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    CD Rom 1 Optional Introduction Slides

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    Tâm Nguyễn Minh
    This document discusses Six Sigma and ISO 15189. Six Sigma is a statistical process that blends process control and project planning to reduce errors in processes. The table shows that as the error percent decreases from 10% to 0.0001%, the process sigma increases from 2.78 to 6.25. ISO 15189 provides requirements for quality management systems and competence in medical laboratories. It was developed based on ISO 15189 and ISO 9001 standards for quality management. The ISO 15189 family of documents provides additional guidance for safety, point-of-care testing, and reducing errors through risk management.

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    CD Rom 1 Optional Introduction Slides

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    Tâm Nguyễn Minh
    22 views3 pages
    This document discusses Six Sigma and ISO 15189. Six Sigma is a statistical process that blends process control and project planning to reduce errors in processes. The table shows that as the error percent decreases from 10% to 0.0001%, the process sigma increases from 2.78 to 6.25. ISO 15189 provides requirements for quality management systems and competence in medical laboratories. It was developed based on ISO 15189 and ISO 9001 standards for quality management. The ISO 15189 family of documents provides additional guidance for safety, point-of-care testing, and reducing errors through risk management.

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    This document discusses Six Sigma and ISO 15189. Six Sigma is a statistical process that blends process control and project planning to reduce errors in processes. The table shows that as the error percent decreases from 10% to 0.0001%, the process sigma increases from 2.78 to 6.25. ISO 15189 provides requirements for quality management systems and competence in medical laboratories. It was developed based on ISO 15189 and ISO 9001 standards for quality management. The ISO 15189 family of documents provides additional guidance for safety, point-of-care testing, and reducing errors through risk management.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    22 views3 pages

    CD Rom 1 Optional Introduction Slides

    Uploaded by

    Tâm Nguyễn Minh
    This document discusses Six Sigma and ISO 15189. Six Sigma is a statistical process that blends process control and project planning to reduce errors in processes. The table shows that as the error percent decreases from 10% to 0.0001%, the process sigma increases from 2.78 to 6.25. ISO 15189 provides requirements for quality management systems and competence in medical laboratories. It was developed based on ISO 15189 and ISO 9001 standards for quality management. The ISO 15189 family of documents provides additional guidance for safety, point-of-care testing, and reducing errors through risk management.

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    Six Sigma Total Error Error Process

    Percent Sigma
    A modern tool that
    blends statistical 1,000,000 100,000 10% 2.78
    process control and 1,000,000 10,000 1% 3.83
    structured project
    planning. 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 1


    Development of ISO 15189
    Argentina Finland Mexico
    Australia France Netherlands
    Austria Germany   New Zealand  
    Belgium Iran, Norway  
    Brazil Ireland Portugal
    Canada Singapore  
    Chile Israel
    Spain 
    China Italy Sweden 
    Jamaica Switzerland 
    Czech Republic
    Japan   Turkey
    Denmark
    Korea  United Kingdom
    United States

    ISO
    17025:1999
    ISO Quality
    Management
    9001:2000
    Systems

    General requirements for the


    ISO
    competence of testing and
    calibration laboratories 15189:2003

    Medical Laboratories –
    Particular requirements for
    Introduction Laboratory Quality Management Systems-Module 1 quality and competence 2
    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 3

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