ISO/IEC/IEEE 16085:2021

INTERNATIONAL ISO/IEC/
STANDARD IEEE
First edition
2021-01
Systems and software engineering —
Life cycle processes — Risk
management
Ingénierie des systèmes et du logiciel — Processus du cycle de vie —
Gestion des risques
Reference number
©
ISO/IEC 2021
©
IEEE 2021
© ISO/IEC 2021
© IEEE 2021
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Published in Switzerland
© ISO/IEC 2021 – All rights reserved
ii © IEEE 2021 – All rights reserved

Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
1.1 Overview . 1
1.2 Purpose . 1
1.3 Field of application . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Conformance . 5
4.1 Intended usage . 5
4.2 Conformance to information items . 5
4.3 Conformance to process . 5
4.4 Full conformance. 5
5 Key concepts and application . 5
5.1 Key concepts . 5
5.1.1 Risk and opportunity . 5
5.1.2 Project and organizational specific terminology . 5
5.1.3 Systems and software . 6
5.1.4 Uncertainty and its relationship to risk . 6
5.1.5 Complexity and its relationship to risk . 6
5.1.6 Risk management above the project level . 6
5.1.7 Purpose and principles for risk management . 6
5.2 Application . 7
5.2.1 General. 7
5.2.2 Application with ISO/IEC/IEEE 15288 or ISO/IEC/IEEE 12207 . 8
5.2.3 Application with ISO 31000 . 8
5.2.4 Application with ISO 9001 . 8
5.2.5 Application with other ISO, IEC, ISO/IEC, and ISO/IEC/IEEE standards . 9
6 Risk management process . 9
6.1 Purpose . 9
6.2 Process . 9
6.3 Outcomes .11
6.4 Activities and tasks .11
6.4.1 General.11
6.4.2 Plan risk management .11
6.4.3 Manage the risk profile.12
6.4.4 Analyze risks .13
6.4.5 Treat risks .16
6.4.6 Monitor risks .18
6.4.7 Evaluate the risk management process .18
7 Risk management in life cycle processes .19
7.1 Overview .19
7.2 Risk management in agreement processes .19
7.2.1 General.19
7.2.2 Acquisition process .19
7.2.3 Supply Process .20
7.3 Risk management in organizational project-enabling processes .21
7.3.1 General.21
7.3.2 Life cycle model management process .22
7.3.3 Infrastructure management process .22
7.3.4 Portfolio management process .23
7.3.5 Human resource management process .23
© ISO/IEC 2021 – All rights reserved
© IEEE 2021 – All rights reserved iii

7.3.6 Quality management process.24
7.3.7 Knowledge management process .24
7.4 Risk management in technical management processes .25
7.4.1 General.25
7.4.2 Project planning process .25
7.4.3 Project assessment and control process .26
7.4.4 Decision management process .27
7.4.5 Risk management process .27
7.4.6 Configuration management process .28
7.4.7 Information management process .29
7.4.8 Measurement process .30
7.4.9 Quality assurance process .30
7.5 Risk management in technical processes .31
7.5.1 General.31
7.5.2 Business or mission analysis process .31
7.5.3 Stakeholder needs and requirements definition process .32
7.5.4 System/Software requirements definition process .33
7.5.5 Architecture definition process .34
7.5.6 Design definition process .35
7.5.7 System analysis process.35
7.5.8 Implementation process .36
7.5.9 Integration process .37
7.5.10 Verification process .37
7.5.11 Transition process .38
7.5.12 Validatio
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