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Internal and External Issues as they relate to the QMS

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by claudiogut, Sep 12, 2023.

  1. claudiogut

    claudiogut Member

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    A significant part of our company's business comes from one customer that is very insistent on ISO certification by the end of the year. We're scheduled for a Stage 2 at the end of October and I just want to make sure I'm covering all the bases... especially the ones relating to internal or external issues.

    We are a distributor of industrial components. Our business model is buying up large quantities of components, storing them in a warehouse, shipping them out when needed.

    Can you give me an example of a change in the external or internal issue related to the Quality Management System?
     
    claudiogut, Sep 12, 2023
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  2. Miner

    Miner Moderator Staff Member

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    These can vary widely depending on your organization. An internal issue might be moving your storage to a new warehouse. An external issue might be dealing with a recall initiated by a supplier of the components.
     
    Miner, Sep 12, 2023
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    One way for your own people to do this - and be far more meaningful than our on-the-fly guesses, is to do a "S.W.O.T analysis. Strengths, Weaknesses, Opportunities and Threats. S & W are internal, O & T are external in nature. Or a P.E.S.T or P.E.S.T.L.E analysis works too... (ISO/TS 9002 references these in the guidance.)
     
    Andy Nichols, Sep 12, 2023
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    Miner likes this.
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    And... don't create a special document for "risks and opportunities" or a "risk register" or some other burdensome BS. Simply record the SWOT (or PEST/LE) in your records of Management Review (cl9.3). The information required to be reviewed (in cl 4 Context) is pretty much the same as what cl9.3 says should be reviewed...
     
    Andy Nichols, Sep 12, 2023
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