UNE 179007 System for quality management in assisted human reproduction laboratories

Better protection in assisted human reproduction

Professionals dedicated to Assisted Human Reproduction recognise the need for a specific standard that can allow for efficient quality management.

This standard specifies the quality requirements for a management system for assisted human reproduction organisations.

The Standard UNE 179007 certifies laboratories of care units that carry out activities related to gametes and pre-embryos for assisted human reproduction, whether for own use, donation within the couple or donation outside the couple. The scope applies until the use of gametes or pre-embryos has been completed, in accordance with legislation in force.

Care units where the standard is applied are grouped into: Andrology laboratories, embryology laboratories and cryopreservation laboratories.

Despite the legal environment in Spain surrounding assisted human reproduction, and the fact that the need for care given to infertile patients is an increasingly relevant requirement that has a socio-sanitary impact, the Laboratory of Assisted Human Reproduction needs to be better defined in practically all departments:

• Professional training 
  
• Human resources and materials 
  
• Requirements and follow-up of the activity 
  
• Specific areas of professional endeavours, etc. 
  

The definition of these areas will be beneficial to healthcare quality and safety, as well as for professional endeavours.

There are various initiatives both nationally and internationally, particularly among scientific societies, which seek to improve healthcare quality, at least in part, through:

• Assisted Human Reproduction-Clinical Embryology training programmes, including master's and postgraduate programmes in universities.
  
• Clinical Embryology certificates.
  
• Best practice guides.
  
• Recommendations for human and physical resources in laboratories.
  

Among others, the purposes of this standard are:

• To unify quality management criteria for Assisted Human Reproduction Laboratories (hereinafter, 'LRHA').
  
• Help to plan process management in LRHA.
  
• Define:
  
• Specific terminology of LRHA.
  
• Minimum criteria for human resources, infrastructure and environmental requirements.
  
• Minimum criteria for monitoring and assessing processes.
  
• Minimum criteria for quality assurance and control.
  
• To facilitate the adaptation to complex legal requirements that affect the LRHA: traceability, environmental quality, preembryonic destination, etc.
• To contribute minimum requirements for communication with customers and suppliers.