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BS ISO 35001:2019

$167.15

Biorisk management for laboratories and other related organisations

Published By Publication Date Number of Pages
BSI 2019 38
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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.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
17 4 Context of the organization
4.1 Understanding the organization and its context
18 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
19 5.2 ​Policy
5.3 Roles, responsibilities, and authorities
20 5.3.1 ​Top management
5.3.2 Senior management
5.3.3 Biorisk management committee
21 5.3.4 Biorisk management advisor
5.3.5 Scientific management
22 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
23 6.1.3 Risk mitigation
6.1.4 ​Performance evaluation
6.2 Biorisk management objectives and planning to achieve them
24 7 Support
7.1 Resources
7.1.1 Worker health programme
25 7.2 Competence
7.2.1 Behavioural factors and worker management
7.2.2 Personnel reliability measures
26 7.3 Awareness
7.3.1 Training
7.4 Communication
27 7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
28 7.5.4 Information security
7.6 Non-employees
7.7 Personal security
7.8 Control of suppliers
29 8 Operation
8.1 Operational planning and control
8.2 Commissioning and decommissioning
30 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
31 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
32 8.10.1 Transport security
9 ​Performance evaluation
9.1 ​Monitoring, measurement, analysis, and evaluation
9.2 ​Internal audit
33 9.3 ​Management review
10 Improvement
10.1 General
34 10.2 Incident, nonconformity, and corrective action
10.3 ​Continual improvement
36 Bibliography
BS ISO 35001:2019
$167.15