ISO 13485--Question regarding performing calibrations in house.

duff999

Quite Involved in Discussions
Regarding calibrations for laboratory equipment - currently we use an outside vendor to perform calibrations on our laboratory equipment. Would we have the opportunity to perform these calibrations in house, and not use our service provider, if we are using our own calibrated equipment to verify the instruments are working within specifications. I didn't know if this be scrutinized under an ISO13485 audit.

Any advice would be appreciated.
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
Regarding calibrations for laboratory equipment - currently we use an outside vendor to perform calibrations on our laboratory equipment. Would we have the opportunity to perform these calibrations in house, and not use our service provider, if we are using our own calibrated equipment to verify the instruments are working within specifications. I didn't know if this be scrutinized under an ISO13485 audit.

Any advice would be appreciated.

Good day @duff999 ;
The first prompt I would give is to consider the type of equipment being considered and whether you are truly describing calibrating (or possibly verification). These are significantly different. The reason I ask is because you are mentioning " ...using our own calibrated equipment to verify if instruments are working...."

By "...our own calibrated equipment..." are you for to equipment which has undergone "your own" internal calibration?...or equipment calibrated by a commercial lab?

Maybe you could provide us with a scenario/example so we can better assist.

Be well.
 

ScottK

Not out of the crisis
Leader
Super Moderator
It would absolutely be scrutinized in an ISO 13485 audit. I have been there.
They'd want to see the qualifications of the people performing the calibration, calibration logs, calibration of your calibration master equipment, traceability of your standards, etc.
 

AuditFan

Retired
if we are using our own calibrated equipment to verify the instruments are working within specifications.
Do you have the resources to perform calibrations? Typically, the resolution/discrimination is 10:1 better than the items under test. You have such equipment? You have the people with the technical understanding/abilities to perform the calibrations and to determine the measurement uncertainties etc.?
 

Tidge

Trusted Information Resource
There is (in my experience) a LOT of administrative overhead with performing "in-house" calibrations. It is perfectly reasonable to perform calibrations in-house, but as the nature of the calibrations becomes more diverse the overhead increases in complexity. Some elements that will have to be considered and controlled:
  • The in-house calibration standards (e.g. gauge blocks) need to be traceable to national standards.
  • The in-house calibration standards need to be isolated (controlled) such that their status isn't jeopardized (between their own periods of re-checking)
  • The calibration methodologies used need to be applicable, current, and appropriately executed. You aren't obligated to use industry-accepted calibration practices, but if you do not... you will be required to have done test method validation (supported appropriately by valid study designs) on the non-standard validation practices.
Years ago I had some accountability for calibration of (rather simple, mostly mechanical) metrological equipment. This was rather straightforward, but even so it was time-consuming. We also had many electromechanical (and purely electrical) measurement devices that were MUCH more of a PITA to establish calibration for. We were maintaining membership in far too many (for my taste) standards organizations, in addition to the effort of maintaining a dedicated calibration lab that I wouldn't quickly recommend this approach to anyone who has alternatives. I feel like I got quite a bit out of my time on the various metrology committees, but mileage varies.
 

duff999

Quite Involved in Discussions
Good day @duff999 ;
The first prompt I would give is to consider the type of equipment being considered and whether you are truly describing calibrating (or possibly verification). These are significantly different. The reason I ask is because you are mentioning " ...using our own calibrated equipment to verify if instruments are working...."

By "...our own calibrated equipment..." are you for to equipment which has undergone "your own" internal calibration?...or equipment calibrated by a commercial lab?

Maybe you could provide us with a scenario/example so we can better assist.

Be well.
Thanks for your feedback. For "our own calibrated equipment" I meant we send these devices (Fluke multimeter, tachometer, calibrated weight set) out for calibration to a service provider. We would then want to use these devices to perform calibration checks on scales, balances and small laboratory equipment, rather than having an outside firm come in and perform calibration services. For larger pieces of equipment I would still want an outside service provider to perform this service for us. I didn't know how much this would be scrutinized in an audit. It seems, by reading further posts, that this might not be the best practice.
 

ScottK

Not out of the crisis
Leader
Super Moderator
Thanks for your feedback. For "our own calibrated equipment" I meant we send these devices (Fluke multimeter, tachometer, calibrated weight set) out for calibration to a service provider. We would then want to use these devices to perform calibration checks on scales, balances and small laboratory equipment, rather than having an outside firm come in and perform calibration services. For larger pieces of equipment I would still want an outside service provider to perform this service for us. I didn't know how much this would be scrutinized in an audit. It seems, by reading further posts, that this might not be the best practice.

Sure, I've done this dozens of times in different industries - so you're verifying calibration with these, not performing calibration... that's a significant difference in the level of training you need for your people. Just make sure you keep records of the checks, keep the standards in calibration and traceable, and have a process for what to do if something if found to be out of calibration.

This is a perfectly acceptable practice and I've done it with different kinds of equipment at just about every job I've had in multiple industries.
 

duff999

Quite Involved in Discussions
Thanks again for your response. It seems like we would only be verifying calibration from what I described. This would not allow me to update the calibration status (sticker and update asset register)since I am only verifying?
 

ScottK

Not out of the crisis
Leader
Super Moderator
Thanks again for your response. It seems like we would only be verifying calibration from what I described. This would not allow me to update the calibration status (sticker and update asset register)since I am only verifying?

Yes - Verification is done between calibrations at an interval that you would set.
For Example: At my last job where dispense amount was a critical characteristic of a pump, as measured in grams of DI water per cycle, I generally did scales daily and kept a log book by every scale. The operators were trained to do the check. The test weights were replaced every year as it was cheaper than having them calibrated outside. And the logs were audited regularly.
Then annually an outside contractor would do a full service and re-calibration on-site.
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
Sure, I've done this dozens of times in different industries - so you're verifying calibration with these, not performing calibration... that's a significant difference in the level of training you need for your people. Just make sure you keep records of the checks, keep the standards in calibration and traceable, and have a process for what to do if something if found to be out of calibration.

This is a perfectly acceptable practice and I've done it with different kinds of equipment at just about every job I've had in multiple industries.

@duff999 ...
What @ScottK said...

Be well.
 
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