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Measuring Equipment

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Guest Created:   Nov 09, 2022 Last commented:   Nov 11, 2022

Measuring Equipment

Hello,

is the definition of the measuring equipment in ISO 9000 applicable for ISO 13485?

“Measuring equipment” is defined in ISO 9000 as “measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process”.

Could you elaborate on what type of equipment we must take in consideration during the implementation process?

Thanks.

 

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ISO 13485 DOCUMENTATION TOOLKIT

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Nov 10, 2022

Yes, the definition regarding measuring equipment is the same in ISO 13485 and ISO 9001. 

Measuring equipment can be scales, thermometers, pressure meters,  equipment for measuring length, pH meters, and so on, so anything that you use in your production that is necessary to define some characteristic, or for the medical device or for the environment. 

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Guest Nov 10, 2022

In case the production is outsourced,  do we need to get the info from the manufacturer itself? Or this requirement is for "in-house" equipment?

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Kristina Zvonar Brkić Nov 11, 2022

If your production is outsourced, you need to have information on which measuring equipment is used for the production, quality control, and storage of your medical device and definitively you need to have proof that that equipment is regularly calibrated (you need to see the calibration certificates). 
Usually, you will check this during the audit that you will conduct on your outsourced production. 

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Nov 09, 2022

Nov 11, 2022