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 The development of
International standards is the purview of the International Organization
for Standardization (ISO). ISO is a network of the national standards
institutes of 148 countries, one member per country, with the Central
Secretariat in Geneva, Switzerland that coordinates the system. ISO
standards are developed by technical committees, composed of experts
that participate as national delegations, chosen by the ISO national
member body for the country concerned. |
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Participation in the ISO process is through the country member body.
There are currently 32 participating (P) member countries and 16
observer (O) countries.
The Clinical and Laboratory Standards Institute (CLSI) participates
in the development of International standards as the Secretariat
of ISO/TC 212, Clinical laboratory testing and in
vitro diagnostic test systems, a responsibility that was delegated to
CLSI by the American National Standards Institute (ANSI), which is an
ISO member body.
ISO/TC 212 is responsible for "standardization and guidance in the field
of laboratory medicine and in vitro diagnostic test systems.
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This includes, for example, quality management, pre- and
post-analytical procedures, analytical performance, laboratory safety,
reference systems and quality assurance."
The work of ISO/TC 212 is overseen by Dr. Donald M. Powers, ISO/TC 212
Chairman and is currently supported by four working
groups.
CLSI also serves as the administrator for the US
Technical Advisory Committee (TAG) for ISO/TC 212.
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