Introduction Laboratory Quality Management Systems-Module 1 1

Six SigmaA modern tool that blends statistical process control and structured project planning.

Total Error ErrorPercent

Process Sigma

1,000,000 100,000 10% 2.78

1,000,000 10,000 1% 3.83

1,000,000 5,000 0.5% 4.08

1,000,000 1,000 0.1% 4.59

1,000,000 500 0.05% 4.79

1,000,000 100 0.01% 5.22

1,000,000 50 0.005% 5.39

1,000,000 10 0.001% 5.76

1,000,000 5 0.0005% 5.92

1,000,000 1 0.0001% 6.25

Introduction Laboratory Quality Management Systems-Module 1 2

Development of ISO 15189

ISO17025:1999

ISO15189:2003

ISO9001:2000

ArgentinaAustraliaAustria Belgium Brazil Canada Chile China Czech Republic Denmark

Finland FranceGermany  Iran,Ireland Israel Italy Jamaica Japan  Korea 

Mexico Netherlands New Zealand  Norway  PortugalSingapore  Spain Sweden Switzerland Turkey United KingdomUnited States

QualityManagementSystems

General requirements for the competence of testing and calibration laboratories

Medical Laboratories – Particular requirements for quality and competence

Introduction Laboratory Quality Management Systems-Module 1 3

ISO 15189 Family of Documents ISO 15189:2007 Medical laboratories–

Particular requirements for quality and competence

ISO 15190:2003 Medical laboratories– Requirements for safety

ISO 22870:2006 Point-of-care testing (POCT)— Requirements for quality and competence

ISO/TR 22869:2005 Medical laboratories– Guidance on laboratory implementation of ISO 15189:2003

ISO/TS 22367:2008 Medical laboratories– Reduction of error through risk management and continual improvement