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Calibration Management

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How to Properly Use and


Interpret an ISO 17025
Calibration Certi cate
by EDSPONCE with 43 COMMENTS
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Calibration Certificates

As a Calibration Technician, an Equipment Engineer, a QA or just a user of a calibration


certificate, let me ask you below questions:

Q1: Do you know how to interpret a calibration certificate during measurements and/or preventive
maintenance?

Q2: If you receive a newly delivered calibration certificate, what would you do?

Q3: What are the important parts of a calibration certificate we need to fully understand?

Q4: What are the requirements of a calibration certificate based on ISO 17025?

Q5:How can you determine and understand if the instruments you are using are performing as
expected?
In this post, I will share with you the importance of a calibration certificate review, discuss its
true purpose and how to use it properly. I will also explain and answer the questions I listed
above.

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Once you understand its features (I will call it features because of its application), you will
appreciate the importance of a calibration certificate while performing measurements,
preparing for an audit, or just simply evaluating the performance of your measuring
instruments.

I will also share the requirements of a calibration certificate based on ISO 17025 as applied to
an accredited calibration laboratory that every Calibration Technician must know.
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What is an Accredited Calibration Certi cate?


I believe most instrument users are aware of what a calibration certificate is. But I am not sure
if all who uses a measuring instrument with a calibration certificate knows how to read
calibration certificate content.

A calibration certificate is a record of the results of calibration performed on a specific


Instrument or measuring equipment. This is also known as calibration report.
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An accredited calibration certificate has the below information:

1. Issued by an accredited calibration laboratory


2. It has traceability information, these are:
The details of the reference standard used
The measurement results
The estimated measurement uncertainty results
The name of the Higher Lab or Organization where traceability originates (ex: NIST)
3. It has all the elements that I listed below. It complies with the requirements of ISO 17025:2017
under clause 7.8, reporting the results.
4. And of course, it has the logo of the accreditation body.
To ensure that the lab is accredited under ISO 17025, we should have a copy of their
accreditation certificate and scope as evidence that they are accredited.

This is to differentiate it from other non-accredited calibration records where there is no


measurement uncertainty result and with limited information.

These kinds of certificates are just a verification result/record.

Mostly, what I observe in most users (quality personnel, safety officer, or other technicians) is
that they only use the calibration certificate as evidence that the measuring instruments that
they are using are calibrated.

Only a show part for the auditors telling ..“Hey Mr. Auditor, our Instruments are calibrated, we
have here the calibration certificate, we have complied with your requirements”.

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And some technicians, only use the calibration certificate to verify the date and due dates if the
instruments are still within the said calibration date and nothing follows.

Sometimes, calibration certificates are kept directly without reviewing them.

We need to change this habit and start using the calibration certificate for its intended purpose.
Below are the Calibration Certi cates Speci c
Requirements Based on ISO 17025:
A title (calibration certificate).
The name and the Address of the Calibration Laboratory.
Unique identification number of the calibration certificate and the pages until the last
page of the calibration certificate ( an example is a serial number; page 2 of 2).
The name and contact details of the customer.
Identification of the calibration method.

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Example of Method Used to calibrate the Instrument

A description of the condition and identification of item calibrated.


The date of the receipt of the calibrated item and the date of the calibration.
The date of issue of the calibration certificate.
Calibration results and the unit of measurement. (see below table-under correction
or error)
The names, functions, and signature of persons authorizing calibration report.
A statement to the effect that the results relate only to the item calibrated.
Any addtions, deviations or exclusions made during the calibration.
Deviation from the calibration method, and information on specific calibration
conditions such as environmental conditions (an example is a limited calibration).
Where relevant, a statement of conformity with requirements and specification.
The result of the estimated measurement uncertainty of the equipment (see below
sample tables).
Where appropriate and needed opinion and interpretations.
The environmental conditions under which the calibrations were made that have an
influence on the measurement results;

Example of environmental conditions

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evidence that the measurements are traceable to SI units of measurements.

