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.
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:
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:
Among others, the purposes of this standard are:
This standard applies to the medical-hospital sector.
UNE 179007 Quality management system for assisted human reproduction laboratories is perfectly integrable with the management system
Once the Audit process is complete, if the system set up adapts to the requirements of standard UNE 179007 System for quality management in assisted human reproduction laboratories, the organisation obtains:
UNE 179007 Mark for the Quality management system
AENOR has extensive experience in specific certifications for the medical sector.