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New to ISO 9001? What frustrates you about the standard?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Andy Nichols, Oct 15, 2020.

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  1. John C. Abnet

    John C. Abnet Well-Known Member

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    Welcome to the site @Bruce Brannon . Assuming the "ISO" you are referring to is 9001, then here are your answers...

    1-What written procedures are required? -NONE
    2-In what form must they be written? - ANY
    3-How extensive must the Quality Manual be, and is a Quality statement required? - A quality manual is NOT required. A quality policy IS.

    As @Eric Twiname noted, you should own the standard and be familiar with it. These answers are all in there (i.e. if it does not state "it" is required, then it is not).

    Hope this helps.
    Be well.
     
    John C. Abnet, Dec 28, 2020
    #41
    tony s and Andy Nichols like this.
  2. Eric Twiname

    Eric Twiname Well-Known Member

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    ask yourself every day..."Does it say "shall"...

    Quality Policy: "Make money doing things right." works fine...BTDT...
     
    Eric Twiname, Dec 28, 2020
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The answers you seek are IN the standard! When people ask what's "required" the simplistic answer is the standard doesn't specify any, but it still REQUIRES your organization to determine what needs to be defined in some form of documented information. So, if you understand section 4, then you might identify the there are interested parties and they might need/expect a level of documentation. Often customers will want you to document your processes, even if you don't (or that standard is mute)

    The standard has never defined a form(at) for documents. Never, ever.

    See above on the Quality Manual. I'm not sure what you mean by a Quality "statement", but a documented policy IS required (it's IN the standard)
     
    Andy Nichols, Dec 28, 2020
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    But isn't compliant with the ISO 9001:2015 requirements, however...
     
    Andy Nichols, Dec 28, 2020
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  5. Eric Twiname

    Eric Twiname Well-Known Member

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    Show me the shall...please.
     
    Eric Twiname, Dec 29, 2020
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It says "includes a commitment to..." and goes on to mention "complying with requirements" and "continual improvement" (working from memory here, so forgive not using the EXACT words)
     
    Andy Nichols, Dec 29, 2020
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  7. Eric Twiname

    Eric Twiname Well-Known Member

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    Well perhaps another item on this appropriate "what frustrates you" thread then...not me frustrated, but perhaps you...toward the auditors who passed it...
    "Make money doing things right"

    The Quality Policy is 5.2
    5.2.1a. is appropriateness to purpose and content...covered by "doing it right"
    5.2.1b. is a framework for setting objectives...covered, "Does this fit our view today of right, will it make money?"
    etc. etc.

    I've seen more vague policies than what I reference as an example of how simple it can be.

    End of the day, I still don't know why 5.2 is even in the standard..."Scope" already covers what you intend to do, 5.2 is a meaningless exercise for compliance IMO.
     
    Eric Twiname, Dec 30, 2020
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, and no. Quality objectives are not financial objectives. Sure, you can make money, but I've seen margins so huge - for bizarre reasons - that the idea of setting and achieving a 90%+ FTC objective was missed and products were scrapped... There are such things as "loss leaders" where there is no profit. Some processes cannot achieve a high yield, and there may not be much in it, which drives the need for continual improvement of the process. Don't forget that ISO 9001 is a literal one size fits all and you cannot "spin" it to simply suit your circumstances as a justification why it shouldn't be done by others.

    All that means is poor policies exist and auditors buy into that.

    Scope is nothing to do with policy. Not all organizations have the same policy when it comes to quality and satisfying customers. It's actually a very good discussion point for top management. I have no idea what your implementation experience is Eric, however, I regularly encounter companies which have never had their feet put to the fire over a quality policy and as a result there are many issues which affect day-to-day operations because they never considered it. If it's not considered correctly and the result is a trite statement like "meet and exceed customers' expectations", then good luck meeting THAT!
     
    Last edited: Dec 30, 2020
    Andy Nichols, Dec 30, 2020
    #48
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