ISO 15189:2003 – Quality management, evaluation and continual improvement
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David Burnett
Abstract
The requirements of ISO 15189:2003 are discussed in the context of a process- and outcome-based quality management model in which the user's needs are the central focus. The requirements of ISO 15189:2003 are examined in terms of organisation and a quality management system, stressing the importance of evidence, document control, and control of records and clinical material. Examples are provided from the areas of resource management, and pre-examination, examination and post-examination processes. In the final section the importance of evaluation and continual improvement is presented in relation to internal audit and external assessment, non-conformity, corrective and preventative action and management review.
References
1. ISO 15189:2003. Medical laboratories − particular requirements for quality and competence.Suche in Google Scholar
2. ISO/IEC 17025:1999. General requirements for the competence of testing and calibration laboratories.Suche in Google Scholar
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©2006 by Walter de Gruyter Berlin New York
Artikel in diesem Heft
- Foreword
- Evidence-based policy-making
- Clinical Governance – from rhetoric to reality?
- Realising the developmental potential of Clinical Governance
- Re-energising Clinical Governance through Integrated Governance
- Clinical Governance: from clinical risk management to continuous quality improvement
- Involvement of patients in Clinical Governance
- Teaching and Continuing Professional Development: an Italian experience
- New National Healthcare Information System
- Clinical Governance and Laboratory Medicine: is the Electronic Medical Record our best friend or sworn enemy?
- Technology to improve quality and accountability
- Clinical Governance and evidence-based laboratory medicine
- ISO 15189:2003 – Quality management, evaluation and continual improvement
- External Quality Assessment: an effective tool for Clinical Governance in Laboratory Medicine
- Errors in clinical laboratories or errors in laboratory medicine?
- Laboratory request appropriateness in emergency: impact on hospital organization
- Point-of-care-testing and Clinical Governance
- Integration between the Tele-Cardiology Unit and the central laboratory: methodological and clinical evaluation of point-of-care testing cardiac marker in the ambulance
Artikel in diesem Heft
- Foreword
- Evidence-based policy-making
- Clinical Governance – from rhetoric to reality?
- Realising the developmental potential of Clinical Governance
- Re-energising Clinical Governance through Integrated Governance
- Clinical Governance: from clinical risk management to continuous quality improvement
- Involvement of patients in Clinical Governance
- Teaching and Continuing Professional Development: an Italian experience
- New National Healthcare Information System
- Clinical Governance and Laboratory Medicine: is the Electronic Medical Record our best friend or sworn enemy?
- Technology to improve quality and accountability
- Clinical Governance and evidence-based laboratory medicine
- ISO 15189:2003 – Quality management, evaluation and continual improvement
- External Quality Assessment: an effective tool for Clinical Governance in Laboratory Medicine
- Errors in clinical laboratories or errors in laboratory medicine?
- Laboratory request appropriateness in emergency: impact on hospital organization
- Point-of-care-testing and Clinical Governance
- Integration between the Tele-Cardiology Unit and the central laboratory: methodological and clinical evaluation of point-of-care testing cardiac marker in the ambulance
