Suppliers’ Charter Support to Clinical Laboratories seeking accreditation

This Charter was initially developed by the French national association SIDIV, and signed by their members. This document was found very useful for other countries by EDMA and was translated in English after the agreement with SIDIV to circulate it to all the EDMA members, enabling them to identify and take account of all the different obligations of the suppliers who are signatories of this Charter. EDMA would like to thank SIDIV for this thoughtful and generous gesture, and to encourage other NAMs to benefit from SIDIV’s work by translating / adapting this Charter to their countries.

It is the responsibility of the laboratory management to ensure that the quality system of a medical laboratory is compliant with the provisions of EN ISO 15189:2012 standard. Accreditation gives formal recognition not only for the quality management system but also to peer evaluated technical skills. This standard describes how a medical laboratory can implement a quality system and requires the specific designation of a quality manager. The quality system must include a quality manual and procedures which deal with the three phases of medical examination: pre-analytical, analytical and post-analytical.