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Making ISO 9001 work for you

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Mauricio Vega, May 14, 2016.

  1. Mauricio Vega

    Mauricio Vega New Member

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    For those who might be thinking or actively pursuing ISO 9001 certification, I thought I would provide my own perspective on the subject, particularly on the more challenging requirements of the 2015 edition. I have attached a paper which I completed a few months ago that might help those struggling with the assignment. I hope you find it useful.
     

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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Is this paper based on your practical experience of implementation, Mauricio? It helps to know if it is. Perhaps you can add some background. For example, you make some strong comments about CB auditors, How many have you actually had experience of? In which country? Which CB? An IAF accredited one? All this information is good background on which to understand your perspective...
     
  3. Mauricio Vega

    Mauricio Vega New Member

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    Glad to oblige, Andy. I have been involved in the Quality busines for almost twenty years, as a practitioner at IBM (manufacturing, software development), a certified Lead Assesor (I.R.C.A.) working for SGS and a consultant to medium and small businesses for the last ten years. I'm on my third assignment advising my clients in the upgrade effort to ISO 9001:2015. My strong comments, as you call them, derive from personal experience. There are some excellent ones that are prepared to explore the client experience and follow logical and systematic audit trails. Many others that prefer to follow the standard verbatim using ISOspeak terms; some types spend their audit time cloistered in the executive meeting room and never venture to where the action is. I have personally tasted all flavors.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm glad to hear about your experience. However, your comments on page 15 appear to throw ALL CB auditors under the same bus - for those coming new to ISO 9001 (and certification) - and it can be read as if your experience is typical therefore, for ALL CB auditors. I can assure you that while some do what you describe, they are in the minority in my experience. Let's also not forget that there are plenty of people who give inaccurate advice etc on the standard - but everyone expects every auditor to magically "know" the requirements perfectly! Experience of a (small) handful presents an unfair picture.

    Another observation, you seem to be discussing the implementation of ISO 9001:2015 and the benefits in the same breath as being certified - they aren't the same, are they? For example, you comments about the Internal Audits include commentary on CB Audits - there's nothing in the standard about CB audits/auditors. Since your paper isn't simply related to the use of ISO 9001, why not re-title the paper to include Certification as well?
     
  5. Mauricio Vega

    Mauricio Vega New Member

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    Andy, on the subject of CB auditors, we agree to disagree.

    Certification is not necessary to maintain an effective QMS. There are a vast number of companies in the planet that excel without ISO certification. Those who, either voluntarily or contractually compelled, are seeking registration should try to maximize the benefits inherent in ISO 9001 by developing effective methods and practices. ISO tells you what is required, not how it's to be implemented.

    My reference to certification audits in the Internal Audit section was to make the point that this activity is a primary function of the QMS, with the CB audit being complementary to their in-house efforts. I am well aware certification audits are not a requirement of ISO 9001; my piece neither implied nor suggest anything of the sort.

    As for the title of my piece, my objective was to provide some guidance on how to take advantage of the principles of the Standard when developing a QMS and feel it's appropriate.
     
  6. Eric Twiname

    Eric Twiname Well-Known Member

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    Pretty nicely done.

    The one area I would suggest expanding on on examples of wasted time or straightjackets.
    Those who paint themselves into corners typically do not know they are doing it.
    If this text is geared to avoid popular mistakes in this area...describe a number of the popular mistakes, and how they may be handled differently.
    Terminology like "Quality System" can be daunting if a person comes in with their own pre-conceived notions...and we all do come in that way.

    Examples are a powerful teaching tool. HTH
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That was my point.
     

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