Overview
ISO 35001:2019/Amd 1:2024 is the latest amendment to the ISO 35001:2019 standard, focused on biorisk management for laboratories and related organizations. Published by the International Organization for Standardization (ISO), this amendment integrates key climate action changes to the existing biorisk management framework. The update highlights the relevance of climate change as a factor in managing biological risks, reinforcing the importance of considering environmental impacts within laboratory safety systems.
Key Topics
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Integration of Climate Change Considerations
Organizations implementing ISO 35001 must now assess whether climate change is a relevant issue impacting their biorisk management system. This addition emphasizes the increased importance of environmental factors in laboratory safety and risk mitigation.
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Stakeholder Requirements Related to Climate
The amendment clarifies that interested parties, such as regulators, customers, and community groups, may have specific requirements linked to climate change. Laboratories are advised to consider these in their risk management processes.
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Enhanced Risk Assessment
By including climate change as a potential risk driver, laboratories are encouraged to expand their risk identification and mitigation strategies to address climate-related biological hazards, such as those arising from extreme weather events or shifts in pathogen prevalence.
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Standards Governance and Compliance
This amendment aligns with ISO’s ongoing commitment to updating standards in response to global challenges like climate change. Organizations must stay compliant by integrating these updates into their existing biorisk management practices.
Applications
ISO 35001:2019/Amd 1:2024 is applicable to a wide range of entities involved in biological research and testing, including but not limited to:
- Clinical laboratories
- Research institutions
- Diagnostic testing facilities
- Pharmaceutical and biotechnology companies
- Environmental and public health laboratories
Implementing this amendment helps organizations:
- Enhance laboratory biosafety and biosecurity by factoring in climate-related risks
- Meet evolving regulatory and stakeholder expectations regarding climate action
- Improve organizational resilience against biological threats influenced by environmental changes
- Foster sustainable practices within laboratory operations consistent with global climate objectives
Related Standards
To complement ISO 35001:2019/Amd 1:2024, organizations may consider integrating the following related ISO standards for a comprehensive management approach:
- ISO 14001: Environmental Management Systems – Supports the integration of environmental sustainability and climate action goals within organizational management.
- ISO 45001: Occupational Health and Safety Management Systems – Ensures workplace safety, which is critical when managing biological risks under changing environmental conditions.
- ISO 31000: Risk Management – Provides overarching principles for risk assessment and mitigation, including emerging risks from climate change.
Practical Value
By incorporating climate action into biorisk management, ISO 35001:2019/Amd 1:2024 enables laboratories to proactively address emerging biological hazards linked to climate variability. This approach not only improves safety and compliance but also aligns laboratory practices with international climate goals, fostering sustainability and resilience in the global bioscience community.
For organizations engaged in laboratory operations and biohazard management, adopting this amendment is vital to:
- Strengthen risk management frameworks against the backdrop of climate change
- Stay competitive and compliant in a rapidly evolving regulatory landscape
- Demonstrate leadership in responsible and sustainable laboratory practice
For more information, visit the official ISO website at www.iso.org and consult the ISO 35001:2019/Amd 1:2024 publication for full details on the amendment and implementation guidance.
Open preview (PDF)Biorisk management for laboratories and other related organisations — Amendment 1: Climate action changes