Protocols & standards
The method behind
the certificate.
Calibration is only worth what its method can defend. This is how we run one, which standards govern it, and where to read more before your next audit.
The standards
What governs the work.
Four documents decide what a pipette must do, how you prove it, and whether the electronic record behind it holds up.
ISO/IEC 17025
Testing and calibration laboratory competence
The general requirements for the competence, impartiality, and consistent operation of calibration laboratories. It governs how we control methods, equipment, traceability, and reporting.
ISO 8655-1
Piston-operated volumetric apparatus — terminology and requirements
Defines the terminology, general requirements, and maximum permissible errors for piston-operated volumetric apparatus, including the accuracy and precision limits a pipette must meet.
ISO 8655-2
Piston-operated pipettes
The specific requirements and test methods for piston-operated pipettes — the protocol that determines how many measurements are taken, at which volumes, and under what conditions.
21 CFR Part 11
Electronic records and electronic signatures
Our calibration software is 21 CFR Part 11 compliant, so the electronic records and signatures behind your certificates hold up in a regulated environment.
The protocol
How a gravimetric calibration actually runs.
The order matters as much as the measurements. Each step exists because skipping it costs you the defensibility of the result.
The environment is measured first
Temperature, barometric pressure and relative humidity are recorded at the point of test. Those readings drive the Z-factor correction that converts a mass reading into a volume, which is why a calibration performed without them is not traceable.
Mass, on a balance that is itself calibrated
Water is dispensed onto an analytical balance with traceable class weights, on a vibration-isolated bench, inside a draft shield with an evaporation trap. The balance is verified before the instruments are.
As-found before anything is adjusted
The instrument is measured in the state it arrived in. Without an as-found result you cannot scope which work was affected, and that is the first question an auditor asks when a pipette fails.
Then preventive maintenance, then as-left
Cleaning, lubrication, and seal and O-ring replacement happen after the as-found record exists. The instrument is then re-measured so the certificate shows both states.
How many measurement points you get at each volume is what separates the Silver, Gold and Platinum plans — not whether the method is followed.
Compare the plansFurther reading
Written for the people who run the program.
Intervals, audit preparation, handling habits, and what the standards actually ask for.
Put it to work
Bring the method to your bench.
Send your instrument list and we'll recommend the plan tier that matches how your results get used.
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