What risk to cover when NOT using ISO 17025 accredited/certified labs for calibration

#1
Hello All,

Working in production of medical devices we do assembly of purchased subcomponents (to our design).
For this we do the occasional measurment during production. We have our internal master maesurement devices that are calibrated/verified by external labs and we use these verified master tools to verify our own tools. (With our own procedure for that)
Sometimes there are discussions on what we need from certification point of view for our laboratories that calibrate these tools.
Of course the ISO 17025 jumps in immediately.

However we notice that on a lot of the calibration reports the companies confirm that they work according to the ISO 17025 but do not mention they are accreddited or certified (most of they are I believe) so in the past we have had some discussions on the subject. To have them certified according ISO 17025 there will be more costs for the calibratio certificates.

What we can or cannot do basically comes down to what risks there are in using labs that work according but not accredited.

I would like your oppinions in this how we can make a thourough risk analysis that we can be sure we are within the expectations of our field.

The only uncertain aspect might be for incoming goods inspection where we confirm the quality of the delivered products with these measurement devices.
Thanks for your help in this.
 
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#2
Hello All,

Working in production of medical devices we do assembly of purchased subcomponents (to our design).
For this we do the occasional measurment during production. We have our internal master maesurement devices that are calibrated/verified by external labs and we use these verified master tools to verify our own tools. (With our own procedure for that)
Sometimes there are discussions on what we need from certification point of view for our laboratories that calibrate these tools.
Of course the ISO 17025 jumps in immediately.

However we notice that on a lot of the calibration reports the companies confirm that they work according to the ISO 17025 but do not mention they are accreddited or certified (most of they are I believe) so in the past we have had some discussions on the subject. To have them certified according ISO 17025 there will be more costs for the calibratio certificates.

What we can or cannot do basically comes down to what risks there are in using labs that work according but not accredited.

I would like your oppinions in this how we can make a thourough risk analysis that we can be sure we are within the expectations of our field.

The only uncertain aspect might be for incoming goods inspection where we confirm the quality of the delivered products with these measurement devices.
Thanks for your help in this.
Good day Janthero;
As you seem to be aware, there is no requirement in ISO 13485 to utilize laboratories that are accredited (FYI...the term "certification" does not apply to such labs. The correct term for ISO 17025 is indeed 'accreditation') to ISO 17025.

There is, however, the requirement ..."against measurement standards traceable to international or national measurement standards"

I would council that you clearly define the requirements your organization (also considering your customers), NEEDS to mitigate any risks associated with calibration and then hold your organization nd the providers accountable to those requirements.

Also, ensure any calibration service requirements applicable regulatory governance of your organization may specify.

Hope this helps.
Be well.
 

dwperron

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#4
I can give you an example of where accredited calibrations can make a difference. It depends on who you need to comply with, who will be auditing you.

I have worked with companies who were seeking UL approval for their products. UL does not require 17025 accreditation of the test and measuring equipment being used, but they are very specific that if you choose not to get accredited calibrations (very different from using a 17025 accredited lab or a 17025 "compliant" lab) then you will need to be able to demonstrate traceability to a National Lab, such as NIST in the United States. That will require you to demonstrate records of all calibrations in the chain from your equipment through every calibration instrument used in each lab for your calibration - including measurement uncertainties - then continuing this process all the way to NIST through every calibration lab involved for every piece of equipment that is part of the reverse traceability for your instruments.
Not impossible, but it can be a daunting task.

If you have 17025 accredited calibrations then it is automatically assumed to have a valid traceability chain back to NIST.
 
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