2 QUALITY POLICY
Present the goals which are expected to be achie–
ved by implementating of the provisions of the
quality system. These goals are common!y given
as a management policy statement.
Example:
QUAL/TYPOLICYOFA LABORATORY
The aim ojthe laboratory
is
to provide elini–
cal/y usejul information through laoorotory
measurement ofsamples from patients, tak–
ing into account the allocated resources
(et
1.5-1.
7). Thereported data should be reliable
and the random and systematic analytical
variation should be in accordance with the
appropriate technical standards oj the pro–
fession. The qua/ity policy
is
implemented,
e.g., through the jollowing points.·
-
Proper sample collektion, stabilization,
transport, sample preparation and identi–
fication.
-
Reliable analytical work so that systema–
tic and random error do not exceed specifled
limits.
-
1Urnaround time within specifled limits,
e.g., for emergency measurements within 1 h,
and for rare routine measurements within 1
week ajter receipt ofsamples.
-Data reported in a e/earfrom and supple–
mented with relevant information (e.g. reje–
rence interval to allow reliable clinical inter–
pretation.
-
Appropiate communication with the cli–
nicians so that results wi/1 be interpreted cor–
rectly and logica/ly integrated into jurther
(clinical and laboratory) evolution ojthe pa–
tient. Close contact with elinidans is a/so im–
portant in order to become aware of unex–
pected problems and errors.
.
Note: According to EN45001 the qua/ity manu–
al sha/1 contain a qua/ity policy statement.
4.7 Laboratory management personnel
Designate the person(s) having management
authority and persons responsible for operation
Klinisk kemi
i
Norden
J,
1992
of the quality system in different sections of the
laboratories. Describe how the management
and the quality assurance are carried out during
out-of-hours service.
Example:
GENERAL INSTRUCTIONS FOR AN
EMERGENCY LABORATORY [in–
complete].
As a technician on duty at the emergency la–
boratory you are responsible for analytical
work during non-regutar hours, and during
weekends and holidays. Furthermore, you
are responsible for the operation oj the Blo–
od Bank during these hours; see special in-
,
strucionsjrom the Blood Bank. Ifa Disaster
Alarm is ca/led, you are responsible for con–
tacting the persons mentioned on page 8 oj
the Disaster Binder; a copy oj this Binder is
found on the desk at telephone extension
1932.
A laboratory doctor is on ca/l. If you have
problems with test results etc., you should al–
ways contact himlher. !t is importont to un–
derstand that the clinical doctors are not yo–
ur immediate superiors. They cannot give
orders to you. The analytical work in the
emergency laboratory is normal/y limited to
those measurements mentioned in the Lobo–
ratory Handbook.
There is no engineer on ca/l. Ifyou needengi–
neering assistance you should contact the la–
boratory docfor on ca/l who wi/1 then decide
how to arrange assistance.
Ifyou obtain a test resu/t above or below the
alarm limit, it is yourpersonal responsibility
to immediately notijy the doctor, nurse or
ward that requested the test, whether or not
a telephone answer was requested. If you
cannot reach himlher, then contact the lobo–
ratory doctor on ca/l.
Alarm limits:
B-G/ucose; amsc.
<
1,0 mmoi/L, or> 25
mmol/L
S-Potassium; amsc.
<
3,0 mmoi/L, or> 6,5
mmol/L.
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