R&D and Design procedures - can one procedure cover both activities

#1
Hi,
I am developing procedures for a company which does R&D as well as design. The design activities are currently not based on customer requirement but what the market is suggesting. If the product developed is not based on customer specification, can I say the clauses 8.3.1& 8.3.2 of iso9001:2015 does not apply. Furthermore do I need create another procedure for R&D or can I combine the 2 activities under the same procedure
 
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John C. Abnet

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#2
If the product developed is not based on customer specification, can I say the clauses 8.3.1& 8.3.2 of iso9001:2015 does not apply. Furthermore do I need create another procedure for R&D or can I combine the 2 activities under the same procedure
Good day @Hari Varma ;
Can we assume based on your post that your organization is certified to ISO 9001:2015?
Can we assume based on your post that your organization is NOT certified to IATF 16949:2016?

If your organization "...does R&D as well as design", then no, your organization would have no justification for claiming non-applicability.

Why (if your organization "...does R&D as well as design", would your organization want to claim those clauses do not apply?

Remember: ISO 9001:2015 requires NO procedures. Any procedures your organization should be done selfishly for the benefit of your organization and its customers. What and how you create in regard to procedures is totally up to your organization.

Hope this helps.
Be well.
 
#3
Good day @Hari Varma ;
Can we assume based on your post that your organization is certified to ISO 9001:2015?
Can we assume based on your post that your organization is NOT certified to IATF 16949:2016?

If your organization "...does R&D as well as design", then no, your organization would have no justification for claiming non-applicability.

Why (if your organization "...does R&D as well as design", would your organization want to claim those clauses do not apply?

Remember: ISO 9001:2015 requires NO procedures. Any procedures your organization should be done selfishly for the benefit of your organization and its customers. What and how you create in regard to procedures is totally up to your organization.

Hope this helps.
Be well.
Hi John,
The organisation is not certified to ISO9001:2015 as yet. It is NOT certified to IATF 16949:2016.
They have researched and developed a prototype product based on market research but NOT to any customer requirements. There is no customer input to this product. Can I say that Design & Development activities are not applicable? However, if there are customer driven changes to the product, then I expect an element of design and development would need to considered. I have taken consideration that the procedures/processes developed thus far, are for the benefit of the organisation and potentially with customer in mind.
 

Peter Fraser

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#4
Any procedures your organization should be done selfishly for the benefit of your organization and its customers. What and how you create in regard to procedures is totally up to your organization.
John
Totally agree. Don't define a system for ISO, do it for your business - how does a new start know what to do / who does what / where is the supporting information? what happens when someone leaves?
 

John C. Abnet

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Leader
Super Moderator
#5
Hi John,
The organisation is not certified to ISO9001:2015 as yet. It is NOT certified to IATF 16949:2016.
They have researched and developed a prototype product based on market research but NOT to any customer requirements. There is no customer input to this product. Can I say that Design & Development activities are not applicable? .
The organisation is not certified to ISO9001:2015 as yet. It is NOT certified to IATF 16949:2016:
Then I'm not sure what your question is related to. Obviously the standards referenced are not applicable, so in that sense your organization can claim/do whatever it wishes.

They have researched and developed a prototype product based on market research but NOT to any customer requirements. There is no customer input to this product. Can I say that Design & Development activities are not applicable?
Based on industry norms (and ethics?) then the answer is "no" . Your organization can NOT claim design and development are not applicable.

Hope this helps.
Be well.
 
#7
Hi,
Many thanks for your input. After careful consideration, I have taken the view that we will have design and development process in place which will compliment the scope of the Quality Management System. We already have documented activities (hardware and software requirements specification and functional specification in place) in place for the prototype product that has been developed and as such makes sense to build on this information.
 
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