Effect of accreditation schemes on the setting of quality specifications by laboratories

Scandinavian Journal of Clinical and Laboratory Investigation

Volumn 59, Issue 7, 1999, Pages 575-578

  Libeer, Jean Claude ^a  

^a SCIENTIFIC INSTITUTE OF PUBLIC HEALTH   (Belgium)

Author keywords

EN 45001; ISO 15189; ISO 17025; Quality requirements

Indexed keywords

ACCREDITATION; CERTIFICATION; GOOD LABORATORY PRACTICE; HEALTH CARE QUALITY; LABORATORY DIAGNOSIS; LAW; PRIORITY JOURNAL; REVIEW; STANDARD; TOTAL QUALITY MANAGEMENT;

EID: 0033374631     PISSN: 00365513     EISSN: None     Source Type: Journal    
DOI: 10.1080/00365519950185382     Document Type: Review

References (12)

1. 1 ISO/IEC Guide 2: standardization and related activities. General Vocabulary, 1996.
2. 2 EN 45001: General criteria for the operating of testing laboratories. CEN/CENELEC, 1989.
3. 3 ISO/IEC Guide 25: General requirements for the competence of calibration and testing laboratories, 1990.
4. 4 ISO 9002: Quality systems-model for quality assurance in production, installation and servicing. 1994.
5. 5 Libeer JC. Total quality management for medical laboratories: a European point of view, http:// www.westgard.com.guest9.htm 1998.
6. 6 ISO/DIS 15189: Quality management in the medical laboratory, 1999.
7. 7 Deming WE. Out of the crisis. Cambridge, MA: MIT Center for Advanced Engineering Study, 1982.
8. 8 ISO/TC 212. ISO CD 15190: Clinical laboratory safety.
9. 9 International federation of Clinical Chemistry (IFCC): Strategic Plan 1996.
10. 10 CLIA'88. Clinical Laboratory Improvement Amendments of 1988. Federal Register Vol. 58, No. 11, 19-1-1993.
11. 11 NATA/RCPA Medical requirements 1996 (downloadable from http://www.nata.asn.au)
12. 12 Haeckel R, Böhm M, Capel PJA, Høiby 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: 399-403.