Road vehicles - Functional safety - Part 8: Supporting processes

ISO 26262 is intended to be applied to safety-related systems that include one or more electrical and/or electronic (E/E) systems and that are installed in series production passenger cars with a maximum gross vehicle mass up to 3 500 kg. ISO 26262 does not address unique E/E systems in special purpose vehicles such as vehicles designed for drivers with disabilities. Systems and their components released for production, or systems and their components already under development prior to the publication date of ISO 26262, are exempted from the scope. For further development or alterations based on systems and their components released for production prior to the publication of ISO 26262, only the modifications will be developed in accordance with ISO 26262. ISO 26262 addresses possible hazards caused by malfunctioning behaviour of E/E safety-related systems, including interaction of these systems. It does not address hazards related to electric shock, fire, smoke, heat, radiation, toxicity, flammability, reactivity, corrosion, release of energy and similar hazards, unless directly caused by malfunctioning behaviour of E/E safety-related systems. ISO 26262 does not address the nominal performance of E/E systems, even if dedicated functional performance standards exist for these systems (e.g. active and passive safety systems, brake systems, Adaptive Cruise Control). ISO 26262-8:2011 specifies the requirements for supporting processes, including the following: interfaces within distributed developments, overall management of safety requirements, configuration management, change management, verification, documentation, confidence in the use of software tools, qualification of software components, qualification of hardware components, and proven in use argument.

Véhicules routiers — Sécurité fonctionnelle — Partie 8: Processus d'appui

General Information

Status
Withdrawn
Publication Date
13-Nov-2011
Withdrawal Date
13-Nov-2011
Current Stage
9599 - Withdrawal of International Standard
Start Date
17-Dec-2018
Completion Date
13-Dec-2025
Ref Project

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Standard
ISO 26262-8:2011 - Road vehicles -- Functional safety
English language
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Frequently Asked Questions

ISO 26262-8:2011 is a standard published by the International Organization for Standardization (ISO). Its full title is "Road vehicles - Functional safety - Part 8: Supporting processes". This standard covers: ISO 26262 is intended to be applied to safety-related systems that include one or more electrical and/or electronic (E/E) systems and that are installed in series production passenger cars with a maximum gross vehicle mass up to 3 500 kg. ISO 26262 does not address unique E/E systems in special purpose vehicles such as vehicles designed for drivers with disabilities. Systems and their components released for production, or systems and their components already under development prior to the publication date of ISO 26262, are exempted from the scope. For further development or alterations based on systems and their components released for production prior to the publication of ISO 26262, only the modifications will be developed in accordance with ISO 26262. ISO 26262 addresses possible hazards caused by malfunctioning behaviour of E/E safety-related systems, including interaction of these systems. It does not address hazards related to electric shock, fire, smoke, heat, radiation, toxicity, flammability, reactivity, corrosion, release of energy and similar hazards, unless directly caused by malfunctioning behaviour of E/E safety-related systems. ISO 26262 does not address the nominal performance of E/E systems, even if dedicated functional performance standards exist for these systems (e.g. active and passive safety systems, brake systems, Adaptive Cruise Control). ISO 26262-8:2011 specifies the requirements for supporting processes, including the following: interfaces within distributed developments, overall management of safety requirements, configuration management, change management, verification, documentation, confidence in the use of software tools, qualification of software components, qualification of hardware components, and proven in use argument.

ISO 26262 is intended to be applied to safety-related systems that include one or more electrical and/or electronic (E/E) systems and that are installed in series production passenger cars with a maximum gross vehicle mass up to 3 500 kg. ISO 26262 does not address unique E/E systems in special purpose vehicles such as vehicles designed for drivers with disabilities. Systems and their components released for production, or systems and their components already under development prior to the publication date of ISO 26262, are exempted from the scope. For further development or alterations based on systems and their components released for production prior to the publication of ISO 26262, only the modifications will be developed in accordance with ISO 26262. ISO 26262 addresses possible hazards caused by malfunctioning behaviour of E/E safety-related systems, including interaction of these systems. It does not address hazards related to electric shock, fire, smoke, heat, radiation, toxicity, flammability, reactivity, corrosion, release of energy and similar hazards, unless directly caused by malfunctioning behaviour of E/E safety-related systems. ISO 26262 does not address the nominal performance of E/E systems, even if dedicated functional performance standards exist for these systems (e.g. active and passive safety systems, brake systems, Adaptive Cruise Control). ISO 26262-8:2011 specifies the requirements for supporting processes, including the following: interfaces within distributed developments, overall management of safety requirements, configuration management, change management, verification, documentation, confidence in the use of software tools, qualification of software components, qualification of hardware components, and proven in use argument.

