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ISO 9001:2015- Is your calibration program ready?

Posted by Phil Wiseman on Mar 18, 2016 9:33:43 PM
Phil Wiseman
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Recently I was in a discussion with several Quality Managers regarding ISO 9001:2015 and the focus on Risk. 

The discussion focused on what tools/techniques people would be using for Risk Assessment, Risk Management and Mitigation. The numbers of tools available is almost limitless and everyone had a good sense of where they were going to focus. There was keen focus on Process and Supplier Management.

What did not come up in the conversation was calibration. So I brought it up.

How are you going to assess your risk from your calibration program, I asked.

What exactly do you mean? Where does calibration introduce risk? We use an accredited Lab.

While I would never discourage anyone from using an ISO 17025 accredited Lab for external calibrations, that alone does NOT mitigate or manage your risk.Bus_Ride_to_audit.jpg

As the end user of calibration, be it internal or external, a sticker and a piece of paper do  nothing to mitigate your risk if you simply file them away and never look at the data. A proper calibration report/certificate has data that must be reviewed:

  • Traceability- physical standards used must have an unbroken chain of traceability through NIST or another NMI(National Metrology Institute) back to the SI Unit.

  • Measurement Uncertainty- it is critical to look at this number as part of your risk management program. Don't measure a gage block with a ruler! The end user of calibration must look at the tolerance of the product being manufactured and determine if Measurement & Test Equipment used is suitable. Take the value recorded on your calibration report/certificate and add/subtract the measurement uncertainty. Is that number good enough for your end use?


  • Flow through Measurement Uncertainty- What are the contributors to measurement uncertainty through your entire process? Draw a process map. What are the critical measurements? Dimensional? Time? Temperature? Vibration? Rotational? Humidity? etc. These contributors must be accounted for as part of your risk management strategy.

We have prepared a Calibration Audit Checklist that can assist you in evaluating your calibration program from a risk perspective. The download would be too large if we covered everything possible, but you should find it valuable in starting your path looking at calibration from a risk perspective.

 Calibration Audit Checklist



Topics: Standards and Compliance

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