ISO 35001:2019
Biorisk Management System
For laboratories and organisations working with hazardous biological materials.
ClassManagement system standard
Edition2019
What is this standard?
Applicable to any laboratory or organisation that works with, stores, transports and/or disposes of hazardous biological materials. It builds on elements adapted from ISO 45001.
Who is it for?
Laboratories and related organisations handling hazardous biological materials.
What triggers an assessment?
- Hazardous biological material is handled, stored or transported.
- Biosafety and biosecurity risks need systematic management.
- Regulatory or institutional biorisk assurance is required.
What does it not replace?
- Laboratories testing for microorganisms or toxins in food or feed, and management of risks from genetically modified crops in agriculture, are out of scope.
- It is not laboratory competence accreditation (ISO/IEC 17025, ISO 15189).
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