title: Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO).
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 countries.
authors.forename: Marc H M
authors.initials: MH
authors.lastname: Thelen
authors.forename: Florent J L A
authors.initials: FJ
authors.lastname: Vanstapel
authors.forename: Christos
authors.initials: C
authors.lastname: Kroupis
authors.forename: Ines
authors.initials: I
authors.lastname: Vukasovic
authors.forename: Guilaime
authors.initials: G
authors.lastname: Boursier
authors.forename: Edward
authors.initials: E
authors.lastname: Barrett
authors.forename: Francisco
authors.initials: F
authors.lastname: Bernabeu Andreu
authors.forename: Pika Meško
authors.initials: PM
authors.lastname: Brguljan
authors.forename: Duilio
authors.initials: D
authors.lastname: Brugnoni
authors.forename: Maria
authors.initials: M
authors.lastname: Lohmander
authors.forename: Ludek
authors.initials: L
authors.lastname: Sprongl
authors.forename: Tatjana
authors.initials: T
authors.lastname: Vodnik
authors.forename: Irina
authors.initials: I
authors.lastname: Ghita
authors.forename: Michel
authors.initials: M
authors.lastname: Vaubourdolle
authors.forename: Willem
authors.initials: W
authors.lastname: Huisman
mesh_terms: D000068:Accreditation; D002624:Chemistry, Clinical / Q000592:standards*; D064790:Clinical Laboratory Services / Q000592:standards*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D015510:Clinical Medicine / Q000592:standards*; D005060:Europe; D006801:Humans; D011786:Quality Control