Quality Management Systems: Risk Assessment


Two observable facts have gradually amplified the significance of quality assurance: the demand for more performance and the demand for better quality, both at a lower cost. The conventional price per performance ratio has intensified the relationship between price, performance and quality. Almost all organizations all over the world have realized the need for quality assurance in the production of goods and services. In most organizations quality by design or quality assurance is implemented through a Quality management system (QMS). QMS are the activities in the management function that influence the quality of policies, responsibilities, objectives and their implementation through quality control, quality planning, and quality improvement. Most organizations are focusing on the quality improvement process than on the product itself (Lari, 2002). In other terms a quality management system is the process of quality improvement where skills are used to add value to the quality of the products and enhance their future. This is done to retain present customers, and welcome new ones. This paper will look at quality assurance in electrons, quality management systems in Malaysia, and quality by design in pharmaceutical technology.

Quality by design in electrons

The performance of computers mostly office computers or small mainframes has increased in the last few years. The gate tot up and the performance of computer mainframes increased too, while their proportions remained untouched or lessened. The demand for more quality office computers and mainframes has been on the increase despite the increasing performance and complications. Both, the rise in complexity and the demands for more quality or electronic devices, have led t more demands on the quality of the single apparatus and production techniques and to more concentration on quality management. This means that not only the incoming assessment of all apparatus, usually a 100% test of input factors, but also the methodical assessment and prerequisite of these apparatus on a sample base. Prerequisite tests include measurement of all electrical and mechanical properties, and also include environmental and life tests. In the same sense, qualification of all production methods, as well as transitional and final tests of the products, is part of quality assurance (Barnes, 2004).

Quality management systems in Malaysia

Quality management in Malaysia started in 1995. It was initiated by the government after realizing the importance of adopting the International Organization for Standardization Standards (ISA 9000). The Manpower and Planning Unit (MAMPU) established a set of strategies for the implementation of Malaysian Standard International Organization for Standardization Standards (MS ISO 9001:2000). The prime minister later gave an order to the public sectors to implement QMS using MS ISO 9001:2000 (Lee, et.al 1992). The aim of setting the ISO standards was to establish a level to which producers and consumers would adhere as a way of promoting quality. The education sector was one of the sectors that made an immediate move to implement these standards. This was more evident in the libraries of public universities in the country

The purpose of the ISO certification was to boost quality in organizations, enhance communications, and decrease the cost of operation. The information management system required for ISO certification had to be based on decision making, problem shooting and prior understanding of management (Sirim, 2005).

QMS is a concept that is being applied in the Malaysian Construction Industry and other public sectors. Its implementation takes place at either the project level or the organization level (Ahmadinejad & Keymanesh, 2006). In Malaysia’s construction industry, there are about 4000 ISO 9001:2000 QMS certified organizations. This represents a small percentage of the total number of organizations in the construction industry (Chan & Nealey, 1998). The compliance of QMS is one of the key factors required for the improvement of quality in the Malaysian construction industry.

Quality by design in pharmaceutical technology

Product and process traits important to preferred performance must be a resultant of a combination of former knowledge and experimental appraisal during product development. The clinical study is viewed as assenting performance testing to the model (Ermer & Miller, 2005). Quality system in pharmaceutical development reflects and addresses the following

  • Customer requirements
  • combination of product and process acquaintance gained during growth
  • sustained control of the manufacturing procedure
  • Continuous developments.

The new major dispute that the pharmaceutical industry is facing in the innovation and development of new drugs is to decrease costs and time needed from invention to market, while at the same time lifting principles of quality. Technologies are considering developing and opening doors to new openings in no way seen before. Some of the best examples of new technologies existing in the life sciences are microarray technologies or high-throughput transmission. These new technologies are positive routes that all pharmaceutical companies pursue (Brittain, 1999). The new technologies have been included to do the same things as before, but faster and deeper, with more computerization, with more accuracy, and by gathering more data per investigational unit. The quantity of data and disk room required for the storage of experiments has blown up exponentially.


Many organizations all over the world have realized the need for quality improvement in their service delivery and production process. Quality management is the improvement of the activities carried out in production or service delivery. Malaysia is one of the countries that have been upholding quality management in all sectors of the economy. it has also been implemented in the electronic industries and pharmaceuticals.

Reference list

  1. Lee, S.F et.al (1992). Survey on ISO 9001 Quality Management System Implementation in Hong Kong, 14, (77-88).
  2. Sirim, A. (2005). Standard and Quality News: Quality Management Beyond ISO 9000, Vol. 12(3)/2005
  3. Ahmadinejad, M. & Keymanesh, M. (2006). The Survey Of Implementing Quality Management System In Iran Construction Industry, International Civil Engineering Conference “Towards Engineering Practice” Surabaya, 2006.
  4. Chan, Y.K & Nealey, K. (1998). ISO 9004-2 Quality Management System – The way to World-Class Service, 6, (395-401).
  5. Lari, A. (2002). An Integrated Information System for Quality Management. Business Process Management, Vol. 8, no. 2:169-182.
  6. Barnes, J. R. (2004). Robust electronic design reference book, Volume 1 ISBN 1402077394, 9781402077395. New York: Springer
  7. Brittain, H.G. (1999). Polymorphism in pharmaceutical solids Volume 95 of Drugs and the pharmaceutical sciences. New York: Informa Health Care
  8. Ermer, J. & Miller J. M. (2005). Method validation in pharmaceutical analysis: a guide to best practice. Wiley-VCH
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