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Applicable requirements (Exclusions)

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by B Kari, Jan 18, 2018.

  1. B Kari

    B Kari New Member

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    Hi !
    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!
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes! You don't do it and you can't control it, so it would be inappropriate to claim responsibility - you simply document the design process is inapplicable.

    Incidentally, how would you map a process you don't do, don't have people who can explain during an audit and have no records of the process to show that you followed the process?
     
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  3. tony s

    tony s Well-Known Member

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    Since the design process is outsourced, you have to provide justification on the description of your organization's QMS scope. You will also need to ensure that the outsourced design process is being controlled in accordance with the requirements in clause 8.4 - Control of externally provided processes, products and services.
     
  4. Daniel Padilla T

    Daniel Padilla T Member

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    So in this case the scope could say something like: "The scope of the QMS is the manufacture, inspection and shipping of office furniture. The design and development requirements (8.3) have been excluded because the organization outsources all the design of its products"?

    Also, Could the Design and development process appear in the process map (maybe as a striped box) indicating that it is outsourced?
     
  5. Qualmx

    Qualmx Well-Known Member

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    Maybe you could declare as well as non applicable , 8.5.1f, validation of products ...(called special processes) are you agree ?
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    We'd have to know what they are manufacturing first, before we can suggest it's not applicable. Plus, not everyone knows the "old terminology" of "special processes". You may wish to share what they are to assist.
     
  7. tony s

    tony s Well-Known Member

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    Or something like this: "The scope of the QMS is the manufacture, inspection and shipping of office furniture. The design and development requirements (8.3) do not apply to the scope of the QMS since our customer maintains the responsibility for the product design and development by approving the design outputs provided by our company's third party office furniture designer"
     
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  8. tony s

    tony s Well-Known Member

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    Since you're claiming non-applicability of 8.3, IMHO, there's no need to indicate it in the map.
     
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This is untrue. It depends on a number of factors including who has authority for the design approval. You CANNOT simply claim something in the scope if you don't control it. There are strict rules over what can be in a scope.
     
  10. tony s

    tony s Well-Known Member

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    By ISO 9000 definition, design and development is a "set of processes that transform requirements for an object into more detailed requirements for that object". If the organization owns this set of processes then the requirements of 8.3 must be included in their QMS scope. If an organization outsources this set of processes and the responsibility for the DnD inputs and outputs remains with the customer, then 8.3 is not applicable to the organization's QMS scope.
     
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  11. Daniel Padilla T

    Daniel Padilla T Member

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    So, if my organization has the authority for the design approval (even though the DnD is subcontracted), we would need to consider 8.3 in the scope?
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not in my experience. If you don't have, as Tony states, a design and development process, then although you maintain design authority you cannot claim a D & D process. Authority is just one factor. Your QMS scope should state the "control of subcontract (or outsourced, as you like) design and development", so it clearly shows that it's an outsourced process (as ISO 9001:2015 requires, incidentally). To simply claim D & D in your scope is a gross misunderstanding of the application of the purpose of "scope".
     
  13. tony s

    tony s Well-Known Member

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    Let me share the guidance from ISO/TC 176/SC 2/N 524R6 in claiming exclusions for ISO 9001:2008 version. I don't know whether the 2015 version has this guidance. Anyway, I believe, this is still suitable as a reference:
    Based on the above example, your organization will need to include 8.3 in the QMS scope.
     
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  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    So, this is an interesting example, and shows their personnel are significantly involved in the design and development process (reviews etc.) In such a case, they can be shown to have responsibility. What if the design process was treated as a "black box" process? Personnel were NOT involved? That's not a scenario described by the ISO group is it? It would be interesting to see if, since the whole idea of "exclusions" is now "applicability" it may need to be revised. If you don't HAVE a process - it's outsourced - how can an organization claim it in their QMS?
     
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  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    BTW - I have posted the same question - with the excerpt Tony provided, in the Linkedin TC 176 SC2 group, run by our friend Paul Simpson.
     
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  16. tony s

    tony s Well-Known Member

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    Yeah. After posting the reference from ISO/TC 176, I realized that it's not entirely in consonance with the DnD definition. In the ISO/TC 176 example, the organization that "transforms the requirements into more detailed requirements" is the engineering consulting firm - not the construction company. Although, the construction company is the one "responsible" for the DnD review, verification and validation activities and ensures conformity with 7.3, but this can also be interpreted as part of the controls under 8.4.2.
     
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  17. John C. Abnet

    John C. Abnet Well-Known Member

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    ????
    The OP indicated that the organization does not control the design . For the organization to "approve" the drawing would be terribly risky. What authority does the manufacturing organization have to "approve" a drawing which they did not design and over which they have no control? This could unduly expose the organization to liabilities (Product safety comes to mind) .

    I respectfully disagree @Martin.suda
     
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  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I wouldn't suggest that. I've been in far too many registered companies to know that it's a common occurrence for the scope to be highly inaccurate. Like the company who "designs" tools and fixtures. Clearly the auditor doesn't understand the 8.3 requirements. Or the automotive company which had "brake components" in the scope, when all they made were intake manifolds etc. I guess the auditor was incompetent. Who was it said that you don't have to know the industry to audit it? Maybe not, but boy things go badly wrong when you don't!

    And, FWIW we're talking about the scope of the QMS, not the scope of certification - two different things in some cases.
     
  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Experience shows this isn't true! Many is the time it's the consultant who does the best job of sorting out the most accurate scope, not the CB and certainly NOT the auditor. I'm constantly amazed at the times CB auditors throw the work of a consultant under the bus in favor of their bias and prejudices.
     
  20. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It seems you deleted your own comment in this thread BTW.
     

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