CALIBRATION CERTIFICATE REQUIREMENTS

Calgirl319

Involved In Discussions
DOES THE SPEC USED FOR CALIBRATION HAVE TO ON THE CERTIFICATE OF CALIBRATION OR JUST THE PROCEDURE OR BOTH? WHAT STANDARD TELLS ME EVERYTHING THAT MUST BE ON A CERTIFICATE OF CALIBRATION?
 

BradM

Leader
Admin
Hello there!!

A few questions. Is this a calibration being performed by a commercial entity for an end user? A customer?

Does the calibration lab have any certifications/ accreditations?

Is this an "inside" calibration? One performed for equipment owned by a company by employees of that company?

Finally... what kind of industry specifications/ guidelines are in place here?

I would suggest minimally the certificate should attest to what kind of accuracy performance the instrument was tested against. It could be a simple statement like "Caliper xxx was verified and found within specifications listed in procedure YYYYY". But to me the piece of paper is pretty worthless if it doesn't have some kind of statement what was tested, what standard was used, and what it was tested against.
 

Ron Rompen

Trusted Information Resource
In my past experience (QS9000, ISO 9001, TS 16949) I have used software to keep records of the 'as found' and 'as left' status of any calibrated gauge. I don't reference any specific procedure number - I have a set of calibration guidelines which have fairly generic statements (e.g. calibrate calipers using gauge block set GB-001). The software contains the values that I compare against, and the limits of accuracy of the gauge. So far, I have not had any complaints or criticism from external and RB auditors.
With that being said, it will depend a LOT on who you are doing this for, and under what conditions/requirements. If I send a gauge out to a 3rd party for calibration, I expect that they will have documented procedures in place which detail how to perform the calibration on the gauge - this may also be a requirement under some standards.
 

BradM

Leader
Admin
In my past experience (QS9000, ISO 9001, TS 16949) I have used software to keep records of the 'as found' and 'as left' status of any calibrated gauge. I don't reference any specific procedure number - I have a set of calibration guidelines which have fairly generic statements (e.g. calibrate calipers using gauge block set GB-001). The software contains the values that I compare against, and the limits of accuracy of the gauge. So far, I have not had any complaints or criticism from external and RB auditors.
With that being said, it will depend a LOT on who you are doing this for, and under what conditions/requirements. If I send a gauge out to a 3rd party for calibration, I expect that they will have documented procedures in place which detail how to perform the calibration on the gauge - this may also be a requirement under some standards.

Agreed, Ron. The only "certificates" I get now are from standards sent out for calibration. Everything else is logged in the software system.
In case of audit and we need to print stuff out, it has the ID, make, model, etc. As-found/ as-left data, procedure used, standard used and such.

Ironic... they offer to send instead a PDF file. But... they lock them down so we're not able to add a cover page from our software system.
So we have to obtain, scan, and shred the paper copy. If they would lock down the text and contents, that would be fine. But they lock the whole file, so you can't do anything with it!
 

qualitymanagerTT

Involved In Discussions
...
Ironic... they offer to send instead a PDF file. But... they lock them down so we're not able to add a cover page from our software system.
So we have to obtain, scan, and shred the paper copy. If they would lock down the text and contents, that would be fine. But they lock the whole file, so you can't do anything with it!

Have you asked if they would add your cover page to the file?
 

dwperron

Trusted Information Resource
DOES THE SPEC USED FOR CALIBRATION HAVE TO ON THE CERTIFICATE OF CALIBRATION OR JUST THE PROCEDURE OR BOTH? WHAT STANDARD TELLS ME EVERYTHING THAT MUST BE ON A CERTIFICATE OF CALIBRATION?

What standard do you want to comply with?

For instance ANSI Z540, ISO 17025, and ISO 10012 all have lists of what is required to be on a calibration report. If you are not complying with one of these calibration standards then you probably don't have such guidance. Documents like ISO 9001, AS9100, ISO 13485, etc. will have sections on control of monitoring and test equipment, but they don't go into detail as to what they require to be on a calibration record.
 

qualitymanagerTT

Involved In Discussions
... Documents like ISO 9001, AS9100, ISO 13485, etc. will have sections on control of monitoring and test equipment, but they don't go into detail as to what they require to be on a calibration record.

This is correct (at least for ISO 9001 as I can't speak for the others listed), however, the "ISO 9001 Auditing Practices Group Guidance on Measurement Traceability" references ISO/IEC 17025 (though the APG guidance is a 2016 document, and thus references the 2005 version of 17025, and not the 2017 version).

In the 2017 version, clauses 7.8.2 and 7.8.4 list requirements for calibration certificates. In the Caribbean, I haven't met anybody outside of a National Standards Body / National Metrology Institute who understands measurement traceability, far less metrological traceability.

And, of course, much more needs to be on a calibration certificate than just metrological traceability.
 

jerry bambach

Registered
The above is correct, but as a customer, you may not have a copy of ISO17025, so I will give you a list of the requirement from the standard.
This is from section 7 of the standard.
7.8.2 Common requirements for reports (test, calibration, or sampling)
7.8.2.1 Each report shall include at least the following information unless the laboratory has valid
reasons for not doing so, thereby minimizing any possibility of misunderstanding or misuse:
a) a title (e.g. “Test Report”, “Calibration Certificate,” or “Report of Sampling”);
b) the name and address of the laboratory.
c) the location of performance of the laboratory activities, including when performed at a customer
facility or at sites away from the laboratory’s permanent facilities, or in associated temporary or
mobile facilities.
d) unique identification that all its components are recognized as a portion of a complete report and a
clear identification of the end.
e) the name and contact information of the customer.
f) identification of the method used.
g) a description, unambiguous identification, and, when necessary, the condition of the item;
h) the date of receipt of the test or calibration item(s), and the date of sampling, where this is critical
to the validity and application of the results.
i) the date(s) of performance of the laboratory activity.
j) the date of issue of the report.
k) reference to the sampling plan and method used by the laboratory or other bodies were
these are relevant to the validity or application of the results.
l) a statement that the results relate only to the items tested calibrated or sampled.
m) the results with, where appropriate, the units of measurement.
n) additions to, deviations, or exclusions from the method.
o) identification of the person(s) authorizing the report.
p) clear identification when results are from external providers.
7.8.4.1 In addition to the requirements listed in 7.8.2, calibration certificates shall include the
following:
a) the measurement uncertainty of the measurement result presented in the same unit as that of the
measurand or in a term relative to the measurand (e.g. percent);
NOTE According to ISO/IEC Guide 99, a measurement result is generally expressed as a single measured
quantity value including unit of measurement and measurement uncertainty.
b) the conditions (e.g. environmental) under which the calibrations were made that have an influence
on the measurement results;
c) a statement identifying how the measurements are metrologically traceable (see Annex A);
d) the results before and after any adjustment or repair, if available;
e) where relevant, a statement of conformity with requirements or specifications (see 7.8.6);
f) where appropriate, opinions and interpretations (see 7.8.7).
you can use this as a checklist
also, watch out for the statement that UNC was not considered in the compliance statement, as this will now be your responsibility to add it to the specification to determine if is in or out of specification this is often called shared risk.
 
Top Bottom