ISO 15189, some comments on its application in the coagulation laboratory

Blood Coagulation and Fibrinolysis

Volumn 15, Issue 7, 2004, Pages 613-617

  Wiwanitkit, Viroj ^a  

^a CHULALONGKORN UNIVERSITY   (Thailand)

Author keywords

Coagulation laboratory; ISO 15189

Indexed keywords

ACCREDITATION; ARTICLE; BLOOD CLOTTING TEST; CLINICAL LABORATORY; GOOD LABORATORY PRACTICE; HEALTH CARE QUALITY; HEMOSTASIS; ISO 15189; LABORATORY TEST; ORGANIZATION; PERFORMANCE; PRIORITY JOURNAL; STANDARD; STANDARDIZATION; TOTAL QUALITY MANAGEMENT; WORLD HEALTH ORGANIZATION;

BLOOD COAGULATION TESTS; CLINICAL LABORATORY TECHNIQUES; HUMANS; LABORATORIES, HOSPITAL; QUALITY CONTROL;

EID: 5644273774     PISSN: 09575235     EISSN: None     Source Type: Journal    
DOI: 10.1097/00001721-200409000-00013     Document Type: Article

References (21)

1. Wiwanitkit V. Types and frequency of preanalytical mistakes in the first Thai ISO 9002:1994 certified clinical laboratory, a 6-month monitoring. BMC Clin Pathol 2001; 1:5.
2. Plebani M. Appropriateness in programs for continuous quality improvement in clinical laboratories. Clin Chim Acta 2003; 333:131-139.
3. Dati F. Quality management and standardization programs in hemostaseology. J Int Fed Clin Chem 1996; 8:110-116.
4. Tatsumi N, Takubo T, Tsuda I, Hino M. Current problems in quality contro (QC) in hematology. Rinsho Byori 1997; 45:997-1002.
5. Kuwa K. Laboratory accreditation and proficiency testing. Rinsho Byori 2003; 51:449-455.
6. Horvath AR, Ring R, Feher M, Miko T. Accreditation of medical laboratories. Orv Hetil 2003; 144:1481-1487.
7. Kenny D. ISO and CEN documents on quality in medical laboratories. Clin Chim Acta 2001; 309:121-125.
8. Wiwanitkit V. ISO 9000 quality system in laboratory medicine. Med J Ubon Hosp 1999; 20;217-225.
9. Dellavalle A, Marzocchi A, Steffenino G. Certification of quality in catheterization laboratories: from the requirements of GISE to ISO 9002. Ital Heart J 2003; 4(suppl):28-31.
10. Wiwanitkit V. ISO 14000 quality system in laboratory medicine. Bull Lampang Hosp 2000; 21;62-66.
11. Honsa JD, McIntyre DA. ISO 17025: practical benefits of implementing a quality system. J AOAC Int 2003; 86:1038-1044.
12. Haeckel R, Kindler M. Effect of current and forthcoming European legislation and standardization on the setting of quality specifications by laboratories. Scand J Clin Lab Invest 1999; 59:569-573.
13. Haeckel R, Bohm M, Capel PJ, Hoiby N, Jansen RT, Kallner A, et al. Concepts for a model of good medical laboratory services. Clin Chem Lab Med 1998; 36:399-403.
14. Burnett D, Blair C. Standards for the medical laboratory - harmonization and subsidiarity. Clin Chim Acta 2001; 309:137-145.
15. Bremond J, Plebani M. IVD industry role for quality and accreditation in medical laboratories. Clin Chim Acta 2001; 309:167-171.
16. White B. The impact of ISO 15189 and ISO 9001 quality management systems on reducing errors. Vox Sang 2002; 83(suppl 1):17-20.
17. Kubono K. Quality management system in the medical laboratory - ISO 15189 and laboratory accreditation. Rinsho Byori 2004; 52: 274-278.
18. Libeer JC. Effect of accreditation schemes on the setting of quality specifications by laboratories. Scand J Clin Lab Invest 1999; 59: 57S-578.
19. Wiwanitkit V. Rejection of specimens for prothrombin time and relating pre-analytical factors in blood collection. Blood Coagul Fibrinolysis 2002; 13:371-372
20. Cooper G. Preparation and considerations when seeking laboratory accrediation under ISO 15189 [http://www.sacb.org.sg/documents/ PreparinglabforISO15189-Gcooper.pdf].
21. Technical Committee ISO/TC 212. Clinical Laboratory Testing and In Vitro Diagnostic Test System. ISO 15189, Medical Laboratories - Particular Requirements for Quality and Competence, 1st edition. Philadelphia, PA: ISO; 15 February 2003.