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

This guideline describes four requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, optimizing efficient use of resources, and contributing to patient safety and positive outcomes.