Abstract
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.
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A detailed exposition of quality management system implementation in an external PGD/PGS laboratory based on the firsts international standards.
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Vendrell, X., Carrero, R., Alberola, T. et al. Quality management system in PGD/PGS: now is the time. J Assist Reprod Genet 26, 197–204 (2009). https://doi.org/10.1007/s10815-009-9307-9
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DOI: https://doi.org/10.1007/s10815-009-9307-9