QUALITY APPROACH
Since November 2011, Synlab Opale 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 Synlab Opale 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.
The technical evaluators and the quality assessors ensure the correct application of the rules listed under the various chapters of the regulation:
Management
Organisation Quality Management Documentary system Sub-contracted exams Treating claims and non conformity Corrective and Preventative actions Ongoing improvements Evaluations and Audits Directors review
Technical:
Personnel Buildings and surrounding environment Laboratory material (reagents and other consumables) Pre-analytical process Analytical process Equipment Calibration and meeting national set standards Methods & Procedures Guarantee quality results Post-analytical process Results reviews Results publication Managing Laboratory information
An accredited laboratory is thus proof of successful and reliable test results and quality patient care.