Quality planning in the 'in vitro diagnostic' industry

Accreditation and Quality Assurance

Volumn 6, Issue 9-10, 2001, Pages 415-420

  Lasky, Fred D ^a  

^a Ortho Clinical Diagnostics Inc   (United States)

Author keywords

Design; In vitro diagnostics; Manufacturing; Quality system

Indexed keywords

EID: 0035438137     PISSN: 09491775     EISSN: None     Source Type: Journal    
DOI: 10.1007/s007690100376     Document Type: Article

References (12)

1. Harry M, Schroeder R (1999) Six sigma: The breakthrough management strategy revolutionizing the world's top corporations. Doubleday & Company, New York
2. Hinckley CM (1997) Clin Chem 43:873-879
3. United States Department of Health & Human Services (1992) 42 CFR Part 820, Quality system regulation. Washington D.C.
4. ISO 9001 (1994) Quality systems -model for quality assurance in design/development, production, installation and servicing. International Standards Organization (ISO), Geneva
5. ISO 13485 (1998) Quality systems -medical devices - particular requirements for the application of ISO 9001, installation and servicing. ISO, Geneva
6. United States Department of Health & Human Services, Food and Drug Administration, (7 October 7, 1996) 21CFR Part 820, Medical devices current good manufacturing practice (cGMP), Final Rule, Fed Regist (1996) 61:52601-52662
7. Lasky FD, Boser RB (1997) Clin Chem 43:866-872
8. Powers DM, Greenberg N (1999) Scand J Clin Lab Invest 59:539-543
9. United States Department of Health & Human Services (1992) 42 CFR Part 405 et al. Clinical laboratory improvement amendments of 1988. Washington D.C.
10. Qualitätssicherung der quantitativen Bestimmungen im Laboratorium. Neue Richtlinien der Bundesärztekammer (1988) Deutsches Ärzteblatt 85: B517-532
11. United States Department of Health & Human Services (1992) 21 CFR Part 809.10 In vitro diagnostic products for human use; Labeling. Washington D.C.
12. Directive 98/79/EC of the European Parliament and of the Council. Brussels