A practical guide to validation and verification of analytical methods in the clinical laboratory
J Pum - Advances in clinical chemistry, 2019 - Elsevier
Although the measures to improve quality in the clinical laboratory have been enormous in
the past years, not least of all due to the introduction of the ISO standards 15189 and 17025,
the handling of validation and verification of method performance often still differs widely
from laboratory to laboratory. Much of what is published on the topic contains complex
statistics and is difficult to implement in routine laboratories. The result is, that this point is
often neglected or implemented incorrectly, which in turn can lead to false conclusions about …
the past years, not least of all due to the introduction of the ISO standards 15189 and 17025,
the handling of validation and verification of method performance often still differs widely
from laboratory to laboratory. Much of what is published on the topic contains complex
statistics and is difficult to implement in routine laboratories. The result is, that this point is
often neglected or implemented incorrectly, which in turn can lead to false conclusions about …
