CLSI QMS14 A : 1ED 2012

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
4 Vision for Quality
5 Making the Case for a Quality Management System
6 Committing to Quality and Good Professional Practice
7 Creating and Maintaining an Organizational
   Structure to Ensure Quality
8 Effectively Implementing the Quality
   Management System
9 Managing Resources
10 Planning for Quality
11 Management Review
12 Communicating Quality-Related Information
13 Conclusion
References
Additional References
Appendix A - Force Field Analysis Template
Appendix B - Force Field Analysis - Culture
             Assessment Example
Appendix C - Laboratory Director delegation of
             Duties Template
Appendix D - Examples of Laboratory Personnel
             Responsibilities in a Quality
             Management System
Appendix E - Basic Organisational Chart Example
Appendix F - Complex Oragnisational Structure Example
Appendix G - Quality Committee Structure Example
Appendix H - Committee Charter Template
Appendix I - Prioritization Matrix for Quality
             Management System Implementation Example
Appendix J - Quality Management System
             Implementation Plan Template
Appendix K - Internal Audit Program
             Implementation Timeline Example
Appendix L - Meeting Agenda Template
Appendix M - Meeting Record Template
Appendix N - Change Announcement Example
Appendix O - Quality System Essential Policy
             Statement - Single Document Example
Appendix P - Sample Quality System Essential
             Policy Statement: Organisation
Appendix Q - Basic Organisation of a Quality
             Manual Chapter (With Document Titles)
Appendix R - Implementation Plan for Laboratory
             Instrumentation Template
Appendix S - Excerpt From a Quality Plan Example
Appendix T - Quality Report Template by Quality
             System Essential
Appendix U - Sample Quality Report
Appendix V - Management Review Meeting Agenda Example
Appendix W - Sample Management Review Agenda Template
Appendix X - Management Review Meeting Record Example
Appendix Y - Communication Program Overview Example
Appendix Z - Communication Plan for Quality
             Management System Implementation Example
Appendix AA - Sample Communication Plan Template
Appendix AB - Staff Meeting Planning Template
The Quality Management System Approach
Related CLSI Reference Materials

This guideline is intended to assist laboratories in meeting the leadership-based requirements for their QMS, as represented by quality system essential (QSE) Organization.