Compliance to the ISO/IEC 17025:2017 standard is understood to be an important criterion by many of those seeking a qualified pipette calibration service provider. Unfortunately, when it comes to pipette calibration, most don’t realize ISO/IEC 17025:2017 compliance is a necessary but not sufficient criterion.
ISO/IEC 17025:2017 is a written set of general requirements calibration providers must follow to be deemed “competent” by a suitable accreditation body. It requires firms to document internal processes, and to develop systems intended to insure that those processes are always followed.
The ISO/IEC 17025:2017 standard, however, has nothing to say about how good or effective those processes may be. Nor are the guidelines specific to any device; they apply equally well to a broad range of equipment requiring calibration, including not just pipettes, but also medical devices, communication equipment, electronic devices, weight scales, pressure meters, calipers, and many more.
ISO 8655, on the other hand, is a very detailed set of standards, methods and controls that a pipette calibration provider must follow to correctly and accurately calibrate piston pipettes. The specifications of ISO 8655 are rigorous and define in detail exactly what is required for a valid, trustworthy and reliable pipette calibration. ISO 8655 was not written just for regulated laboratories, but for the entire pipetting industry: scientists, pipette manufacturers and, of course, pipette calibration providers.
This difference explains how onsite pipette calibration companies can be accredited to ISO/IEC 17025:2017 but not to ISO 8655. Because they travel from one site to another, it is impossible for them to perform measurements in the stable, controlled test environment ISO 8655 requires (see for example TTE’s environmental controls and their importance in minimizing measurement uncertainty).
Even worse, the test equipment they use cannot possibly meet the ISO 8655 sensitivity requirements at low test volumes because the correct balances required for sub-uL measurements are very costly and certainly not designed for travel. In fact, ISO 8655 compliant calibration balances loose traceability to the SI(NIST), when moved after they are certified. Why? In an uncontrolled environment, 5, 6 and 7 place balances struggle to stabilize, producing a pendulum effect, and resulting in an unreliable measurement reading. This is not accurate and a poor way to calibrate pipettes.
TTE Laboratories is completely committed to the difficult task of providing pipette calibration services that are comprehensive, complete, reliable and fully compliant to ISO 8655. In fact, we are so committed to this standard that we are the only pipette calibration provider that complies with ISO 8655 and also provides free, 24-hour turnaround.
The simple truth is that if your pipette calibration vendor—whether traveling or lab-based—does not comply with ISO 8655, you can not be assured you are receiving reliable, repeatable and accurate pipette calibration.