Purpose: Governments and international authorities require an accreditation of the PGD/PGS laboratories in order to ensure the safety and reproducibility of these analytical procedures. The implementation of a Quality Management System is the first mandatory step prior to accreditation. Our aim is to offer a detailed guidance to the PGD/PGS community that would like to implement this system in the future.
Methods: The certification was based on the norm ISO 9001:2000 and requires the identification of procedures, definition of the flowchart, documentation of the processes, recognition of the critical control points, establishment of quality controls, performance of validation and audit system.
Results: The achievement of ISO certification with the specific scope of "preimplantation genetic diagnosis".
Conclusion: Certification of PGD/PGS allows to achieve evaluation of the efficiency to ensure the sensitivity and a continuous improvement of the genetic diagnosis of embryonic single cells.