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