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Does the phrase "take into consideration" mandatory?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by tony s, Sep 1, 2016.

  1. Golfman25

    Golfman25 Well-Known Member

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    A lot depends on the size and beauracracy of the organization. Large org with layers of management a formal meeting with an agenda and minutes may make sense. Small organization a simple checklist may suffice. We bring it to every meeting and if we cover something we make a note of it. Drives me crazy when the auditor specifically asks for "minutes" as if they are required. Some auditors have a hard time with it.
     
  2. tony s

    tony s Well-Known Member

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    If there is still time, you can raise an appeal with your CB. This move may not change the result but at least it will send a message to your CB that their auditors need to have well-thought-out judgment.
     
  3. MCW8888

    MCW8888 Well-Known Member

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    The appeal was completed and it was quite a win-win situation.
     
  4. tony s

    tony s Well-Known Member

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    Were you able to overturn the finding?
     
  5. askartsolutions

    askartsolutions Member

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    An interesting discussion. Here is my take on this topic:
    1. The word consideration is used at least 7 times in ISO 9001:2015. Wherever it is used, it is preceded with the word "can" or "shall" in the sentence. In this case the sentence says "shall be planned and carried out taking into consideration". This means all the agenda items must be addressed in the management review.
    2. The review of these agenda items does not have to be done at an exclusive "management review" meeting, but may be spread over several business or operational meetings that a business would normally conduct, as long as they are all covered at least once in a typical business cycle (usually a year). This standard encourages integration of QMS requirements within the overall business of the organization (see clause 5.1.1.c). You run your business to suit your organization.
    3. A member brought up the issue that 9.3.2 does not mention that records be kept. The reason being that every one of the agenda items is covered under a separate clause and each of these clauses require records to be kept. For example, customer satisfaction is covered under clause 9.1.2 where records include customer surveys; warranty claims; market analysis; etc. Quality objectives is covered under clause 6.2.1 and requires documented information. And so on for the other agenda items. There is so much overlap and connectivity in the Standard, so always look for such linkages when in doubt.
    4. What needs to be brought to these meetings (for discussion) are the results of analysis of these agenda items (see clause 9.1.3), including trends (see clause 9.3.2.c) so that top management can make an informed decision on the overall health of the QMS in terms of its suitability, adequacy, effectiveness, etc...(see 9.3.1 general. This follows the the quality management principle under clause 0.2 "evidence based decision-making". You'll find more on these principles in ISO 9000:2015 or the iso.org link I provided in another post relating to records needed under documentation information.
    5. The ISO 9001:2015 has many flaws in terms of terminology, structuring, requirements, etc, but if you put all that aside and examine the "intent and spirit" of the requirements as opposed to the "letter', you can develop effective QMS's that will withstand the scrutiny of any Registrar auditor.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Your last comment has been proven to be somewhat inaccurate! Given the huge variety of interpretations, "intent" is very often lost on CB auditors
     
  7. tony s

    tony s Well-Known Member

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    Or would you say "all the agenda must be taken into consideration". "Address" is different from "taken into consideration".
     
  8. tony s

    tony s Well-Known Member

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    I believe what Chris said was:
    "..and the odd thing is there is no requiremnt to keep any records of that consideration"
     
  9. askartsolutions

    askartsolutions Member

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    Yes, CB auditors interpret requirements in a variety of different ways, because they can get away with it. as most clients don't have in-depth knowledge of the ISO 9001 standard nor the CB rules and regulations to challenge them or just want to get it over and done with. For some of my clients, I have had auditors withdraw their n/c when challenged, because they could not support their interpretation with proper evidence.
    Years ago I was tasked with providing an independent review of a major Registrar's certification and surveillance audit files and I found shortcomings in audit evidence in a significant percentage of n/c's. Their clients just accepted these findings as they had no one to guide them.
     
  10. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Since ISO 9000:2015 does not include a definition of "take into consideration" and we are not referring to ISO 14001:2015, it seems fair to refer to dictionary sources. Many of the online sources I found equated the phrase with "take into account" but Dictionary.com was a bit more nuanced.

    If you want to claim one or more of the input subclauses don't apply to your organization, I would be interested to explore why but I would probably write an action request. It could make a good point for dispute though. I would welcome that, since authoritative guidance is not readily available and we should not be left to get creative with interpretations. Where official guidance falls short, the CBs can address the variation presented in disputes in training and work toward better consistency among the auditors. For this reason I wish more people would file disputes than actually do.

    That said, nothing specifies the venue in which these considerations are to be reviewed. Some with more tactical level detail (like the performance of external providers) could certainly be appropriate in departmental level meeting on a more frequent basis, while summaries and longer trends could be presented to top managers for strategic purposes (should we place a greater emphasis on multi-sourcing or work to develop single-source suppliers?).