Accreditation of a medical biology analysis laboratory
 /  Accreditation of a medical biology analysis laboratory
Accréditation d’un laboratoire d’analyses de biologie médicale

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

A. COFRAC, Accreditation process, accreditation guides, standard 15 189

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....

 


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