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PD ISO/TS 7446:2026 Implementation guidance for biorisk management for laboratories and other related organizations, 2026
- undefined
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Context of the organization [Go to Page]
- 4.1 Understanding the organization and its context [Go to Page]
- 4.1.1 General
- 4.1.2 Organization’s external context
- 4.1.3 Organization’s internal context
- 4.2 Understanding the needs and expectations of interested parties
- 4.3 Determining the scope of the biorisk management system [Go to Page]
- 4.3.1 General
- 4.3.2 Documenting the biorisk management system scope
- 4.4 Biorisk management system
- 5 Leadership [Go to Page]
- 5.1 Leadership and commitment
- 5.2 Policy [Go to Page]
- 5.2.1 General
- 5.2.2 Communicating the biorisk management policy
- 5.3 Roles, responsibilities and authorities [Go to Page]
- 5.3.1 General
- 5.3.2 Top management
- 5.3.3 Senior management
- 5.3.4 Biorisk management committee
- 5.3.5 Biorisk management advisor
- 5.3.6 Scientific management
- 6 Planning [Go to Page]
- 6.1 Actions to address risks and opportunities
- 6.2 Hazard and threat identification and analysis
- 6.3 Risk assessment
- 6.4 Risk mitigation
- 6.5 Performance evaluation
- 6.6 Biorisk management objectives and planning to achieve them [Go to Page]
- 6.6.1 General
- 6.6.2 Biorisk management objectives
- 6.6.3 Biorisk management system control plan considerations
- 7 Support [Go to Page]
- 7.1 Resources [Go to Page]
- 7.1.1 General
- 7.1.2 Worker health programme
- 7.2 Competence [Go to Page]
- 7.2.1 General
- 7.2.2 Behavioural factors and worker management
- 7.2.3 Personnel reliability measures
- 7.3 Awareness [Go to Page]
- 7.3.1 General
- 7.3.2 Training
- 7.4 Communication and consultation
- 7.5 Documented information [Go to Page]
- 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 [Go to Page]
- 8.1 Operational planning and control [Go to Page]
- 8.1.1 General
- 8.1.2 Facility and operational planning, design, and redesign
- 8.1.3 Control measures
- 8.2 Commissioning and decommissioning [Go to Page]
- 8.2.1 General
- 8.2.2 Commissioning
- 8.2.3 Decommissioning
- 8.3 Maintenance, control, calibration, certification, and validation [Go to Page]
- 8.3.1 General
- 8.3.2 Maintenance roles and responsibilities
- 8.3.3 Maintenance documentation
- 8.3.4 Maintenance planning
- 8.4 Physical security
- 8.5 Biological materials inventory [Go to Page]
- 8.5.1 General
- 8.5.2 Scope of inventory
- 8.5.3 Elements of the inventory process
- 8.5.4 Changes to the inventory
- 8.5.5 Inventory security risk assessment
- 8.5.6 Verifying, reviewing, and checking inventory
- 8.6 Good microbiological technique (GMPP) [Go to Page]
- 8.6.1 General
- 8.6.2 Training and monitoring
- 8.6.3 Biological hazards
- 8.6.4 Personal hygiene and dress
- 8.6.5 Work area and organization
- 8.6.6 Aseptic technique
- 8.6.7 Technical procedures for minimizing aerosol generation
- 8.6.8 Use of biological safety cabinets (BSC) and other similar containment equipment
- 8.6.9 Waste disposal procedures
- 8.7 Clothing and personal protective equipment (PPE) [Go to Page]
- 8.7.1 General
- 8.7.2 Personal clothing
- 8.7.3 Personal protective equipment (PPE)
- 8.7.4 Laboratory coats
- 8.7.5 Footwear
- 8.7.6 Gloves
- 8.7.7 Eye protection
- 8.7.8 Respiratory protection
- 8.7.9 PPE program
- 8.8 Decontamination and waste management [Go to Page]
- 8.8.1 General
- 8.8.2 Decontamination processes and procedures
- 8.8.3 Waste management
- 8.9 Emergency response and contingency planning [Go to Page]
- 8.9.1 General
- 8.9.2 Identification of emergency scenarios
- 8.9.3 Emergency plans
- 8.9.4 Emergency plan training
- 8.9.5 Emergency exercises and simulations
- 8.9.6 Contingency plans
- 8.10 Transport of biological materials [Go to Page]
- 8.10.1 General
- 8.10.2 Transportation planning
- 8.10.3 Transportation security
- 9 Performance evaluation [Go to Page]
- 9.1 Monitoring, measurement, analysis, and evaluation
- 9.2 Incident investigation [Go to Page]
- 9.2.1 General
- 9.2.2 Incident description
- 9.2.3 Initial incident reporting
- 9.2.4 Incident documentation
- 9.2.5 Incident analysis
- 9.2.6 Incident: lessons learned
- 9.3 Internal audit [Go to Page]
- 9.3.1 General
- 9.3.2 Audit and inspection programme
- 9.3.3 Audit planning
- 9.3.4 Conducting audits and inspections
- 9.3.5 Reporting audit results
- 9.3.6 Audit programme record keeping
- 9.4 Management review
- 10 Improvement [Go to Page]
- 10.1 General
- 10.2 Incident, nonconformity and corrective action [Go to Page]
- 10.2.1 Nonconformity
- 10.2.2 Corrective action
- 10.2.3 Continual improvement
- Annex A (informative) Identification and characterization of biorisk
- Annex B (informative) Selection of biorisk controls
- Annex C (informative) Biorisk reduction strategies
- Annex D (informative) Biorisk management of design and construction
- Annex E (informative) Biorisk management system framework
- Annex F (informative) Training and competency
- Annex G (informative) Enhanced control measures for high biorisk activities
- Bibliography [Go to Page]
