Do you know, the biggest bottleneck in your lab process is Calibration Certificate preparation?

“ Preparing a Calibration Certificate takes way more effort than copy-pasting the raw data into a pdf document “

One of the biggest differentiator for you as a Calibration lab is the quality of certificates you issue. A neatly structured certificate with all the essential information and no errors will help you stand tall amongst completion.

Preparing a Calibration Certificate takes way more effort than copy-pasting the raw data into a pdf document. The calibration data needs to be corrected for CMC ( calibration measurement capability), precision adjustments ( rounding based on significant digits) etc.

As the standards become more and more comprehensive, the process of preparing calibration certificates has become cumbersome and error-prone. Needless to say, things get overly complicated when the customer asks for supplementary or superseding copies.

Here is the list of essential information a Calibration Certificate/Test Report should contain in order to comply with ISO/IEC 17025:2017 each time you issue one

a) A Title indicating the type of report (e.g.: ”Test Report”, “Calibration Certificate” etc )

b) The name and address of the laboratory in which calibration is performed.

c) Location in which calibration is performed, the most common indicators used are in-house ( for calibrations performed within the lab ) & on-site ( for calibrations performed outside of the lab mostly at customer locations ).

d) A unique identifier for the report indicated as certificate number or test report number.

e) Name and contact information of the customer.

f) The list of methods used for calibration along with appropriate document numbers for identification.

g) Environmental conditions under which the calibration is performed such as temperature, relative humidity & atmospheric pressure.

h) A statement indicating the traceability of the measurement results (for calibration certificates).

i) Description of the unit under test (UUT) along with its condition.

j) A unique identification number for the unit under test(UUT). The unique identification number should be unambiguous.

k) Date of receipt of the UUT & the date of sampling (note: this is extremely critical to understanding the validity of the results).

l) Date of issue of the report.

m) A statement to the effect that the results apply only to the items tested or calibrated.

n) Calibration or test results with appropriate units of measurement, preferably in tabular form with relevant headers.

o) Show results before and after adjustments (as found & as left calibrations).

p) Measurement uncertainty (applies to Calibration certificates)

q) Mention any deviations or exclusions from the method.

r) Identification of the person(s) authorising the report (for electronic signatures follow FDA 21 CFR PART 11 guidelines).

s) Clearly, indicate if the calibration/test results are obtained from external providers (applicable to subcontracted jobs).

t) A statement specifying that the report shall not be reproduced except in full without the approval of the laboratory.

The intelligent report management feature in metquay condenses the entire report generation and management process to a single button click with an exponential decrease in turn around time while maintaining strict quality standards.

Metquay allows you to set up calibration certificates/test report templates and associate them with customer requirements so that you could generate reports on the fly without having to make modifications to the base template each time you generate them. Certificate revisions are handled via predefined workflow which maintains complete traceability across different versions.

To know more about Metquay and its capabilities, please get in touch with us @ consulting@metquay.com or logon to www.metquay.com and signup for a free trial & webinar.

Reference: ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.

Image source: Getty Images

Leave a Reply

Your email address will not be published. Required fields are marked *