Reap the rewards of quality with ISO 9000

Ben-Yaacov, G.

doi:10.1109/67.468292

Cited by 4 publications

(3 citation statements)

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“…The main reference in developing this reference model is the road maps of ISO 9001 implementation developed by Yaacov (1995) and Motwani ISO 13485:2003ISO 9001:2000 The requirements are specific to organizations providing medical devices regardless of type or size of the organization…”

Section: Tqm 211mentioning

confidence: 99%

“…As the effective quality system's implementation, SMEs strongly require involvement and commitment from the entire organization, especially the lower level employees from the very beginning of the implementation project (Yaacov, 1995 Mackau, 2003). Thus, in order to gain this commitment, the employees must be informed on how the new QMS would benefit them and the company (Angelogiannopoulos et al, 2006).…”

Section: Phase 2: Implementation Phasementioning

confidence: 99%

“…As the effort moves forward, it is important to measure progress (Yaacov, 1995). The monitoring and measuring process is important for three reasons; to ensure product conformance, to ensure conformance of the QMS, and to maintain effectiveness of the QMS.…”

Section: Phase 2: Implementation Phasementioning

confidence: 99%

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Iso 13485:2003

et al. 2009

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If you would like to write for this, or any other Emerald publication, then please use our Emerald for Authors service information about how to choose which publication to write for and submission guidelines are available for all. Please visit www.emeraldinsight.com/authors for more information. About Emerald www.emeraldinsight.comEmerald is a global publisher linking research and practice to the benefit of society. The company manages a portfolio of more than 290 journals and over 2,350 books and book series volumes, as well as providing an extensive range of online products and additional customer resources and services.Emerald is both COUNTER 4 and TRANSFER compliant. The organization is a partner of the Committee on Publication Ethics (COPE) and also works with Portico and the LOCKSS initiative for digital archive preservation. Abstract Purpose -The purpose of this paper is to provide an understanding on implementation and operation of ISO 13485:2003 -"Medical Devices -Quality Management System -Requirements for Regulatory Purposes" -in the perspective of medical device industries in Malaysia. The study is focused on the Malaysian Small and Medium Enterprises (SMEs) which currently have accredited to ISO 9001:2000 quality management systems. Design/methodology/approach -Literature research and comparative analysis between ISO 13485:2003 and ISO 9001:2000 standard and requirements. A reference model is developed to assist the Malaysian SMEs towards ISO 13485:2003 accreditation.Findings -Unlike ISO 9001:2000, ISO 13485:2003 stresses the safety and efficacy of medical devices that are being produced. For this reason risk management is an essential process that needs to be adopted into the ISO 13485:2003 quality management system. Moreover, to demonstrate the effectiveness of the ISO 13485:2003 implementation, this standard has placed great emphasis on documentation requirements which are more prescriptive in insisting on the use of formal procedures. Originality/value -The paper provides guidelines to ISO 13485:2003 implementations as well as risk management approaches for small and medium-sized businesses of Malaysian medical device manufacturers, which at the same time maintains its ISO 9001:2000 certification.

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Section: Tqm 211mentioning

confidence: 99%