Overview
ISO 35001:2019 - Biorisk management for laboratories and other related organisations - defines a management-system approach to identify, assess, control and monitor risks associated with hazardous biological materials. Designed to complement existing international laboratory standards, ISO 35001 helps organizations integrate biosafety and biosecurity into governance, planning and day-to-day operations. It is applicable to any laboratory or organization that works with, stores, transports or disposes of hazardous biological materials (with specific exclusions such as routine testing of food/feed for microorganisms and agricultural management of genetically modified crops).
Key SEO terms: ISO 35001, biorisk management, biosafety, biosecurity, laboratory safety, biological materials.
Key Topics and Requirements
ISO 35001 structures biorisk management using a Plan‑Do‑Check‑Act (PDCA) cycle and follows the common ISO management-system format. Major technical topics include:
- Context and scope: understanding organizational context and interested parties; defining the biorisk management scope.
- Leadership and policy: top-management commitment, documented biorisk policy, roles and responsibilities (including senior management, scientific management, advisors and committees).
- Planning: hazard identification, risk assessment and risk mitigation; setting biorisk objectives.
- Support: resourcing, worker health programmes, competence, behavioural factors, personnel reliability, training, awareness and communication.
- Operational controls: commissioning/decommissioning, maintenance and validation, physical security, biological materials inventory, good microbiological technique, PPE, decontamination, waste management, transport and transport security.
- Emergency preparedness: emergency scenarios, response plans, exercises and contingency plans.
- Performance evaluation and improvement: monitoring, internal audit, management review, incident investigation, corrective action and continual improvement.
- Documentation and information security: control of documented information relevant to biorisk.
Practical Applications and Users
ISO 35001 is practical for organizations that handle hazardous biological agents, including:
- Research laboratories and academic institutions
- Clinical and diagnostic laboratories (where applicable)
- Biobanks and specimen repositories
- Public-health and reference laboratories
- Companies involved in storage, transport or disposal of biological materials
Benefits and uses:
- Establishes consistent biosafety and biosecurity practices
- Integrates biorisk into organizational governance and continuous improvement
- Supports regulatory compliance, risk reduction, and incident prevention
- Guides emergency planning, inventory control and personnel competence programs
Related Standards (if applicable)
ISO 35001 is intended to complement other ISO management and laboratory standards, for example:
- ISO 45001 (occupational health & safety management - PDCA alignment)
- ISO 9001 (quality management systems)
- ISO 15189 (medical laboratories - quality & competence)
Adopting ISO 35001 helps organizations strengthen laboratory safety culture, reduce biosafety and biosecurity risks, and improve resilience when working with hazardous biological materials.
