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Management Review acc. to ISO9001:2015 - example

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

  1. Kristof

    Kristof Member

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    Hello All,

    I'm busy with Management Review acc. to ISO9001:2015.

    Can you tell me or give me an example how this report should looks like?

    Thank You in advance.

    Gr. Kristof
     
  2. Qualmx

    Qualmx Well-Known Member

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    Do a simple spreadsheet with a header,mentioning line by line every clause the standard require, having space to write down how you comply the standard, that's all
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's very difficult to do - it depends on too many factors. You know what the expected ou puts are and what the inputs are, from a review of the requirements. What are you thinking you need? Did you do a review according to 2008?
     
  4. The PPAP Assassin

    The PPAP Assassin Active Member

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    Look at the sub-clauses (9.3.2) & (9.3.3) They tell you everything you need to discuss. Make a power point presentation and for each item they want you to "take into consideration" create a page and elaborate on it. Include documents like corrective action, calibration, & internal audit logs. It's quite simple really if you have followed all the other requirements of the standard.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    And, in doing so, may have missed the point...
     
  6. RoxaneB

    RoxaneB Moderator Staff Member

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    This may sound like a crazy idea, but why not see what leadership already does that could be considered "management review." For example, in my experience, organizations have "operations review" on a fairly regular basis where they discuss things like metrics results, what they might need to do to get back on track, requirements (e.g., resources, technology, etc.), anticipated changes coming their way, and so. Sounds rather "management review"-ish to me. My own take is that creating a separate meeting with it's own presentation or spreadsheet adds little value and simply perpetuates the feeling that "we're doing this only because the requirement says so." The development and sustainability of a QMS is so much easier if you first determine how the standard fits YOU rather than changing yourself to fit it.
     
  7. Golfman25

    Golfman25 Well-Known Member

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    That's it exactly. In all but the most disfunctional businesses "management review" is already going on. You just have to capture it and maybe add some elements that the standard requires.
     
  8. tony s

    tony s Well-Known Member

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    I agree with RoxaneB and Golfman25. The management review should not be treated as another kind of meeting. Organizations can integrate the specified inputs to already existing meetings. Actually, ISO 9001 clause 5.1.1c wants the top management to demonstrate leadership by ensuring integration. See below statement:

    Top management shall demonstrate leadership and commitment with respect to the quality
    management system by:
    c) ensuring the integration of the quality management system requirements into the organization’s
    business processes;

    ISO/TS 9002:2016 - Quality management system - Guidelines for the application of ISO 9001:2015 (with the equivalent clause), clarifies the intention of the above requirement with the statements below:

    Each organization has different needs and its own specific solution that will be decided by top
    management. It is important for top management to ensure that the organization’s quality management
    system processes are integrated with its business processes.
    For ISO 9001:2015[28], 5.1.1, bullets a) to j), this includes:
    c) ensuring that the organization’s quality management system processes are integrated and managed
    within its overall business processes, and not treated as “add‐on” or conflicting activities;

    ISO/TS 9002 clause 9.3.1 (last paragraph) gives additional guidance as stated below:

    The timing of management reviews can be scheduled to coincide with other business activities (e.g.
    strategic planning, business planning, annual meetings, operations meetings, other management
    system standards’ reviews) to add value and to avoid redundant multiple meetings.
     
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  9. RoxaneB

    RoxaneB Moderator Staff Member

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    This doesn't sound like Management Review to me, but rather a table-top gap analysis.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    How do you intend to perform your review? That is key. Can you get all the process owners in a meeting? That is, IMHO, the most effective, IF they come prepared to present on THEIR process performance to the objectives and goals set for the performance of their process, plus the status of any actions to be/being taken to improve or correct the performance. This is then balanced by the results of internal audits - which are there to (independently) confirm that the results are BECAUSE the documented QMS is being implemented as described, by the people. This is what an effective Management Review looks like.

    What's YOUR plan for the review?
     
  11. Serious Man

    Serious Man Active Member

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    INPUTS
    1. Audit results show that organization follows own procedures.
    2. Performance results show that goals are achieved.
    OUTPUTS
    1 Revise organizational procedures to increase process efficiency keeping still process effectiveness on a expected level.

    INPUTS
    1. Audit results show that organization follows own procedures.
    2. Performance results show that goals were not achieved.
    OUTPUTS
    1 Revise organizational procedures to achieve expected process effectiveness level.

