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

Wes Cisco
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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  • That's a lot O' stuff to work on Wes. I'm not about to break a pinata that size in one swing. (sorry Rudi)
    I will say this. Am not a big fan of Gage Trak.
    Maybe the latest release has improved, but for something critical to keeping one's a-s-s from an auditor's reamer, well... My last 2 companies used it, and it wasn't pretty. Current company uses an older release, so I'll give 'em a mulligan. but last one? Nothing but problems with the cloud crap, crashes, freezes... I could go on. And am talking thousands of gages. My 2 cents.
    The 'Reference Only' idea is good for vises and such. It depends on what you make and how anal audits have been in the past. The 5S stuff has been taken too far sometimes. I can see pencils with Ref Only' in absurd situations.
    Super Mic? Yeah, If you need it.
    Get rid of anything you can't Cal/Cert OR 'Ref Only within reason.
    And everything really depends on who you answer to. In my case? Previous job, we answered to FDA alone. Current one? To customer and FDA.
    And as for the Quality Manual? You're not recreating the wheel. Just documenting your existing one. How detailed you gotta be is the challenge.
    Personally, I see too much hat and not enough cattle when it comes to this topic, but then again, I'm not that high up on the Totem pole...... Sunglasses
    Good luck my friend!
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  • That's a lot O' stuff to work on Wes. I'm not about to break a pinata that size in one swing. (sorry Rudi)
    I will say this. Am not a big fan of Gage Trak.
    Maybe the latest release has improved, but for something critical to keeping one's a-s-s from an auditor's reamer, well... My last 2 companies used it, and it wasn't pretty. Current company uses an older release, so I'll give 'em a mulligan. but last one? Nothing but problems with the cloud crap, crashes, freezes... I could go on. And am talking thousands of gages. My 2 cents.
    The 'Reference Only' idea is good for vises and such. It depends on what you make and how anal audits have been in the past. The 5S stuff has been taken too far sometimes. I can see pencils with Ref Only' in absurd situations.
    Super Mic? Yeah, If you need it.
    Get rid of anything you can't Cal/Cert OR 'Ref Only within reason.
    And everything really depends on who you answer to. In my case? Previous job, we answered to FDA alone. Current one? To customer and FDA.
    And as for the Quality Manual? You're not recreating the wheel. Just documenting your existing one. How detailed you gotta be is the challenge.
    Personally, I see too much hat and not enough cattle when it comes to this topic, but then again, I'm not that high up on the Totem pole...... Sunglasses
    Good luck my friend!
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