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6.3 QMS Planning of changes ?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by jaltangerel, Jan 4, 2018.

  1. jaltangerel

    jaltangerel Member

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    What is this mean in clause 6.3 "When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner " ?

    is it a changes of procedures and work instructions?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, but not only those. If your organization makes a change to, say, the sales process because they are going to use a software tool, like SalesForce etc. planning for the change will also include software support, training of users, changes to methods, equipment and so on.
     
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  3. Qualmx

    Qualmx Well-Known Member

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    Any change who may impact negatively your qms, must be planned adequatelly.
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Any change - including improvements - must be planned.
     
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  5. Golfman25

    Golfman25 Well-Known Member

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    What does that even mean? What is a "planned manner?" Seriously, who does things without at least a minimal plan? What level of planning?
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Unsophisticated organizations in emerging economies who want to supply a global marketplace...
     
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  7. The PPAP Assassin

    The PPAP Assassin Active Member

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    All you should need to do is show proof of any changes that impact the QMS. For instance, meeting sign in sheets, minutes, ect..
     
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  8. jaltangerel

    jaltangerel Member

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    Very helpful me. Thanks all.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I wouldn't suggest this at all. Section 6 is pretty clear about what has to be considered in planning changes. In fact there's a list. Showing someone lists of names from meetings is almost inconsequential. What's needed is a) a plan and b) measureable results once the change has been implemented.
     
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  10. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    6.3 does include change planning aspects that are expected, but I want to add that personnel changes should also be planned. Reorganizations, promotions, downsizing etc. all can leave responsibilities untended unless the responsibilities are reassigned and personnel prepared to successfully accomplish their new tasks on time.
     
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  11. The PPAP Assassin

    The PPAP Assassin Active Member

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    I wouldn't suggest this either.. You cant pretend like every company is the same. Each company has there own way of dealing with changes.

    Changes to the QMS can come from CAR's. Most of them do here. An error has occurred, the CAR calls for a change in the QMS.

    "Changes shall be carried out in a planned manner."

    We have had several documented meetings about changes that happen that take into account requirements a.) b.) c.) and d.)

    All of which can be proved with objective evidence..

    Thanks for you opinion, Andy.
     
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  12. tony s

    tony s Well-Known Member

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    Just want to share this form if you need to record changes for improvement.
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

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  13. jaltangerel

    jaltangerel Member

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    Thanks Tony s
     

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