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ISO 9001:2015 Preparedness Audit Requirements.

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Javed Iqbal, Jan 13, 2018.

  1. Javed Iqbal

    Javed Iqbal New Member

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    Respected Members and Seniors.

    Please Guide me, what are the basic requirements for Transition Phase?
    1- Context of Organization been Stated
    2- Risk and Opportunities been identified
    3- Core Process and Supported Processes been List down.
    4- Quality Policy as per the new requirement has been updated.


    Please, what next I need to do?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Implementation, audit, action and review... (...Do, Check, Act)
     
  3. Qualmx

    Qualmx Well-Known Member

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    Do a gap analysis, have the standard ready to be followed up.
     
  4. Javed Iqbal

    Javed Iqbal New Member

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    Thanks Seniors :)
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    These aren't the ONLY things you have to do, of course...
     
  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Please contact your registrar immediately. You need to get accurate information from those who will be doing the transition assessment. There is not enough time to make mistakes.
     
  7. Javed Iqbal

    Javed Iqbal New Member

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    Dear Seniors please also guide me regarding risk assessment, We are manufacturing tin can, so when I will list down all the processes, I have to conduct the risk assessment for all processes? including supporting processes like Maintenance? Any idea what kind of risks i can consider?
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    There's no requirement for "risk assessment". Certainly not for all processes, either. You are supposed to identify internal and external issues which represent risks and opportunities. Doing something like a SWOT analysis will help identify risks. You decide which ones to address.
     
    John C. Abnet likes this.
  9. tony s

    tony s Well-Known Member

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    According to ISO/TS 9002:2016 Clause 6.1.1:
    "The intent of this subclause is to ensure that when planning the quality management system processes, the organization determines its risks and opportunities and plans actions to address them."

    So, you should plan for the processes. Focus on the processes that are critical to manufacturing your products. In analyzing the risks, opportunities and actions for each process, I am comfortable in using a simple tool as illustrated below:
    upload_2018-1-16_11-48-0.png

    I attached the file for your reference.
     

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

  10. Javed Iqbal

    Javed Iqbal New Member

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    Dear Tony Sir,
    Much Appreciated.

    Best Regards
    Javed
     
  11. Qualmx

    Qualmx Well-Known Member

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    Hi Tonys
    Could you share two more examples of R and O, In order to understand better your approach regarding opportunities?
    Your example looks simple and practical and I have no doubts that works for you, however, like in this case , the taken action resulted from the opp. "Have an electronic stock...." , for me , could be an added action to "request for materials must be submitted.." to minimize/mitigate the risk , this way the the opp. Wouldnt be considered.
    The approach I have been followed to opps.
    Is, no. 1 , to look the opp. in an isolated manner.
    In this case could be "an improved project " focused to speed up the arriving of materials.
    No. 2, having detected the risk "requests for materials are sent with less time....", ok , the proposed action to eliminate risks, at this point, to look around this risk, what similar actions we need to take to improve adyacent areas, e.g. could be , the materials are arri ving late at the production areas , thus delaying delivery to clients, so I could use same or similar actions to attack risks.
    Maybe Im wrong, but I'd like to hear your comments.
    Thanks
     

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