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Complete ISO 9001 Quality Management System documents for free?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by QualityMan, Feb 22, 2019.

  1. QualityMan

    QualityMan Member

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    Hi fellow members of The Quality Forum!

    I am newbie in quality, bus has an education as mechanical engineer. I just joined a small electronics manufacturing company, where I landed a position as Quality Assurance Engineer. My only task so far, is to establish a ISO 9001 quality management system. A super interesting task. I have full buy-in from top management. I am responsible for developing and establishing a quality management system according to ISO 9001. It must be certified this year, in 2019!

    However, I am the driver inside the company, and also the writer-boy. We don't want an external consultant to come and write our system. We want to engage our employees to ensure buy-in and commitment.

    I have been reading a lot of books about ISO 9001, besides the standard. I among others have been skimming ISO 9001:2015 – A complete Guide to Quality Management Systems, Itay Abuhav, ISBN 978-1-4987-3321-2 (very god, but extremely detailed).

    I have visited an other small company, and saw their ISO 9001 system, which was very very light document content wise.

    So, in order to land right on the spot, with a QMS that complies with ISO 9001 requirements, but also is as less bureaucratic as possible, I am looking for free complete examples on a QMS with all documents (overview, procedures etc.) required from section 4. Context of the organisation to 10 improvement.

    I am interested in a version where the sections 4 to 7, and 9-10 from the ISO have been boiled down to ie. 5-7 documents / procedures outlining alle the support process in the QMS. And then some other docuements outlining section 8 operation.

    The only one I have found so far is here https://www.masquality.com/free-iso-9001-2015-documents.html. However, I would like to see other compact examples before, I decide which one to go for.

    Can anyone point me or (give me :)), to where such totally free complete QMS examples can be found?
    Best regards,
    QualityMan
     
  2. Golfman25

    Golfman25 Well-Known Member

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    Frankly I think you're using the wrong approach. Start with what you have. You have something. Cross reference the standard with what you have --- answering the question "how do we comply with section abc?" Then fill in the gaps. You can use examples here and on the web for reference purposes. Personally for documentation purposes I like flowcharts. Good luck.
     
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  3. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @QualityMan and welcome to the site.
    You have received EXTREMELY wise council from @Golfman25
    It is indeed highly unlikely that the organization you joined does not already have established processes, a business scope, identified roles and responsibilities, metrics to analyze performance, etc, etc, etc,....
    It would, therefore, help with your good goal of minimal bureaucracy if you would do as already suggested and reverse engineer what is already established. The goal is not to “establish “ a QMS, but to identify, capture, and sustain what already exists in a manner that serves the organization (first and foremost) in a way that complies with the standard.
    Hope this helps.

    Be well.
     
  4. QualityMan

    QualityMan Member

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    Hi Golfman25 and John,
    Thanks to both of you for replying to my thread.

    I of course agree with you, that the ISO 9001 framework is generic and must be adapted to the specific organisation. And I will start-out by describing our current processes.

    However, I still don't understand why you consider it valuable, to have one or more complete examples, showing how a minimum certifiable ISO 9001 implementation looks like. That will give a lot of good insight for the newbie. It will bring a super foundation, for starting of the work of implemeting an ISO 9001 QMS.
    Let me give you an example. If you are told be make a car, and only have requirements from the state motoring department, regarding what a car must comply with, then it is quite a challenge to build a car! But, if you can get yours hands on one or more cars. Then it gives a very good understanding of what the end goal looks like.

    I found that Advisera.com is selling a complete toolkit, and that they provide both downloadable and online preview of all documents. Se below link. that is quite informative I think. However, it still seems as a bit of big solution. I have the impression that it can be boiled further down, if the company is only link 20 employees.
    I heard that some companies, make a few over all documents describing the support processes, and each document covering multiple sections in the ISO model. So, that section 4-7 and 9-10 are boiled down to just some few documents and the relevant procedures. Then section 8 Operation is of course more large.
    Has, any one seen such QMS, and is able to send me examples of the content of these documents. and furthermore, is it a gain to make the QMS extremely short, and loosing the direct crossreference between the ISO 9001 model and your QMS. At future update time, it will be a challenge to upda the QMS, I guess?

    https://advisera.com/9001academy/is...en&utm_campaign=paid-toolkit-9001-2015-update
    Go to approx. mid page with headline TOOLKIT DOCUMENTS.

    Best regards,
     
  5. RoxaneB

    RoxaneB Moderator Staff Member

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    Free documents are boilerplate at best and are simply a regurgitation of the standard. They probably add little value to helping you develop a QMS beyond giving you an idea on how to structure your own actual documents.

    As for others sharing their own documents, if members here are willing to share, that's great. Others, however, may be hesitant due to proprietary considerations. The higher level steps are probably quite common, but how the steps are applied will vary between organizations. For example - corrective action. Identify issue. Determine root cause. Take action(s) to reduce likelihood of recurrence. That's your process. But the details - tracking mechanism, assigning responsibility, determining triggers for when to do a correction versus corrective action, and so on...well, these are often more organization-specific and make for more pointed conversations here in QFO, not to mention adding more value beyond a simple sharing of procedures.

    To be honest, the idea of documenting what you already do - as already suggested above - is the best first step, in my opinion. This allows EVERYONE to understand the current state of the organization. By then comparing your existing processes to the standard, you can identify gaps and areas that might need some enhancing. This then allows to prioritize and timeline everything out - and shows if your 2019 is a realistic goal.
     
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    A quick look at the stuff at the link you posted tells me these folks don't have much idea and, hence, the old adage "If it's free it has no value", is true... It's far too bureaucratic.

    I've also reviewed the stuff at the other link and it's also inaccurate, suggesting there are more "required" document than the ISO 9001 standard actually states. When such basics are "missed" I wonder what the rest is like...

    Creating documentation isn't that difficult. If you pm me I'll send some examples...
     
  7. Golfman25

    Golfman25 Well-Known Member

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    Because most canned systems are crap. Years ago when we started this, we looked and looked and found most people going way overkill with their systems. We finally found a local guy who put together some "samples" and worked with groups of companies to tailor it to their own company. We used it for years. But as time went by and the standard where updated, we started stripping it down. At the end of the day, it's basically flowcharts of our relevant processes/procedures with commentary as necessary. The important thing wasn't the documentation, but was his approach to the documentation -- Flowcharts, KISS, etc. We can now create our own without "thinking" about it.
     
  8. QualityMan

    QualityMan Member

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    Hi Roxane, Andy and Golfman,
    Thanks for your inputs. I appreciate your advises about how to approach the development of such a QMS.

    Andy: I have sent you a pm.
     

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