CLSI QMS11 : 2ED 2015

Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Nonconforming Event Management
Chapter 3 - Path of Workflow and Quality System Essentials
Chapter 4 - Conclusion
Chapter 5 - Supplemental Information
References
Appendix A1 - Data Collection Tools
Appendix A2 - Investigation and Data Reporting Tools
Appendix B - Potential Components of an Internal
             Nonconforming Event Report
Appendix C1 - Nonconforming Event Report Form (Example 1)
Appendix C2 - Nonconforming Event Report Form (Example 2)
Appendix C3 - Nonconforming Event Report Form (Example 3)
Appendix C4 - Nonconforming Event Report Form (Example 4)
Appendix D - Risk Classification Example
Appendix E - Information to Consider When Conducting Root
             Cause Analysis
Appendix F1 - Root Cause Analysis Process (Example 1)
Appendix F2 - Root Cause Analysis Process (Example 2)
Appendix G1 - Nonconforming Event Case Study
              Example - The Process
Appendix G2 - Nonconforming Event Case Study
              Example - The Report
Appendix G3 - Nonconforming Event Case Study
              Example - The process Map
Appendix G4 - Nonconforming Event Case Study
              Example - The Cause and Effect Diagram
              and 5 Whys Analysis
Appendix H - Nonconforming Event log
Appendix I - Application of Data Analysis: A
             Laboratory Example
Appendix J - Management Review Agenda Template
Appendix K1 - Quality Report Example
Appendix K2 - Quality Report by Quality System Essential
The Quality Management System Approach
Related CLSI References Materials

Gives an outline and content for developing a program to manage a laboratory's nonconforming events.