design is purchased.

"We are going into manufacturing a product , however the design is purchased from external sources. The design will not be controlled by us..."

Then you are NOT design responsible and you document it's not applicable to your "context" or "scope" (there are no "exclusions in 2015). Job done.
Thanks to AndyN for your informative Post and/or Attachment!
  Post Number #5  
Old 18th January 2018, 08:42 AM
qualprod

 
 
Total Posts: 104
re: ISO 9001 2015 Exclusions - Product Design is purchased.

You are not applicable to 8.3, and need to write it down somewhere.
Check , maybe nor 8.5.1 f.
Hope this helps
  Post Number #6  
Old 18th January 2018, 10:26 AM
Randy's Avatar
Randy

 
 
Total Posts: 8,704
re: ISO 9001 2015 Exclusions - Product Design is purchased.

Been there done that on a couple audits already and just as has been said, document those elements/clauses/whatever that aren't applicable to you, have evidence available to verify it including some kind of information showing no risk to product conformity, customer satisfaction, compliance obligations and all that stuff.

It's easier than it sounds and it ain't rocket science (I'll be with those guys in a couple weeks)
  Post Number #7  
Old 18th January 2018, 11:37 AM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,308
Look! re: ISO 9001 2015 Exclusions - Product Design is purchased.

Quote:
In Reply to Parent Post by Karib1 View Post

however the design is purchased from external sources.
It is not clear what you mean here. If you mean to say that you are outsourcing the product design to an external provider, you would still be responsible for ensuring that the product design process complies with the applicable and relevant requirements of the standard. Outsourcing a process is NEVER a justification to deem it not applicable.

On the other hand, if you mean that you are acquiring the intellectual property of a well developed and established product design and will manufacture the product against this, I believe you would be ok to claim partial non-applicability of the product D&D processes.
Thank You to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #8  
Old 19th January 2018, 07:05 AM
a_bardi's Avatar
a_bardi

 
 
Total Posts: 16
Re: ISO 9001 2015 Exclusions - Product Design is purchased.

D&D company or partner seems to be you supplier in that case.
So -selection/verification/evaluation etc...
You delivering them customer expectations (defined inputs) and gaining results(products portfolio- ensure some control )
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