UNE 179007:2013 – Systems of quality management for assisted reproduction laboratories

The UNE 179007:2013 standard is aimed at organisations of assisted human reproduction in order to provide efficient quality management. The standard of Applus+ Certification certifies the laboratories carrying out activities related to gametes or pre-embryos with the sole aim of assisting human reproduction. 

The healthcare units this standard applies to can be grouped in:

• Andrology laboratories
• Embryology laboratories 
• Cryopreservation laboratories

It is becoming increasingly frequent to assist patients with infertility, so the Assisted Human Reproduction Laboratory (AHRL) requires a greater degree of definition in practically every area:

• Professional training
• Human resources and materials
• Activity requirements and monitoring
• Specific areas of professional practice

WHAT ARE THE OBJECTIVES OF UNE 179007:2013?

• Unifying the criteria of quality management
• Facilitating the planning of the AHRL through process management.
• Providing a specific terminology of the AHRL.
• Setting the minimum criteria for human resources, infrastructure and environmental requirements, as well as for process monitoring and evaluation.
• Facilitating compliance with the legal requirements of the AHRL: traceability, environmental quality, pre-embryo location, etc.
• Providing the minimum requirements for the communications between customers and providers.

BENEFITS

• Improves the processes that contribute to improving the quality of the healthcare and service provided to the patient.
• Guarantees legal compliance.
• Reduces costs and improves operating processes.
• Builds trust with customers by ensuring good management of the processes related to assisted reproduction.
• Develops a competitive advantage for the laboratory.
• Improves the efficiency of the organisation.

WHO IS THIS STANDARD FOR?

It is aimed at laboratories of healthcare units carrying out activities related to gametes or pre-embryos with the sole aim of assisted human reproduction. 

WHY CHOOSE CERTIFYING WITH APPLUS+ CERTIFICATION? 

Applus+ Certification is an independent entity of recognized prestige, both nationally and internationally, whose mission is to help organizations achieve their commitment to continuous improvement. 

The technical and personal competence of our auditors, well-recognised specialists in each sector of activity, do their work with utmost effort to ensure that the evaluation process provides maximum value, assessing the conformity of each of the centres and organizations in this sector.