title: Accreditation of medical laboratories in the European Union.
abstract: BACKGROUND
  Using a questionnaire, the EC4 (European Communities Confederation of Clinical Chemistry and Laboratory Medicine) has collated an inventory of the accreditation procedures for medical laboratories in the EU.
  
  
  CONCLUSIONS
  Accreditation of medical laboratories in the countries of the EU is mostly carried out in cooperation with national accreditation bodies. These national accreditation bodies work together in a regional cooperation, the European Cooperation for Accreditation (EA). Professionals are trained to become assessors and play a prominent role in the accreditation process. The extent of the training is diverse, but assessors are kept informed and up-to-date by annual meetings. The frequency of assessments and surveillance visits differs from country to country and ranges from 1 to 4 years. More harmonisation is needed in this respect, based on a frequency that can be pragmatically handled by laboratory professionals. In the majority of EA bodies, accreditation is carried out on a test-by-test basis. Many professionals would prefer accreditation of the entire service provided within the actual field of testing (i.e., haematology, immunology, etc.), with accreditation granted if the majority of tests offered within a service field fulfil the requirements of the ISO 15189 standard. The scope of accreditation is a major point of discussions between the EC4 Working Group on Accreditation and representatives of accreditation bodies in the EA Medical Laboratory Committee.
authors.affiliation: Department of Clinical Chemistry, Medisch Centrum Haaglanden, The Hague, The Netherlands. w.huisman@mchaaglanden.nl
authors.forename: Wim
authors.initials: W
authors.lastname: Huisman
authors.forename: A Rita
authors.initials: AR
authors.lastname: Horvath
authors.forename: David
authors.initials: D
authors.lastname: Burnett
authors.forename: Victor
authors.initials: V
authors.lastname: Blaton
authors.forename: Rózsa
authors.initials: R
authors.lastname: Czikkely
authors.forename: Rob T P
authors.initials: RT
authors.lastname: Jansen
authors.forename: Anders
authors.initials: A
authors.lastname: Kallner
authors.forename: Desmond
authors.initials: D
authors.lastname: Kenny
authors.forename: Pika
authors.initials: P
authors.lastname: Mesko
authors.forename: Mario
authors.initials: M
authors.lastname: Plebani
authors.forename: José
authors.initials: J
authors.lastname: Queralto
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schumann
authors.forename: Ludek
authors.initials: L
authors.lastname: Sprongl
authors.forename: Dalius
authors.initials: D
authors.lastname: Vitkus
authors.forename: Hans
authors.initials: H
authors.lastname: Wallinder
authors.forename: Simone
authors.initials: S
authors.lastname: Zerah
mesh_terms: D000068:Accreditation / Q000592:standards*; D005060:Europe; D007755:Laboratories, Hospital / Q000592:standards*; D011795:Surveys and Questionnaires