CLSI QMS01 A4 : 4ED 2011

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
4 The Quality Management System Model
5 The Quality System Essentials
6 The Path of Workflow Concept
7 Establishing the Quality Management System
8 Applying Quality Management Systems Beyond the
  Laboratory to a Health Care Organisation's Services
9 Conclusion
References
Appendix A - QSEs With ISO 1725, ISO 9001, and ISO 15189
Appendix B - Sample QSE Policy: Documents and Records
Appendix C - QSE Processes
Appendix D - Example Table of Contents for a Quality Manual
Appendix E - Example Quality Report Form
Appendix F - Excerpt From a Position Description Showing
             Duties in the Path of Workflow
Appendix G - Example Orientation Program
Appendix H - Laboratory Training Program Contents
Appendix I - Sample Outline for a Validation Plan
Appendix J - Sample Document Master Index Form
Appendix K - Sample Document Change Request Form
Appendix L - Example Record Retention Schedule Form
Appendix M - Sample Laboratory Information System
             Software Validation Worksheet
Appendix N - Example of a Formula Verification Worksheet
Appendix O - Sample Nonconforming Event Report Form
Appendix P - Example Audit Report Form
Appendix Q - Examples of Laboratory Quality Indicators
Appendix R - Published studies on Laboratory Performance
             Indicators Grouped by QSE and Path of Workflow
Appendix S - Indicators Development Form
Appendix T - Example of a Sample Retention Form
The Quality Management System Approach
Related CLSI Reference Materials

Gives a model for medical laboratories that will assist with implementation and maintenance of an effective quality management system.