1. Six Sigma
Total
Error
Percent
Process Sigma
1,000,000
100,000
10%
2.78
10,000 1%
3.83
5,000
0.5%
4.08
1,000
0.1%
4.59
500
0.05%
4.79
100
0.01%
5.22 50
0.005%
5.39 10
0.001%
5.76 5
0.0005%
5.92 1
0.0001%
6.25
A modern tool that blends statistical process control and structured project planning.
Introduction Laboratory Quality Management Systems-Module 1

2. Development of ISO 15189 ISO 17025:1999 ISO 15189:2003 ISO 9001:2000
Argentina Australia
Austria Belgium Brazil Canada Chile
China
Czech Republic
Denmark
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
ISO 17025:1999
ISO 9001:2000
Quality Management Systems
General requirements for the competence of testing and calibration laboratories
ISO
15189:2003
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
Introduction Laboratory Quality Management Systems-Module 1