Business Risk Management

ISO 31000 supports organizations and companies to manage the risks they face. The application of these guidelines can be tailored to any organization and its context and can be used throughout the life of the organization

ISO and European standards provide guidelines to organizations on how to manage the risk they face. The application of these guidelines can be customized to any organization, sector or environment. These standards provide a common approach to managing any type of risk, but they are normally not industry or sector-specific. They can be used throughout the life of the organization and can be applied to any activity, including decision-making at all levels.


Technical committee




Risk management - risk assessment

Risk management - Risk assessment techniques

60.60 Standard published

CLC/SR 56

Risk management - Risk assessment techniques

60.60 Standard published

CLC/SR 56

Risk management - Risk assessment techniques

60.60 Standard published

TC 56



Risk management — guidelines

Risk management — Guidelines

60.60 Standard published

ISO/TC 262

Risk management — Guidelines for the management of legal risk

60.60 Standard published

ISO/TC 262

Risk management — Guidelines on using ISO 31000 in management systems

60.60 Standard published

ISO/TC 262



Application of risk management

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

60.60 Standard published

CLC/TC 62

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

60.60 Standard published

CLC/TC 62

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

CEN/CLC/JTC 3

Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)

60.60 Standard published

CEN/TC 140

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

60.60 Standard published

CEN/TC 206

Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls

90.92 Standard to be revised

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices — Part 2-8: Application guidance — Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2

90.92 Standard to be revised

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices — Part 2-9: Application guidance — Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities

60.60 Standard published

ISO/TC 215

Medical products containing viable human cells — Application of risk management and requirements for processing practices

90.20 Standard under periodical review

ISO/TC 194

Medical devices — Application of risk management to medical devices

60.60 Standard published

ISO/TC 210

Medical devices - Application of risk management to medical devices

60.60 Standard published

TC 62/SC 62A

Medical laboratories — Application of risk management to medical laboratories

60.60 Standard published

ISO/TC 212

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

60.60 Standard published

ISO/TC 194

Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

60.60 Standard published

ISO/TC 215



Laboratory biorisk management

Laboratory biorisk management

90.93 Standard confirmed

CEN/WS 031

Laboratory biorisk management - Guidelines for the implementation of CWA 15793:2008

90.93 Standard confirmed

CEN/WS 055



Project

Quality management systems — Requirements

90.93 Standard confirmed

ISO/TC 176/SC 2