ISO/IEC TS 15504-10:2011

Information technology — Process assessment — Part 10: Safety extension

ISO/IEC 15504 provides a framework for the assessment of processes. This framework can be used by organizations involved in planning, managing, monitoring, controlling, and improving the acquisition, supply, development, operation, evolution and support of product and services. The published ISO/IEC 15504 process assessment models for systems and software do not currently provide a sufficient basis for performing a process capability assessment of processes with respect to the development of complex safety-related systems. Developing safety-related systems requires specialized processes, techniques, skills and experience. Process amplifications (safety extension) are needed in the area of safety management, safety engineering and safety qualification. ISO/IEC TS 15504-10:2011 presents these amplifications (a safety extension) as three process descriptions: safety management, safety engineering and safety certification processes. The aim of ISO/IEC TS 15504-10:2011 is not to provide a way to verify the compliance with one or more domain-specific safety standards, nor to extend ISO/IEC 15504 in order to use it as a safety standard against which to verify compliance. The aim is to provide assessors with the necessary means and information for measuring the capability of processes and also defining possible process improvement actions when the software/system under development is safety-related. ISO/IEC TS 15504-10:2011, as a standalone document, can be used in conjunction with ISO/IEC 15504-5 and/or ISO/IEC TR 15504-6 process assessment models by experienced assessors with minimal support from safety domain experts. ISO/IEC TS 15504-10:2011 is developed independent of any specific safety standards that define safety principles, methods, techniques and work products. However, elements of relevant safety standards are able to be mapped to the safety extension and the safety extension is intended to be extendable to include specific safety standards requirements. The influence of the safety extension on the assessment of the processes in ISO/IEC 15504-5 and ISO/IEC TR 15504-6 is described in ISO/IEC TS 15504-10:2011. For each process contained in ISO/IEC 15504-5 and ISO/IEC TR 15504-6, there is an indication of additional issues to be taken into account at assessment time. The issues are provided by means of sentences indicating specific relationships between ISO/IEC 15504-5 and ISO/IEC TR 15504-6 processes and the ISO/IEC TS 15504-10:2011 processes as well as highlighting relevant aspects to be considered to improve the completeness of the data-gathering phase of the assessment. In this way, an assessor can use ISO/IEC TS 15504-10:2011 to check whether, in assessing an ISO/IEC 15504-5 or ISO/IEC TR 15504-6 process, some relevant aspects related to the safety development environment have been missed.

Technologies de l'information — Évaluation des procédés — Partie 10: Extension de sécurité

General Information

• Status: Published
• Publication Date: 20-Nov-2011
• ICS: 35.080 - Software
• Technical Committee: ISO/IEC JTC 1/SC 7 - Software and systems engineering
• Drafting Committee: ISO/IEC JTC 1/SC 7 - Software and systems engineering
• Current Stage: 9599 - Withdrawal of International Standard
• Start Date: 21-Oct-2025
• Completion Date: 26-Oct-2025

Relations

• Revised: ISO/IEC TS 33064:2025 - Information technology — Process assessment — Process assessment model for safety processes
• Effective Date: 12-Jul-2025

Standards Content (Sample)

TECHNICAL ISO/IEC
SPECIFICATION TS
15504-10
First edition
2011-11-15
Information technology — Process
assessment —
Part 10:
Safety extension
Technologies de l'information — Évaluation des procédés —
Partie 10: Extension de sécurité

Reference number
©
ISO/IEC 2011
©  ISO/IEC 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
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ii © ISO/IEC 2011 – All rights reserved

Contents Page
Foreword . iv
Introduction . v
1  Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4  The process dimension . 2
4.1  Safety Management process . 2
4.2  Safety Engineering process . 5
4.3  Safety Qualification process . 7
5  Life-cycle guidance . 9
Annex A (informative) Work Product Characteristics . 17
Annex B (informative) Process Reference Model . 22
Bibliography . 25

