Archive for June 4th, 2009
What Has To Be Calibrated: ISO 9001
Measuring and test equipment that has an effect on the product/service you supply to your customer must be objectively verified and calibrated (where possible) so that the degree of measurement uncertainty is known. Devices used to “demonstrate conformance to requirements” must be “controlled and calibrated.
The further away a measurement device is, in the process, from the product/service, the less critical this is. If a measurement is worth doing, it’s worth doing with a device that you can have confidence in because it’s been objectively verified.
It is not necessarily required that this be done by a third party. If you have internal capability and certified / traceable measurement equipment to calibrate with, you can do it yourself. All such calibrations need to be traceable to national / international standards. For example, if you have hand held measurement tools (calipers, micrometers), you can calibrate them with a set of certified gauge blocks. This reduces the need for external calibration.
Calibration / verification of test equipment is a huge and target rich environment for ISO 9001 audits. Make sure your system is up to snuff and covers all of the equipment (and all the requirements in 7.6). Make sure there are work instructions covering calibration of equipment that you verify in-house.