CLSI QMS25 : 1ED 2016

Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Answer to Question About a Quality Manual
Chapter 3 - Guidance for Contents of a Quality Manual
Chapter 4 - Getting Started
Chapter 5 - Conclusion
Chapter 6 - Supplemental Information
References
Additional Resources
Appendix A - Structure and Contents of a Template for a Quality
             System Essential-Based Policy
Appendix B1 - Organization and Leadership
Appendix B2 - Customer Focus
Appendix B3 - Facilities and Safety Management
Appendix B4 - Personnel Management
Appendix B5 - Supplier and Inventory Management
Appendix B6 - Equipment Management
Appendix B7 - Process Management
Appendix B8 - Documents and Records Management
Appendix B9 - Information Management
Appendix B10 - Nonconforming Event Management
Appendix B11 - External and Internal Assessments
Appendix B12 - Continual Improvement
Appendix C -Crosswalk of Quality System Essential to Related
             Clauses of ISO 15189:2012 and ISO 17025
Appendix D1 - Example Quality Process Flow Chart: ?Document
              Management Process
Appendix D2 - Example Quality Process Flow Chart: ?Training
              and Competence Assessment Process
Appendix D3 - Example Quality Process Flow Chart: ?Nonconforming
              Event Response Process
Appendix D4 - Example Quality Process Flow Chart: ?The Audit
              Process
Appendix D5 - Example Quality Process Flow Chart: ?Process
              Management Process
Appendix E1 - Example Quality Procedure: ?Correcting a Laboratory
              Paper Record Procedure
Appendix E2 - Example Quality Procedure: ?Electronic Reporting
              of a Laboratory Nonconforming Event Procedure
Appendix F1 - Example of a Quality Manual Table of Contents
              With Process and Other Supporting Documents
              Included in the Supporting Documents Section
Appendix F2 - Example of a Quality Manual Table of Contents With
              Process and Other Supporting Documents Included in the
              Applicable QSE Section
The Quality Management System Approach
Related CLSI References Materials

Defines laboratories in developing a quality manual a vital component of implementing and maintaining a complete laboratory quality management system.