Clinica Chimica Acta 309 Ž2001.

111–114
www.elsevier.comrlocaterclinchim

European Communities Confederation of Clinical Chemistry

Working Group on Accreditation: past, present and future
Willem Huisman
Medical Centre Haaglanden, PO Box 432, 2501 CK, Hague, Netherlands

Abstract

During the past 10 years, many activities have taken place in the field of quality systems and accreditation in medical
laboratories.
Each country in Europe has a slightly different approach. The Working Group on Accreditation of the European
Communities Confederation of Clinical Chemistry ŽEC4. tries to support harmonisation of these efforts. For this purpose,
they edited the Essential Criteria for quality systems of medical laboratories and supported the forthcoming International ISO
standard AQuality management for the medical laboratoryB. At this moment, a Model Quality Manual is nearly ready for
publication. The next items are setting up criteria for auditing the quality system and criteria for the accreditation process.
q 2001 Elsevier Science B.V. All rights reserved.

Keywords: Accreditation; Quality system; ISO 15189; European Communities Confederation of Clinical Chemistry ŽEC4.

1. Introduction working group on accreditation was formed, with as

official name: WG on Harmonisation of Quality
In 1989, for Europe, the EN 45001 w1x was ac-
Systems and Accreditation.
cepted as the standard for accreditation of a testing
This name was chosen intentionally.
laboratory. At that time, different approaches were
Ž1. It is directed on harmonisation of quality
followed in European countries concerning the de-
systems. The famous European principle of sub-
mands for a quality system in a medical laboratory,
sidiarity was taken seriously. Its task was to steer
and for the choice between certification or accredita-
existing systems in a concordant direction with space
tion: The Netherlands w2x, Scandinavia w3x, France
w4x, United Kingdom w5x. In 1990, the Forum of for specific national items.
Ž2. It was directed on accreditation Žnot certifica-
European Societies of Clinical Chemistry ŽFESCC.
tion.. This is an essential difference. From the start,
was formed, and it was formalised in 1993 during
it was stated that the quality system should be di-
the European Congress of Clinical Chemistry in
rected on Athe laboratory serviceB, not on the AtestB.
Nice. At that time the European Communities Con-
This was quite clearly stated by Burnett w6,7x in his
federation of Clinical Chemistry ŽEC4. was re-
overview on accreditation systems. It was also the
shaped, and one of its tasks was accreditation. A
message from my lecture during the Nice Confer-
ence of 1993 w8x.
E-mail address: huisman@westeinde.ziekenhuis.nl Ž3. From the start, the European Diagnostic Man-
ŽW. Huisman.. ufacturers Association ŽEDMA. was invited to par-

