EBSA Thursday - How ISO standards and technical specifications can support you in your daily life as BSO (and how you can support ISO with your technical knowledge as BSO)
ISO35001:2019 Biorisk management for laboratories and related organizations is the well-known ISO management system standard supporting you in organizing biosafety and biosecurity in your organization and helping you to address all biorisk management issues that need to be addressed in a concerted manner. It builds on the continuous improvement plan- do-check-act-cycle to keep your biosrisk management system up to date and under control. ISO35001 was designed by biosafety experts like you form different countries around the globe, being a truly international standard, within the context of the International Standardization Organization, ISO, Technical Committee TC212, Clinical laboratory testing and in vitro diagnostic test systems
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Ursula Jenal
Working address:
Jenal & Partners Biosafety Consulting,
Magdenerstrasse 1
4310 Rheinfelden
Switzerland
Academic Education and Degrees
PhD in Microbiology from the Swiss Federal Institute of Technology, ETH, Zürich,
Post Doc in Environmental Engineering and Sciences at Stanford UniversityAttendance of numerous biosafety trainings ABSA, EBSA
ISO9001 certified lead auditorPresent Professional Position
Since 2001, executive manager of Jenal & Partners Biosafety Consulting advising industry, academia and authorities on an international level on all issues related to biosafety and biosecurity: risk assessment of contained use activities; risk assessment of nano-bio-materials; environmental risk assessment for gene and cell therapy and recombinant vaccine clinical trials and market authorisation applications; guidelines on safe use of cell cultures, plant pathogens, transport, waste treatment; ISO35001 biorisk management systems and audits, crisis management, ISO140001 certification audits, biosafety training, safe procedure design, project management. She has been involved in capacity building projects in South East Asia.
1996-2000 senior scientist at the Swiss Federal Office for the Environment acting as co-author of the Swiss Biotechnology Regulations harmonised with the corresponding EU directives.
Member of EBSA since 2001, acting as secretary for 4 years, member of the Education and Training Working Group until 2018 and representing EBSA at the Biological and Toxins Weapons Convention meetings.
Member of the certification body of IFBA representing EBSA 2016 – 2020.
Co-chair of the CEN workshop process to develop the CWA16335 on BioSafety Professional (BSP) competence, and project leader for the development of ISO Technical Specification TS5441 Competence Requirement for Biorisk Management Advisors.