The release of ISO 9001:2015 has many companies reevaluating how they do business. Why? While inherent in every business model, the concept of Risk-based thinking now requires a more articulated approach to measure inputs and outputs.
So, where does calibration fit in Risk-based thinking and where is calibration mentioned in ISO 9001:2015?
If you are struggling with Calibration as a risk management approach then you might want to read:
ISO 9001:2015 is focused on Risk-based thinking. Calibration is intrinsic in Risk-based thinking in1.3.3, Inputs and Outputs in 4.4.1, the necessary Infrastructure to accomplish this in 7.1.3, measurement traceability in 220.127.116.11(the actual word calibration is mentioned) and performance Evaluation in 9.1 just to name a few.
It is highly unlikely that risk can be managed without a calibration program. In fact ISO 9001:2015 when viewed holistically requires more attention to your calibration program. It is no longer enough to just "calibrate" equipment and process, you now must actually use the data provided to determine if it is appropriate to your Risk Policy.
We have written several articles that help explain some of the terms used in calibration to help you as a consumer make better informed purchases and decisions about calibration and what the data is telling you.
Choosing the proper Measurement and Test Equipment(MTE) has always required an understanding of instrument resolution and tolerance and measurement uncertainty. The methods and criteria used for the selection of Measurement and Test Equipment is threaded everywhere in ISO 9001:2015 as part of risk based thinking.
A sticker and a certificate/report are not adequate. You must read the calibration report/certificate and make fit for use conclusions looking at all contributors to risk. We see this as a challenge for many companies so we will continue to write articles that explain all these terms.
Don't know where to start? Download our calibration checklist.
Visit our International Standards used in Calibration page for more on standards used in calibration.