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Medical laboratory quality systems - a management review
Dimitris Theodorou1, Padelis Giannelos
1Priority Quality Consultants, Athens, Greece.
International Journal of Health Care Quality Assurance
|April 11, 2015
Summary
This study details changes in ISO 15189 management review requirements, offering a checklist to help medical laboratories implement effective quality management reviews. The process approach aids in achieving key system inputs and outputs.
Area of Science:
- Medical Laboratory Management
- Quality Management Systems
Background:
- ISO 15189 is crucial for medical laboratory quality management.
- Management reviews are a key component of these systems.
Purpose of the Study:
- To highlight changes in ISO 15189:2012 versus ISO 15189:2007 regarding management review.
- To provide a comprehensive management review checklist aligned with ISO 15189:2012.
Main Methods:
- Analysis of ISO 15189:2012 and ISO 15189:2007 standards.
- Development of a management review checklist based on revised requirements.
Main Results:
- ISO 15189:2012 emphasizes a process approach for management reviews.
- The updated standard includes additional topics for management review.
Conclusions:
- A structured checklist aids laboratory staff in conducting effective management reviews.
- The process approach facilitates better achievement of quality management system objectives.
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