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QUALITY APPROACH

Since November 2011, the Biological Centre has been officially accredited with the norme NF EN ISO 15189 : 2007. N° 8-3028 : more information at www.cofrac.fr.

This means that all of the laboratories under the Biological Centre have defined their quality approach in relation to the NF EN ISO 15189:2007 regulation, standard regulation for Medical Biological Laboratories.

The award of this regulation is proof of the laboratory’s technical competence and the correct functioning of its quality management system.

An accredited laboratory undergoes detailed external evaluations on its organisation and regular audits on its management and technical competency.

tl_files/centrebio/communication/images/cycle accreditation 2.jpg

The technical evaluators and the quality assessors ensure the correct application of the rules listed under the various chapters of the regulation:

tl_files/centrebio/interface/img/puce.gif Management

tl_files/centrebio/interface/img/puce_noire.gif Organisation
tl_files/centrebio/interface/img/puce_noire.gif Quality Management
tl_files/centrebio/interface/img/puce_noire.gif Documentary system
tl_files/centrebio/interface/img/puce_noire.gif Sub-contracted exams
tl_files/centrebio/interface/img/puce_noire.gif Treating claims and non conformity
tl_files/centrebio/interface/img/puce_noire.gif Corrective and Preventative actions
tl_files/centrebio/interface/img/puce_noire.gif Ongoing improvements
tl_files/centrebio/interface/img/puce_noire.gif Evaluations and Audits
tl_files/centrebio/interface/img/puce_noire.gif Directors review

tl_files/centrebio/interface/img/puce.gif Technical:

tl_files/centrebio/interface/img/puce_noire.gif Personnel
tl_files/centrebio/interface/img/puce_noire.gif Buildings and surrounding environment
tl_files/centrebio/interface/img/puce_noire.gif Laboratory material (reagents and other consumables)
tl_files/centrebio/interface/img/puce_noire.gif Pre-analytical process
tl_files/centrebio/interface/img/puce_noire.gif Analytical process
tl_files/centrebio/interface/img/puce_noire.gif Equipment Calibration and meeting national set standards
tl_files/centrebio/interface/img/puce_noire.gif Methods & Procedures
tl_files/centrebio/interface/img/puce_noire.gif Guarantee quality results
tl_files/centrebio/interface/img/puce_noire.gif Post-analytical process
tl_files/centrebio/interface/img/puce_noire.gif Results reviews
tl_files/centrebio/interface/img/puce_noire.gif Results publication
tl_files/centrebio/interface/img/puce_noire.gif Managing Laboratory information

An accredited laboratory is thus proof of successful and reliable test results and quality patient care.