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

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

This guideline is intended for individuals and laboratories that perform medical testing and focuses on general and service-specific equipment, instruments, and analytical systems. Recommendations for establishing criteria and methods for all aspects of equipment operation—including selection, identification, validation, reverification, use, and decommission of equipment—are provided.
Although the requirements for the quality system essential (QSE) Equipment include those for computer system hardware, middleware, and software, guidance for meeting those requirements is provided in other documents8-10 and CLSI documents AUTO08,11 AUTO11,12 and GP19.13
A detailed description of acquisition options is beyond the scope of this document.