Example of a Traceability statement

Other evidences of traceability that can be seen in the calibration certificate are:

1. The LOGO of the accreditation body


2. Measurement Uncertainty results
3. The details of the reference standard used
4. The Measurement results
Example of Accreditation Body Logo with reference number

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Example of Reference Standard description

Complete details of reference standard used with the


name of the National or International lab who performs
the calibration

A statement specifying that the calibration certificate shall not be reproduced except
in full, without the written approval of the laboratory. (This is usually seen at the bottom
of the certificate.); … What does this mean?
>> It means that the calibration certificate cannot be reproduced (to make another copy) in part only where
some page is missing (in cases where there are multiple pages). Certificates are allowed to be reproduced
considering that it was reproduced with a complete number of pages. This will ensure that the user will get
the complete information, and therefore, proper interpretation of data results. In any case, you want to
reproduce it with one part only (1 page only), ask first for the approval of the laboratory.

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>> To understand easily, let us take the opposite statement, it can be: “The calibration certificate can only be
reproduced in complete pages only.”

an example of remarks regarding the reproduction of a calibration certificate

Clear identification when the results are from a 3rd party or external providers;
If available, the results before and after adjustments;
Opinions and Interpretations if relevant;
Additional information which may be required by a specific method or customers.

We should consider the above list when creating a format for a calibration certificate, following
the requirements above will ensure that all relevant details for a calibration certificate will be
covered.

Their location in the calibration certificate is not the same, some certificates are one-paged
only while others are 2 pages or more. It depends on the measuring instruments being
calibrated.

Furthermore, as per Clause 7.8.1.3, which states that “When agreed with the customer, the
results may be reported in a simplified way”.

Shares This means that some Information stated above can be omitted or not reflected in the
calibration certificate as long as it is agreed with the customers or users. But make sure that
the omitted information is available in the records or raw data.F

What To Do Once You Have Received a Calibration Certi cate?


Definitely, we review them. But what needs to review, or in simple terms, do you know how to
read a calibration certificate? We can use the above list as a checklist when reviewing a
calibration certificate or verify the completeness of a calibration certificate.

If you received a calibration certificate from a calibration laboratory, it should contain the above
list or ensure that it follows the above requirements. More specifically when the calibration
laboratory that we have outsourced is not accredited to ISO 17025.
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If you are under quality or handling calibration, one of your main concerns is to check all the
above requirements of a calibration certificate to verify if complete or properly labeled and
spelled.

One mistake for example, on a serial number, will invalidate the traceability of the instrument,
traceability in a sense that the identification on the specific instrument is lost.

In addition to most details, I want to emphasize the Number 12 in the list above which is the
“Statement of compliance with requirements and specification”.

This should be reviewed immediately to ensure that a newly calibrated instruments have
passed the calibration and are safe or acceptable to use. Below is a sample statement.

There are some cases where you will encounter an “Out of Tolerance” results upon receipt
from the external calibration lab.
By determining this in the first place will prompt you to apply the corrective actions. (please
see below info on how to check the results or data under as found/as left)

If ever you encounter an OOT (Out-of Tolerance) results, one corrective action is to adjust or
reduce the calibration interval. How to perform this? Check out my other post here>> calibration
interval adjustment

What to Inspect in a Calibration Certificate During Measurement


and/or Preventive Maintenance?
Many of the technicians engaged in measurements or preventive maintenance do not check or
review the calibration certificate in terms of the result of calibrations.

They are already confident that the calibrated instruments they use are accurate. This is what I
usually hear, ”My caliper is accurate because this is newly calibrated!”.
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Yes, they are correct at some point, but not always…if this is how you think about calibration
then you are missing something. Not all calibrated instruments are being adjusted during
calibration.

Once a newly calibrated Instruments are received with a calibration certificate, of course, one
must know how to review and interpret the content of the calibration certificate.

This is not just a job of quality personnel (calibration technician) but specifically, the one who
directly uses the instrument, the technician, or the operator.
But if you are a technician or an engineer directly using the instruments, in addition to the
above requirements, concentrate to review on below checkpoints:

As found /as left data


Traceability information
Uncertainty results
Correction/error
Usually, the above contents can be seen on the second page of the calibration certificate, we
commonly call it calibration results (for the traceability details mostly it is on the first page).

How to Use the Calibration Certificate during the Measurement


Process and/or Preventive Maintenance?
We need to determine and understand the calibration certificate on this part as an engineer or
technician simply because it has a significant effect on our measurement process. Most of the
calibration results have what we call a Correction Factor.
To understand better, below is an example:
Correction or Error

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Calibration Results of a digital thermometer showing the correction factor and uncertainty results to be used
during a measurement process.

