ISO documentation

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    Is ISO documentation a non value added acitivity or required non value added activity ?



    Does your customer see any value in your ISO certificate? If not,  documentation produced to get an ISO 9000 certificate is pure muda.
    Minimum documentation necessary for product assurance (doesn’t have to be ISO certtified), on the other hand, is a required NVA activity.



    Value Adding Activity: 

    Physically changes the product/service (form or function)
    In a way the customer recognizes and is willing to pay for
    And is done right the first time
    Certainly not value added, and unless you need it as a regulatory requirement, then not ¨NVA but necessary¨  either.  My experience with ISO 9000 (albeit limited) is that it is concerned with ensuring that the process is documented and the documentation surrounding the process is actually being followed….Are you doing what is actually in the Work Instructions, SOP, etc?  It does not take into account the relevence or effects of the SOP itself…if following the SOP perfectly, you are in accordance with ISO thinking
    Again, it doesnt take into account process capability or quality of output, only if you are following your documented procedures.  ….so to me, why bother asking the question?  
    Use something that will quantify your VOC and VOP and spend your time on a methodology that will actually improve your process in a way that can be verified …SOP and WI are simply tools like any other, and have value only if you understand your Y = f(x) first……good luck and verify.


    tony c

    I have experience with several quality system certifications and lean mfg, including ISO-9001, QS-9000, and FDA (medical devices).  While I believe ISO 9001 is the weakest of these, it does provide a basic structure beyond what is often perceived as “do what you say, and say what you do.”  I agree that the requirements of your customer base will drive the answer to whether it is pure waste or required waste.  ISO has value if you have no other standard, and it does provide customers with a well established frame of reference.
    I personally like QS-9000 because it forces companies to use good quality tools (i.e., FMEAs, control plans, process capability) and encourages 6 Sigma methodology. 
    A sound continuous improvement strategy is infinitely more valuable than any quality system certification.

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