Anachem is urging all accredited laboratories in the UK to embrace the new ISO 15189 standards for UKAS accreditation.
The company believes that positive support for the new standards will only increase confidence in the results they produce by eliminating, wherever possible, the causes of variability in their protocols.
ISO 15189 emphasises the need for laboratories to implement calibration and testing regimes conforming to ISO 17025 for all pieces of equipment that may have a significant impact on results. Whether hand-held pipettes, pH meters or complex PCR thermocyclers, laboratories must demonstrate that they adhere to defined quality assurance levels and retain traceable records of consistent testing, competently performed.
According to Anachem, the key step to implementing ISO 15189 is to work out the impact on variability for every piece of equipment in every protocol, and then test and calibrate only the significant contributors to ISO 17025.
It is the influence that the scale of error has that is important rather than the size of the error itself. It may be that a large error in an individual instrument may not significantly influence the overall accuracy of a test. However, where it can be demonstrated that a tiny error will impact overall accuracy, 17025 is called for.