Based on the figure above, as we observe, there is the column of a correction.


What is a Correction Factor and How to Calculate Correction Factor in calibration results?
When we are measuring temperature, for example at 0 settings using our newly calibrated
thermometer, we notice that at zero points; it has a correction of + 0.035 (where the error is
-0.035).
Therefore, every time that we make a zero-point measurement, our actual value should be
added with a +0.035. The same thing with the other test points.
We call this value a Correction Factor (CF). It is a value that we either add or subtract in the
actual measurement in order to compensate for the error. Correction Factor is the opposite of
Error

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It is simply the difference of STD value and the UUC results. To calculate correction factor, just
subtract the ‘UUC reading’ from the ‘Nominal Value’ (STD-UUC).

Example:
…… Nominal Value = 10.00
…… UUC reading = 9.24
…… Therefore: 10.00 – 9.24 = 0.076, which means that the correction is +0.076

.
This is important if we are targeting a smaller error or implementing a strict tolerance. In this
way, we will ensure that the results we get are the most accurate ones.
The most technician does not use this correction factor because they do not review the certificate
they received or does not know its purpose (luckily if they have a wider tolerance in which correction
does not matter).

They simply use the instruments and knowing that it is already perfect because it is calibrated.
The correction factor is very important in Measuring Instruments or machines that can be
adjusted physically or electronically.
An example of this is during preventive maintenance, once we determine the correction factor,
we can input this on the calibration part or program of the equipment and compensate or
correct the errors.
As found/As Left
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Sample Calibration results of a Multimeter Showing As Found and As Left data.

If you observe the figure above, it has the ‘as found’ and ‘as left’ column. This is the “before
and after” we calibrated the instrument.
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It has no correction but as long as the measurement value lies within the limit, your
measurement is acceptable. The ”As Left” column will be different just in case an adjustment
Shares was done if ever the “As Found” value is outside the limit.
As an engineer or quality personnel, one should check if ever the “as found” to be within the
upper and lower limit. Just in case it is out of this limit, it means that your instrument is “out of
tolerance” before it was calibrated.
By being aware of this information, you can make a proper adjustment and perform corrective
action and assessment to scope up regarding the affected units or parts where these
instruments are used.
To understand more regarding data interpretation, visit my other post >> Differences Between
Accuracy, Error, Tolerance, and Uncertainty in a Calibration Results

Compra ahora

Uncertainty Results and Traceability


One of the ways to determine that we have a traceable calibration is to check that the
calibration results have a computed or estimated measurement uncertainty result.
This will ensure traceability because, during estimation or computation, the accredited
laboratory’s BMC (Best Measurement Capability) is included which they also acquire from a
higher laboratory standard.
What is measurement uncertainty? Measurement uncertainty is a computed range of value,
usually an estimate to quantify the doubt that exists in a certain measurement result of a
specific instrument.
It is the combined effect of the most valid sources of error with a confidence level of 95%.

For example on the measured voltage above, 1 mV is the true value where the
measured or actual value is 1.01 and the uncertainty result is 0.007960 or
(1.01+/-0.007960)mV at a confidence level of 95%
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This means that we are 95% sure that the measured value lies within the limits of 1.00204 to
1.01796 (+/-0.007960) mV. The smaller the uncertainty, the better the accuracy.
With this result or statement, clearly, uncertainty and error are NOT the same.
Where to use this uncertainty results?
In creating a specification to determine the tolerance of a certain instrument, we can use the
uncertainty results as a basis besides the Manufacturers specification.
Uncertainty results are also used during the assessment of compliance to specifications,
included with the tolerance to determine a pass or failed results.
If we are also performing calibration and estimating the uncertainty of measurements (this is
another topic), we will use the uncertainty results as part of our uncertainty budget, a type-B
source of uncertainty computation.
To see the presentation regarding the use of actual uncertainty results, visit my other post
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>> Differences Between Accuracy, Error, Tolerance, and Uncertainty in a Calibration Results
>> 8 Ways How You Can Use the Measurement Uncertainty Reported in a Calibration Certificate

Conclusion
We have determined what is a calibration certificate and its importance in our industry and in
our measurement process. The need to review a calibration certificate and what are the
necessary checkpoints which are based on ISO 17025 requirements are discussed. And
finally, the important requirements to consider for technical personnel in the calibration
certificate when measuring or performing an equipment preventive maintenance are also
presented.
In using a calibration certificate, one must also be familiar with the principles of calibration
through training on calibration awareness.
Thank you for visiting my site, please leave a comment, subscribe and share.
Best Regards,
Edwin

 Calibration Management

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43 Responses

Jerry | Reply

Thank you for this very useful information, additional for ny knowledge.

edsponce | Reply

Hi Jerry,
Your Welcome. I appreciate you liked and learned something
from it.

