ISO 35001:2019, including Amendment 1: Climate action changes
Biorisk Management System
ISO 35001 (2019) is a management system standard: Biorisk Management System. 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. It applies to laboratories and related organisations handling hazardous biological materials.
- Class
- Management system standard
- Edition
- 2019
- Related sectors
- 1
- Last verified
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.
What ISO 35001 does 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).
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.
Official source
Amendment source
- Amendment 1: Climate action changes ↗ — Last verified:
Last verified:
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