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Quality management system in PGD/PGS: now is the time
Xavier Vendrell1, Raquel Carrero, Trinitat Alberola
1Reproductive Genetics Unit, Sistemas Genómicos S.L., Paterna, Spain. javier.vendrell@sistemasgenomicos.com
Journal of Assisted Reproduction and Genetics
|March 7, 2009
Summary
Implementing a Quality Management System is crucial for preimplantation genetic diagnosis (PGD) and preimplantation genetic screening (PGS) laboratories seeking accreditation. This guidance supports laboratories in achieving ISO certification for enhanced safety and reproducibility.
Area of Science:
- Reproductive Medicine
- Clinical Genetics
- Laboratory Science
Background:
- Accreditation of Preimplantation Genetic Diagnosis (PGD) and Preimplantation Genetic Screening (PGS) laboratories is essential for ensuring safety and reproducibility.
- Implementing a Quality Management System (QMS) is a mandatory prerequisite for laboratory accreditation.
- Guidance is needed for PGD/PGS laboratories aiming to implement a QMS.
Purpose of the Study:
- To provide detailed guidance for the PGD/PGS community on implementing a Quality Management System.
- To support laboratories in their journey towards accreditation for PGD/PGS services.
Main Methods:
- Certification based on ISO 9001:2000 standards.
- Key steps include procedure identification, flowchart definition, process documentation, critical control point recognition, quality control establishment, validation, and audit system implementation.
Main Results:
- Successful achievement of ISO certification specifically for preimplantation genetic diagnosis.
Conclusions:
- ISO certification for PGD/PGS laboratories enables efficiency evaluation, ensuring sensitivity.
- Certification facilitates continuous improvement in the genetic diagnosis of single embryonic cells.
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