CLSI GP37 P : 1ED 2011

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
4 Planning for New Equipment Implementation
5 Equipment Selection, Acquisition and Identification
6 Equipment Validation Plan
7 Calibration and Maintenance
8 Quality Control of Examination (Analytical) Equipment
9 Use
10 Troubleshooting, Service and Repair
11 Decommissioning of Equipment
Appendix A - Implementation Plan for Specialized
             Laboratory Instrumentation Template
Appendix B - Examples of Criteria for Comparing
             Equipment Options and Qualifying the Best
             Option Selection
Appendix C - Validation Documentation Matrix Example
Appendix D - Installation Qualification Protocol Example
Appendix E - Template for Installation Qualification Checklist
Appendix F - Protocol for Operational Qualification Example
Appendix G - Template for Operational Qualification of
             Basic Laboratory Equipment Checklist
Appendix H - Template for Operational Qualification of
             Specialized Laboratory Instrumentation Checklist
Appendix I - Protocol for Performance Qualification Example
Appendix J - Template for Performance Qualification of
             Specialized Laboratory Instrumentation Checklist
Appendix K - Template for Equipment Reverification Checklist
Appendix L - Template for Hazard Analysis Checklist
Appendix M - Template for a Calibration Schedule
Appendix N - Template for Nonconforming Situation Action
             Checklist
Appendix O - Template for Equipment Decommissioning Plan
Appendix P - Template for Equipment Decontamination Label
Appendix Q - Template for Equipment Master File - History
             Form
Quality Management system Approach
Related CLSI Reference Materials

Gives recommendations for establishing equipment management processes from selection through decommission of all items of equipment used in the provision of laboratory services.