CLSI QMS15 A : 1ED 2013

Abstract
Committee Membership
Foreword
Chapter 1: Introduction
Chapter 2: Rationale for a Laboratory Internal
           Audit Program
Chapter 3: Development of the Laboratory Internal
           Audit Program
Chapter 4: Structure of the Internal Audit Process
Chapter 5: Conclusion
Chapter 6: Supplemental Information
References
Appendix A1: Laboratory Internal Auditor Training Guide
Appendix A2: Laboratory Internal Audit Trainer
             Responsibilities
Appendix A3: Laboratory Internal Auditing Learner
             Responsibilities
Appendix A4: Training Checklist for the Laboratory Internal
             Auditing Process
Appendix B - Annual Audit Schedule
Appendix C - Laboratory Internal Audit Plan
Appendix D - Example (Excerpt) of an abbreviated
             Internal Audit Tool
Appendix E - Sample Laboratory Product Management Audit
Appendix F - Sample Audit Sheet
Appendix G1 - Assessment Tool for Verifying the Effectiveness
              of Document Control (Formant 1)
Appendix G2 - Assessment Tool for Verifying the Effectiveness
              of Document Control (Formant 2)
Appendix H1 - Example of an Audit Findings Report
Appendix H2 - Sample Audit Report
Appendix H3 - Example of a Quality Assessment Audit
              Findings Report
Appendix H4 - Assessment Findings and Quality Action Form
Appendix I - Audit Evaluation Example
Appendix J - Sample Internal Audit Feedback Form
The Quality Management System Approach
Related CLSI References Materials

Specifies guidance for how a laboratory can establish an internal audit program to enhance the quality of its services through continual improvement.