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[Medical biology accreditation at EFS].

F Trapadoux¹, C Guitton Bliem, E Hergon

¹EFS Île-de-France, site de Rungis, 83-87, rue des Alpes, Silic 504, 94623 Rungis cedex, France. Francois.trapadoux@efs.sante.fr

Transfusion Clinique Et Biologique : Journal De La Societe Francaise De Transfusion Sanguine

|April 8, 2011

Summary

France mandates ISO 15189 accreditation for medical biology laboratories by October 2012. The EFS (Etablissement Français du Sang) is proactively implementing this, with 24 labs already accredited.

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Area of Science:

Medical laboratory science
Quality management systems

Context:

France is implementing statutory accreditation for medical biology laboratories.
The ISO 15189 standard is the benchmark for this accreditation.
The Etablissement Français du Sang (EFS) is a key organization involved.

Purpose:

To outline the requirements and implementation of ISO 15189 accreditation in French medical biology laboratories.
To detail the EFS's proactive approach and progress towards meeting the accreditation deadline.

Summary:

The article discusses the mandatory ISO 15189 accreditation for medical biology labs in France, effective October 2012.
The EFS has adopted a six-process approach, achieving accreditation for 24 labs and anticipating full compliance.
ISO 15189 requirements align with existing EFS certification and risk management protocols.

Impact:

Ensures enhanced quality and reliability in medical laboratory services across France.
Facilitates the successful and timely accreditation of EFS laboratories.
Promotes harmonization of practices and risk management within the EFS network.