CLSI QMS06 A3 : 3ED 2011

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
4 Continual Improvement: Common Supporting Elements
5 Continual Improvement: Fundamental Processes
6 Conclusion
References
Additional References
Appendix A - Quality Report Template by Quality Indicator
Appendix B - Quality Report Template by Quality System
             Essential
Appendix C - Plan-Do-Check-Act Example
Appendix D - Plan-Do-Check-Act Template
Appendix E - Decision Matrix - Opportunity for Improvement
             Prioritization Example
Appendix F - Decision Matrix - Prioritization Template
Appendix G - Failure Modes, Effects, and Criticality Analysis
             (FMECA) Template
Appendix H - Workplace Audit Template
Appendix I - 5S Plus Audit Template
Appendix J - Customer Survey Example
Appendix K - Waste Walk Observation Template
Appendix L - Management Review Meeting Agenda Example
Appendix M - Management Review Meeting Record Example
Appendix N - Continual Improvement Team Meeting agenda
             Template
Appendix O - Meeting Record Template
Appendix P - Document Change Request Form Template
Appendix Q - Risk Management Plan Elements and File Elements
Appendix R - Communication Plan Example
Appendix S - Examples of Laboratory Quality Indicators
Appendix T - Sample Data Presentation for Key Performance
             Indicators
Appendix U - Laboratory Scorecard Examples
Appendix V - Continual Improvement Charter Template
Appendix W - Implementation Plan Template
Appendix X - Sample Turnaround Time Reduction
             Implementation Plan
Appendix Y - Evaluation Report Template
Appendix Z - Control Plan Template
Appendix AA - Close-Out Plan Template
The Quality Management System Approach
Related CLSI Reference Materials

Covers written and graphic descriptions of the fundamental processes and common supporting elements in a continual improvement (CI) program.

This guideline includes written and graphic descriptions of thefundamental processes and common supporting elements in a continualimprovement (CI) program. It provides the user with definitions, concepts,methods, and tools for implementing an effective program and meetingapplicable requirements. The CI fundamental processes include thefollowing:Identifying opportunities for improvement (OFIs)Selecting an opportunityGenerating solution(s)Implementing solution(s)Evaluating effect of solution(s)Integrating and sustaining improvement(s)The CI common supporting elements include, but are not limited to:Management reviewTeamworkImprovement models and toolsDocuments and recordsChange managementRisk managementCommunicationThis guideline is intended for use by all organizations and individualsinvolved in the management or execution of preexamination, examination,and postexamination phases of the medical laboratory. This documentmay be applicable to other laboratories and nonlaboratory settings.This guideline is not meant to be prescriptive nor a comprehensiveinstructional manual for using the tools described. It does not addresscontent and detail covered in other CLSI documents nor requirementsspecific to any regulatory or accrediting organization.