© ISO/IEC 2011 – All rights reserved iii

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. In the field of information
technology, ISO and IEC have established a joint technical committee, ISO/IEC JTC 1.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of the joint technical committee is to prepare International Standards. Draft International
Standards adopted by the joint technical committee are circulated to national bodies for voting. Publication as
an International Standard requires approval by at least 75 % of the national bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, the joint
technical committee may decide to publish an ISO/IEC Technical Specification (ISO/IEC TS), which
represents an agreement between the members of the joint technical committee and is accepted for
publication if it is approved by 2/3 of the members of the committee casting a vote.
An ISO/IEC TS is reviewed after three years in order to decide whether it will be confirmed for a further three
years, revised to become an International Standard, or withdrawn. If the ISO/IEC TS is confirmed, it is
reviewed again after a further three years, at which time it must either be transformed into an International
Standard or be withdrawn.
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.
ISO/IEC TS 15504-10 was prepared by Joint Technical Committee ISO/IEC JTC 1, Information technology,
Subcommittee SC 7, Software and systems engineering.
ISO/IEC 15504 consists of the following parts, under the general title Information technology — Process
assessment:
 Part 1: Concepts and vocabulary
 Part 2: Performing an assessment
 Part 3: Guidance on performing an assessment
 Part 4: Guidance on use for process improvement and process capability determination
 Part 5: An exemplar Process Assessment Model
 Part 6: An exemplar system life cycle process assessment model [Technical Report]
 Part 7: Assessment of organizational maturity [Technical Report]
 Part 9: Target process profiles [Technical Specification]
 Part 10: Safety extension [Technical Specification]
The following part is under preparation:
 Part 8: An exemplar process assessment model for IT service management [Technical Report]
iv © ISO/IEC 2011 – All rights reserved

Introduction
The published ISO/IEC 15504 process assessment models for systems and software do not currently provide
a sufficient basis for performing a process capability assessment of processes with respect to the
development of complex safety-related systems.
This part of ISO/IEC 15504 provides a general framework in which assessments can take place. However,
additional guidance and processes are needed to support the use of the existing process assessment models
for systems and software when applied to safety-related systems development in order to make consistent
judgment regarding process capability or improvement priorities.
Developing safety-related systems requires specialized processes, techniques, skills and experience. Process
amplifications are needed in the area of safety management, safety engineering and the safety qualification.
This part of ISO/IEC 15504 presents these amplifications (a safety extension) as three process descriptions.
This part of ISO/IEC 15504 also provides additional informative components concerning additional life-cycle
verification activities related to the methods and techniques selected relevant to safety requirements adopted
and tailoring guidance for users intending to use the safety extension as part of a process assessment.
This part of ISO/IEC 15504, as a standalone document, can be used in conjunction with ISO/IEC 15504-5
and/or ISO/IEC TR 15504-6 process assessment models by experienced assessors with minimal support from
safety domain experts.
This part of ISO/IEC 15504 is developed independent of any specific safety standards that define safety
principles, methods, techniques and work products. However, elements of relevant safety standards can be
mapped to the safety extension and the safety extension is intended to be extendable to include specific
safety standards requirements.
NOTE According to the purpose of ISO/IEC 15504, this part is to be considered independent of any domain-specific
standard. Consequently, technical engineering solutions and methods as well as specific working products required by any
domain-specific safety standard are not explicitly mapped on the safety engineering process and the other processes
defined in this part of ISO/IEC 15504. At assessment time, these technical engineering solutions and methods, as well as
specific working products, are to be considered by the assessor as project-specific solutions/choices or project
requirements related to specific corresponding processes.

