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QMS as a preventive tool

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Leonid, Aug 16, 2016.

  1. Leonid

    Leonid Well-Known Member

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    “One of the key purposes of a quality management system is to act as a preventive tool” (quoted from ISO 9001:2015 Appendix Section A4). This conclusion is applicable not only to the new 2015 version in context of risk based thinking. A wider perception is that the QMS requirements, as such, have intrinsically borne a preventive character and their mandatory fulfillment have always provided prevention of negative effects should these requirements have not been fulfilled. As a confirmation of the above-said, ISO 9001:2015 cl 4.3 and ISO 9001:2008 cl.1.2 require that the exclusions from the standard have not affected the organization’s ability to achieve the intended results. In this respect, the elements of the standard represent the factors of the organization’s context to ISO 9001:2015 cl.4.1. If these elements are not executed to the standard requirements a risk to achieving the conformity of products and services and the enhancement of customer satisfaction would appear. To summarize, the organization’s actions to establish, implement, maintain and improve the QMS can be interpreted as a proactive response to particular risks. Particular actions through risk based thinking will be within the scope and intentions of relevant standard’s elements.
     
  2. RoxaneB

    RoxaneB Moderator Staff Member

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    Is there a point or a question here? With all due respect, there are a lot of big words and citations in that paragraph and your intent/message is lost on me (and English is my first language).
     
  3. normzone

    normzone Well-Known Member

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    I think he said " if you're doing it, then you're doing it ".

    o_O
     
  4. Leonid

    Leonid Well-Known Member

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    Implications are as follows:
    1. Once the fulfillment of a particular QMS/standard requirement ensures prevention of relevant negative effects this suggests that related risks are defined and addressed (6.1).
    2. QMS requirements belong to particular standard elements which, due to the above-said, define the organization's context factors which can afftect the achievement of intended results (4.1).
    Risks are mostly addressed just by maintaining the QMS to 9k requirements. For instance, contracting a new outsource is identified as a risk. To address it, requirements of cl.8.4 are to be applied anyway. But the certified organization shall have the element 8.4 duly maintained. Thus, the QMS requirements are proactive and bear a prevention character.
     
  5. RoxaneB

    RoxaneB Moderator Staff Member

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    So, to be clear, concise AND articulate, you are giving your perspective on an undeclared aspect of ISO 9001:2015. If I had to guess, you are attempting to say that ISO 9001 is, by its very nature, risk management.

    I still don't know what you are attempting to do. Are you asking a question, Leonid? Are you attempting to create a discussion? Are you asking for our opinions? Are you asking for our critique of your written words? We really can't do much unless we understand WHY you posted this.

    If I posted "The sky is blue", people would be asking the same questions. Am I asking for confirmation that the sky is blue? Am I asking for a discussion on the various shades of blue? To create a post and provide no context is confusing and we are uncertain how to respond beyond "What are you asking?".
     
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  6. Leonid

    Leonid Well-Known Member

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    “QMS as a preventive tool” is a new, not talked-up subject and I just wanted to share my view on it with the Forum. The 2000/2008/2015 versions point out that non-fulfillment of requirements of standard elements (factors of context per se) can affect the organization’s ability to achieve the intended results. Any certified organization maintains the QMS to prevent risks of deviation from the standard requirements (addressing risk per se). Existing documented information may provide evidence of risk-based thinking to the 2015 version. ISO 9001 is, indeed, a part of risk management with regard to quality.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I don't agree with this at all. In fact, it's been a long held understanding, going back to the very first versions of the various supplier QA requirements on which ISO 9001 was (ultimately) based. When I implemented NATO AQAP 1 it was UNDERSTOOD by NATO's SHAPE organization to be a preventive measure! I don't know when you came to "ISO", but I and many of my peers have known this for a long time - being "talked up" is because it's understood not needing hype...
     
    Last edited: Aug 18, 2016
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  8. RoxaneB

    RoxaneB Moderator Staff Member

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    Like Andy, I disagree about the "new, not talked-up" status of the subject - if you do a search here in QFO for "preventive", "preventative" and "risk", you'll see a lot of conversation on the topic. However, to take it a step further, I also disagree with "Any certified organization maintains the QMS to prevent risks of deviation from the standard requirements." Considering ISO 9001 is pseudo-voluntary standard, organizations pursue either because it will gain new business or maintain existing business, with the added bonus of standardizing (and possibly creating) their management system activities. The level to which they maintain their management system is what separates the "just a piece of paper on the wall" organizations from the platinum performers.

    When ISO 9001 was first issued, as long as an organization was producing consistent product, that's all that mattered. It could have been consistent crap (i.e., failed to meet Customer requirements) and an organization could still manage to attain certification. Over time, the standard has evolved to include the consideration of meeting customer and other statutory/regulatory requirements, plus the evaluation of these efforts, but again, this is not done because an organization (at least a benchmark one) wishes to avoid a nonconformance associated to deviating from the requirements. An organization that understand the value of a best practices, standardized system designs and develops processes that support their ability to meet customer and statutory/regulatory requirements, while adding value to the organization...a smart organization examines how ISO 9001 can fit its processes, not the other way around.

    Naturally, "non-fulfillment of standard elements...can affect the organization's ability to achieve the intended results". We all know this. However, I think of "results" in terms of value - I'm more concerned with process results, meeting Customer and regulatory/mandatory requirements, quality of product/service, adding something positive to the organization, reducing waste. I don't consider certification to be a "result"...it's really just the icing on my management system cake.
     
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  9. Pondo

    Pondo Member

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