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Differences between 6.1 vs 10 (9001:2015)?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Sep 13, 2018.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi all
    I want to know if opportunities in 6.1 have other purpose compared to clause 10
    in respect to improvements?
    If there are no differences, why is mentioned in both?
    I suppose would it be better just be mentioned in clause 10, because is
    in a global coverage.

    Please advice
    Thanks
     
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  2. Brian Beasley

    Brian Beasley New Member

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    I believe 6.1.1 wants to know how you plan to achieve improvement (using risks and opportunities), and 10.3 wants to see evidence (achieve quality objectives? Action items from management reviews).
     
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  3. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Opportunities in 6.1 may be external, as in setting up a relationship with an area technical college to help students for entry level positions to address the risk of losing intellectual capital from retirements. 10.3 is for improvements within the organization's own system.
     
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  4. Qualmx

    Qualmx Well-Known Member

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    W
    Would it be valid to state that opportunities detected in 6.1 are always external opportunities?, while improvements (10.3) are internal? Both are improvements to the system,
     
  5. Artem

    Artem Member

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    Hi I have drawn you a small ppt to show the difference. Sorry for the quality - have some problems with my laptop.
    Basically 6.1 grows out of the global context of the organization and is in general an external input into QMS at its planning stage (plan) while needs and opportunities at 10.3 are results of monitoring and measurement of existing QMS (act)
     

    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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  6. tony s

    tony s Well-Known Member

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    Identifying "opportunities" in clauses 6.1 and 10 have common expectations, which are:
    • to enhance desirable effects;
    • to enhance customer satisfaction;
    • to improve products and services;
    • to improve the quality management system and its processes;
    • to improve performance and effectiveness;
    • to improve suitability, adequacy, etc.
    However, the timing and intentions are different. One is when an organization is "planning" for its system and processes while another is when an organization is "checking and acting" on its system and processes.
     
  7. Qualmx

    Qualmx Well-Known Member

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    Thanks Tonys
    When You say "planning' you mean when a system is being setup for the first time? the starting of a qms? Or could exist planning while a system is running ?
    On the other hand, why in 6.1 requests to ensure effectiveness and not so in clause 10?
    Could you help me in Clarify?
    Thanks
     
  8. tony s

    tony s Well-Known Member

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    Both. Typically, on a periodical basis e.g. annually, organization plans for their processes and operations. Planning can also happen when changes on the organization are needed.
    According to 6.1.2 "The organization shall PLAN...how to evaluate the effectiveness...". That's why it is stated in clause 6 - PLANNING. The actual conduct of the evaluation, as specified in the standard, happens at clause 9 - PERFORMANCE EVALUATION.
     
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  9. Qualmx

    Qualmx Well-Known Member

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    Thanks Tonys
    Maybe I didn't explain clearly.
    Why in 6.1 requires to ensure effectiveness and in 10.3 (continual improvement) doesn't require the effectiveness?
    Thanks
     
  10. tony s

    tony s Well-Known Member

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    Effectiveness of what? Clause 10 mentions "effectiveness" several times:
    • improving the performance and effectiveness of the quality management system (10.1c);
    • review the effectiveness of any corrective action taken (10.2.1d);
    • The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system (10.3).
     
  11. Qualmx

    Qualmx Well-Known Member

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    I refer to this:
    If in 6.1 opportunities (which is improvement) the standard requires to evaluate effectiveness of actions, while in 10, 10.3 don't specifically require to evaluate effectiveness of improvements (which in my point of view are also actions).
    Thanks
     
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  12. tony s

    tony s Well-Known Member

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    The standard is structured using the PDCA cycle.
    PLAN - 6.1 requires the organization to plan how to evaluate effectiveness of the actions to address risks/opportunities;
    DO - 8.1 requires to implement the actions determined in 6.1;
    CHECK - 9.1, 9.3 requires to evaluate and review effectiveness of the actions;
    ACT - 10.2.1 prescribes that when we take corrective actions, we need to update risks/opportunities. Then in 10.3, through the outputs of the management review, says that we have to determine opportunities in order to continually improve. Then we go back to PLAN. Thus, there's no need to require evaluation of effectiveness again.​
     
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  13. BufferMess

    BufferMess Member

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    Hello. 'Opportunity' defined in clause 6.1 is somewhat different from clause 10.3. Although both are proactive measurements, the one in clause 6.1 is basically taking benefits from organization's changing environment. On the other hand, clause 10.3 requires you to determine internal opportunities (by considering the results of analysis, evaluation and management review) for continual improvement. The reason for this is to have a full control over an opportunity determined for continual improvement.

    Note that you must still plan actions for opportunities detected during analysis and evaluation phase. This is required to complete the PDCA cycle.
     
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  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    No, opportunities can be external or internal.

    When we improve our system we may be acting on an opportunity, or simply want to add efficiency or reduce errors (could be both).
     
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  15. BufferMess

    BufferMess Member

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    Perfect explanation reflecting clear difference between the two.
     
  16. BufferMess

    BufferMess Member

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    Consider an example like this...

    1. I have to cross the road to reach the opposite side in a shortest possible time. To accomplish this, I've to take risk since there is traffic on the road. ----> Risks (according to Clause 6.1)

    2. I'll keep waiting beside the road. When there are no cars approaching, I'll cross the road. ----> Opportunities (according to Clause 6.1)

    3. While crossing the road, I'll measure width of the road ;) and the time I spent to complete it. I'll later analyse the data, evaluate and seek a better solution. What if I use the time waiting for the traffic to ease, plus time for crossing the road, for a footbridge only 50 meters away? ----> Opportunities (according to Clause 10.3)

    In the first situation, you're taking risk.
    In the second situation, you're trying to take advantage of your changing environment (which is not under your control).
    In the third situation, you're trying to improve your operation (which is under your control).
     
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