ISO 17025 and Design/Process Control Requirements

M

Mark M. Sweeny

#1
Hello.

My company is working with a vendor that designs, manufacturers and calibrates thermometers. My company uses this vendor to store blood samples that are used for clinical trial.

During the vendor qualification, we learned that the vendor had 17025 registration.

However, from my limited knowledge of 17025, it doesn't include design or process controls unlike ISO 9001 or 13485.

Here is my questions.

Is 17025 sufficient for a vendor that designs and manufacturers equipment?

Thanks,

Mark
 
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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#2
Generally, a manufacturer will have ISO9001 for the design and manufacture, as that standard is better suited for that function.

That this one is accredited to ISO/IEC 17025:2005 is completely appropriate for the calibration of the thermometers prior to shipment or storage.

However, ISO/IEC 17025 does require control of processes, documentation, oversight by management, and all other clauses of ISO9001 that are applicable under the ISO/IEC 17025 standard. That is why an accredited lab does not also need registration.
 
A

Allasm

#3
That this one is accredited to ISO/IEC 17025:2005 is completely appropriate for the calibration of the thermometers prior to shipment or storage.

However, ISO/IEC 17025 does require control of processes, documentation, oversight by management, and all other clauses of ISO9001 that are applicable under the ISO/IEC 17025 standard. That is why an accredited lab does not also need registration.
I agree with harshal here, your vendor need ISO 17025 for his lab which do calibration activities for the thermometers, as this part of the scope of 17025, but the scope is not covering design/process control requirements; outside the premises of the their laboratory where ISO 9001 does.

So if your vendor will have the two ISO Std 9001 & 17025 then it s a credit for them.


regards
 
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