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Medical City
March 28, 2012
AKRAM AL-TAWARAH
Yuri ,I appreciate your suggestion and agree with you 100% for production line in
manufacturer companies , but my question related to any service company as - clinical
engineer department in hospital who hav the responsability to make services for all medical
equipment used in hospital - in this case always we have new equipment from known
medical equipment manufacturer companies can be used to be assure for the accuracy of
our test tool or compare it with other new test tool.
Cristopher again thanks for you intervention , I know their is no limitation for calibrated
period or time in ISO 9001 . Only focused in making calibration or verification ,I mention for
one year becuse many of calibration services in Metrology and Calibrated Centers specify
the frequency and expiration date by one year - as Yuri said-.
Yuri , from my knowledge and my experince , it a must to use calibrated test equipment to
make accurate test for your medical equipment since you deal with safety of the patient humanity.
March 28, 2012
Dominador, Jr. Garrovillas
Hi Akram.
Based on your comments above, I think there is a need for a review of all your equipments.
Starting from the basic of reading and understanding equipment manual. The best source of
the frequency for calibration is the manufacturer's recommendationin the manual. And in
some of the equipment manuals, they even provide the calibration/ verification procedure to
be applied. Another is new equipment as per acquired, usually been provided by the
manufacturer with initial calibration records/ results.
In case that you need to calibrate old equipment, verification using the new equipment is
applicable as long as the latter is provided with calibration record showing that it was
traceanbe to known national or international standards.
Setting the frequency of calibration in the absence of manufacturer's recommendation will
be based on other factors like how often you used the equipment, history of calibration of
similar equipment, etc.. It is not the external calibration services providers who will be the
one to set the calibration frequency. They just provide the validity of their services/ warranty
in case you have claims. However based on records, you may set a different calibration
frequency in some of your equipment if you have not seen any changes in the results.
Lastly, if you worry about cost of calibration. There are some equipment in which cost of
calibration is high because of the absence of calibrant for the external calibrator, and
sending it in other countries just to provide you with the service. However service charge
was been added to your cost. In said instance, prior in buying an equipment, this is one
factor we considered. Or probably buy another equipment if the cost of calibration will be
almost equal to the cost of the equipment.
Hope above comments will be of help to you. Regards
March 28, 2012
AKRAM AL-TAWARAH
Dear Dominador
I appreciate all of your all of your ideas ... so when you make quality audit - external audit for any service or manufacture company you may asked for calibration certificate for these
test equipment that calibration in any calibrated center ...what about these test tools not
calibrated , only made verification by its owner ... what kind of form you think will see to
check its verification process is ok.
thanks
AKRAM AL-TAWARAH
Dear Dominador
Thanks for sharing your rich point for this topic.
April 6, 2012
Jack Fletcher
Along with Christopher's caution on long calibration intervals.... you can use the "precalibration" data from equipment coming in for calibration to determine acceptable intervals
based on your equipment's use risk tolerance.
April 12, 2012
AKRAM AL-TAWARAH
thanks jack ... Here we can say many factors effect in calibration interval either
manufacturer recommendation , calibration history or reliability of your test equipment .......
for yearly budget proposal many company assume 1-year calibration is the best interval
So, I think the best and important point is to search for possible long interval that eliminate
failed of calibration .
April 12, 2012
verification you did. In case you don't record it seems that the QMS doesn't work.
Gill Pasternak
Quality Services North America
April 12, 2012