TY  - JOUR
AU  - Ferrer Robles, Empar
AU  - Vilella, Cristina
AU  - Lozano, Bienvenida María
AU  - Tio , Mª Carmen
AU  - Sevillano, Estefanía
AU  - Ortiz, Nereyda
AU  - Veiga, Ernesto
AU  - Iglesias, Miriam
PY  - 2023/05/08
Y2  - 2026/09/18
TI  - Une 179007: quality management system applied to IVF laboratories, outdated or current.
JF  - Revista Iberoamericana de Fertilidad y Reproducción Humana
JA  - RIF
VL  - 40
IS  - 1 Enero-Febrero-Marzo-Abril
SE  - 
DO  - 
UR  - /index.php/rif/article/view/88
SP  - 
AB  - &lt;p&gt;Assisted reproductive laboratories have to provide a Quality Management System (QMS) to help the monitoring of the processes and techniques performed in them, as well as obtaining a high quality and reliable service for their patients.&lt;/p&gt;&lt;p&gt;&amp;nbsp;In order to have a quality certification specifically applied to IVF laboratories, it was published in 2013 UNE 179007 granted by AENOR and based on the Quality Management System of the International Organization for Standardization (ISO) in force in that year, ISO 9001:2008.&lt;/p&gt;&lt;p&gt;The 4th version of ISO 9001 was published in 2015 including content and format changes tailoring to the structure fixed by Annex SL, which was prepared in order to unify structures in ISO standards.&lt;/p&gt;&lt;p&gt;Faced to this new edition, as UNE 179007 is based in its previous version, these changes force us to consider if the specific standard for LRHA has become obsolete or is it still valid?&lt;/p&gt;&lt;p&gt;In the present work, a thorough review of the structures and contents of the different publications was carried out to determine to what extent it may have affected the validity of UNE 179007. Once this exhaustive analysis was performed, we concluded that future updates should take into account the changes contemplated in ISO 9001:2015, which are more structural than content-related, as well as the evolution of the techniques used in the IVF laboratories. However, we believe that it cannot be considered obsolete because it is still the only specific rule for the implementation of a QMS in assisted reproductive laboratories.&lt;/p&gt;
ER  -