OBJECTIVES
> Understand and interpret the requirements of the current ISO 15 189 standard
> Understand the value of implementing a quality management system (QMS) in a medical biology laboratory
> Know the different steps required to implement the required provisions and applications
PREREQUISITE
> Concept of Quality
METHOD PROVIDED
> Practical work, case studies, submission of a technical file
DETAILED PROGRAM
B. Organisation and management, quality function, document management
C. Contract review, subcontracting management, external services and procurement
D. Complaints, non-compliance, quality and management reviews, continuous improvement
A. Exigences relatives au personnel, locaux et conditions environnementales
B. Laboratory equipment, metrology, quality controls
C. Pre-analytical phase, analytical phase
D. Post-analytical phase, reporting of results, information system management
E. Conducting an accreditation process, chronological steps, tips....