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[Quality assurance and management in pulmonary function labs]
1Laboratoire d'Explorations Fonctionnelles Respiratoires, Service de Physiologie, Hôpital Saint-Antoine, AP-HP, Paris, France. jean.francois.vibert@upmc.fr
Introduction:
Pulmonary function laboratories (PFT labs) have the duty to provide diagnostic examinations at the request of clinicians. They must guarantee the accuracy and safety of these examinations while responding to the requirements of both the clinicians and the patients.
Background:
After reviewing the historical background to quality standards this article details the principles that have led from quality assurance (ISO 9000 standards: 1994) to quality management (ISO 9000 standards: 2000), as well as the principles that it is advisable to implement to obtain certification or accreditation.
Viewpoint:
In order to obtain these formal recognitions a laboratory should be in a position to control all the procedures underlying these examinations and be able to set up a systematic range of preventative and corrective measures. These elements are the basis of a programme of quality assurance and management.
Conclusion:
This article outlines the approach of the pulmonary function laboratory of the Hospital Saint Antoine, Paris that is certified ISO 9001: V2000 and accredited ISO 17025 for blood gas measurements.
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