Best regards,
edsponce
Rakesh | Reply

I learned a lot from all your posts. Thanks for sharing your knowledge with us. And also
please post calibration management of ISO 9001

edsponce | Reply

Hi Rakesh,
Your Welcome and thank you for taking time reading my post.
appreciate that you learned from it. I will consider your
suggestion about Calibration Management for ISO 9001.
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For the moment, if you did not read yet my related post about In-
house calibration, here is the
link..https://calibrationawareness.com/elements-in-
implementing-internal-calibration-laboratory

Best Regards,
Edwin

Rakesh | Reply

Thanks for your reply Edwin, i read the post about in-house calibration, but i would like
to know about external calibration laboratory management. And you mentioned the
temp & humidity limits to be maintain in in-house calibration. Am staying at sea areas
so generally the temp and humidity is very high over here, like 32 deg and 75%rh in
normal days. but at the same time as you said we have to consider the equipment
specifications. so if the temp & humidity values at laboratory are within the limits of
specifications on the equipment, can i carry out the calibration at 32 deg and 75%rh??
and i will mention these environmental conditions on the calibration certificate so if
auditor ask me about that,Then, if i tell him the same reason like those are within the
limits of operational conditions suggested by manufacturer, will the auditor agree for it
or not?? please clear my doubt. because as an external vendor most of the instruments
to be calibrated at on site… so it is very difficult to control the environmental
conditions… hope u will understand my intention.

edsponce | Reply

Hi Rakesh,
Humidity and Temperature is not that big deal for an Electrical or
pressure measurements because they have a wide acceptance
Shares operating range unless it is in a dimensional calibration where
you are using a gauge block and change in temperature is very
critical.
I understand your intentions and I agree to what you have said.
Your concern is how can you answer just in case the auditor will
ask you regarding the environmental conditions outside the
laboratory which is different inside the lab.
The specified humidity and temperature is applicable only inside
the lab because we can control it and it is required by an
international standard. But during on-site calibration, we cannot
control it so the best thing to do is to control or prepare some
quality control procedure before performing field calibrations.
The best question now is, how to we prove that we have an
acceptable calibration even in a different environmental
condition?
In your first question, Yes, you can still carry out and record the
calibrations in that environmental conditions, we are also doing
that. Most of the instruments are best calibrated on the site or
location where they are being used. The highest temperature I
experience while performing a calibration is 46 Deg C.
When the auditor ask you, just prove to the auditor that your
standard is capable to that environmental conditions by having it
documented in your procedure basing it on its specs, I believe
you have a procedure for internal calibration, then you may add
this part.
The most important things to consider like I said is to perform a
quality control procedure, we call it an Intermediate Check or
Functional check. Before you let your standard out of the Lab or
office, perform a functional check,.Just perform a simple
calibration check by measuring a certain value. Then when the
standard will return back to the lab, perform again the same
measurement. Record everything. This is to ensure that the
standard or equipment used is still in tolerance even exposed to
different temperatures and other factor like vibrations while
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performing on-site calibration.
Based on my experience, this is the only thing you need, just
prepare all these documents and all will be fine just in case an
auditor will ask or investigate. And lastly, include in your report or
record the site calibration performed is a request or approved by
your customer.
I hope this helps.
Edwin

Rakesh | Reply

Thanks a lot edwin. You are a great


teacher.
edsponce | Reply

You’re welcome,
happy to help.

best regards,
Edwin

Antony | Reply

Shares
Hi
Thanks for your valuable article it is worth reading
Can you send me how to calculate uncertainty for pressure gauge calibration report
Also Temperature instrument and other process instruments
Antony, antonypallan@gmail.com

edsponce | Reply

Hi Antony,
I am glad you liked my article. What do you mean about uncertainty
calculation, is it how to use the uncertainty result indicated in the calibration
certificate to be used in uncertainty computation or how to calculate
uncertainty of instruments to be displayed in a calibration Certificate?

