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Abstract
Under the frame of WTO, all the organizations or companies have to develop the laboratory quality management and proficiency testing in order to acquire international trust and accordance. This can also promote the quality of their services and products. Applying the guideline of ISO/IEC43:1997, the International Standard Organization has developed a proficiency testing scheme to evaluate the ability of laboratory in each district. That has increased the trust of a certified laboratory. The trust of a certified laboratory has been increased from the people in the government, the industries, the businesses and social areas.
The present has advanced to the twenty-first century and has expanded forward to the era of nanometer technology. No matter whether it is an organization belonging to the government, academic or industrial organization, all of these organizations regard providing high quality services and/or products as the first target to pursue. Therefore, to ensure good quality of services and/or products becomes an important lesson of the company. This can be accomplished through good laboratory management.
The major subject of this study is about the quality management of a laboratory and its proficiency testing. Two main guidelines, including the ISO/IEC 17025 (1999 edition) and ISO/IEC Guide 43 (1997 edition), are used in this study. The related contents can be applied to all kinds of organizations or companies such as the one in the bio-industry, food industry, other industries and academic or research areas.
The main purpose of this study is twofold. The first is to construct a laboratory management system for the company. This system will meet the management and technical requirements specified in ISO/IEC 17025. The company has three laboratories, one domestic and the other two oversea. These three laboratories all follow the guideline of ISO/IEC 17025, and devote to win a worldwide trust.
The second purpose of this study is to carry out the laboratory proficient testing plan and to ensure the analytical ability of these three laboratories. This company also has several manufacturing plants located in Taiwan and oversea. Their rubber products (tires) are sold worldwide. The uniform and good quality of their products from different plants is an important index that customers pay attention to. The analytical abilities of all three laboratories are maintained at the same level through a frequent crosscheck. Consequently, their products are checked by these laboratories and, therefore, can be well maintained at the same quality.
This thesis has proposed a laboratory quality management guideline which lays out the basis of a laboratory. The manager of the laboratory has to carry out daily work according to this guideline in order to succeed. This thesis also described how to carry out a crosscheck among laboratories and how to analyze data using statistical methods. Several examples, including raw materials, semi-finished products, and final products, were demonstrated to show a complete cycle of the entire process.
The company has built up a laboratory quality management system, and carried out the proficiently testing for the three laboratories. In the near future, the company will continue to extend and to acquire accreditation on other analytical items through domestic and oversea proficiency testing. In addition, the company will ensure that their laboratories have reached the same level as other well-developed countries have. Hopefully, their products can win a worldwide trust and also become very competitive.
Key words: WTO, ISO, IEC, ISO/IEC 17025, ISO/IEC Guide 43, Laboratory quality management, Proficiency testing..
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