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

The UNE 179007:2013 standard is designed for assisted human reproduction organizations to support effective quality management. Applus+ Certification certifies laboratories conducting activities related to gametes or pre-embryos exclusively for the purpose of assisted human reproduction.

The healthcare units covered by this standard can be grouped into:

• Andrology laboratories
• Embryology laboratories
• Cryopreservation laboratories

As the number of patients requiring infertility treatments continues to increase, Assisted Human Reproduction Laboratories (AHRL) require greater definition and control across all areas of operation, including:

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

What Are the Objectives of UNE 179007:2013?

• Standardize quality management criteria.
• Facilitate AHRL planning through process management.
• Establish specific terminology for Assisted Human Reproduction Laboratories.
• Define minimum requirements for human resources, infrastructure, environmental conditions, and process monitoring and evaluation.
• Support compliance with legal requirements related to traceability, environmental quality, pre-embryo location, and other regulatory aspects.
• Establish minimum requirements for communication between clients and service providers.

Benefits

• Improves processes that contribute to higher-quality healthcare and patient services.
• Helps ensure compliance with applicable legal requirements.
• Reduces costs and improves operational efficiency.
• Builds confidence among clients through effective management of assisted reproduction processes.
• Creates a competitive advantage for the laboratory.
• Enhances overall organizational efficiency.

Who Is This Standard For?

This standard is intended for laboratories and healthcare units performing activities involving gametes or pre-embryos exclusively for assisted human reproduction purposes.

Why Choose Applus+ Certification?

Applus+ Certification is an independent certification body with recognized national and international prestige. Our mission is to help organizations achieve their commitment to continuous improvement.

The technical expertise and professional competence of our auditors, recognized specialists in their respective sectors, ensure that every assessment delivers maximum value while verifying compliance across organizations and laboratories operating in this field.