AKRAM AL-TAWARAH Biomedical Engineering Manager / Medical Project Manager at Faruk

Medical City
March 28, 2012

Test equipment for medical device need to be calibrated

yearly...sometimes for many reason we cant do that for one
or two test equipment ... need your suggestion
http://www.linkedin.com/grp/post/1268337-104036977
See previous comments

Yuri Tan, P.Eng

I am not sure that it is worth the risk of testing medical devices with uncalibrated test
equipment. The penalties from regulatory agencies may be very severe. Even if you were
not heavily penalized, would the thought that you could be contributing to the harm of
patients be enough to cause you to ensure that you are delivering the highest quality
product possible?
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

March 29, 2012

Dominador, Jr. Garrovillas

Hi Akram.
In doing audits, we just follow the auditing principles and audit standards. We need to
understand first the requirements. For instance, ISO 9001 requirements, we do not ask
specifically for a calibration certificate of certain equipment, what we ask are records of
calibrations being maintained by the organization. In case an organization chooses to use a
calibration service provider, we ask for the evidence usually in records presented by the
service provider. We have to review the records if it complies with the calibration principles,
i.e., the process or method used in calibration is acceptable,the reference materials used in
calibration is traceable to known international or national measurement standards, and the
validity of the calibration results. Linking it to purchasing, you have to ensure that the one
conducting calibration is capable in doing the task.
You can also do internal calibration as long as you have applicable standard method,
controlled environment and calibrated equipment .
Verification is a process of making confirmation that results obtained from your equipment is
still reliable using another equipment measuring the same medium you have tested using
the former. This is considered still traceable to standard as long as the latter was calibrated
to known international or national measuring standard. You may also make verification using
standard/stastical methods, or combination of both
There is no specific form to be used. It will be dependent on the criteria the organization
established in ensuring the reliability of the measuring equipment. Making form will be
dependent on your needs. It depends on the verification process you need to apply. Beside,
presentation of verification data may not need a form. Instead you just make a verification
report as long as it is sufficient to ensure that the equipment after such verification will be
considered reliable (accuracy and precision). You need to consider the number of verification
samples are enough, used of statistical method to back-up your verification results, and the
one doing the verification is capable/ competent in doing such.
Hope above comments help.
March 29, 2012

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

Gill Pasternak Realtor

Hi Akrahm, The issue of calibration intervals, depends mostly on the usage of the
equipment, for example; a vernier in daily use in a machine shop should be calibrated twice
a year, and some times even in shorter intervals (No matter what is the manufacturer's
recommendation) If the same vernier is kept in a closet and used to verify raw material
thickness once in awhile the calibration interval can be totally different.
A small clarification regarding to ISO 9000 and calibrating requirements.
1. Although the calibration interval is determined by yourself, most auditors will not accept
arbitrary extension of calibration interval, their must be a paper work explaining the reason
for the extension (Regarding the equipment stability - not the cost of calibration !!).
1. If any of your equipment could not be calibrated on calibration expiry date (regardless of
the reason) you must record the reason for extending the calibration interval and the

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

Noe Del Bosque, MBA,CHSP

How are you all doing with your processes? And so now you have determined an inspection
cycle, but now you discovered that one of your test equipment devices is out of calibration.
What is your process to going back and determining the amount/number of equipment need
to be rechecked?