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BS ISO 35001:2019+A1:2024 Biorisk management for laboratories and other related organisations, 2024
- undefined
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Context of the organization
- 4.1 Understanding the organization and its context
- 4.2 Understanding the needs and expectations of interested parties
- 4.3 Determining the scope of the biorisk management system
- 4.4 Biorisk management system
- 5 Leadership
- 5.1 Leadership and commitment
- 5.2 Policy
- 5.3 Roles, responsibilities, and authorities
- 5.3.1 Top management
- 5.3.2 Senior management
- 5.3.3 Biorisk management committee
- 5.3.4 Biorisk management advisor
- 5.3.5 Scientific management
- 6 Planning
- 6.1 Actions to address risks and opportunities
- 6.1.1 Hazard and/or threat identification and analysis
- 6.1.2 Risk assessment
- 6.1.3 Risk mitigation
- 6.1.4 Performance evaluation
- 6.2 Biorisk management objectives and planning to achieve them
- 7 Support
- 7.1 Resources
- 7.1.1 Worker health programme
- 7.2 Competence
- 7.2.1 Behavioural factors and worker management
- 7.2.2 Personnel reliability measures
- 7.3 Awareness
- 7.3.1 Training
- 7.4 Communication
- 7.5 Documented information
- 7.5.1 General
- 7.5.2 Creating and updating
- 7.5.3 Control of documented information
- 7.5.4 Information security
- 7.6 Non-employees
- 7.7 Personal security
- 7.8 Control of suppliers
- 8 Operation
- 8.1 Operational planning and control
- 8.2 Commissioning and decommissioning
- 8.3 Maintenance, control, calibration, certification, and validation
- 8.4 Physical security
- 8.5 Biological materials inventory
- 8.6 Good microbiological technique
- 8.7 Clothing and personal protective equipment (PPE)
- 8.8 Decontamination and waste management
- 8.9 Emergency response and contingency planning
- 8.9.1 Emergency scenarios
- 8.9.2 Emergency plan training
- 8.9.3 Emergency exercises and simulations
- 8.9.4 Contingency plans
- 8.10 Transport of biological materials
- 8.10.1 Transport security
- 9 Performance evaluation
- 9.1 Monitoring, measurement, analysis, and evaluation
- 9.2 Internal audit
- 9.3 Management review
- 10 Improvement
- 10.1 General
- 10.2 Incident, nonconformity, and corrective action
- 10.3 Continual improvement
- Bibliography [Go to Page]