Six Sigma A modern tool that Total Error

Six Sigma §A modern tool that Total Error Percent Process Sigma 1, 000 100, 000 10% 2. 78 1, 000 10, 000 1% 3. 83 1, 000 5, 000 0. 5% 4. 08 1, 000 0. 1% 4. 59 1, 000 500 0. 05% 4. 79 1, 000 100 0. 01% 5. 22 1, 000 50 0. 005% 5. 39 1, 000 10 0. 001% 5. 76 1, 000 5 0. 0005% 5. 92 1, 000 1 blends statistical process control and structured project planning. 0. 0001% 6. 25 Introduction Laboratory Quality Management Systems-Module 1 1

Development of ISO 15189 Argentina Australia Austria Belgium Brazil Canada Chile China Czech Republic Denmark ISO 17025: 1999 Finland France Germany Iran, Ireland Israel Italy Jamaica Japan Korea Mexico Netherlands New Zealand Norway Portugal Singapore Spain Sweden Switzerland Turkey United Kingdom United States Quality ISO Management 9001: 2000 Systems General requirements for the competence of testing and calibration laboratories ISO 15189: 2003 Medical Laboratories – Particular requirements for Introduction Laboratory Quality Management Systems-Module 1 quality and competence 2

ISO 15189 Family of Documents n ISO 15189: 2007 Medical laboratories– Particular requirements for quality and competence n ISO 15190: 2003 Medical laboratories– Requirements for safety n ISO 22870: 2006 Point-of-care testing (POCT)— Requirements for quality and competence n ISO/TR 22869: 2005 Medical laboratories– Guidance on laboratory implementation of ISO 15189: 2003 n ISO/TS 22367: 2008 Medical laboratories– Reduction of error through risk management and continual improvement Introduction Laboratory Quality Management Systems-Module 1 3