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Applicable requirments ( 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?
     
    Jennifer Kirley likes this.
  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.
     

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