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Monitoring and review 4.1, 4.2 evidences?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Mar 27, 2018.

  1. Qualmx

    Qualmx Well-Known Member

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    Hello to all

    I have been trying to set a method (easy, practical, fully understood by an auditor) to prove that we are monitoring and review 4,1 and 4.2

    First option = In the MR meetings , example, in customer, is just to say " I have monitored and have not seen changes " that will be recorded in the MR records.

    Second option = In the MR meetings, to show a spreadsheet (like a checklist) and put a cross, on customer, to prove have monitored the customer and commenting out on it, "no changes".
    In here a checklist would be the record, also the MR meeting.

    In the first option , would be easier, but it is so vague and not precise when monitored
    and in second option, at least i think it is a like a more compromise.

    Dont know at what extent do we need to prove we have done this activity and also an important issue, is the involvement of each process owner.

    Thanks
    Ideas are welcomed.
     
  2. RoxaneB

    RoxaneB Moderator Staff Member

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    I'm not sure I see any monitoring happening in either option. Monitoring implies some sort of data - being qualitative or quantitative - be reviewed or taken into consideration, does it not? Or am I missing the point here?
     
  3. Qualmx

    Qualmx Well-Known Member

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    Thanks

    You are right (data to be reviewed)

    In 4.1 competitors, External issue, to monitor if there is a difference between a list of current registered competitor against new ones, detected recently.

    In 4.1 competitors, external issue, goverment laws, to compare the list of registered laws against
    current laws, this could be an activity of entering into the goverment web page.

    In 4.2 in customer, (needs and expectations) I would check specifically, list of complaint, list of product rejects.

    The results of these monitored activities, how can be evidenced?
    What is more important ?, to show that activity is monitored?
    or to report in the MR, what were the results? and would be enough just to say
    " no changes" or to show a list of activities marked as they have been carried out?

    Thanks for your help.
     
  4. Qualmx

    Qualmx Well-Known Member

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    Correction, in third paragraph, is only goverment kaws
     
  5. tony s

    tony s Well-Known Member

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    Although the the easiest approach is through the Management Review. There can be many ways an organization can demonstrate that internal/external issues and needs and expectations are being "monitored and reviewed". Methods can include:
    • monitoring national and international press or news,
    • checking the internet or websites (e.g. new regulatory requirement),
    • monitoring publications of government requirements,
    • monitoring professional and technical publications,
    • participating in conferences,
    • meeting with customers,
    • consultations with stakeholders,
    • participating in professional associations,
    • subscriptions on national and international agencies,
    • reviewing orders received or contracts,
    • market surveillance,
    • benchmarking,
    • meeting with suppliers,
    • conducting customer surveys, etc.
     
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  6. Qualmx

    Qualmx Well-Known Member

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    Thanks
    But what an audit of expect to see?
    What you reported in the records (minute meeting) output of MR? Would expect a signed document or is enough a statement like this" nithing found"
     
  7. Qualmx

    Qualmx Well-Known Member

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    And would it be needed to have evidences that activities were carried out?
    E.g .Participating in meetings?, CgChecki newspapers, internet?
    Thanks
     
  8. tony s

    tony s Well-Known Member

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    To demonstrate "review and monitor", records are helpful as part of the evidences. However, auditors should not rely only on records as the only form of evidence. You may refer to the definitions of "objective evidence" and "audit evidence" in ISO 9000:2015 - QMS Fundamentals and Vocabulary.
     
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  9. Qualmx

    Qualmx Well-Known Member

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    Thanks
    But still have the doubt.
    In case there were no changes, would be enough in MR to say "no changes" or should be needed to show some format or document signed? To prove it was done?
    Thanks
     
  10. tony s

    tony s Well-Known Member

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    Why do you need to demonstrate that you have reviewed the internal and external issues if there's no changes on them. Clause 9.3.2b only requires an organization to "take into consideration" the changes on internal and external issues. So, if there are no changes, then no need to discuss it and no need to include a statement in the minutes of the MR to say "no changes".
     
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