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Looking to simplify

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by usernameron, Feb 12, 2018.

  1. usernameron

    usernameron New Member

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    I have heard some organizations are using an excel file where they show the Context and interested parties does anyone have an example?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Better still, why not just make it part of your management review record? No point in creating more documents to control...
     
  3. tony s

    tony s Well-Known Member

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    Does the standard require a "list of internal/external issues or a list of interested parties and their needs/expectations"? Or does the standard require "understanding of the internal/external issues and the needs/expectations of interested parties"?
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Good points Tony! I've seen a worrying number of people who want to create more and more documentation, without a clear understanding of what the task/requirement is. It's as if time has stood still in "ISO Land" and people are still creating documents when, in fact, nothing like that is what's needed. Worse, the use of the requirement - how to implement it - is not at all well understood, especially the linkages.

    For a start, interested parties: Customers, (end users, if they are different), employees, owners and suppliers is about as basic as it needs to be. Could you thrown in regulatory bodies - if applicable, yes. Anyone after that? Not usually, for the vast majority of businesses. Hmm, maybe the bank, but waaaay down the pecking order. Not much to put in an Excel spreadsheet, to then have to control - it's not likely to need updating, ever...

    Needs? Expectations? Meet the contract requirements, deliver on time (sounds like the quality policy) be a good place to work, make some money (sounds like some quality objectives). Again, committing them to "tab 2" in an Excel spreadsheet seems a little pointless...
     
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  5. Golfman25

    Golfman25 Well-Known Member

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    Which makes it kind of a stupid meaningless requirement.

    But then you get the auditor who says "if you didn't document it you didn't do it" regardless of what the standard says.

    So how do you "prove" you understand your interested parties?
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Because it WAS documented, in the Management Review process...
     
  7. Golfman25

    Golfman25 Well-Known Member

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    You're right. It was probably documented in the management review on an excel spreadsheet. :)
     
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  8. tony s

    tony s Well-Known Member

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    If I have to demonstrate "understanding" of the requirements in clauses 4.1 and 4.2, I'm not limited to just showing the auditor a list from an excel or a table/matrix in a quality manual enumerating the internal and external issues and the interested parties visavis their needs/expectations. Evidences to demonstrate "understanding" can be one or more of the following ways:
    • documented SWOT analysis (IMHO clauses 4.1 and 4.2 are inputs for establishing the strategic directions/goals of any organization);
    • establishing objectives that are relevant to interested parties needs and expectations. For example:
      • if a customer expects quality products, then set objectives like "high acceptance rate", "low reject rate", "Cpk not lower than 1.33", etc.
      • if a customer expects timely delivery, then set objectives like "100% on-time", "delivery within 24 hours", etc.
      • for internal customers expectations, then set objectives like "high production yield", "low downtime rate", "GRR% not greater than 10%", etc.
      • for regulatory bodies expectations, then set objectives like "drug-free workplace", "100% waste segregation", "100% compliance", etc.
    • the scope of the organization clearly covered the relevant issues, needs and expectations (this is very true to government agencies, since there are agencies that only want the certificate but don't want to include in their scope all the products and services they are mandated to provide);
    • when determining risks/opportunities in planning the processes of the organization, the documented actions to address risks/opportunities should be intended to fulfill the needs and expectations (e.g. risk matrices, risk registers, risk response plans, fmea, etc);
    • a register that monitors compliance to all relevant legal and other requirements;
    • records of the management reviews include the review of the:
      • changes in internal and external issues
      • customer satisfaction
      • feedback from relevant interested parties
      • objectives relevant to interested parties
     
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