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8.3 Design and development of Products and Services

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Haddad9921, Feb 28, 2018.

  1. Haddad9921

    Haddad9921 New Member

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    Hi,
    looking at 8.3.2 Design and development Planning, do we need to keep records of us considering the items a-J?
    would one of the questions by the auditor be " show me that you considered the internal and external resources for the design and development of the product"?
    thanks
     
  2. yodon

    yodon Active Member

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    Since the standard doesn't state that documented information is required, I wouldn't think an auditor would require records (but invariably some will, I'm sure). They may (should) ask "how" you're considering those elements. By and large, those ARE good things to consider when planning out your D/D activities.

    I think many of us have hope that audits are moving towards assessment of effectiveness rather than strictly compliance. From that perspective, are your D/D activities getting sidetracked / derailed because any of these things aren't considered? Are you monitoring the effectiveness of your planning work? The aspects in a-j are really just part of risk-based thinking and risk control.
     
  3. Erickson Rabena

    Erickson Rabena Member

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    Hello Haddad..

    May we know your products?
     
  4. Haddad9921

    Haddad9921 New Member

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    Hi,
    The product is paperboard cartons.
    Thank you
     
  5. Lafir Ali Rinos

    Lafir Ali Rinos Member

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    Hello Haddad9921,

    As you said, "do we need to keep record of us considering the items a - j?"..
    yes as stated in the clause No.8.3.2.j - "the documented information needed to demonstrate that design and development requirements have been met."
    so, in order to demonstrate the internal / external resources that you considered for the design and development needed to be maintain / retain as a documented information.
     

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