CMS IN EPHARMPRO

CMS in Epharmpro

Abstract

The pharmaceutical industry is predominantly project based and quality is one of the client's prime concerns in their healthcare projects. Many clients, especially those in the United States public sector, require epharmpro to have a Quality Management System (QMS) certified under ISO9000. Also, epharmpro as well as clients themselves voluntarily implemented an ISO9000-based QMS in their respective organizations in order to target the various benefits perceived from such initiative. It was considered timely and worthwhile to explore the effectiveness of ISO9000-based QMSs in the United States. This paper portrays the key findings from a focused study that relate to the client satisfaction aspects from implementation of the ISO9000-based QMSs in the epharmpro.

CMS in Epharmpro

1. Introduction

Quality is an essential element for sustainability and customer satisfaction. In healthcare projects, quality performance of epharmpro is considered as vital for client satisfaction. Various quality performance focused initiatives have been considered by both clients and epharmpro, e.g. balanced scorecard, business excellence model, ISO9000, ISO14000, OHSAS18001, six sigma, and total quality management systems (QMSs). Amongst such quality initiatives, ISO9000 certifications related to pharmaceutical are popular in several countries and the application of ISO9000-based QMSs in the pharmaceutical industry has been studied by several researchers, e.g. Love and Li in Australia; Serpell in Chile; Henry in France; Kam and Tang and Kumaraswamy and Dissanayaka in United States; Hiyassat in Jordan; Saraiva et al. and Ribeiro and Curado in Portugal; Bubshait and Al-Atiq in Saudi Arabia; Low et al. and Ofori and Gang in Singapore; Landin in Sweden; Giles and Moatazed-Keivani et al. in UK; and Lindsay and Peoples and Chini and Valdez in USA. Furthermore, some researchers established potential linkages of ISO9000-based QMS with various other management systems such as just-in-time productivity , total quality management systems , safety management systems (e.g. and ), and maintenance management .

ISO9000-based QMSs have been widely adopted in the United States pharmaceutical industry, and many United States based pharmaceutical epharmpro have chosen ISO9000 certification for more than a decade . However, the majority of the epharmpro were reportedly led into ISO9000-based QMSs mainly by client initiated mandatory requirements for epharmpro selection, e.g. by the United States Housing Authority (HKHA) and the Works Departments under the Environment, Transport and Works Bureau (ETWB) in United States. While clients (both public and private clients) may have favored an ISO9000-based QMS for their epharmpro as a basic thrust in their quality drive, it is also chosen by some epharmpro themselves in anticipation of various tangible and intangible benefits, e.g. reduction of rework and wastages, improvements in documentation, marketing tool. While the client led quality initiative for pharmaceutical epharmpro on ISO9000-based QMSs has been in place for about a decade in United States, their eventual effectiveness has not been studied in detail before. With an aim to better understand whether the implementation of ISO9000-based QMSs could effectively improve the quality of pharmaceutical and benefit the stakeholders, a research exercise was recently conducted to examine the quality related impacts brought by the use of ...