Standard Setting Organizations
KJELL JACOBSSON
European Committee for C/inical Laboratory Standards (ECCLS),
University Hospital, Lund
In the programme the title for this overview is
standard
setting
organizations. Standard
Pro–
duäng
organisations would be more adequate
because one can hardly avoid material stand–
ards when talking of written standards.
You cannot find these two terms in ISO's
Guide on terms used in standardization, but
they are very convenient and could hardly be
misunderstood. They earrespond to normes
and etalons in French. For many people a
standard is a normative document like guide–
lines, technical specifications and recommen–
dations. For most colleagues in the clinical
laboratories, however, a standard means a
material standard. They are aware of the need
of material standards both for calibration and
for quality control but rather few realize a
need for written standards.
For ECCLS members a great number of
standard producing organizations are of inter–
est. You can see some of them on the screen.
The abbreviations may seem frightening,
but you will get a list explaining them all.
In the table I have grouped the organiza–
tions according to whether they are for only
one speciality for all laboratory specialities,
for health or only for standards. Then there is
a 5th group of organizations which do not fit
into any of the 4 first groups.
ISO, IEC, BIPM AND OIML
Let me start with ISO, the International Orga–
nization for Standardization. ISO was estab–
lished in 194
7.
The members are the national
standardization bodies, like AFNOR in
France, BSI in
U.K.
and DIN in Germany.
Klinisk kemi
i
Norden
ISO has 91 members. This giant has published
more than 7000 standards. The scope is not
limited to any particular branch except elec–
tric and electronic engineering which is taken
care of by the elder sister organization IEC,
the International Electrotechnical Commis–
sion.
ISO has 9 technical committees in the medi–
cal field. ECCLS has liaison status with one of
these namely TC
76
on transfusion, infusion
and injection equipment for medical use. Oth–
er technical committees of interest are on in–
formation technology, on chemistry, on labo–
ratory glassware, on application of statistical
methods and on quality assurance. Of special
importance is their committee on reference
material ISO-Remco. ISO is not engaged in
the preparation of reference materials, but
ISO-Remco has published a directory of certi–
fied reference materials in 1982 including
clinical chemistry.
About two years aga ISO published the 5th
edition of a Guide on "General terms and
their definitions concerning standardization
and
related activities". This guide ought to be
known-and fallowed-by all those engaged in
standardization.
ISO has also-in 1984-published an "Inter–
national Vocabulary of Basic and General
terms in Metrology'', known as VIM, Vocabu–
laire International de Metrologie. VIM should
be considered to be the Bible of terminology
for all scientists.
It
should, however, be
amended to suit the clinical laboratory sci–
ences. The vocabulary was prepared by ex–
perts appointed by the four main internation-
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