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Control Of Records

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by KyleG, Jan 17, 2019.

  1. KyleG

    KyleG Active Member

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    Tony S said this on another thread and now im thinking.
    Control of documented information applies to:
    • those that your organization needs to "maintain" - i.e. documented information that support the operation of the processes (e.g. procedures, instructions, etc.;
    • those that your organization needs to "retain" - i.e. documented information that provide evidence of conformity with requirements (i.e. records)
    Some of my customers require a CoC, This specific customer simply does not want one or care to have one, the product we send them in nature is virtually impossible to have a visible defect on it. Can my SO/PO be considered a Record of documented information that provides evidence of conformity with requirements.

    We Still inspect and audit for appearance and mechanical operation. The customer has
    never returned or complained about the quality of the product. (we ship hundreds a week)
    If not do i have to create/retain a separate inspection form to prove that is in fact conforming with requirements.
     
  2. tony s

    tony s Well-Known Member

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    Do your SO/PO contain ALL the required criteria for the acceptance of products? If both forms only contain SOME of the requirements (e.g. quantity, delivery date, price), then both can only provide evidence of conformity to "assigned" requirements. In ISO 9000:2015, characteristics that are assigned to an object are not considered as quality characteristics (see definition of "quality characteristic"). If your customer is more concerned on the quality characteristics that are "inherent" (see definition of "quality"), then you have to retain documented information to demonstrate conformity to product requirements (see 8.1e.2; 8.5.1c and 8.6a). This means evidence of conformity to requirements related to the characteristics that are existing in the product (e.g. product specifications) must be retained.
     
  3. KyleG

    KyleG Active Member

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    My question is if the customer does not require a CoC, do i have to create, complete and keep a document for the sake of just saying i have one? The operation is checked off with a pass/fail percentage on our "traveler/router" saying these products went through this process on this date. Attached is a photo of the Specific Item in question.
     

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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Kyle, when you say "do I have to..." your answer is in the standard! I have failed, since 1987, to understand why folks ask this question, because such things are either in the standard or they aren't. The ONLY times you are required to do something not in the standard is a) if a customer contractually requires something, b) a regulation requires it or c) your chosen CB has additional requirements in their services agreement. If it ain't in the standard, don't do it!