How to handle suppliers that are not ISO 17025 certified

duff999

Quite Involved in Discussions
#1
Any advice on how to handle suppliers that are not ISO 17025 certified. We have a company we used to perform certification of our fume hoods, they are not certified to the 17025 standard. What type of risk do I run into when being audited for ISO 13485.

Thank you in advance.
 
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dwperron

Trusted Information Resource
#4
Any advice on how to handle suppliers that are not ISO 17025 certified. We have a company we used to perform certification of our fume hoods, they are not certified to the 17025 standard. What type of risk do I run into when being audited for ISO 13485.

Thank you in advance.
Labs are "accredited" to ISO 17025, not certified. That will clear up some issues here.
ISO 13485 does nor specifically state a requirement for ISO 17025 accredited calibrations. Instead, they actually refer to ISO 10012 for guidance. This is where things get squirrelly... In ISO 10012 7.3.2 Traceability there is this guidance:
"Guidance
Traceability is usually achieved through reliable calibration laboratories having their own traceability to
national measurement standards. For example, a laboratory complying with the requirements of
ISO/IEC 17025 could be considered reliable.
"
So it will depend on a few things. If your auditor questions the "reliability" of your calibration provider you can either show that they are 17025 accredited, or you will have to show that the lab is "reliable". Underwriters Laboratories does something very similar to this: they do not demand that you use a 17025 accredited laboratory, but they can instead have you show that the laboratory you do use is "traceable" to NIST or another National Lab - including measurement uncertainties.
Because of this a lot of companies just choose to use a 17025 accredited lab and skip the heartburn.
 

duff999

Quite Involved in Discussions
#5
What does "perform certification" mean?
Thanks for your response. I should have used the word accredited. I was questioned recently if we use suppliers who were not accredited to that standard. I think the thought process is that we start using suppliers who are accredited to this standard. I was trying to determine the risk that I would face if we have used a supplier for are fume hoods who are not.
 

dwperron

Trusted Information Resource
#6
Thanks for your response. I should have used the word accredited. I was questioned recently if we use suppliers who were not accredited to that standard. I think the thought process is that we start using suppliers who are accredited to this standard. I was trying to determine the risk that I would face if we have used a supplier for are fume hoods who are not.
The risk you should normally face would be to be required to get 17025 calibrations in the future. The hope is that they will find your current calibration provider for fume hoods to be acceptable.
 
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