Pregled bibliografske jedinice broj: 496169
Integrating Six Sigma into Quality Management Systems in the Medical Device Industry
Integrating Six Sigma into Quality Management Systems in the Medical Device Industry // Proceedings of the 19th Central European Conference on Information and Intelligent Systems / Auer, Boris ; Bača, Miroslav ; Rabuzin, Kornelije (ur.).
Varaždin: Fakultet organizacije i informatike Sveučilišta u Zagrebu, 2008. str. 563-570 (predavanje, međunarodna recenzija, cjeloviti rad (in extenso), stručni)
CROSBI ID: 496169 Za ispravke kontaktirajte CROSBI podršku putem web obrasca
Naslov
Integrating Six Sigma into Quality Management Systems in the Medical Device Industry
Autori
Hrgarek, Nadica ; Bowers, Kerri-Anne
Vrsta, podvrsta i kategorija rada
Radovi u zbornicima skupova, cjeloviti rad (in extenso), stručni
Izvornik
Proceedings of the 19th Central European Conference on Information and Intelligent Systems
/ Auer, Boris ; Bača, Miroslav ; Rabuzin, Kornelije - Varaždin : Fakultet organizacije i informatike Sveučilišta u Zagrebu, 2008, 563-570
ISBN
978-953-6071-043
Skup
19 th Central European Conference on Information and Intelligent Systems (CECIIS)
Mjesto i datum
Varaždin, Hrvatska, 24.09.2008. - 26.09.2008
Vrsta sudjelovanja
Predavanje
Vrsta recenzije
Međunarodna recenzija
Ključne riječi
Medical device ; QMS ; quality improvement ; quality management system ; Six Sigma
Sažetak
Six Sigma is a valuable management strategy to improve business processes, reduce development and production costs, increase profit margin and improve customer satisfaction. The purpose of this paper is to describe how applicable Six Sigma concepts may complement and support formal quality management systems (QMS) in the medical device industry. A significant number of issues, which increase the development costs and times, is often found during different phases of a medical device life cycle. Some defects with high patient safety risk may result in dangerous and very costly product recalls. The basic idea of this paper is to explore the possibilities of integrating Six Sigma techniques with an existing QMS throughout the entire life cycle of a medical device. This paper addresses how Six Sigma techniques, when appropriately integrated into the QMS at medical device companies, can eliminate defects earlier in the medical device life cycle, identify major opportunities for cost savings, focus on customer needs and expectations, and improve the overall business processes.
Izvorni jezik
Engleski
Znanstvena područja
Temeljne medicinske znanosti, Informacijske i komunikacijske znanosti
