title: Reflections and proposals to assure quality in molecular diagnostics.
abstract: Molecular diagnostic testing has become an important tool in clinical laboratories. Accreditation according to the international quality standard ISO15189:2007 for medical laboratories is required for reimbursement of several molecular diagnostic tests in Belgium. Since the ISO15189:2007 standard applies to medical laboratories in general, the particular requirements for quality and competence are mentioned in general terms, not taking into account the specificities of molecular biology testing. Therefore, the working group "MolecularDiagnostics.be" described a consensus interpretation of chapter 5, Technical requirements, of the ISO standard for application in molecular diagnostic laboratories. The manuscript can be used as an instrument to prepare internal and external audits that meet the 15015189:2007 (chapter 5) criteria.
authors.affiliation: Laboratorium voor Moleculaire Biologie, Klinisch Laboratorium, Jessa Ziekenhuis, campus Virga Jesse, Hasselt, België. marijke.raymaekers@jessazh.be
authors.forename: M
authors.initials: M
authors.lastname: Raymaekers
authors.forename: M
authors.initials: M
authors.lastname: Bakkus
authors.forename: E
authors.initials: E
authors.lastname: Boone
authors.forename: B
authors.initials: B
authors.lastname: de Rijke
authors.forename: H
authors.initials: H
authors.lastname: El Housni
authors.forename: P
authors.initials: P
authors.lastname: Descheemaeker
authors.forename: P
authors.initials: P
authors.lastname: De Schouwer
authors.forename: S
authors.initials: S
authors.lastname: Franke
authors.forename: F
authors.initials: F
authors.lastname: Hillen
authors.forename: F
authors.initials: F
authors.lastname: Nollet
authors.forename: O
authors.initials: O
authors.lastname: Soetens
authors.forename: A
authors.initials: A
authors.lastname: Vankeerberghen
mesh_terms: D001530:Belgium; D006801:Humans; D007755:Laboratories, Hospital / Q000592:standards; D025202:Molecular Diagnostic Techniques / Q000592:standards*; D021141:Nucleic Acid Amplification Techniques / Q000592:standards*; D011786:Quality Control