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.
A LOT of companies will take the ISO standard & re-write it word for word and will call that their manual. The only difference between the standard and their Quality Manual would be substituting their company name where it says "The Organization". This is totally fine as long as you practice what you preach.

We are going to purcahse the official ISO 9001:2015 document. Are there any accompanying ISO docs that we will also need?
No. Unless you want to get into aerospace or med device manufacturing. AS9100 (aerospace) and ISO 13485 (med) are the ISO 9001 standard verbatim with extra clauses added & written in bold in that are specific to those industries. IF you bought AS9100 for example...you could just ignore the bold stuff for now because all of the plain the would be the ISO stuff but would have the benefit of knowing you have the aerospace standard for future use should you decide to grow more into that industry.

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

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. awesome!

Can we designate most of that stuff as 'ref only' under ISO 9001:2015? NO!!!! You must establish, document, implement, and maintain a procedure that is ISO compliant with regard to your monitoring and measuring equipment. All equipment used to measure product MUST be controlled. Once you start playing in the big leagues you have to control, identify, as well as track your gaging.

Or should we plan to get rid of anything we can not calibrate/certify? Thats up to you. If you have a piece of measurement equipment that you'd like to keep around but isn't going to be used to measure product (meaning you don't want it in your system), then it should be identified as such. A lot of companies will designate such equipment as "reference only".

What Gauge Tracking software do you like or dislike and why? gagetrak is pretty sweet

Is anyone just using Excel and storing associated documents in folders by Gauge number? Any problems from auditors about doing it this way. I've done it in the past. It works. As long as the system you set up is established, documented, implemented, and maintained... and can be explained to the auditor... then there will be no issue. I find this method of gage control to be cumbersome. There are relatively inexpensive softwares available that do a better job then excel but to each their own I suppose.

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. Start looking into getting a proper ERP. Excel is the cheap and at first comfortable way to go..but as you grow you need something that will grow with you and not hold the company back.

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.) Yes. Do this. We have an expensive set of blocks that we send out to calibration and then use those for all calipers, mics, layout equipment, etc...

What do you do? See above

Do you think a Super Micrometer or the like is necessary? If you're making parts that require that level of accuracy, heck yes. I have multiple super mics and we use them every day.

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) I am not sure what your engineer is talking about. NIST is an organization that writes standards that are then used to calibrate things in our industry. Every calibration house I use will utilize NIST traceable standards and those will be listed on our cal certs....

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. agreed.

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?

I also use a "self made" standard*, to follow the cmm rotations / linear defects.

Is that the one patented by someone having the same name as you?