Title: Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemitry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)
Authors: Thelen, Marc ×
Vanstapel, Florent
Kroupis, Christos
Vukasovic, Ines
Boursier, Guillaume
Barrett, Edward
Andreu, Bernabeu Andreu
Brguljan, Pika Meško
Brugnoni, Duilio
Lohmander, Maria
Sprongl, Ludek
Vodnik, Tatjana
Ghita, Irina
Vaubourdolle, Michel
Huisman, Willem #
Issue Date: 2015
Publisher: Walter de Gruyter
Series Title: Clinical Chemistry and Laboratory Medicine
Abstract: The recent revision of ISO15189 has further
strengthened its position as the standard for accreditation
for medical laboratories. Both for laboratories and their
customers it is important that the scope of such accreditation
is clear. Therefore the European co-operation for
accreditation (EA) demands that the national bodies
responsible for accreditation describe the scope of every
laboratory accreditation in a way that leaves no room for
doubt about the range of competence of the particular
laboratories. According to EA recommendations scopes
may be fixed, mentioning every single test that is part of
the accreditation, or flexible, mentioning all combinations
of medical field, examination type and materials for
which the laboratory is competent. Up to now national
accreditation bodies perpetuate use of fixed scopes, partly
by inertia, partly out of fear that a too flexible scope may
lead to over-valuation of the competence of laboratories,
most countries only use fixed scopes. The EA however
promotes use of flexible scopes, since this allows for more
readily innovation, which contributes to quality in laboratory
medicine. In this position paper, the Working Group
Accreditation and ISO/CEN Standards belonging to the
Quality and Regulation Committee of the EFLM recommends
using an approach that has led to successful introduction
of the flexible scope for ISO15189 accreditation as
intended in EA-4/17 in The Netherlands. The approach is risk-based, discipline and competence-based, and focuses
on defining a uniform terminology transferable across
the borders of scientific disciplines, laboratories and
ISSN: 1434-6621
Publication status: accepted
KU Leuven publication type: IT
Appears in Collections:Department of Health and Technology - UC Leuven
Biomedical Quality Assurance Research Unit
× corresponding author
# (joint) last author

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