Processing issues relating to standardization

The section was founded with the aim of preparing questions and statements in connection with the accreditation and recognition of medical laboratories and their associated standards in relation to clinical chemistry and laboratory medicine and coordinating them within the DGKL and with the DGKL Presidium. This is intended to strengthen the position and perception of the DGKL as a scientific society in the field of accreditation and recognition.

As the largest German scientific society in the field of clinical chemistry and laboratory medicine, the DGKL has delegates in national and international committees that deal with questions of accreditation and recognition of laboratories and pass corresponding resolutions and regulations.

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

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

• Processing requests for accreditation and recognition of medical laboratories (DIN EN ISO 15189 and 17025)
• Processing of inquiries at the interface between DIN EN ISO 15189 and RiliBÄK
• Preparation of statements on topics relating to the accreditation and recognition of medical laboratories on behalf of the DGKL
• Coordination of statements and resolutions on the accreditation and recognition of medical laboratories within the DGKL committees and with the DGKL Presidium
• Selection and confirmation of expert reviewers for clinical chemistry
• Revision and maintenance of the clinical chemistry checklist for the DIN EN ISO 15189 standard on behalf of the DAkkS and the ZLG