Abstract
Background: A quality management system (QMS) will improve quality in health care units. This report describes the introduction of a QMS according to ISO 9001:2000 in a university cardiovascular surgery department. Methods: First, a thorough analysis of all processes of patient treatment and clinical research was obtained. Multiple interfaces were defined to different departments as well as to administration units. We evaluated and optimized all necessary resources, evaluating customer satisfaction using patients' and referring physicians' surveys. We started quality rounds including surgeons, nurses and technicians. Based on this preparation, we redefined and explained all processes including their responsibilities and necessary resources in the quality manual. Results: After a process of 18 months, an independent, accredited organization recommended that our QMS be given certification according to ISO 9001:2000. Conclusions: Certification of a university cardiovascular surgery department according to ISO 9001:2000 is possible, and may represent the first step towards total quality management (TQM). In complex health care units, certification of separate departments may help generate a consciousness of quality on the way to TQM.
Key words
Quality management - ISO 9001:2000 - Cardiac surgery
References
-
1 Deutsches Institut für Normung e.V .DIN EN IS0 9001:1994. Berlin: Beuth 1994
-
2 Deutsches Institut für Normung e.V .DIN EN IS0 9002:1994. Berlin: Beuth 1994
-
3 Deutsches Institut für Normung e.V .DIN EN IS0 9003:1994. Berlin: Beuth 1994
-
4 Deutsches Institut für Normung e.V .DIN EN IS0 9004:1994. Berlin: Beuth 1994
-
5
Ekkernkamp A.
Akkreditierung und Zertifizierung im Gesundheitswesen. Anspruch und Realität.
Total Quality Management im Gesundheitswesen.
2000;
7
43-49
-
6
Kolkmann F W, Scheinert H D, Schoppe C, Walger M.
KTQ - a project on hospital accreditation.
ZaeFQ.
2000;
94
651-657
-
7
Baldi G, Burani M, Ghirelli L, De Petri S.
Certification of an emergency department according to UNI EN ISO 9002 criteria.
Eur J Emerg Med.
2000;
7
61-66
-
8
Duvauferrier R, Rolland Y, Philippe C. et al .
From accreditation to certification. Quality management in a radiology department.
J Radiol.
1999;
80
1629-1632
-
9
Schönherr U, Händel A.
Quality management system of the Ophthalmology Clinic at the Polyclinic of the Erlangen-Numberg Friedrich Alexander University, Erlangen. Certification according to DIN EN ISO 9001.
Klin Monatsbl Augenheilk.
1999;
215
(Suppl 5)
1-16
-
10 Deutsches Institut für Normung e.V .DIN EN IS0 9001:2000. Berlin:Beuth 1994
-
11 Beholz S, Koch C, Konertz W. Qualitätsmanagementsysteme im Gesundheitswesen - Vorteile durch Revision der DIN EN ISO 9000 - 9004. In: Krian A, Scheld HH, editors Dokumentationsverfahren in der Herzchirurgie. Darmstadt; Steinkopff 2002: 51-59
-
12
Eckert H, Böhmer K.
Reform of the Law DIN EN ISO 9001:2000. Commentary on the new requirements on quality management systems.
ZaeFQ.
2000;
94
669-675
-
13
Fleisch M, Hergan K, Oser W.
Implementation of the quality management system ISO/CD2 9001:2000 in a radiology institute.
Rofo Fortschr Geb Rontengenstr Neuen Bildgeb Verfahr.
2000;
172
195-202
-
14
Jansen-Schmidt V, Paschen U, Kröger S, Bohuslavizki K H, Clausen M.
Introduction of a quality management system compliant with DIN EN ISO 9001:2000 into a university department of nuclear medicine.
Nuklearmedizin.
2001;
40
228-238
-
15
Sens B.
The BAK/KBV/AWMF curriculum “Quality management for physicians”: summary of three years of putting a practical program in a goal-oriented qualification.
ZaeFQ.
2000;
94
689-694
-
16 Schröder T, Korn M, Ennker J. Einführung eines Qualitätsmanagementsystems im Herzzentrum Lahr/Baden zur Verbesserung der Krankenversorgung. In: Krian A, Scheld HH, editors Dokumentationsverfahren in der Herzchirurgie V. Darmstadt; Steinkopff 2000: 117-120
-
17
Paschen U, Bastek A.
Do we need a special language in quality management?.
ZaeFQ.
2000;
94
733-739
-
18
van Dongen.
Good clinical practice, a transparent way of life. A review.
Comp Med Imag Grap.
2001;
5
213-216
-
19 European Agency for the Evaluation of Medicinal Products .ICH Topic E 6. Guideline for Good Clinical Practice. URL: http://www. emea.eu.intlpdfs/human/ich1013595en.pdf 1996
-
20 World Medical Association .IDeclaration of Helsinki. URL: http://www.wma.net/elpolicy/17c.pdf 2000
-
21
Steinbrecher E, Sohr D, Hansen S.
al. Surveillance postoperativer Wundinfektionen - Referenzdaten des Krankenhaus-Infektions-Surveillance-Systems (KISS).
Chirurg.
2002;
73
76-82
-
22
Möller J.
Accreditation and Certification in Health Care. German Experiences with the EFQM Approach.
Total Quality Management im Gesundheitswesen.
2000;
7
59-73
MD Sven Beholz
Department of Cardiovascular Surgery, Charité Humboldt-University Berlin
Luisenstraße 65
10117 Berlin
Germany
Phone: ++49-30-450-522196
Fax: ++49-30-450-522921
Email: sven.beholz@charite.de
