To Calibrate or Not to Calibrate Devices in ISO9001:2000

One recent consulting gig was done at a company that wanted to have the ISO9001:2000 certificate, but wasn’t too thrilled at the prospect of actually doing everything needed to actually implement an ISO9001 quality management system. Unfortunately there are far too many companies like this out in the world.

One major area of concern was calibrating the company’s measuring equipment. They have about 50 employees, and over 100 various gauges and test equipment that you’d think would need to be calibrated. You’d think so, but the company quality manager didn’t.

About 20 of the measuring devices were used in the inspection department, and the rest used by production people in the course of their job. The quality manager wanted to control and calibrate only the devices in the inspection department, and label the rest “for reference only”. The reason given for this is that only the inspection department devices are actually used to sign off the various processes. The production devices are only used for “monitoring”, and to get the piece “in the ballpark”. No nonconforming material could make it to the customer without a final inspection by the inspection department, so no problem there. The worst thing that could happen is that a small number of products might be made out of tolerance and would have to be reworked, or produced again.

This didn’t fly with me.

It seemed that they had way too many guages in the company, many of which were rarely or never used. The “for reference only” argument doesn’t make sense to me. I see it as a pretty much black-or-white issue. Either the measurement matters, and you calibrate the equipment, or the measurement does not matter, and you should not make it. Why complicate things if the measurement doesn’t matter? What value is added to your process by performing measurements with out-of-calibration instruments? Not much.

My advice- if there’s value added by performing a measurement, then do it right and calibrate your equipment. If you don’t think a particular measurement is important enough to warrant regular calibration of your device, then I’d say you ought to seriously consider deleting that measurement from your process.

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2 Responses to “To Calibrate or Not to Calibrate Devices in ISO9001:2000”

  1. Paul R. says:

    I agree with you in principal and your rational is correct.
    Your conclusion that this would be the requirement of the standard is not correct.
    I have passed 3 tough ISO-9000-2000 AS9100 RevB audits with the system suggested by the companies “Quality Manager”.
    (1 recertification audit, 1 surveillance audit, and one NAVAIR audit not to mention constant DCMA inspections.)
    My only minor finding was I had posted signs to indicate calibration status and the auditors insisted on actual stickers on each piece of “equipment”.
    I was a skeptic of this style systems ability to pass an audit because I had inherited it.
    I come from two different calibrate the paper clips industries Medical and Aerospace and never would have believed an auditor would have let this type of system pass.
    I would guess that from ISO’s view point that you are supposed to have your process in control and if your product passes final inspection and your customer’s happy they are happy too.
    Don’t forget that if your process starts making junk your corrective action system should flag this condition and an honest root cause analyses will highlight the fact that there is a calibration issue that need to be addressed.

  2. Ed Bones says:

    From a reading of the above it appears that nobody in the discussion has taken the trouble to read the standard. ISO9001:2000 section 7.6.

    The Organisation shall determine…
    The Organisation shall establish processes…
    Where necessary to ensure valid results, measuring equipment shall be calibrated or verified…..

    Any reasonably competant auditor would examine the evidence for the effectiveness of the established process and base his/her decision on the outcome. Its called evidence based auditing. Anything else is opinion based.

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