ISO 35001:2019
Biorisk management for laboratories and other related organisations
This document defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. This document is applicable to any laboratory or other organization that works with, stores, transports, and/or disposes of hazardous biological materials. This document is intended to complement existing International Standards for laboratories.
This document is not intended for laboratories that test for the presence of microorganisms and/or toxins in food or feedstuffs. This document is not intended for the management of risks from the use of genetically modified crops in agriculture.
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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
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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