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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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  • Wes, so your company is not ISO 9001 certified. ISO 9001:2015 is the easiest of all certifications to get and you can implement it yourself or bootstrap it but I would not advise it. Hire a firm to set it up for the whole company. ISO is not a quality function alone, its a management system.
    I hate that people refer to it as a Quality Manual like it is only part of Quality Control but it is not. It is in actuality a Quality Management Manual which encompasses the whole company from upper Business Management, purchasing, shipping and receiving, maintenance, HR, every department including Quality.

    We are right now stepping from ISO 9001 ( which is the easiest accreditation you can get) up to ISO/TS 16949:2009 which allows us to do aerospace and international and its a pain in the *** and it really is at least 1 person job to keep it going let alone to set it up. Sure you can do the quality department side but not the whole thing.

    ​

    The ISO 9001:2015 standard requires your organization address seven key areas to achieve continual improvement:
    • Context of the organization.
    • Leadership.
    • Planning.
    • Support.
    • Operation.
    • Performance evaluation.
    • Improvement.
    ​As for gage calibration system I use excel for tracking. No one really needs a complicated system to let you know what is due today and tomorrow.
Reply

  • Wes, so your company is not ISO 9001 certified. ISO 9001:2015 is the easiest of all certifications to get and you can implement it yourself or bootstrap it but I would not advise it. Hire a firm to set it up for the whole company. ISO is not a quality function alone, its a management system.
    I hate that people refer to it as a Quality Manual like it is only part of Quality Control but it is not. It is in actuality a Quality Management Manual which encompasses the whole company from upper Business Management, purchasing, shipping and receiving, maintenance, HR, every department including Quality.

    We are right now stepping from ISO 9001 ( which is the easiest accreditation you can get) up to ISO/TS 16949:2009 which allows us to do aerospace and international and its a pain in the *** and it really is at least 1 person job to keep it going let alone to set it up. Sure you can do the quality department side but not the whole thing.

    ​

    The ISO 9001:2015 standard requires your organization address seven key areas to achieve continual improvement:
    • Context of the organization.
    • Leadership.
    • Planning.
    • Support.
    • Operation.
    • Performance evaluation.
    • Improvement.
    ​As for gage calibration system I use excel for tracking. No one really needs a complicated system to let you know what is due today and tomorrow.
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