Best Regards,
Edwin
Antony | Reply

Dear Edwin
How to calculate uncertainty of instruments to be displayed in a calibration certificate
Thanks in advance
Antony

edsponce | Reply

Hi Antony,
Do you have some background about uncertainty computation? for me to
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know how much I can help you about the subject.
Regards,
Edwin

Antony | Reply

I have gone through the papers available in the net.


I want a excel sheet for measured value entries and master
instrument details . The uncertainty result should be displayed in
the calibration report. Our present report does not calculate the
uncertainty component
We are doing calibration of Pressure & Temperature gauges,
Digital Temperature indicators, Pressure & Temperature
Transmitters etc used in Chemical process industries
Regards
Antony
BachNga Le | Reply

Hello
If the certification show 2 points at 0 and 50 C, how could I figure out the correction factor at 32 C?

edsponce | Reply

Hi Bachnga,
Shares Thank you for reading my post.

There are 3 ways you can do to determine the best correction factor, these
are:
1. You can choose the one that is nearer to the value of your test point. In
your example, 32 is nearer to 50, so use the correction factor (CF) for 50.
2. You can perform averaging of the 2 nearest range. For example, 0 has a
CF of 1 and 50 has a CF of 3, add 1 and 3 then get the average (1+3 = 4;
4/2 = 2).
3. If you have so many data results where the correction factor is increasing
with range, use the linear interpolation (many examples if you google ‘linear
interpolation’).

I hope this helps.

Best regards,

Edwin
Rahman | Reply

Hi sir,

I just read your answer as this issue is also my recent concern. A


great article for my reference.
I just want to ask some questions if u don’t mind.

1) Referring to your answer no. 2, after averaging the 2 nearest


range and the answer is 2, at 32c we can use the correction factor
of 2 instead of using the correction factor of 3?

2) May I know which guideline you referred to? Can you show me
or provide me the guideline regarding this issue?

Thanks.

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edsponce | Reply

Hello Rhaman,

You are correct. I am using the averaging


method to determine the best estimate for
evaluating results.

Regarding the reference, as per my


understanding, there is no single answer
for it, it also includes experience and
professional judgment utilizing the results
from statistical methods or techniques.

There are other more detailed references


out there that are not in my awareness but I
will share with you one of my references.
You can use ISO 17025:2017 as a
reference. Below are the requirements
under clause 7.7 :

7.7.1 The laboratory shall have a


procedure for monitoring the validity of
results. The resulting data shall be
recorded in such a way that trends are
detectable and, where practicable,
statistical techniques shall be applied to
review the results.

There are many statistic books and


references that you can find online
regarding this topic.

Shares 2 of the statistical techniques that I usually


use and presented as an example are the
mean or averaging and the linear
interpolation.

You can also check JCGM 100:2008,


Evaluation of measurement data — Guide
to the expression of uncertainty in
measurement.

I hope this helps,

Thank you for reading my posts.


Edwin

Rahman |
Thanks a lot for your
explanation. Keep up your great
sharing. It’s really helpful.

edsponce |

H Rahman,
You are welcome. I
appreciate your
comments.

Thanks for reading


my posts.
Shares Best Regards,
Edwin

Antonio | Reply

Hi Ed,

How about, the test points detailed in the certificate were 0,10, … .100% of range. there was a
correction on 0% test point and 10% test point, your application (user) is at 5% test point for
example, how will you apply the correction factor? is interpolation applicable to all type of
testing/calibration parameters?
edsponce | Reply

Hellow Mr. Antonio,

Yes, it is applicable to all type of testing or calibration. You can perform either
interpolation or average (add the result of 0% and 10% then divide by 2).

Thank you for reading my post.

