Quality System Essentials Framework - Phase 4

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The Clinical and Laboratory Standards Institute (CLSI) has developed a guideline for clinical laboratories providing more information on the requirements of the ISO 15189 quality standard. It describes what quality management is and how a quality management system is incorporated in the routine laboratory processes.*

In this guideline the CLSI uses a framework dividing a quality management system into 12 essential elements: the Quality System Essentials (QSE). These together cover all elements of the quality management system.

• Facilities and Safety
• Organization
• Personnel
• Equipment
• Purchasing and Inventory
• Process Control
• Information Management
• Documents and Records
• Customer Service
• Assessment
• Occurrence Management
• Process Improvement

The same framework is used in this tool for presentation of the activities in each phase. The activities shown in this framework are the same as shown in the Roadmap structure, only than structured in another order. Whereas the Roadmap structure provides an indication of a useful sequence in which activities can be completed, the QSE framework provides an overview of which activities need to be completed on a specific element of the laboratory.

For example: when clicking on the QSE “Facilities and Safety” one can see which activities need to be completed to improve the quality of the laboratory facility and safety situation.

* NCCLS Application of a Quality Management System Model for Laboratory Services; Approved Guideline-Third Edition. NCCLS document GP26-A3 [ISBN 1-56238-553-4]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.