Quality and Safety Management Office (QSMO)

activities

The mission of the QSMO is to design, implement and maintain an integrated Quality Management System (iQMS) at LIH, which combines the pillars of “Quality Management”, “Health & Safety Management”, “Risk Management” and “Research Quality & Ethics” in close collaboration with the research, operational and administrative stakeholders.

The iQMS addresses regulatory compliance, quality requirements, research ethics & quality and health, (bio)safety & environmental questions. Therefore, the following regulations, guidelines and norms are guiding our approaches (non-exhaustive list):

ISO 9001, ISO 17025, ISO 17043, ISO 20387, ISO 27001, ISO 31000, ISO 35001, ISO 45001, GCP, GCLP, GDPR, European Code of Conduct for Research Integrity, ISBER Best Practices, ECRIN.

We focus our standardization efforts on research service units as they have been combined in the Translational Medicine Operations Hub (TMOH), where biospecimen generation and biospecimen exploration contribute to intra- and inter-institutional translational research by targeting operational excellence.

Our principles in supporting LIH to achieve its objectives are

  • fostering the process approach with risk-based thinking and
  • promoting continuous improvement by the “Plan – Do – Check – Act” cycle to
  • strengthen evidence-based decision-making.

The institute’s commitment to quality has been formalized since 2013:

  • LIH has been ISO 9001 certified
  • IBBL has been ISO 9001 certified and has been accredited as testing laboratory according to ISO 17025.
Sabine
Lehmann

Head of unit

After a PhD in Chemistry from the Free University Berlin, Dr. Sabine Lehmann worked in the Quality Assurance Unit of BRAHMS Diagnostica in Germany, where she contributed to the initial ISO 9001 certification in 1992. In 2000, Sabine moved to France, to join the Clinical Pharmacology Unit of PAREXEL at Poitiers, where she was responsible for the quality management system of the Bioanalyical Laboratory and a Phase I Clinic according to GLP and GCP. From there she moved in 2010 to Luxembourg. As Quality Manager of the Integrated Biobank of Luxembourg (IBBL) she built up the quality system under ISO 9001 and ISO 17025. Related certification respective accreditation was achieved in 2014 respective 2016. In 2015, IBBL was awarded with the “Prix Luxembourgeois de la qualité et de l’excellence”, recognizing its outstanding commitment to continuous improvement. Sabine acts also as Technical Expert respresenting Luxembourg in ISO standardization committees; for example, she was actively involved as Co-Project Leader in the development of ISO 20387 “Biotechnology – Biobanking – General requirements for biobanking”. In 2021, she took over the lead of the current Quality & Safety Management Office (QSMO) at LIH to further promote the development of the iQMS on the institute’s level.

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