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Journal of Assisted Reproduction and Genetics

Published in:

01-04-2009 | GENETICS

Quality management system in PGD/PGS: now is the time

Authors: Xavier Vendrell, Raquel Carrero, Trinitat Alberola, Rosa Bautista-Llácer, Elena García-Mengual, Reyes Claramunt, Manuel Pérez-Alonso

Published in: Journal of Assisted Reproduction and Genetics | Issue 4/2009

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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Title: Quality management system in PGD/PGS: now is the time
Authors: Xavier Vendrell
Raquel Carrero
Trinitat Alberola
Rosa Bautista-Llácer
Elena García-Mengual
Reyes Claramunt
Manuel Pérez-Alonso
Publication date: 01-04-2009
Publisher: Springer US
Published in: Journal of Assisted Reproduction and Genetics / Issue 4/2009
Print ISSN: 1058-0468
Electronic ISSN: 1573-7330
DOI: https://doi.org/10.1007/s10815-009-9307-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Quality management system in PGD/PGS: now is the time

Abstract

Purpose

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

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