ISO 13485 NIST Traceability requirements for calibration of test equipment

[Raffy]

Hi
I am quite new to the requirements of ISO13485:2003.
One of our medical devices supplier is ISO13485 Certified in UK.
One of their scope is calibration of test equipment. They are the OEM of the said medical devices and falls under test equipment.
My concern is NIST Traceability not required for calibration of medical devices since they are ISO13485 Certified? Is it acceptable that a medical device calibration not traceable to a national/international standard as long as you are ISO13485 certified? Please advice.
Thank you very much in advance.
Best regards,
Raffy

 

[Stijloor]

A Quick Bump!

Can someone help Raffy? Thank you very much!

 

[BradM]

Hello Raffy!

If I understand what you're asking, you have a supplier that calibrates instruments for you. This supplier is certified within ISO13485, but the calibrations that are performed are not traceable to a national standard.

To my knowledge, if the calibration standard does not maintain traceability to a national standard/ SI unit, it's not a calibration.

That activity may be referred to as some kind of verification or performance check. But if there is no traceability, it's not a suitable standard for calibration.

 

[howste]

One of their scope is calibration of test equipment. They are the OEM of the said medical devices and falls under test equipment.

If their scope includes calibration of their product under ISO 13485, then they must have traceability to national/international standards. Here's what ISO 13485 says:

Where necessary to ensure valid results, measuring equipment shall a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards.... Records of the results of calibration and verification shall be maintained.

My concern is NIST Traceability not required for calibration of medical devices since they are ISO13485 Certified? Is it acceptable that a medical device calibration not traceable to a national/international standard as long as you are ISO13485 certified? Please advice.

Per the above, traceable devices must be used, and they must maintain records. However, ISO 13485 does not require them to provide those records to YOU.

What does your purchasing information (PO or contract) specify to the supplier? These are the legal agreements between you and your suppliers. If your purchase order only specifies the product (without documentation) then they aren't required to provide the traceability information. If your PO specifies that they must provide traceability documentation, then they have to provide it.

I know many companies that will provide traceability information for an added cost. This needs to be negotiated BEFORE you buy. If you have the product without the traceability, then you may have to calibrate it yourself.