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)

Clinical Chemistry and Laboratory Medicine

Volumn 53, Issue 8, 2015, Pages 1173-1180

  Thelen, Marc H M ^a   Vanstapel, Florent J L A ^b   Kroupis, Christos ^c   Vukasovic, Ines ^d   Boursier, Guilaime ^e   Barrett, Edward ^f   Andreu, Francisco Bernabeu ^g   Brguljan, Pika Meško ^h   Brugnoni, Duilio ⁱ   Lohmander, Maria ^j   Sprongl, Ludek ^k   Vodnik, Tatjana ^l   Ghita, Irina ^m   Vaubourdolle, Michel ⁿ   Huisman, Willem ^o  

^a AMPHIA HOSPITAL   (Netherlands)

^b UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^c NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS   (Greece)

^d SESTRE MILOSRDNICE UNIVERSITY HOSPITAL   (Croatia)

^e MONTPELLIER UNIVERSITY HOSPITAL   (France)

^f Consultant Clinical Biochemist ^*  (Ireland)

^g HOSPITAL UNIVERSITARIO PRÍNCIPE DE ASTURIAS   (Spain)

^h UNIVERSITY CLINIC OF RESPIRATORY AND ALLERGIC DISEASES   (Slovenia)

ⁱ SPEDALI CIVILI   (Italy)

^j SIS NU Hospital Care Northern Elfsborg Hospital   (Sweden)

^k Sumperk Hospital   (Czech Republic)

^l CLINICAL CENTER OF SERBIA   (Serbia)

^m Synevo Central Lab Clinical trials   (Romania)

ⁿ University Hospital   (France)

^o Clinical Chemistry and Laboratory Medicine   (Netherlands)

more..

Author keywords

flexible scope; ISO15189; laboratory accreditation; quality management system

Indexed keywords

ACCREDITATION; ARTICLE; CLINICAL CHEMISTRY; COMPETENCE; DISCIPLINES RELATING TO BIOMEDICINE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LABORATORY; LABORATORY TEST; MEDICAL SOCIETY; NETHERLANDS; POTENTIOMETRY; PREVENTIVE HEALTH SERVICE; PRIORITY JOURNAL; QUALITY CONTROL; STANDARD; TANDEM MASS SPECTROMETRY; TOTAL QUALITY MANAGEMENT; CLINICAL MEDICINE; EUROPE; HUMAN; LABORATORY DIAGNOSIS; PRACTICE GUIDELINE; STANDARDS;

ACCREDITATION; CHEMISTRY, CLINICAL; CLINICAL LABORATORY SERVICES; CLINICAL LABORATORY TECHNIQUES; CLINICAL MEDICINE; EUROPE; HUMANS; QUALITY CONTROL;

EID: 84934326356     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2015-0257     Document Type: Article

References (9)

1. ISO 15189-2012, Medical laboratories - Requirements for quality and competence.
2. Huisman W. European medical laboratory accreditation. Present situation and steps to harmonisation. Clin Chem Lab Med 2012;50:1147-52.
3. ISO9001-2008 Quality management systems - Requirements.
4. ISO/IEC 17025-2005, General requirements for the competence of testing and calibration laboratories.
5. List of approved accreditation organizations under the clinical laboratory improvement amendments (CLIA). Available from: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/AOList.pdf. Accessed on March 12, 2015.
6. EA-2/15. EA requirements for the accreditation of flexible scopes.
7. EA-4/17 EA position paper on the description of scopes of accreditation of medical laboratories.
8. Wieringa G, Zerah S, Jansen R, Simundic AM, Queralto J, Solnica B, et al. European Communities Confederation of Clinical Chemistry, The EC4 European syllabus for post-graduate training in clinical chemistry and laboratory medicine: version 4, 2012. Clin Chem Lab Med 2012;50:1317-28.
9. Raad voor Accreditatie RV. Medical laboratories source scopes [Dutch]. Available from: https://www.rva.nl/en/document/download/F004-3. Accessed on March 12, 2015.