CLSI QMS03 A3 : 3ED 2009

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 Quality Management System Approach
5 Education, Training and Competence - The Differences
6 Training - A Four-Stage Process
7 Documentation of Training and Competence Assessment
8 How to get Started
9 Conclusion
References
Additional References
Appendix A1 - Example Work Process Flowchart
Appendix A2 - Example ABC Analyzer Process as a Table
Appendix B - Sample Training Guide Form
Appendix C1 - Sample Trainer Responsibilities Form
Appendix C2 - Sample Learner Responsibilities Form
Appendix D - Sample Training Schedule Form
Appendix E - Sample Training Checklist Form
Appendix F - sample Learner Evaluation Form
Appendix G - Sample Written Assessment Form
Appendix H1 - Preparing a Direct Observation Checklist
Appendix H2 - Example of a Direct Observation Checklist for
              a Procedure
Appendix I1 - Example of a Direct Observation Form for
              Technologists
Appendix I2 - Example of a Direct Observation Form for
              Laboratory Assistants
Appendix J1 - Sample Competence Assessment Form for
              Quantitative Testing
Appendix J2 - Sample Competence Assessment form for
              Qualitative Testing
Appendix J3 - Example of a Competence Assessment Form for
              an Instrument
Appendix K - Sample Form for Follow-up of Competence or
             Learning Assessment Requiring Remediation
Appendix L1 - Example of a Training Guide for the ABC Analyzer
              Testing Process
Appendix L2 - Example of Trainer Responsibilities for ABC
              Analyzer Testing Process
Appendix L3 - Example of Learner Responsibilities for ABC
              Analyzer Testing Process
Appendix L4 - Example of a Training Schedule for the ABC
              Analyzer Testing Process
Appendix L5 - Example of a Training Checklist for the ABC
              Analyzer Testing Process
Appendix L6 - Example of a Direct Observation Checklist for
              the ABC Analyzer Testing Process
Appendix L7 - Example of a Written Assessment for the ABC
              Analyzer Testing Process
Appendix L8 - Example of Evaluation of Training for the ABC
              Analyzer Testing Process
Appendix M - Sample Group Training Record
Appendix N1 - Example of an Annual Competence Assessment Plan
              for a Laboratory Assistant
Appendix N2 - Example of an Annual Competence Assessment Plan
              for a Laboratory Technologist/Scientist
Summary of Delegate Voting Comments and Working Group Responses
The Quality Management System Approach
Related CLSI Reference Materials

Describes background information and recommended processes for the development of training and competence assessment programs that meet quality and regulatory objectives.

QMS03 provides the necessary background information and processes to develop training and competence assessment programs that meet regulatory and accreditation requirements and help ensure knowledgeableand competent personnel in all laboratory disciplines.