ISO 9001 7.6a Calibration and Traceability


Q: ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements, clause 7.6a states, in part:

“Where necessary to ensure valid results, measuring equipment shall

a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international standards or national measurement standards…”

Does this sub clause require that the calibration process be performed in accordance with international or national calibration procedures? Or does it require that the measurement standards (hardware) used for calibration be traceable to international or national measurement standards (hardware)?

A: The standard is clear that it is the traceability of the calibration standards they are looking for.

Note: By definition, the traceability needs to eventually lead to an accredited lab who will be following procedures such as those set forth in ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories.

 Your internal calibration processes can best be guided by acquiring a copy of ANSI/NCSL Z540.3.

I hope this helped answer your questions.

Bud Salsbury
ASQ Senior Member, CQT, CQI

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Measure for Measure: Improved Gage R&R Measurement Studies, Quality Progress

Back to Basics: Assessing Failure — The effect of faulty measurement on previously produced products, Quality Progress

The Prediction Properties of Classical and Inverse Regression for the Simple Linear Calibration Problem, Journal of Quality Technology

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