Quality specifications for the reliability of performance characteristics o
f laboratory testing, particularly precision and bias, are necessary prereq
uisites for creation and control of analytical quality. Many strategies hav
e been promulgated for setting these specifications. Recently, the availabl
e approaches have been fixed into a hierarchical framework that has now bee
n accepted by experts in the field to be the best current approach to a glo
bal strategy for setting quality specifications in laboratory medicine. The
y should be incorporated into quality planning strategies everywhere irresp
ective of the settings in which laboratory medicine is practised, including
the point of care testing (POCT). Models higher in the hierarchy are prefe
rred to lower approaches but lower approaches are better than none and shou
ld be used as the minimum standard. (C) 2001 Elsevier Science B.V. All righ
ts reserved.