The eclectic mix of participants in the forum had a surprisingly singu
lar focus when it came to the topic of quality in clinical laboratorie
s. All sensed that the time is right for a transition from laws, rules
, and inspections to a true quality-based system. Such a system can ac
hieve the goals, implicit and explicit, that are the rationale for the
multiplicity of regulations affecting today's laboratories. A true qu
ality-based system has great potential benefits to laboratories, regul
ators, and manufacturers, and ultimately to our true customers, the pa
tients. The benefits include lower costs, superior products, and bette
r test results; in short, better patient tare. This transition will be
possible only through formation of a ''Quality Alliance,'' composed o
f those skilled in the ''theory'' of quality-laboratory personnel, man
ufacturers, and regulators, acting as one to implement the quality sys
tem. The Quality Alliance requires a team of individuals with differen
t skills, aligned as one, for the purpose of achieving a common goal.
On the basis of views expressed in this Forum, our collective future w
ill be defined by the evolving Quality Alliance, an alliance focused o
n true quality systems in clinical laboratories.