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Risks in 4.4?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Jan 3, 2018.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi everybody
    First of all, happy new year 2018, best wishes for all of you.

    At addressing risks, the standard refers 6.1, "when planning for the quality management system, the organization..." .
    But I wonder why doesnt consider 4.4, where are defined processes, procedures, resources,etc.?
    In this clause (4.$) it seems it considers a wider aspects in a system, than just planning (6.1).

    Somewhere I read that planning in a QMS, it is an activity for the planning a job, e.g. the planner plans a production, using which is named a "traveler plan", where is defined the activity, the responsible, the check points, etc.

    But there are other processes, in which there are not planning, they just do the daily activities (Purchasing process) to follow-up of the purchase orders and other minor activities.

    So could someone explain, strictly what means "planning", if it seems the most important activities of the processes are carried out in 4.4?

    Thanks
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I think there's a post where I already answered this question or something similar. Clause 6 is strategic planning and NOT to be confused with the planning anywhere else you think it happens.
     
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  3. 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. Its purpose is to prevent nonconformities, including nonconforming outputs, and to determine opportunities that might enhance customer satisfaction or achieve an organization’s quality objectives."

    That would mean - we should Plan for the Processes.

    There are at least two types of planning i.e. Strategic and Operational according to ISO/TC 176/SC 2/N 1283. See their earlier presentation below:
    upload_2018-1-5_19-10-59.png

    Clause 6.1.1 covers both types of planning. The actions to address risks/opportunities determined through the use of planning tools such as SWOT (for strategic level) or Risk Registers/FMEA (for operational level) should be incorporated into the processes as per 6.1.2b.1 and be implemented as per 8.1.
     
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  4. Qualmx

    Qualmx Well-Known Member

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    Thanks Tony and Andy,it is clear now.
     
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