Effect of current and forthcoming European legislation and standardization on the setting of quality specifications by laboratories

Scandinavian Journal of Clinical and Laboratory Investigation

Volumn 59, Issue 7, 1999, Pages 569-573

  Haeckel, Rainer ^a   Kindler, M ^a  

^a Institut fur Laboratoriumsmedizin   (Germany)

Author keywords

Accreditation; Certification; IVD Directive; Total quality management

Indexed keywords

ACCREDITATION; EUROPE; HEALTH CARE ORGANIZATION; HEALTH CARE QUALITY; LABORATORY DIAGNOSIS; LAW; PRIORITY JOURNAL; REVIEW; STANDARD; TOTAL QUALITY MANAGEMENT;

EID: 0033393474     PISSN: 00365513     EISSN: None     Source Type: Journal    
DOI: 10.1080/00365519950185373     Document Type: Review

References (13)

1. 1 Qualittssicherung der quantitativen Bestimmungen im Laboratorium. Neue Richtlinien der Bundesräztekammer. Deutsches Ärzteblatt 1988; 85: B517-32.
2. 2 Haeckel R. Validation of analytical procedures in laboratory medicine. Workshop report. Mitt Dt Ges Klin Chem 1999 (in preparation).
3. 3 Directive 98/79/EC of the European Parliament of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices. Offic J Europ Commun 1998; L331: 1-37.
4. 4 Guidelines for the evaluation of analysers in clinical chemistry. ECCLS Doc 1986; 3: 1-32.
5. 5 Ettarp L. An overview of international conformity assessment systems. SWEDAC Doc 1998; 10: 1-42.
6. 6 Jansen RTP, Blaton V, Burnett D, Huisman W, Queralto JM, Zérah S, et al. Essential criteria for quality systems of medical laboratories. Eur J Clin Chem Clin Biochem 1997; 35: 123-32.
7. 7 ISO/DIS 15189. Quality management in the medical laboratory International Organization for Standardization ISO/TC 212/WG 1, 1998.
8. 8 The European Quality Award 1997. Information Brochure. European foundation for Quality Management. B-1200 Brussels.
9. 9 Haeckel R, Böhm M, Capel PJA, Hoiby N, Jansen RTP, Kallner A, Kelly A, Kruse-Jarres JD, Küffer H, Libeer JC. Concepts for a model of good medical laboratory services. Clin Chem Lab Med 1998; 36: 339-403.
10. 10 Continuous quality improvement: essential management approaches. Draft guideline. GP 22-A. National Committee for Clinical Laboratory Standards, USA, 1999.
11. 11 Goldschmidt HMJ, Cox MJT, Grouls RJE, van de Laar WAJH, van Merode FGG. Reference information model for clinical laboratories. Amsterdam: IOS Press, 1998: 1-251.
12. 12 ORYX: the next evolution in accreditation. Oakbrook Terrace, IL: Joint Commission on Accreditation in Healthcare Organizations, 1999.
13. 13 Sandberg S, Hellsing K, Jörgensen PJ, Monsen G. SKUP. Skandinavisk samarbeid om utpröving av laboratorieulstyr for primärhelsetjenesten. Klinisk Kemi Norden 1997; 2: 49-52.