ISO/IEC/IEEE 16085:2021

INTERNATIONAL ISO/IEC/
STANDARD IEEE
16085
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/IEEE 16085:2021(E)
©
ISO/IEC 2021
©
IEEE 2021

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ISO/IEC/IEEE 16085:2021(E)

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ISO/IEC/IEEE 16085:2021(E)

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
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ISO/IEC/IEEE 16085:2021(E)

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 Validation process . . .39
7.5.13 Operation process .39
7.5.14 Maintenance process .40
7.5.15 Disposal process .41
7.6 Tailoring process .41
7.6.1 Typical risk areas . .41
7.6.2 Typical opportunity areas .42
7.6.3 Typical treatments .42
8 Information items .42
8.1 Risk management plan .42
8.1.1 Purpose .42
8.1.2 Risk management plan outline .42
8.2 Risk treatment plan .44
8.2.1 Purpose .44
8.2.2 Risk treatment plan outline .44
Bibliography .46
IEEE Notices and Abstract .48
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ISO/IEC/IEEE 16085:2021(E)

Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that
are members of ISO or IEC participate in the development of International Standards through
technical committees established by the respective organization to deal with particular fields of
technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other
international organizations, governmental and non-governmental, in liaison with ISO and IEC, also
take part in the work.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
rules given in the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its
standards through a consensus development process, approved by the American National Standards
Institute, which brings together volunteers representing varied viewpoints and interests to achieve the
final product. Volunteers are not necessarily members of the Institute and serve without compensation.
While the IEEE administers the process and establishes rules to promote fairness in the consensus
development process, the IEEE does not independently evaluate, test, or verify the accuracy of any of
the information contained in its standards.
Attention is drawn to the possibility that some of the elements of this document may be the subject
of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent
rights. Details of any patent rights identified during the development of the document will be in the
Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents) or the IEC
list of patent declarations received (see https:// patents .iec .c).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Joint Technical Committee ISO/IEC JTC 1, Information technology,
Subcommittee SC 7, Systems and software engineering, in cooperation with the Systems and Software
Engineering Standards Committee of the IEEE Computer Society, under the Partner Standards
Development Organization cooperation agreement between ISO and IEEE.
This edition cancels and replaces ISO/IEC 16085:2006, which has been technically revised.
The main changes compared to ISO/IEC 16085:2006 are as follows:
— Use common terminology, common process names, and common process structure with
ISO/IEC/IEEE 15288:2015 and ISO/IEC/IEEE 12207:2017.
— Improve consistency with ISO 31000:2018, which provides generic principles, framework, and
process for managing all forms of risk.
— Provide specialized guidance for performing risk management within the context of systems and
software engineering projects.
This document is intended to be used in conjunction with ISO/IEC/IEEE 15288:2015,
ISO/IEC/IEEE 12207:2017, ISO 31000 and IEC 31010, and is not a replacement.
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ISO/IEC/IEEE 16085:2021(E)

Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO/IEC/IEEE 16085:2021(E)

