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Article
Publication date: 9 January 2009

Izatul Hamimi Abdul Razak, Shahrul Kamaruddin, Ishak Abdul Azid and Indra Putra Almanar

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…

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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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Article
Publication date: 1 July 2006

Rosmaini Ahmad, Shahrul Kamaruddin, Zahid A. Khan, Mohzani Mokthar and Indra Putra Almanar

To introduce a research carried out in a real world for implementing a dust control system (DCS) for controlling the indoor air quality (IAP) on the production floor of one of the…

1907

Abstract

Purpose

To introduce a research carried out in a real world for implementing a dust control system (DCS) for controlling the indoor air quality (IAP) on the production floor of one of the major electronics company in Malaysia.

Design/methodology/approach

The paper is arranged as follows, a brief description of the significant of DCS in electronic industry and brief introduction to the electronic company as a case study company for introducing the DCS. The discussion on the characteristics management and planning tools (MPTs) that have been adopted as the analysing tools for assisting in the decision‐making process in identifying the problems and improvement strategies. It follows by the detail analysis phase regarding the implementation process that it as backbone for introducing the DCS. Finally a discussion about the result obtained from the MPT analysis on the techniques for identifying the root causes of the dust pollution problem as well as the best improvement strategies that can be adopted by the case study company.

Findings

Three analysis techniques from MPT have been used; there are relation diagram, tree diagram and prioritization matrices analyses. These techniques are very powerful for analysing the specific problem using verbal data. The outputs (results) from these techniques have been used as the solutions to the dust pollution problem. As a result, the implementations of DCS successfully reduce the dust level and stabilise the dust distribution on the production floor.

Practical implications

This paper offer a systematic way in identifying and controlling the IAP in industry.

Originality/value

This paper introduces very useful methods in decision making for identifying the solutions for environmental problem and implementation of DCS in a real world environment.

Details

Management of Environmental Quality: An International Journal, vol. 17 no. 4
Type: Research Article
ISSN: 1477-7835

Keywords

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Article
Publication date: 30 December 2021

Nse Udoh and Effanga Effanga

This work seeks to develop a geometric imperfect preventive maintenance (PM) and replacement model (GIPMAR) for aging repairable systems due to age and prolong usage that would…

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Abstract

Purpose

This work seeks to develop a geometric imperfect preventive maintenance (PM) and replacement model (GIPMAR) for aging repairable systems due to age and prolong usage that would meet users need in three phases: within average life span, beyond average life span and beyond initial replacement age of system.

Design/methodology/approach

The authors utilized the geometric process (GP) as the hazard function to characterize the increasing failure rate (IFR) of the system. The GP hazard function was incorporated into the hybridized preventive and replacement model of Lin et al. (2000). The resultant expected cost rate function was optimized to obtain optimum intervals for PM/replacement and required numbers of PM per cycle. The proposed GIPMAR model was applied to repairable systems characterized by Weibull life function and the results yielded PM/replacement schedules for three different phases of system operation.

Findings

The proposed GIPMAR model is a generalization of Lin et al. (2000) PM model that were comparable with results of earlier models and is adaptive to situations in developing countries where systems are used across the three phases of operation depicted in this work. This may be due to economic hardship and operating environment.

Practical implications

The proposed model has provided PM/Replacement schedules for different phases of operation which was never considered. This would provide a useful guide to maintenance engineers and end-users in developing countries with a view to minimizing the average cost of maintenance as well as reducing the number of down times of systems.

Social implications

A duly implemented GIPMAR model would ensure efficient operation of systems, optimum man-hour need in the organization and guarantee customer's goodwill in a competitive environment.

Originality/value

In this work, the authors have extended Lin et al. (2000) PM model to provide PM/replacement schedules for aging repairable systems which was not provided for in earlier existing models and literature.

Details

International Journal of Quality & Reliability Management, vol. 40 no. 2
Type: Research Article
ISSN: 0265-671X

Keywords

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