Edwin

Shares Charlie | Reply

Sir, I just want to ask if this is correct. This is how we apply correction during verification. If our
analyst will weigh a sample of 26 g. Based on cal cert. when weighing a std mass of 26 g there is a
correction of +0.0022 with uncertainty of +_ 0.0008 g. What i told them is that, when they weigh std
mass w/c is 26g during verification, if the reading is withiin 26.0002 (true value of 26g) +_ 0.0008
you have to follow the correction factor w/c is +0.0022 but if out of range you have to apply a new
correction factor w/c is true value – reading of std mass during verification. Is this correct
interpretation sir? Thanks

edsponce | Reply

Hi Charlie,

During verification, you should use a mass with a known value, either a
sample or a standard mass. A standard mass is better.
Now, since the balance has a correction factor of 0.0022, every time you
measure a 26 grams sample, always include (add) the correction in the final
result.

Please see the below presentation if this answers your question.


Given: (example only)
• Std reading (true value) = 26.0002
• Correction Factor = +0.0022 g
• UUC reading (actual value of balance)= 25.9967 g
• Uncertainty = 0.0008g
• Tolerance limit = +/- 0.005g

During verification, your objective or purpose is to check whether the


instrument reading is within the expected tolerance.

First, determine your tolerance (25.9952 to 26.0052)


Shares Second, put the standard mass, the std mass value = 26.0002, this is also
your expected value to be displayed in the balance.

Third, record the actual value displayed which is equal to 25.9967

Fourth, this is the time to add or subtract the correction factor. In this case,
we will add, therefore final value = 25.9989

Finally, compare the final value is within the tolerance.

Other users that do not need a highly accurate result do not include the
correction factor if it is a PASS, but as a good practice to follow, since you
have a correction factor, always include it to give a more accurate result.

Remember that the Correction factor is the result during calibration which is
used to offset the error and therefore should be subtracted (or added) on the
final value of the balance (UUC) results. A correction factor is applied to all
instruments that cannot be adjusted, that is why we use the correction factor
manually.

As per the uncertainty results, this depends on your procedure on how you
use it.
Below are some ways on how to use the uncertainty results:

1. If you are performing measurement uncertainty calculation, this will be


included in your uncertainty budget. (not related to verification)

2. You can use directly as your tolerance for verification.

3. You can include it within the calculation of your process tolerance. For
example, Reference Std tolerance + instrument tolerance + uncertainty
results = total process tolerance

4. Or you can use it to determine a pass or failed results. During


analysis, a passed result means that even if you include the uncertainty
in the results, it should still stay within the tolerance limits (decision rule
as per ISO 17025:2017). See below example (same as above):
UUC reading = 25.9967
Uncertainty results = 0.0008
Shares UCC + correction factor + uncertainty results = 25.9967 + 0.0022 +
0.0008 = 25.9997
Tolerance interval = +/-0.005 (25.9952 to 26.0052)

After the addition of the uncertainty results and still within the +/-0.003
tolerance, therefore it is a PASS. Or if it is outside the limits, then it is a FAIL.

The important thing is that how you use the uncertainty result should be
stated in your procedure.

I hope this helps.

Edwin

Charlie | Reply
Sir in addition, what if during verification your uuc reading (of same std mass) is not the same with
the uuc reading in calibration certificate. We performed verification every start of shift. And that is 3
times a day for ten months, based on verification logbook there were times that our analyst used
new correction by simply true value- reading during verification. Is this correct sir? Thanks.

edsponce | Reply

Hi Charlie,

Yes, it is correct, that is the purpose why we perform verification, to see if it


is still within tolerance or has an acceptable accuracy before we use the
balance. If there is a big error, then we need to adjust or use the correction
factor we obtain.
Shares During verification of the balance, we do not need to use its calibration
certificate. What we need only is the calibration certificate of the standard
mass to obtain the exact value or true value.

Every time we take a reading from the balance, you compare it in the true
value of the reference standard mass and use the correction factor
immediately. I believe this is what you already do.

You can disregard the calibration certificate of the balance if you always use
the standard mass for verification as long as the standard mass has a valid
calibration report, and do not forget to record everything.

If you are monitoring the drift of the balance, this is the time where you can
use the results from its calibration certificate. You compare the before and
after results. This will show you its stability in the long run.

This is also one way of increasing the calibration interval of the balance once
you have shown that it is stable in a defined period of time and use.

Thanks again for the comments.


