Analytical quality--what should we be aiming for?
ISO 15189 5.5.1 "The laboratory shall use examination procedures, ... which meet the needs of the users of laboratory services and are appropriate for the examinations. Requirements for analytical quality include: understanding the analytical goal; seeking an assay that fulfills those goals; establishing your own performance with that assay; setting warning and action limits for your assay; applying quality control tools to every important step.
Sikaris
Ken
K
Melbourne Pathology, 103 Victoria Parade, Collingwood, Victoria, Australia. ken.sikaris@mps.com.au