Clin Biochem Rev 2008; 29 Supplement(i):S5-S10

Analytical Quality – What Should We be Aiming for?

Ken Sikaris
Melbourne Pathology, 103 Victoria Parade, Collingwood, Vic. 3066, Australia.
For correspondence: Dr Ken Sikaris e-mail: ken.sikaris@mps.com.au

Summary
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..