Implementation of a Quality Management System in Drug Testing Laboratories
The Guidance for the " Implementation of a Quality Management System in Drug Testing Laboratories" provides information and assistance to assure essential quality standards in worldwide drug analysis.
Recognising the new challenges and the importance of accurate results, this guidance assists drug analysis laboratories throughout the world to improve the quality of their performance according to international standards (ISO 17025). It includes:
(i) an overview of the impact of Quality Management System (QMS) in the laboratory;
(ii) concrete requirements and guidance for its implementation;
and also provides a model for a quality manual.
Thereby the guidance contributes to the promotion and harmonization of vital quality standards in drug analysis throughout the world.