Addressing Issues Related to Standardization

The section was established with the aim of preparing questions and statements related to the accreditation and recognition of medical laboratories and their associated standards in relation to clinical chemistry and laboratory medicine, and coordinating these within the DGKL and with the DGKL Executive Board. This is intended to strengthen the position and perception of the DGKL as a scientific professional society in the field of accreditation and recognition.

As the largest German scientific professional society in the field of Clinical Chemistry and Laboratory Medicine, the DGKL has delegates in national and international committees that deal with issues of accreditation and recognition of laboratories and make corresponding decisions and issue rules.

In Germany, the German Accreditation Body (DAkkS) or the Central Office of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) is responsible for the accreditation and recognition of medical laboratories. DGKL members are represented in the DAkkS and ZLG committees.

The main focus of the section’s activities lies on:

• Processing inquiries regarding accreditation and recognition of medical laboratories (DIN EN ISO 15189 and 17025)
• Processing inquiries at the interface between DIN EN ISO 15189 and RiliBÄK
• Developing position statements on topics of accreditation and recognition of medical laboratories on behalf of the DGKL
• Coordinating position statements and resolutions on accreditation and recognition of medical laboratories within the DGKL committees and with the DGKL Executive Board
• Selection and confirmation of expert assessors for Clinical Chemistry
• Revision and maintenance of a Clinical Chemistry checklist for the DIN EN ISO 15189 standard.