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 Accreditation procedure. We report here the methodology used for the implementation of a quality system in a Therapeutic Drug Monitoring laboratory. The quality manual, which represents the basis of the quality system, was drafted according to the following methodology: Step 1--study of the requirements 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 and staff organization, quality document management, quality planning relating to specific activities relevant to projects or contracts on drug monitoring and pharmacokinetic studies, and operating procedures. The implementation of a quality system in a public hospital laboratory may be considered as a means of improving the laboratory organization and management.