Guest user Created: Apr 21, 2022 Last commented: Apr 25, 2022

Question on Monitoring and measurement of product

I have a question about section 8.2.6 of ISO 13485, concerning the following: “As appropriate, records shall identify the test equipment used to perform measurement activities.” Exactly how far do we have to satisfy this requirement? Right now all our measuring equipment is listed in our ERP database along with calibration information. But do we have to identify the exact tool used each time a measurement is made on a part? I’m asking as our ERP system doesn’t go into that level of detail: I can list what type of tool to use, but not actually the tool ID used specifically for each measurement.

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Kristina Zvonar Brkić Apr 25, 2022

It is necessary to prove that you have traceability for the calibration process.

There are two possible scenarios:
1. If you are using an accredited laboratory for the calibration, then the certificate of that accredited laboratory will be enough. On that certificate is stated with which etalon calibration is made (ID number of the etalon and certificate number for the etalon).
2. If you are making your own calibration, it means that you need to have some etalon, and that etalon must be also calibrated. Etalon is calibrated also in an external accredited laboratory and with each etalon, you will receive the calibration certificate. When you are performing internal calibration with etalons, you have to record with which etalon you have made it.

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Apr 21, 2022

Apr 25, 2022

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