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That old chestnut that is 8.3 Design & Development

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Steve Morris, Apr 14, 2021.

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  1. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Then their scope would include, "The Design and Development of Packaging and Containers"... which makes zero sense.
     
    Andy Nichols, May 10, 2021
    #21
  2. Leonid

    Leonid Well-Known Member

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    We are discussing the case being not informed what is the scope and how the nonconformity is formulated.
     
    Leonid, May 10, 2021
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If I refer back to the OP's first comment, we are discussing scope. The two are not mutually exclusive.
     
    Andy Nichols, May 10, 2021
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  4. tony s

    tony s Well-Known Member

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    I don't see any categorical statement here that can clearly tie the 8.3 requirements on the containers of the adhesive/sealant that was mentioned by the OP.

    8.5.4 is about ensuring the characteristics of the product from the time it goes out from production area to the time it arrives to its destination or use. If we liberally apply 8.3 to packaging, then the OP should also apply 8.3 to transportation, storage, identification, etc.
     
    Last edited: May 11, 2021
    tony s, May 11, 2021
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  5. Steve Morris

    Steve Morris Member

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    So, having taken on the information provided in Annex A5 (Applicability) as well as the elements of determining the scope (4.3) including 4.1 and 4.2, I have added a new paragraph to 'Scope of the Management System' in the Management Manual. This is headed 'Applicability' and reads:

    "In determining the scope of the Quality Management System as required in ISO9001:2015 art. 4.3 and documented in the Context of the Organisation Log, The Company believes that art. 8.3: Design & Development is not applicable. This does not affect the ability, or responsibility of Techsil to provide services that meet customer and applicable statutory and regulatory requirements".

    FYI the scope is "Suppliers of sealants, adhesives, coatings and lubricants, plus O rings, gaskets and other sealing and bearing solutions encompassing automotive, aerospace, defence, electronics, medical and marine industries globally"

    Oh, and we purchase 'off the shelf' packaging.
     
    Steve Morris, May 12, 2021
    #25
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