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Building a new QMS and/or Calibration system from scratch.

Hello Everyone,

I get to help bootstrap an ISO 9001:2015 compliant, (with an eye towards possibly certified), QMS. We currently have only some ad hoc procedures in place that our many individuals with major automotive manufacturing backgrounds have brought with them. We do not at this time have a Quality Manual. I would greatly appreciate any templates, tips, tricks, words of wisdom or derision you care to share.

We are going to purcahse the official ISO 9001:2015 document. Are there any accompanying ISO docs that we will also need?

Where does one begin to create a Quality Manual? (Why recreate the wheel?)

In addition to helping create a Quality Manual, I am going to be overseeing the creation/implementation of a Gauge Tracking/Calibration/Certification system. We currently do not have anything in place. Aside from our main metrology tools, only a few 'hand tools' recently purchased are still covered by the certification they shipped with, but the vast majority are out of calibration.

Can we designate most of that stuff as 'ref only' under ISO 9001:2015?

Or should we plan to get rid of anything we can not calibrate/certify?

What Gauge Tracking software do you like or dislike and why?

Is anyone just using Excel and storing associated documents in folders by Gauge number? Any problems from auditors about doing it this way.

We as a company are also looking into software to track and plan maintenance needs. It has been suggested here we could make such a platform do double duty by treating each Gauge as an Asset. If anyone is using a single software for both Gauges and Maint, please tell me about it.

From an economic and logistical stand point it seems our best option would be to get/keep our main metrology tools certified/calibrated (CMM, Surface Plate, Optical Comparator, CTS Leak Tester, Torque Wrenches/guns, Hardness Tester, etc.), and some 'master' artifacts like gauge blocks and rings, then do all the small stuff in house, (gauge pins, calipers, micrometers, etc.)

What do you do?

Do you think a Super Micrometer or the like is necessary?

I could use some resources for planning a system, advice on calibration stickers, pitfalls to avoid before an auditor finds them, etc.
One of our engineers has suggested we consider hiring a contractor for calibration/NIST traceable. (Trescal)

We have several devices and fixtures we have custom designed for our manufacturing line. We will need to develop work instructions and pass/fail criterial for all of those.

Thanks in advance for sharing your lessons learned.

tl;dr - If you had the opportunity to build a new ISO 9001:2015 quality or calibration system/department what would your bullet points be?
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  • I have little input, but I mise'well share.

    We use Microsoft Access to keep track of gages, calibration dates, emailing notifications, etc.
    I'm not sure who, but somebody I've never met programmed a custom Access database that stores all of the relevant information, such as the gage, type, location, relevant calibration dates, contact info, etc.
    It's kind of cool, because it can be easily (relatively speaking) customized to fit any application, add/remove items and queries, set up visual representations of whatever crap, blah blah.
    It's quite unprofessional,and as clunky as the guy made it.
    BUT
    If you happen to know a guy, maybe they can get a better set up programmed. It's all VBA, AFAIK, and not intrinsically difficult to add new items and queries, if you have the time.

    I would probably recommend something more professional, but it does work, it's cloud based so anyone can access it from wherever, you can set up custom dashboards and the like.. There are pros and cons to every situation, obviously.

    We also happen to use Access for our rejection database, so anyone with access can go in, fill out a form, save & email it to the relevant departments with a button click.
    Our particular set up is quite inefficient, but that's us; I guarantee this idea taken with a grain of salt can be implemented successfully.

    I don't know much about ISO, but AFAIK they don't necessarily set a standard; they look to you to set a standard for yourself that both you and they can understand and implement, and they just make sure it's implemented and it works for your company.
    As long as you can set something up, it doesn't necessarily matter about professionalism or how much $$$ you spent on the latest and greatest software no one can understand.
    .02
Reply
  • I have little input, but I mise'well share.

    We use Microsoft Access to keep track of gages, calibration dates, emailing notifications, etc.
    I'm not sure who, but somebody I've never met programmed a custom Access database that stores all of the relevant information, such as the gage, type, location, relevant calibration dates, contact info, etc.
    It's kind of cool, because it can be easily (relatively speaking) customized to fit any application, add/remove items and queries, set up visual representations of whatever crap, blah blah.
    It's quite unprofessional,and as clunky as the guy made it.
    BUT
    If you happen to know a guy, maybe they can get a better set up programmed. It's all VBA, AFAIK, and not intrinsically difficult to add new items and queries, if you have the time.

    I would probably recommend something more professional, but it does work, it's cloud based so anyone can access it from wherever, you can set up custom dashboards and the like.. There are pros and cons to every situation, obviously.

    We also happen to use Access for our rejection database, so anyone with access can go in, fill out a form, save & email it to the relevant departments with a button click.
    Our particular set up is quite inefficient, but that's us; I guarantee this idea taken with a grain of salt can be implemented successfully.

    I don't know much about ISO, but AFAIK they don't necessarily set a standard; they look to you to set a standard for yourself that both you and they can understand and implement, and they just make sure it's implemented and it works for your company.
    As long as you can set something up, it doesn't necessarily matter about professionalism or how much $$$ you spent on the latest and greatest software no one can understand.
    .02
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