ISO 35001 (Biorisk Management) Training by Tonex
ISO 35001 (Biorisk Management) Training by Tonex prepares professionals to establish, operate, evaluate, and continually improve a structured biorisk management system for laboratories and related organizations.
The course addresses leadership, risk assessment, operational controls, competence, emergency preparedness, incident management, performance evaluation, and corrective action. ISO 35001 provides a management-system approach for identifying, assessing, controlling, and monitoring risks involving hazardous biological materials.
Cybersecurity is increasingly important because digital laboratory platforms, access systems, records, and connected instruments can influence biological safety and security. Strong cybersecurity controls help protect sensitive biological information, preserve system integrity, and reduce unauthorized access to critical laboratory operations.
Learning Objectives
Upon completing this course, participants will be able to:
- Explain the purpose, scope, terminology, and essential requirements of ISO 35001.
- Establish a structured biorisk management system aligned with organizational objectives.
- Identify biological hazards and evaluate associated biosafety and biosecurity risks.
- Select proportionate controls for handling, storing, transporting, and disposing of hazardous biological materials.
- Define leadership responsibilities, worker participation requirements, and biorisk management accountabilities.
- Develop procedures for emergency preparedness, incident reporting, investigation, and corrective action.
- Strengthen cybersecurity practices that protect biological information, digital records, access controls, and connected laboratory environments.
- Measure biorisk management performance through monitoring, auditing, management review, and continual improvement.
Audience
- Laboratory managers and supervisors
- Biosafety officers
- Biosecurity officers
- Biorisk management professionals
- Biological safety committee members
- Research facility personnel
- Healthcare laboratory professionals
- Public health professionals
- Quality assurance professionals
- Environmental health and safety personnel
- Risk and compliance managers
- Emergency preparedness coordinators
- Internal auditors and assessors
- Cybersecurity Professionals
- Government and regulatory personnel
- Professionals responsible for biological materials
Course Modules
Module 1: ISO 35001 Biorisk Foundations
- Purpose and scope of ISO 35001
- Core biorisk management terminology
- Biosafety and biosecurity principles
- Hazardous biological material categories
- Organizational context and interested parties
- Biorisk management system boundaries
Module 2: Leadership and Organizational Governance
- Leadership commitment and accountability
- Biorisk management policy development
- Organizational roles and responsibilities
- Worker consultation and participation
- Resource allocation and oversight
- Integration with organizational governance
Module 3: Biological Risk Assessment Process
- Biological hazard identification methods
- Exposure pathways and risk scenarios
- Likelihood and consequence evaluation
- Existing control effectiveness assessment
- Risk prioritization and acceptance criteria
- Risk assessment documentation requirements
Module 4: Operational Biorisk Control Measures
- Hierarchy of biological risk controls
- Personnel access and authorization controls
- Biological material handling requirements
- Storage and inventory management practices
- Transportation and transfer safeguards
- Waste treatment and disposal controls
Module 5: Competence and Emergency Preparedness
- Personnel competence and qualification criteria
- Biorisk awareness and communication
- Documented information and record control
- Emergency planning and response responsibilities
- Biological incident reporting procedures
- Recovery and operational continuity planning
Module 6: Evaluation and Continual Improvement
- Biorisk performance monitoring methods
- Compliance evaluation and internal auditing
- Incident and nonconformity investigation
- Root cause identification techniques
- Corrective action effectiveness reviews
- Management review and continual improvement
Additional Module Coverage
Throughout the course, participants examine how biorisk management responsibilities should be coordinated across leadership, scientific personnel, safety teams, information technology personnel, security departments, quality functions, and emergency response groups. This coordinated approach helps ensure that biological risk decisions are not isolated within one department.
Participants also learn how to establish measurable objectives, assign responsible personnel, maintain appropriate documentation, and evaluate whether established controls are achieving intended results. Emphasis is placed on creating practical processes that reflect the nature, complexity, and scale of an organization’s biological activities.
The course addresses the Plan-Do-Check-Act approach used to support continual improvement. Participants learn to plan biorisk objectives and controls, implement approved processes, monitor performance, evaluate findings, and take corrective actions when weaknesses or nonconformities are identified. This approach allows organizations to respond systematically to operational changes, emerging risks, incidents, regulatory expectations, and organizational priorities.
Cybersecurity considerations are incorporated into the broader biorisk framework. Participants explore the importance of protecting electronic inventories, research information, access credentials, monitoring platforms, incident records, and other sensitive digital assets. Appropriate coordination between cybersecurity and biorisk teams can help prevent unauthorized access, data manipulation, operational disruption, and loss of critical biological information.
Enroll in ISO 35001 Training
Build the knowledge needed to manage biological risks systematically and support safer, more secure organizational operations. Enroll in ISO 35001 (Biorisk Management) Training by Tonex today.