“UNE 179007”: NEW QUALITY STANDARD FOR HUMAN ART LABORATORIES
Ortiz N.; Luna M.; Ardoy M.; and Cabello Y.
Quality Interest Group of the Spanish Society for Reproductive Biology (ASEBIR)
Poster presentado el pasado mes de junio de 2014 en el 30th Annual Meeting of the ESHRE celebrado en Múnich.
Human IVF units have been certified to ISO’s management system standards, although this certification is not specific for the human ART labs. To ensure an efficient quality management in ART labs it´s also necessary to define and standardise specific activity control, professional training and tasks and human and infrastructure resources.
Scientific associations have had different initiatives to unify human IVF labs standards and to improve the quality management. These include the Certification for embryologists (ASEBIR; ESHRE), Best Practice Guidelines, Guidelines for human and infrastructure resources, etc.
The aim of this new quality standard, UNE 179007, was to define specific requirements for human ART labs to improve quality and welfare safety. It establishes common criteria regarding professional qualification, processes and responsibilities, characteristics and controls on infrastructure and equipment, product traceability and safety and quality lab indicators. It’s a National Norm developed by the Spanish Association of Normalisation and Certification (AENOR).
The committee to write the UNE was represented by members of scientific associations, public and private human IVF units, AENOR, professional associations and health administration.
Each ISO 9001’s chapter was analysed and adapted to specific requirements of human ART lab.
Consensus for each chapter was mandatory. The final document was approved by AENOR.
The new quality standard for Human ART laboratories, “UNE 179007”, has increased ISO 9001 requirements by definition of human training (e.g., embryology lab’s responsible must have a biomedical science degree, a PhD or Master degree and more than 5 years of work experience); professional tasks (e.g., responsable for the embryology, andrology and cryopreservation laboratory); minimum human and infrastructure resources plus environmental conditions needed (e.g., cleaning and disinfection, personnel clothing, air conditioning, air recycling and filters, positive pressure); labs equipment control (e.g., calibration and validation, control type, frequency, parameter, measurement range, acceptance criteria), traceability (e.g., embryologist, culture media, material and equipment in each process); lab indicators (process, method, periodicity, standard value); and product preservation (e.g., contingency and transport protocol, product data saved in 2 supports).
Once the human ART labs begin getting certification by UNE 179007 (published on November 2013) the AENOR Committee and the Interest Group of Quality (ASEBIR) are permanently active and able to do a feedback work to keep the Norm upto-date.
UNE 179007 was implemented to adapt ISO 9001 to the human ART labs. This new quality management system will allow the certificated labs to improve the monitoring and measuring process by the standardisation of the specific lab processes. All together it will improve the quality of their services, increase their results and will also benefit the comparison among certificated labs. UNE 179007 also intends to be an international standard for human ART labs.