CLSI QMS18 : 1ED 2015

Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Workflow of Process Management
Chapter 3 - Quality system Essentials and process Management
Chapter 4 - Conclusion
Chapter 5 - Supplemental information
References
Appendix A1 - Process Definition Document Example
Appendix A2 - Sample of a Completed Process Definition
              Document
Appendix B - Example of a stakeholder Analysis for the Critical
             Value Reporting Process
Appendix C - How to Constructa a Process Flow Chart
Appendix D - Sample Postexamination Process: 'Critical
             Value Handling Process'
Appendix E - Sample Quality Implementation plan for
             New Laboratory Bar Codes
Appendix F - Example of a Generic Day-of-implementation
             Checklist
Appendix G - Example of Document Inventory for the Critical
             Value Handling process
Appendix H1 - Example Outline for a Validation plan
Appendix H2 - Sample Acceptance Criteria for the Critical
              Value Reporting process
Appendix I1 - Example of a Learner Responsibilities Form
Appendix I2 - Example of a Training Schedule Form
Appendix I3 - Example of Training Schedule Form
Appendix I4 - Example of Training Schedule Form
Appendix 15 - Example of Training Guide Form
Appendix 16 - Sample Written Assessment Form
Appendix I7 - Preparing a Direct Observation Checklist
Appendix I8 - Sample Learner Evaluation Form
Appendix J1 - Communication Plan Template
Appendix J2 - Sample Communication Plan for Changing the
              Critical Value Reporting Process
Appendix K1 - Change Announcement Template
Appendix K2 - Sample Change Announcement for New
              Bar Code Labels
Appendix L - Project Management Tool Template
The Quality Management System Approach
Related CLSI References Materials