ISO/IEC 17025 is the gold standard for the calibration industry, specifically the pipette calibration service industry. But what does this standard actually cover? Many questions are asked regarding this standard and many answers are given. Like many things, the answer isn’t as in depth as you may think.
Pipette calibration services vary from company to company and laboratory to laboratory. You may ask yourself: does my laboratory need 3 pipette readings? or 10 pipette readings? How many different calibration points are sufficient? Do we need uncertainties? If so, are real-time uncertainties required? With so many different pipettes on the market and even more pipette calibration methods, you may not know where to start. Here is a quick, ISO answer: It is you decision. Yes. It is you decision on the level of service you would prefer. It is your decision on the calibration interval, pipette calibration method, calibration points, calibration company and location (on-site or off-site). As long as the company can supply evidence to the customer of the companies ability to perform compliant calibration, you laboratory will be compliant with GLP, GMP, ISO and FDA standards and procedures.
Selecting a company to perform calibrations can be burdensome. When selecting a pipette calibration service, ensure the company uses: ASTM NIST traceable weights, 5 place balances for 10 ul pipettes, humidity traps and validated methods and procedures. If reports are needed, ensure the company reports include the following: Methods, z-factor adjustment, pass/fail criteria, technician signature or initials, a statement of calibration and all pipette information (serial number, manufacturer, etc). Ensure the company can calibrate all types of pipettes such as: electronic, positive displacement and repeater pipettes. For a full list of pipette types and service types, you can visit www.ecs-metrology.com.
Laboratories and their manages who follow the above recommendations can rest easy and be sure they are ISO complaint. Pipette calibration should be the least of your worries, focusing your energy for the real reason you work in the biotech or health industry; research and improvement