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9.3 Management review

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by OFDOBAIDI, Feb 14, 2018.

  1. OFDOBAIDI

    OFDOBAIDI Member

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    Hi,

    During the external audit, the auditor cloud not find any evidence regarding the following:



    9.3 Management review
    9.3.2 Management review inputs
    The management review shall be planned and carried out taking into consideration:
    3) process performance and conformity of products and services;


    The auditor will consider it as a NCR.

    Any feedback please?
     
    OFDOBAIDI, Feb 14, 2018
    #1
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, it is an nc! One of the basic reasons for doing a management review is to consider if products and processes are working! I'm amazed that you would have an audit without these basic things.
     
    Andy Nichols, Feb 14, 2018
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  3. Qualmx

    Qualmx Well-Known Member

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    Yes it is , this is showing kpis of processes and nonconformances found in products and services.
     
    Qualmx, Feb 14, 2018
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  4. Che Promubol

    Che Promubol Member

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    Im certain you will have what the auditor is asking.. perhaps you just dont know?!

    Management review is one of many things these meetings can be called. In general, or my approach is like this - it is the scheduled meeting between the MD, Process Owners and the person who has overall responsibility for the Management System - and Organisational freedom, of which where the performance of the business can be reviewed.
     
    Che Promubol, Feb 14, 2018
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    John C. Abnet likes this.
  5. tony s

    tony s Well-Known Member

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    My approach in satisfying this specific requirement is by integrating it with 9.3.2c.2 - "the extent to which quality objectives have been met". When I establish the quality objectives, I need to make sure that the requirements in 6.2.1 is adequately satisfied i.e. "The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system". So, each process has quality objectives. Then, since there's a requirement that quality objectives must be measurable, I will need to identify "performance indicators" relevant to the quality objectives for each process (see also 4.4.1c). Thus, when we review our quality objectives, we are also reviewing the process performance thru the performance indicators. You can also satisfy 9.3.2c.5 since you need to monitor and measure your set performance indicators. It's like killing three birds with one stone:cool:
     
    tony s, Feb 19, 2018
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    OFDOBAIDI likes this.
  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    9.3(c)(3) says "process performance and conformity of products and services" but you described including 'kpis of processes and nonconformances found in products and services."

    6.2.1 says "The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system." Which functions, levels and processes does your QMS have that are not relevant? What about receiving? What about shipping? What about procurement/purchasing? What about control of documentation? What about design (if you do it)? What about inspection and calibration? All of these, as processes, are expected to also have KPIs that management review; they contribute to product/service quality.

    Additional contributing procecces, however not necessarily direct, include:
    • Planning
    • Human resources and Training
    • Maintenance
    • Customer processes, including complaints and corrective action
    • Internal audit, corrective action
    • Management review
    Are these relevant?
     
    Jennifer Kirley, Feb 20, 2018
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    OFDOBAIDI likes this.
  7. OFDOBAIDI

    OFDOBAIDI Member

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    Do you mean that the quality objectives will be on processes level, not on QMS level?
     
    OFDOBAIDI, Feb 21, 2018
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  8. tony s

    tony s Well-Known Member

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    That's my take for this statement (see 6.2.1) "The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system". But organizations can have objectives at the corporate level, department level, even down to the individual level.

    ISO 9000:2015 definition of "objective" has Notes to entry:
    • "An objective can be strategic, tactical, or operational."
    • "Objectives can relate to different disciplines (such as financial, health and safety, and environmental objectives) and can apply at different levels (such as strategic, organization-wide, project, product and process".
    ​
     
    tony s, Feb 21, 2018
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    OFDOBAIDI likes this.