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a higher demand for regulatory compliance, a higher consciousness of the customer the client wants to know the level of con dence of the reported result and under impulse of new, more exigent European and international standards such as the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 norm for laboratory accreditation The underlying key principle is comparability of results between laboratories and on a wider, international basis In order for results to be comparable, they must be reported with a statement of measurement uncertainty (MU) and they must be traceable to common primary references Methods must be validated to show that they actually measure what they are intended to measure that they are t for their speci c purpose Because validation and quality assurance (QA) apply for a speci c analytical method, it is important to approach each method on a case-by-case basis.



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25th Int Symp: 176; 1995 Xu J, Randell B, Romanovsky A, Stroud RJ, Zorzo AF, Canver E, Von Henke F Rigorous development of an embedded fault-tolerant system based on coordinated atomic actions IEEE Trans Comp 51(2): 164 79, 402 9; 2002 Bauman RA, Gell G, Dwyer SJ III Large picture arching and communication systems of the world Parts 1 and 2 J Digit Imag 9(3 4): 99 103, 172 7; 1996 Dayhoff RE, Meldrum K, Kuzmak PM, Experience providing a complete online multimedia patient record Session 38 Healthcare Information and Management Systems Society, 2001 An Conf and Exhib; 4 8 Feb 2001 GE Medical Systems Technical White Paper Cluster PACS Pilot project proposal for Hong Kong Hospital Authority; Feb 2002 Ha D-H, Moon M-S Effectiveness of wireless communication using 100 Mbps infrared in PACS Dept of Diagnostic Radiology and PACS team, Pundang CHA General Hospital, Pochon CHA University, Sungnam, Korea.





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Proc SPIE Med Imag; 2002 Huang HK PACS: Basic Principles and Applications New York: Wiley; 1999 Huang HK Consultancy study of image distribution and PACS in Hong Kong Final report HA 105/26 VII CL; 21 Mar 2002 Huang HK Development of a digital medical imaging archiving and communication system (MIACS) for services of Department of Health HKSAR government Final report; 15 Jul 2002..

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An analytical method is a complex, multistep process starting with sampling and ending with the generation of a result Although every method has its speci c scope, application, and analytical requirement, the basic principles of validation and QA are the same regardless the type of method or sector of application The information in this chapter is mainly taken from analytical chemistry, but it applies to other sectors as well The validation of analytical methods, the establishment of traceability of results, and the assessment of MU should be done in a uniform, harmonized way, conforming with internationally recognized standards from institutions such as Eurachem, the International Union of Pure and Applied Chemistry (IUPAC), or ISO It is important to issue a common understanding on the topics of method validation, traceability, and uncertainty of measurements Here, the interrelationships between method validation, traceability, and MU of results will be elucidated.

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Throughout the landscape of guidelines and standards, the most relevant information is selected, compiled, and summarized Great importance is attached to the different method performance parameters and their de nitions, ways of expression, and approaches for practical assessment We discuss the role of method validation within QA as well as the topics of standardization, internal and external quality control (IQC and EQC, respectively), and accreditation and the links between these different aspects This chapter provides a general, complete, and up-to-date overview of the topic of quality of analytical measurements in the wide sense of the word It is useful for the completely inexperienced scientist as well as those involved in this topic for a long time who have lost their way in the labyrinth and are looking for more explanation on a particular aspect or deeper insight and knowledge..

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