ISO 9001 2015 Exclusions - Product Design is purchased.

#1
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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dsanabria

Quite Involved in Discussions
#3
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.
 
#4
"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.
 

qualprod

Trusted Information Resource
#5
You are not applicable to 8.3, and need to write it down somewhere.
Check , maybe nor 8.5.1 f.
Hope this helps
 

Randy

Super Moderator
#6
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:lol:)
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
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.
 

a_bardi

Starting to get Involved
#8
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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