    INPUTS
    1. Audit results show that organization doesn't follow own procedures.
    2. Performance results show that goals aren't achieved.
    OUTPUTS
    1 Improve personnel competence/awareness/motivation to ensure, that procedures are followed.

    INPUTS
    1. Audit results show that organization doesn't follow own procedures.
    2. Performance results show that goals are achieved.
    OUTPUTS
    1 Live that dream.

    Questioning own management system is time consuming, therefore it has to be performed occasionally.
    Reporting process performance is "quick", so it can be done more frequently
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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  13. RoxaneB

    RoxaneB Moderator Staff Member

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    I would argue that the input is not "performance results show that goals are/were not achieved", but quite simply "performance results to target". Even then, just because something was achieved does not mean that it is perfect - a discussion can be held on tightening the targets, raising the bar/process expectations. Just because something was NOT achieved, does not mean that the system is flawed - there could be other variables and sometimes we need to accept that these variables are outside of our control or sphere of influence.

    I would argue that personnel are not the reason why procedures aren't followed and results not achieved. Does the organization provide the correct resource to enable process conformance and target achievement? Resources = people, technology, tools, hardware/software, systems, etc.

    I would argue that if results are achieved but procedures are not followed, then an organization either needs to consider their documented system and materials and processes OR change their targets (maybe they have non-value-add targets in place).
     
    Last edited: Aug 23, 2018
  14. Serious Man

    Serious Man Active Member

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    We are in ACT stage, where all CHECK activities were performed and results are available.
    Now it has to be decided what is direction of next PLAN stage - correct or improve?
    Then in PLAN stage we will change current procedures or targets or resources to achieve targets or maybe improve already achieved.

    I would suggest to look on management review from outputs side.

    I've presented only four simplest theoretical scenarios.
    Sorry latest one is practical. Pure miracle.

    You need to have proper approach and then in life you will find different scenarios.
    Poor results could be caused by various reasons, but intention of standard is firstly questionate own procedures (way of performing organizational activities).
    First, management shall ask themselves "Were we right?" and then look elsewhere for reasons why results were poor.
    Anyone willing to say "I was wrong." ?
    I don't see, as expected.
     
  15. Steve Evans

    Steve Evans New Member

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    Following on from Serious Mans' reply regarding inputs and outputs , all data from your audit , this information is then populated into your management report

    We use a spreadsheet to summarise the inputs and outputs and the audits are scored against the expectations of the business in each area/ branch

    All important elements of business requirements and the QMS are scored individually in our audit checklist ( see attached scoring )

    there is a expectation to achieve a ' Green ' overall result for each branch against our business requirements and those laid out in the QMS - Green = 100 - 86 % , Amber = 85 - 71% , Red < 71 %

    These results are then detailed into the spreadsheet attached

    This is just a flavour , but you may have already decided how you are going to do it

    I have to ensure for the management, the report is written in a manner they can understand , so does not contain a lot of ISO speak and they only want to understand areas of concern , risks and what they need to do as the business leaders to help us fix and major concerns in the business
     

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    Last edited: Aug 28, 2018
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  16. Kristof

    Kristof Member

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    Hello everyone,

    Thank You for all the feedback.

    Could someone explain me clause 9.3.2? -> Changes in external issues that are relevant to the QMS & Changes in internal issues that are relevant to the QMS

    What does mean?

    Thank You for responses.

    Gr. Kristof
     
  17. Artem

    Artem Member

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    Hi Kristof

    Basically - this is about making sure that changes in environment, market, Regulation,etc (external ones) as well as changes in processes, infrastructure, etc (internal) are handled. In each process you there shall be a circuit which is activated when an alternated input is provided (be it a new customer requirement, a new law, a new employee, etc). Some of the changes are supposed to be a normal part or a process as it is designed (new ingredients in formulation, a new machine operator). However there are some „significant“ changes which may impact the fundamentals of the business and correspondingly - QMS (your main market is under embargo as of x-mas, or you have a new CEO) - those require review and most probably additional resources (which are provided by the top management). Some pictures from me in the attachment
     

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  18. Kristof

    Kristof Member

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    Thank You Artem.

    Now is clear.

    Have a nice day.

    Gr. Kristof
     

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