QUARTS Lab is an accreditation program specifically designed for IVF laboratories by the medical associations SGRM and AGER. This program was established to meet the requirements of the FMedV article 4.1.c while addressing the unique characteristics of IVF laboratories. According to FMedV article 4.1.c, biological reproductive medicine laboratories must implement a quality management system based on ISO standards ISO/IEC 17025:2005 or ISO 15189:2012. However, these standards alone do not fully capture the specific needs of IVF laboratories. Therefore, the QUARTS accreditation incorporates these ISO standards along with the ESHRE guidelines to ensure comprehensive quality management and operational safety.

The public expects the highest safety and quality standards for fertility treatment. Externally monitored quality is highly valued, and the QUARTS Lab accreditation label allows IVF laboratories to demonstrate their commitment to these standards. Key documents and guidelines that form the basis of QUARTS Lab include:

1. Fortpflanzungsmedizinverordnung - FMedV (Reproductive Medicine Ordinance) - 1 September 2017
2. ISO 17025:2017 "Accreditation Standard for Testing and Calibration Laboratories"
3. ISO 15189:2022 "Accreditation Standard for Medical Laboratories – Quality and Competence Requirements"
4. "Revised Guidelines for Good Practice in IVF Laboratories (2015)" of the European Society of Human Reproduction and Embryology (ESHRE)
5. The Alpha consensus meeting on cryopreservation key performance indicators and benchmarks: proceedings of an expert meeting (2012)

These standards ensure IVF laboratories operate with the highest quality and safety, requiring close collaboration with clinical treatment providers to achieve specific result parameters. 
 

For clinical units in ART, there was previously no specific certification system for sustainable quality development. The QUARTS Med module was created to provide clinical units with a systematic approach to quality assurance and development, focusing on field-specific content and results. The QUARTS Med certification demonstrates a commitment to internal and external quality standards, based on:

1. Fortpflanzungsmedizinverordnung - FMedV - 1 September 2017
2. Fortpflanzungsmedizingesetz, FMedG – 18. Dezember 1998 (Stand am 1. September 2017)
3. The Maribor consensus: report of an expert meeting on the development of performance indicators for clinical practice in ART – 2021
4. ESHRE Guidelines
5. ISO 9001:2018

This ensures that clinical ART units adhere to high standards of quality and safety, enhancing the overall success and credibility of fertility treatments.

By integrating these comprehensive modules, the QUARTS system aims to uphold the highest standards of quality and safety in both the laboratory and clinical aspects of reproductive medicine.