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QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
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Withdrawn date: 23-07-2013
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Published date: 24-08-2018
Publisher: Clinical Laboratory Standards Institute
AbstractCommittee MembershipForeword1 Scope2 Introduction3 Terminology4 The Quality Management System Model5 The Quality System Essentials6 The Path of Workflow Concept7 Establishing the Quality Management System8 Applying Quality Management Systems Beyond the Laboratory to a Health Care Organisation's Services9 ConclusionReferencesAppendix A - QSEs With ISO 1725, ISO 9001, and ISO 15189Appendix B - Sample QSE Policy: Documents and RecordsAppendix C - QSE ProcessesAppendix D - Example Table of Contents for a Quality ManualAppendix E - Example Quality Report FormAppendix F - Excerpt From a Position Description Showing Duties in the Path of WorkflowAppendix G - Example Orientation ProgramAppendix H - Laboratory Training Program ContentsAppendix I - Sample Outline for a Validation PlanAppendix J - Sample Document Master Index FormAppendix K - Sample Document Change Request FormAppendix L - Example Record Retention Schedule FormAppendix M - Sample Laboratory Information System Software Validation WorksheetAppendix N - Example of a Formula Verification WorksheetAppendix O - Sample Nonconforming Event Report FormAppendix P - Example Audit Report FormAppendix Q - Examples of Laboratory Quality IndicatorsAppendix R - Published studies on Laboratory Performance Indicators Grouped by QSE and Path of WorkflowAppendix S - Indicators Development FormAppendix T - Example of a Sample Retention FormThe Quality Management System ApproachRelated CLSI Reference Materials
Gives a model for medical laboratories that will assist with implementation and maintenance of an effective quality management system.
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