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'''[[ISO/IEC 17025]]''' is an [[International Organization for Standardization]] (ISO) standard used by testing and calibration laboratories to provide a basis for accreditation of laboratory quality systems. There are many commonalities with the [[ISO 9000]] family of standards, but ISO/IEC 17025 adds in the concept of competence to the equation, applying directly to those organizations that produce testing and calibration results.
'''"[[Journal:Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study|Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study]]"'''


ISO/IEC 17025:1999 was issued by the ISO in late 1999 and was internationally adopted in 2000. A second release was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000 version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior management, as well as explicit requirements for continual improvement of the management system itself, particularly communication with the customer.
For the release of precise and accurate reports of [[Medical test|routine tests]], its necessary to follow a proper [[quality management system]] (QMS) in the [[clinical laboratory]]. As one of the most popular QMS tools for process improvement, Six Sigma techniques and tools have been accepted widely in the [[laboratory]] testing process. Six Sigma gives an objective assessment of analytical methods and instrumentation, measuring the outcome of a process on a scale of 0 to 6. Poor outcomes are measured in terms of defects per million opportunities (DPMO). To do the performance assessment of each clinical laboratory [[analyte]] by Six Sigma analysis and to plan and chart out a better, customized [[quality control]] (QC) plan for each analyte, according to its own sigma value ... ('''[[Journal:Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study|Full article...]]''')<br />
 
''Recently featured'':
The ISO/IEC 17025 standard itself comprises five elements: scope, normative references, terms and definitions, management requirements, and technical requirements. In particular the management and technical requirements are the most important sections, with the management requirement section detailing the operation and effectiveness of the quality management system within the laboratory and the technical requirements section detailing the factors which determine the correctness and reliability of the tests and calibrations performed in laboratory. ('''[[ISO/IEC 17025|Full article...]]''')<br />
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Revision as of 16:52, 29 April 2024

Fig1 Karaattuthazhathu NatJLabMed23 12-2.png

"Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study"

For the release of precise and accurate reports of routine tests, its necessary to follow a proper quality management system (QMS) in the clinical laboratory. As one of the most popular QMS tools for process improvement, Six Sigma techniques and tools have been accepted widely in the laboratory testing process. Six Sigma gives an objective assessment of analytical methods and instrumentation, measuring the outcome of a process on a scale of 0 to 6. Poor outcomes are measured in terms of defects per million opportunities (DPMO). To do the performance assessment of each clinical laboratory analyte by Six Sigma analysis and to plan and chart out a better, customized quality control (QC) plan for each analyte, according to its own sigma value ... (Full article...)
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