Control of Monitoring and Measuring Devices in an ISO9001:2000 Quality Management System

In chapter 7 of the ISO9001:2000 quality standard there is a requirement that you control devices you use for monitoring or measuring your product. Like so many parts of the ISO quality standard, you have a fair amount of flexibility in how you accomplish this.

First of all you should determine if you actually have monitoring and measuring devices. You might not. If, for example, you are a distributor of automotive distributor caps, and all you do is receive and ship boxes of distributor caps, this section of ISO probably does not apply to you. It is perfectly fine to claim you are exempt from this section of the ISO9001:2000 standard, as long as it’s true. If all you’re doing is visually verifying part numbers, and counting quantities, then you should make a note in your ISO quality manual that this section does not apply to you. However, be warned that if an auditor finds a calipers or a micrometer in your facility, you could have some explaining to do. If you’re going to exclude the “control of monitoring and measuring devices” section of ISO, then it would be best to make sure such devices are not to be found on your premises.

You may also be able to exclude individual devices, but again you’d better have a really good reason for doing so. One company I worked with has a company owner who rarely participates in the business, leaving the company operation to his partner. This owner still comes into the office each day, but works on personal projects that have nothing to do with the company. He’s a gadget freak, too, and has lots of cool little tools laying around. Again, his personal tools have nothing to do with the company, but they are on the premises and would certainly arouse the curiosity of an auditor.

What we did in this case was specifically exclude the owner’s personal tools and devices. We also had to label the devices as “uncontrolled” and instruct everyone in the company not to use those devices. It was an unusual situation, but it worked out fine.

The ISO standard states that “where necessary” your measuring and monitoring equipment must be periodically checked and calibrated to verify accuracy of your measurements. ISO gives you the flexibility to decide for yourself what kind of calibration is necessary, and how often. On one end of the spectrum, a yardstick is a measuring device that most likely does not need periodic calibrating. On the other end, a micrometer should probably be calibrated at least annually.

Calibration of measuring devices should be done by qualified technicians, and records must be kept. If a measuring device is found to be out of calibration, you should take steps to ensure that products measured with that device are rechecked. In extreme cases you may wish to consider a recall of products that already shipped.

ISO wants you to calibrate your measuring devices against measurement standards traceable to national or international measurement standards. If, however, there are no such standards for what you’re measuring, you must have records of what basis you use for calibrating your devices.

You should be able to quickly identify the calibration status of all measuring devices in your organization. A label on each device is usually sufficient.

More on this later.

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