Best regards,
Edwin

jhon lee | Reply

Dear Edwin,

I always see your good suggestion regarding calibration issues i have a one question regarding
calibration certificate that if one company ISO 17025 accredited there accreditation scope cover
temperature only after accreditation they buy a new master tools for pressure than how the will
issue the certificate they mention the accreditation logo on his certificate of pressure or no because
how they will tell the people that we are accredited lab if no logo on certificate even not in scope but
Shares lab is ISO 17025 accreditation.
i saw some companies not cover the scope but they put the accreditation body logo on his
certificate please clarify for this.
Jhon lee

edsponce | Reply

Dear John Lee,


During the accreditation process, the accreditation body will check our
competency based on the scope that we applied for. And once we have
passed their accreditation, we can now use their logo.

Every accreditation body has a policy on the use of the accreditation logo on
every calibration certificate that we use. I suggest you check this policy with
your accreditation body.
The main point is that we cannot use the logo on the scope that we are not
accredited. One rule when using the logo is that you can use the logo on a
non-accredited scope considering that you will put a remark somewhere in
the calibration certificate stating that “this scope or range is not accredited”
or a similar term.

But to be sure, as I said, check or download the accreditation body’s policy


regarding this matter. I believe it is downloadable in their website.

Your accreditation maybe in question once this will be audited during a


surveillance audit if not fixed.

I hope this helps.

Thank you for visiting my site.


Edwin

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rohit roy | Reply

what is relative confidence limit sometimes given in calibration certificate of CRMs? how to
calculate tolerances using a central value when only relative confidence limit is given?

edsponce | Reply

Hi Rohit,
I did not yet encounter a relative confidence limit for a CRM.

The confidence limit is the value of the upper and lower end of a confidence
interval. What I usually see in CRM calibration report is the standard
deviation. As per my understanding, 1 Standard deviation is the same as 1
confidence interval which can be used as a basis for tolerance.
If you want, you can share your certificate with me and I will try to take a
look. My email is edwin@calibrationawareness.com.

Thank you for reading my post.

Best regards,
Edwin

P. Gooljar | Reply

Dear sir, i just joined the your website and got opportunity to read your comments and valuable
information published. Thanks a lot. P. Gooljar Mauritius

Shares

edsponce | Reply

Hi Pravesh,
You are welcome. I hope you will see articles that would help you more.

Thanks for visiting my site.

Best regards,
Edwin

Wahiba REMILI | Reply


Thank you very much for that report about certificate of calibration contents, much appreciated.
I would ask you for the meaning of:
” opinion and interpretation mentioned in this certificate is outside the scope of work”
I found it in the calibration certificate at the end as a “Note”, i didn’t understand what does it
mean!!?
for information the data type is “As left”

Many thanks in advance for your help and clarification

edsponce | Reply

Hi Wahiba,

Opinions and Interpretations are part of the requirements of a calibration


Shares certificate/report. This part of the report is provided by the calibration lab.

It is only provided when appropriate or needed in order to give more


meaning about the results that are reported.
Opinions and interpretations expressed are based on the calibration results
as per the performed calibration procedure. These opinions and
interpretations are given by an authorized person of the lab as per his expert
assessment or understanding of the results.

Some instances where opinions and interpretations are required:


1. If requested by the user or customer;
2. If a result needs more clarifications regarding the use of the reported
results;
3. Some limit of usage;
4. Special instructions on how to properly use the results;
5. Or any important interpretations that can help the user in using the
reported results.

But in order for a person to give opinions and interpretations, he/she must be
authorized by the lab.
As per the remarks,” opinion and interpretation mentioned in this certificate
is outside the scope of work”, the ‘Scope of work’ means that it is what they
are allowed to perform calibration or test as per the approved capabilities
based on their accredited scope.

Accredited scope (also known as Scope of Accreditation) can be found on


the second page of the accreditation certificate provided by the accreditation
bodies under ISO 17025 Standards.

Since I did not see the calibration certificate, below are my inputs about the
reason why the lab has indicated the remarks:

1. The result (or part of the result) they provided is not under their accredited
scope and therefore follows the opinions and interpretations with it. In which
you need to perform an assessment if this opinion and interpretation has an
impact on your process
Shares 2. It is another way of informing you that the results provided are not under
their Scope of Accreditation (this is as per agreement).

But in any case, this is not a problem as long as you completely understand
the results of the report that they have issued as per your process usage
and that you have agreed about the reported results.

As the user of the calibrated instruments, you must fully understand the
results that are being reported in the calibration certificate. In any case, you
cannot understand, you may ask the calibration lab for some explanations or
interpretations of the results.