© ISO/IEC 2011 – All rights reserved v

TECHNICAL SPECIFICATION ISO/IEC TS 15504-10:2011(E)

Information technology — Process assessment —
Part 10:
Safety extension
1 Scope
This part of ISO/IEC 15504 is a safety extension that defines additional processes and guidance to support
the use of the exemplar process assessment models for system and software (ISO/IEC 15504-5 and
ISO/IEC TR 15504-6) when applied to assessment of processes in the development of (functional or non-
functional) safety-related systems in order to make consistent judgment regarding process capability and/or
improvement priorities.
This part of ISO/IEC 15504 is not intended to provide the state of the art for developing or verifying functional
or non-functional safety-related systems or components.
NOTE The aim of this part of ISO/IEC 15504 is not to provide a way to verify the compliance with one or more
domain-specific safety standards, nor to extend ISO/IEC 15504 in order to use it as a safety standard against which to
verify compliance. The aim is to provide assessors with the necessary means and information for measuring the capability
of processes and also defining possible process improvement actions when the software/system under development is
safety-related.
2 Normative references
The following referenced documents are indispensable for the application 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 15504-1:2004, Information technology — Process assessment — Part 1: Concepts and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 15504-1 and the following apply.
3.1
hazard
potential source of physical injury or damage to the health of people or damage to property or the environment
[ISO/IEC Guide 51:1999]
3.2
external resource
resource not developed under project control
NOTE Resources not developed under project control include: tools, libraries, COTS, re-use components.
© ISO/IEC 2011 – All rights reserved 1

3.3
safety demonstration
body of evidence and rationale that shows an item is justified as being safe within allowed limits on risk
NOTE 1 For example, this might include that an item was designed and integrated correctly to approved standards by
competent people in accordance with approved procedures with sufficient mitigation, and tested sufficiently.
NOTE 2 For more information about safety case and assurance case in general, see ISO/IEC 15026.
3.4
safety criteria
limits of acceptable risk associated with a hazard
NOTE These limits may be defined as imposed safety targets or developed from analysis or development policy.
3.5
safety-related incident
incident having an impact on safety
3.6
safety integrity requirement
likelihood of a safety-related system satisfactorily performing the required safety functions under stated
conditions
3.7
safety life cycle
project or product life cycle in which safety processes are performed
3.8
safety requirement
requirement that is needed to ensure the safety of the product
4 The process dimension
In this section the definitions of processes needed to support process assessments are defined.
The performance of one or more of the processes in this part of ISO/IEC 15504 is not intended to cover the
requirements of any other safety standard. The achievement of a certain capability level in one or more of
those processes does not imply the compliance with any other domain specific safety standard.
4.1 Safety Management process
Process ID SAF.1
Process Name Safety Management
The purpose of the Safety Management Process is to ensure that products, services and
Process
life-cycle processes meet safety objectives.
Purpose
As a result of the successful implementation of the Safety Management process:
Process
Outcomes
1) Safety principles and safety criteria are established.
2) The scope of the safety activities for the project is defined.
3) Safety activities are planned and implemented.
4) Tasks and resources necessary to complete the safety activities are sized and
estimated.
5) Safety organization structure (responsibilities, roles, reporting channels, interfaces with
2 © ISO/IEC 2011 – All rights reserved

other projects or OUs …) is established.
6) Safety activities are monitored, safety-related incidents are reported, analysed, and
resolved.
7) Agreement on safety policy and requirements for supplied products or services is
achieved.
8) Supplier’s safety activities are monitored.

SAF.1.BP.1: Define safety objectives and criteria. The limits of acceptable risk
Base Practices
associated with a hazard are defined externally as imposed safety targets or developed
from analysis or development policy. Safety targets and/or acceptable levels of risk are
determined. [Outcome1]
SAF.1.BP.2: Define Safety Life Cycle. The Safety Life Cycle is defined, which is
appropriate to the context, complexity, safety criteria and targets for the project. [Outcome
2]
NOTE 1: Assure Functional safety throughout the product life cycle. For this reason, the safety
management includes and reflects all phases of the product life cycle.
SAF.1.BP.3: Perform safety planning. Safety engineering and management activities are
to be implemented in order to meet and verify that safety requirements are identified, their
dependencies are determined, their implementation planned, and the resource needs are
identified. [Outcome 3]
SAF.1.BP.4: Define safety activities integration. Safety activities integration with product
development, project life cycle and support process is determined. [Outcome 3, 5]
NOTE 2: Examples of integrat
...