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Clause No: 8.3, Design and Development

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Lafir Ali Rinos, Jul 1, 2018.

  1. Lafir Ali Rinos

    Lafir Ali Rinos Member

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    Hello Everyone,

    We are the manufacturers of Detergent powders, liquids and soaps as well, what I felt doubt with the requirement of ISO 9001:2015 in clause no. 8.3 is as follows:

    we do design calculation for to get exact proportion of intended results of the product does it means that we are applicable for 8.3 Clause: Design and Development

    my perspective about this requirement is that the standard is insisting to follow for design and development of product (Product Design) but I feel that we are just make design in terms of calculation / process trials to confirm intended results or Simply as Process Design.

    I need clarification for Process vs Product design & either both are applicable as mandatory for to satisfy Clause No:8.3, Design and Development

    Thanks and Regards
    M. Lafir Ali Rinos
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    In chemistry, formulation isn't the same as the design and development requirements. Yes, someone designed the detergent etc - but a looong time ago. Unless you have new products, using different chemicals and for different applications, then really 8.3 doesn't apply.
     
  3. Lafir Ali Rinos

    Lafir Ali Rinos Member

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    Then in the sense that it is a process design, right?
    ISO 9001 2015, clause no: 8.3, doesn't applicable to out organization ?
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Exactly.
     
  5. tony s

    tony s Well-Known Member

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    Inventing a thing is different from designing and developing a product or service.

    There can be variants of soaps (e.g. germicidal, perfumed, whitening, anti-bacterial, detergent, softening, non-fading, etc.). Aside from "designing" products, an organization will also try to enhance their products - thus "development" should also be considered.

    ISO 9000:2015 defines "design and development" as "set of processes that transform requirements for an object into more detailed requirements for that object". Does your organization own this "set of processes" or you just manufacture your products as per your customers' specifications? If you own this set of processes then 8.3 is applicable to your organization.
     
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  6. nikkilalewis

    nikkilalewis New Member

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    Hi Guys,

    Just can't get my head around the where design and development ends and becomes production for some reason! And so not sure what the Design & Development Output should be...

    I'm doing a case study where the company is in Construction. So they are taking the Building Plans from the customer (Requirements) and then marking these up (then reviewing them) and then designing a product that goes on the building. They are designing the product using a software tool, manufacturing the product in the factory and then installing it onsite before the Builder does a review. So where in that process should we be using the Output procedure and record? Sorry if I'm being dumb!

    Thanks in advance
     
  7. Niko90

    Niko90 New Member

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    If I got it correctly, this company makes something that is incorporated in the building. If so, I would say that the design output is the plan made from the software, the plan they use in the factory to manufacture the product. I hope I was able to help.

    Also, don't call yourself dumb. We've all been stumped somewhere in our lives.;)
     
  8. tony s

    tony s Well-Known Member

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    Some examples of design and development are in this thread.
     

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