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Labeling Instruments with calibration information

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Guest user Created:   Jun 04, 2020 Last commented:   Jun 08, 2020

Labeling Instruments with calibration information

Hello, I was wondering if you could show me in the ISO regs where/if it states that an instrument needs to be labeled with a sticker stating the day it was calibrated and the next time the calibration is due?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jun 05, 2020

In ISO 13485:2016, in requirement 7.6 Control of monitoring and measuring equipment in section c)  is statted that measuring equipment must have identification in order to determine its calibration status. Usually, it is performed by a sticker stating at least when the next calibration needs to be done. 

For more information regarding calibration requirements, please see the following article:

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Guest user Jun 08, 2020

Thank you for getting back to me so quickly and with the specific verbiage.  One more request if it's not too much to ask, please?  That question was specific for calibrating instruments.  Is there any requirement where you have to label an asset with its previous preventive maintenance and it's next PM coming due?

 

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Expert
Kristina Zvonar Brkić Jun 08, 2020

As far as I know, this requirement is from ISO/IEC 17025:2005(en) General requirements for the competence of testing and calibration laboratories.

Since I am not the expert for this standard, for more information please see the following article:

Also, you can see how some of the templates considering maintenance and calibration look like in our toolkit on the following link:

For even more details, you can ask the ISO/IEC 17025 expert here: https://advisera.com/17025academy/free-consultation/

 

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Jun 04, 2020

Jun 08, 2020