I hope this helps


Thanks for reading my post.

Edwin

Wahiba REMILI | Reply


Hello Edwin,

Thank you very much for your detailed explanation, much


appreciated.
it helps me a lot to understand how to deal with laboratories, what
scared me was the mention ‘out of the scope of work’, it is like the
certificate is issued on his laboratory’s name and he says that
what’s mentioned in the certificate is out of his scope of work
something that worried me.
Again thanks a lot

edsponce | Reply

Shares
Hi Wahiba,

You are welcome.

There are 2 meanings of the term ‘out of


the scope of work’, these may be:
1. They are capable to perform the
calibration but they are not accredited to it,
or
2. They cannot do the job because they do
not have the capability to do it.

What I understand now is that, because it


is ‘out of their scope of work’, they use
another lab (we call this a 3rd party lab) to
do the calibration for them, in your behalf,
or in other words, they do not have the
capability to do so that is why another lab
performs the calibration for them.
This is a normal process, as long as the
other lab (3rd party lab) is also an
accredited lab that meets your
requirements, I do not see any problem.
The only problem is that they should ask
your permission or you should have an
agreement about this.

I cannot give an exact answer since I did


not see the certificate. If you want me to
check it out so that I can give a more
detailed comment, you can send it to my
email, edwin@calibrationawareness.com.

Thanks and regards,


Edwin
Shares

Charlie | Reply

Sir Edwin, do you conduct seminars or trainings here in Philippines?

edsponce | Reply

Hi Charlie,

Sorry to inform you that I do not conduct training or seminars (yet), but I
would be glad if I had a chance.
For now, this website is where I share my knowledge and experience.

Thank you for reading my post. If ever you have other related concerns,
please feel free to comment further.

Best Regards,
Edwin

CECILE JOY | Reply

Good Day!

How often will you conduct the verification if you have already had the calibration interval of a
Shares certain equipment?

Thanks,

CECILE

edsponce | Reply

Hi Cecile,

The verification period is the same as the calibration interval. Verification is


implemented every time a calibration is performed. I also conduct an
intermediate check every 3 months where another verification is performed.

You need to continue the verification as per your normal interval to


continuously monitor the performance of the instrument. This will help you to
extend more the calibration interval or maintain the fixed interval chosen.

I hope this helps,


Edwin
Eduardo Sotomayor | Reply

What is the calculation that have you determine the Expanded Uncertainty for (1.01+/-0.007960)mV
at a confidence level of 95%?
What is the process you use for it?
Thanks!

edsponce | Reply

Shares Hi Eduardo,
We use the GUM (ISO/IEC 98-3:2008) approach in calculating the
measurement uncertainty where Type A (repeatability) and Type B
(resolution, drift, specifications/accuracy, standard uncertainty and others)
contributors are combined to come up with final expanded uncertainty, K=2
at 95% confidence level.

I hope this helps.


Edwin

Madoda Nanto | Reply

Dear Sir

Please assist me with this question:


1. CMM calibration is done by an external company.
2. The techinician is qualified to the calibration
3. The bar used is also calibrated and traceable to the national standard
The only issue is that the company is doing the calibration is not accredited to the ISO 17025
standard.

Can the company continue or we should look somewhere else?

Thank you

edsponce | Reply

Hi Madoda,
An accredited laboratory should be the first to consider when using the
service of an external lab. The requirement is to use a competent laboratory,
where competency is evident if the lab is accredited.
Shares
But it is not always the case. You can also determine the competency of a
lab by verifying (through an audit) that they follow the requirements of a
quality system like ISO 17025.

First of all, check your policy regarding 3rd party calibration. Does it say you
need to use an accredited lab? Or as long as you have taken the necessary
control like verification for training, quality system documentation, and
traceability is enough?

There are exemptions where not accredited labs can be used. These are:
1. No available accredited lab for the specific instruments(need to show
evidence that you made a search)
2. The Instrument has a warranty from its manufacturer (OEM)
3. OEM is the only available lab that can provide the service.
4. You have performed an audit where the requirements set (like ISO 17025
requirements) are met and satisfied.

To avoid possible issues with the auditors and to ensure competency without
an in-depth verification or audit, it is better to use an accredited lab.
I hope this helps.
Edwin

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