0009-8981r01r$ - see front matter q 2001 Elsevier Science B.V. All rights reserved.
PII: S 0 0 0 9 - 8 9 8 1 Ž 0 1 . 0 0 5 0 5 - 8
112 W. Huismanr Clinica Chimica Acta 309 (2001) 111–114
ticipate, because harmonisation of quality systems
and accreditation is of common interest.
2. Harmonisation of quality systems
With certification, the standard is directed on the
quality system. According to ISO 9000 in the quality
manual, one indicates voluntarily the extensiveness
of specific rules which have to be followed in the
laboratory, and in this way it can be as strict as
accreditation.
With accreditation, the standard is not only di-
rected on the system itself, but also includes specific
demands of Quality Control and on working accord-
ing to the state of the art as described in ISO 25 w9x
and EN 45001 w1x. This becomes clearer in the new
version of the ISO 25 standard for testing laborato-
ries, the ISO 17025 w10x, which starts with the
general ISO 9000 w11x and then adds specific re-
quirements in the testing field. For medical laborato-
ries, it has to be extended to the laboratory service,
which incorporates the whole process: pre-analytical,
analytical and post-analytical stages.
As first activity, the WG made an inventory of the
existing quality systems and future wishes of the 12
countries in the European Union. For this purpose, a
questionnaire was composed and sent around.
The outcome was published in 1995 w12x. It
indicated clearly that many countries were starting
activities, mostly directed on the whole process of
laboratory service. In line with the intention of har-
monisation, the existing standards of the United
Kingdom, France, The Netherlands, but also ISO
9000 and ISO 25 ŽEN 45001. were collected. Along
the line of the structure of the ISO 9000, a set of
AEssential CriteriaB was composed. It was discussed
in a couple of meetings of the WG in 1995 and 1996,
and the final version was approved by the board of
the EC4. The Essential Criteria were published in
1997 w13x. Already at that time, it was realised that
Point Of Care Testing ŽPOCT. was neglected, and
some criteria had to be made more explicit; espe-
cially about management, role of clients and person-
nel, and effect on environment. This in accordance
with the EFQM approach: Total Quality Model w14x.
It resulted in the AAdditional Essential CriteriaB w15x.
Together, they form the Essential Criteria. The origi-
nal idea was to use the Essential Criteria as the
common standard for the Quality Systems in Clinical
Chemical or, preferentially, Medical Laboratories in
the European Union. The existing systems should be
gradually changed to come in line with this standard.
In the meantime however, the ISO, stimulated by the
NCCLS in the United States, had started within ISO
a number of WGs ŽTC 212. on laboratory medicine,
with the idea to set up a general standard covering
all aspects needed for a Quality System in medical
laboratories. The work of this group was clearly
influenced by the Essential Criteria.
In 1998, our WG decided to stress the importance
of one international standard for medical laborato-
ries and to support the ISO standard. This standard,
ISOrFDIS 15189 w16x, which is now in its latest
version, is expected soon to be an official ISO
standard.
The items mentioned in the Essential Criteria
were compared with the latest discussion version of
the proposed ISO 15189. It proved that the Essential
Criteria had all the components of the ISO 15189
and a few extra. The comparison as set up by the
Working Group has just been published w17x.
The Essential Criteria are much easier to under-
stand within the laboratory. It more clearly states
which items should be regulated in the laboratory
situation. For that reason, we still stress the help the
Essential Criteria could offer in setting up a Quality
System in line with the ISO 15189.
To help a starting laboratory with the implementa-
tion of a Quality System, it was decided in 1997 to
set up a model Quality Manual. The only existing
model at that time was that of The Netherlands,
which was translated into English w18x. Much of this
work is done by Dr. J.M. Queralto. The draft version
is now discussed within the Working Group. We
hope that the first version will be available in the
start of 2001 w19x. In any case, it will be presented
during the Prague meeting by Queralto. This model
handbook is related to the Essential Criteria and, of
course, the ISO 15189.
3. Harmonisation of accreditation
For setting up an accreditation system one needs
the following.
 W. Huismanr Clinica Chimica Acta 309 (2001) 111–114
Ž1. Common standard; ISO 15189, with the Es-
sential Criteria as explanation.
Ž2. Accreditation system. The already stated
choice for accreditation instead of certification means
cooperation with the EA. Every European country
has one organisation which conducts accreditation
Žand recognises Certification Bodies.. These accredi-
tation bodies mutually audit each other and they
together form the European Cooperation for Accred-
itation ŽEA..
Ž3. Part of this accreditation system is the audit:
an external party visits the laboratory and checks if
the Quality System is really implemented.
Concerning the setting up of an accreditation
system for medical laboratories, in 1997, a first
meeting took place in our WG, the accrediting bod-
ies of the UK ŽCPA., The Netherlands ŽCCKL test.
and EA representatives. One of the ideas was to set
up a specific branch, a European cooperation of
accreditation bodies for medical laboratories, under
the umbrella of the EA. At that time, the EA started
to direct its attention to accreditation of hospitals
and, as part of these, medical laboratories. An EA
committee composed of representatives of accredit-
ing bodies and of medical laboratory disciplines was
set up. The EC4 Working Group has a representative
in this group. This EA committee has accepted the
proposed ISO 15189 as the standard for accreditation
of medical laboratories and works on a checklist to
help in its implementation. It has to give an advice to
the EA board concerning accreditation of medical
laboratories. For mutual lateral agreements, the med-
ical laboratory accreditation system needs the EA.
An important task for our EC4 WG is to support
setting up of a medical laboratory branch within the
EA. To make a switch from the existing system to a
system under the umbrella of the EA easier, it is
important to set up the system of the present accred-
iting bodies for medical laboratories as comparable
as possible to the standards which the EA uses at this
moment for the testing laboratories. For instance, the
CCKL test in The Netherlands was set up according
to the demands of the ISO 58, which is an obligation
for an accreditation body. At this moment, the CPA
is implementing this standard.
If one harmonises the accreditation system for
medical laboratories in the EU, this should as well be
done for the auditing process. During an audit for
113
accreditation, knowledge of the laboratory process
and knowledge of all aspects of a quality system are
both needed. This could be accomplished by a mixed
team, composed of experts in the field of quality
system and experts in the field of laboratory disci-
pline.
An alternative is the training of the laboratory
experts in Quality System. This can be done rela-
tively easy because the laboratory people already
have to acquaint themselves with Quality Systems
when setting up the system in their laboratory. This
line is chosen for the UK and The Netherlands.
For choice of auditors, their training and their
evaluation, the existing EA guidelines could be used.
This is already done in The Netherlands.
Another important question is: how should the
audit be done? Should it follow specific checklists
Žas originally done in the USA by the CAP. or
should it be concentrated on the standards itself
ŽEssential Criteria.. A checklist is easier for the
auditors, but the risk exists that the whole idea of
AqualityB gets lost in the bureaucracy. The auditor
should, in fact, use the standard ŽISO 15189. to
judge the existing system in a laboratory and not an
additional checklist. Right now, the ISO 212 WG
works on a guidance document, directed on the
laboratory and accrediting body, for the ISO 15189.
Attention also should be paid to the differences in
non-conformities, the time scale to allow improve-
ment and the frequency of the audit process. In my
opinion, the auditors should consider themselves
more as ambassadors for stimulating a quality sys-
tem directed on improvements, rather than as police-
men only checking the adherence to strict rules.
Another item is: should the audit be restricted to
the laboratory, or should it also involve the clients of
the laboratory Žpatients and medical doctors..
In all these items, the WG intends to produce
criteria. Its focus is now on stimulating the harmoni-
sation of the accreditation process of medical labora-
tories.
4. Conclusion
The WG has edited criteria to come to a harmoni-
sation of the quality systems used in medical labora-
tories. Right now, it is working on harmonisation of
114 W. Huismanr Clinica Chimica Acta 309 (2001) 111–114
the accreditation process. For this purpose, coopera-
tion with the EA is indispensable. To fulfil its har-
monising role:
1. The WG remains a group of medical laboratory
professionals plus diagnostic industry with fun-
damental knowledge of the existing Quality
Systems and Accreditation, within the different
European countries.
2. The WG takes care of renewal Žthe essence of a
quality system is continuous improvement. of
the existing standards.
3. The WG plays its role in influencing activities
outside clinical chemistry, but directed on labo-
ratory medicine and hospitals; for instance, the
work in the EA bodies related to hospitals.
Most important of all, care should be taken that a
Quality System in medical laboratories is about labo-
ratory service, not just the analytical tests, and that is
for improvement of this service and not for just
following rules.
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