CLSI QMS01 A4 : 4ED 2011
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
23-07-2013
24-08-2018
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
4 The Quality Management System Model
5 The Quality System Essentials
6 The Path of Workflow Concept
7 Establishing the Quality Management System
8 Applying Quality Management Systems Beyond the
Laboratory to a Health Care Organisation's Services
9 Conclusion
References
Appendix A - QSEs With ISO 1725, ISO 9001, and ISO 15189
Appendix B - Sample QSE Policy: Documents and Records
Appendix C - QSE Processes
Appendix D - Example Table of Contents for a Quality Manual
Appendix E - Example Quality Report Form
Appendix F - Excerpt From a Position Description Showing
Duties in the Path of Workflow
Appendix G - Example Orientation Program
Appendix H - Laboratory Training Program Contents
Appendix I - Sample Outline for a Validation Plan
Appendix J - Sample Document Master Index Form
Appendix K - Sample Document Change Request Form
Appendix L - Example Record Retention Schedule Form
Appendix M - Sample Laboratory Information System
Software Validation Worksheet
Appendix N - Example of a Formula Verification Worksheet
Appendix O - Sample Nonconforming Event Report Form
Appendix P - Example Audit Report Form
Appendix Q - Examples of Laboratory Quality Indicators
Appendix R - Published studies on Laboratory Performance
Indicators Grouped by QSE and Path of Workflow
Appendix S - Indicators Development Form
Appendix T - Example of a Sample Retention Form
The Quality Management System Approach
Related CLSI Reference Materials
Gives a model for medical laboratories that will assist with implementation and maintenance of an effective quality management system.
DevelopmentNote |
Supersedes NCCLS GP26 A3. (07/2011) Formerly CLSI GP26 A4. (07/2013)
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DocumentType |
Miscellaneous Product
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PublisherName |
Clinical Laboratory Standards Institute
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Status |
Withdrawn
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SupersededBy | |
Supersedes |
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