CLSI QMS13 A : 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
12 Managing Equipment Records
13 Conclusion
References
Appendix A - Implementation Plan for Laboratory
             Instrumentation Template
Appendix B - Example of Using the Quality System Essentials
             as Criteria for Comparing Equipment Options
             and Qualifying the Best Option for Selection
Appendix C - Example of Using Weighted Checklist Criteria
             for Comparing Equipment Options and Qualifying
             the Best Option for Selection
Appendix D - Validation Documentation Matrix Example
Appendix E - Installation Qualification Protocol Example
Appendix F - Template for Installation Qualification Checklist
Appendix G - Protocol for Operational Qualification Example
Appendix H - Template for Operational Qualification of
             Laboratory Equipment Checklist
Appendix I - Template for Operational Qualification of
             Laboratory Instrumentation Checklist
Appendix J - Protocol for Performance Qualification Example
Appendix K - Template for Performance Qualification for
             Laboratory Instrumentation Checklist
Appendix L - Template for Equipment Revivification Checklist
Appendix M - Template for Hazard Analysis Checklist
Appendix N - Template for a Calibration Schedule
Appendix O - Template for Nonconforming Event Action Checklist
Appendix P - Template for Equipment Decommissioning Plan
Appendix Q - Template for Equipment Decontamination Label
Appendix R - Template for Equipment Master File - History Form
The Quality Management System Approach
Related CLSI Reference Materials