Introduction
This document is an elaboration standard for the risk management process described in
ISO/IEC/IEEE 15288 and ISO/IEC/IEEE 12207. This document provides requirements for the tasks
and activities of the risk management process in Clause 6, consistent with these life cycle process
International Standards. This document provides a definition of the content of the risk management
plan (8.1) and risk treatment plan (8.2). This document also provides guidance for how risk management
outcomes, activities, and tasks pertain to other processes.
This document prescribes a continuous process for risk management. Clause 1 provides an overview
and the purpose, scope, and field of application. Clause 2 lists the normative references. Clause 3
provides terms and definitions. Clause 4 prescribes conformance criteria. Clause 5 describes key
concepts and application with other International Standards. Clause 6 elaborates the risk management
process as required by ISO/IEC/IEEE 15288 or ISO/IEC/IEEE 12207. Clause 6 also defines required
purpose, outcomes, tasks, and activities of the risk management process for application to systems
and software engineering projects in an integrated manner as described in Clause 7 and produces the
information products described in Clause 8. Clause 7 suggests some typical risk areas, some typical
opportunity areas, and some typical treatments for each life cycle process. Clause 8 prescribes the
content for the risk management information items. The Bibliography lists informative references that
are either referenced by this document or of interest to users of this document.
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INTERNATIONAL STANDARD ISO/IEC/IEEE 16085:2021(E)
Systems and software engineering — Life cycle processes
— Risk management
1 Scope
1.1 Overview
This document:
— provides risk management elaborations for the processes described in ISO/IEC/IEEE 15288 and
ISO/IEC/IEEE 12207,
— provides the users of ISO/IEC/IEEE 15288, ISO/IEC/IEEE 12207 and their associated elaboration
standards with common terminology and specialized guidance for performing risk management
within the context of systems and software engineering projects,
— specifies the required information items that are to be produced through the implementation of
risk management process for claiming conformance, and
— specifies the required contents of the information items.
This document provides a universally applicable standard for practitioners responsible for managing
risks associated with systems and software over their life cycle. This document is suitable for the
management of all risks encountered in any organization or project appropriate to the systems or
software projects regardless of context, type of industry, technologies utilized, or organizational
structures involved.
This document does not provide detailed information about risk management practices, techniques, or
tools which are widely available in other publications. Instead this document focuses on providing a
comprehensive reference for integrating the large and wide variety of processes, practices, techniques,
and tools encountered in systems and software engineering projects and other lifecycle activities
into a unified approach for risk management, with the purpose of providing effective and efficient
risk management while meeting the expectations and requirements of organization and project
stakeholders.
1.2 Purpose
This document provides information on how to design, develop, implement, and continually improve
risk management in a systems and software engineering project throughout its life cycle.
1.3 Field of application
This document is compatible with risk management as described in ISO/IEC/IEEE 15288 and
ISO/IEC/IEEE 12207 and can also be applied in conjunction with ISO 31000. Depending on the scope
and context of the systems or software engineering project of interest, there are a number of additional
International Standards that can be applicable to the risk management effort including ISO 9001. This
document is intended to provide additional information useful in implementing a system for integrated
risk management for systems and software engineering projects. 5.2 discusses in more detail how this
document can be applied with other standards.
This document is applicable to:
— project teams which use ISO/IEC/IEEE 15288 and ISO/IEC/IEEE 12207 on projects dealing with
man-made systems, software-intensive systems, software and hardware products, and services
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ISO/IEC/IEEE 16085:2021(E)

related to those systems and products, regardless of organization or project scope, product(s),
methodology, size, or complexity;
— project teams performing risk management activities to aid in ensuring that their application of risk
management conforms to ISO/IEC/IEEE 15288 and/or ISO/IEC/IEEE 12207;
— project teams using ISO/IEC/IEEE 15289 on projects dealing with human-made systems,
software-intensive systems, software and hardware products, and services related to those
systems and products, regardless of organization or project scope, product(s), methodology, size,
or complexity; and
— project teams generating information items developed during the application of risk management
processes to conform to ISO/IEC/IEEE 15289.
This document can be applied in conjunction with ISO 31000 and IEC 31010 to augment risk management
performed within the context of ISO/IEC/IEEE 15288 and/or ISO/IEC/IEEE 12207.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/IEC/IEEE 12207:2017, Systems and software engineering — Software life cycle processes
ISO/IEC/IEEE 15288:2015, Systems and software engineering — System life cycle processes
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO, IEC, and IEEE maintain terminological databases for use in standardization at the following
addresses:
— ISO Online browsing platform: available at https:// www .iso .org/
— IEC Electropedia: available at http:// www .electropedia .org/
— IEEE Standards Dictionary Online: available at: http:// dictionary .ieee .org
NOTE Definitions for other system and software engineering terms typically can be found in
ISO/IEC/IEEE 24765, available at www .computer .org/ sevocab.
3.1
consequence
outcome of an event affecting one or more stakeholders (3.11)
Note 1 to entry: An event can lead to a range of consequences.
Note 2 to entry: A consequence can be certain or uncertain and can have positive or negative effects on
objectives (3.3).
Note 3 to entry: Consequences can be expressed qualitatively or quantitatively.
Note 4 to entry: Initial consequences can escalate through follow-on effects.
[SOURCE: ISO Guide 73:2009, 3.6.1.3, modified — In the definition, "objectives" has been replaced by
"one or more stakeholders"; the notes to entry have be
...