Implementation of a quality system in a therapeutic drug monitoring laboratory

The concept of quality assurance is emerging in public and private clinical laboratories in France following the introduction of decrees on Hospital A ccreditation procedure. We report here the methodology used for the impleme ntation of a quality system in a Therapeutic Drug Monitoring laboratory. Th e quality manual, which represents the basis of the quality system, was dra fted according to the following methodology: Step 1 - study of the requirem ents of ISO 9001 Standard; Step 2 - analysis and synthesis of the European EN 45001 Standard and French regulation GBEA system respectively, compared with the 20 headings of the ISO 9001 Standard; Step 3 - elaboration of the quality manual on the basis of steps 1 and 2 and relating to: laboratory an d staff organization, quality document management, quality planning relatin g to specific activities relevant to projects or contracts on drug monitori ng and pharmacokinetic studies, and operating procedures. The implementatio n of a quality system in a public hospital laboratory may be considered as a means of improving the laboratory organization and management.