ISO 26262-8:2011 is classified under the following ICS (International Classification for Standards) categories: 43.040.10 - Electrical and electronic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO 26262-8:2011 has the following relationships with other standards: It is inter standard links to ISO 26262-8:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

You can purchase ISO 26262-8:2011 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.

Standards Content (Sample)


INTERNATIONAL ISO
STANDARD 26262-8
First edition
2011-11-15
Road vehicles — Functional safety —
Part 8:
Supporting processes
Véhicules routiers — Sécurité fonctionnelle —
Partie 8: Processus d'appui
Reference number
©
ISO 2011
©  ISO 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
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved

Contents Page
Foreword . v
Introduction . vi
1  Scope . 1
2  Normative references . 2
3  Terms, definitions and abbreviated terms . 2
4  Requirements for compliance . 2
4.1  General requirements . 2
4.2  Interpretations of tables . 3
4.3  ASIL-dependent requirements and recommendations . 3
5  Interfaces within distributed developments . 3
5.1  Objectives . 3
5.2  General . 3
5.3  Inputs to this clause . 4
5.4  Requirements and recommendations . 4
5.5  Work products . 7
6  Specification and management of safety requirements . 7
6.1  Objectives . 7
6.2  General . 7
6.3  Inputs to this clause . 9
6.4  Requirements and recommendations . 9
6.5  Work products . 12
7  Configuration management . 12
7.1  Objectives . 12
7.2  General . 12
7.3  Inputs to this clause . 12
7.4  Requirements and recommendations . 13
7.5  Work products . 13
8  Change management . 13
8.1  Objectives . 13
8.2  General . 13
8.3  Inputs to this clause . 13
8.4  Requirements and recommendations . 14
8.5  Work products . 15
9  Verification . 16
9.1  Objectives . 16
9.2  General . 16
9.3  Inputs to this clause . 16
9.4  Requirements and recommendations . 17
9.5  Work products . 18
10  Documentation . 19
10.1  Objectives . 19
10.2  General . 19
10.3  Inputs to this clause . 19
10.4  Requirements and recommendations . 19
10.5  Work products . 20
11  Confidence in the use of software tools . 20
11.1  Objectives .20
11.2  General .21
11.3  Inputs to this clause .21
11.4  Requirements and recommendations .22
11.5  Work products .27
12  Qualification of software components .27
12.1  Objectives .27
12.2  General .27
12.3  Inputs to this clause .28
12.4  Requirements and recommendations .28
12.5  Work products .30
13  Qualification of hardware components .30
13.1  Objectives .30
13.2  General .31
13.3  Inputs to this clause .32
13.4  Requirements and recommendations .33
13.5  Work products .35
14  Proven in use argument .35
14.1  Objectives .35
14.2  General .35
14.3  Inputs to this clause .36
14.4  Requirements and recommendations .37
14.5  Work products .40
Annex A (informative) Overview on and document flow of supporting processes .41
Annex B (informative) DIA example .43
Bibliography .48

iv © ISO 2011 – All rights reserved

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 26262-8 was prepared by Technical Committee ISO/TC 22, Road vehicles, Subcommittee SC 3,
Electrical and electronic equipment.
ISO 26262 consists of the following parts, under the general title Road vehicles — Functional safety:
 Part 1: Vocabulary
 Part 2: Management of functional safety
 Part 3: Concept phase
 Part 4: Product development at the system level
 Part 5: Product development at the hardware level
 Part 6: Product development at the software level
 Part 7: Production and operation
 Part 8: Supporting processes
 Part 9: Automotive Safety Integrity Level (ASIL)-oriented and safety-oriented analyses
 Part 10: Guideline on ISO 26262
Introduction
ISO 26262 is the adaptation of IEC 61508 to comply with needs specific to the application sector of electrical
and/or electronic (E/E) systems within road vehicles.
This adaptation applies to all activities during the safety lifecycle of safety-related systems comprised of
electrical, electronic and software components.
Safety is one of the key issues of future automobile development. New functionalities not only in areas such
as driver assistance, propulsion, in vehicle dynamics control and active and passive safety systems
increasingly touch the domain of system safety engineering. Development and integration of these
functionalities will strengthen the need for safe system development processes and the need to provide
evidence that all reasonable system safety objectives are satisfied.
With the trend of increasing technological complexity, software content and mechatronic implementation, there
are increasing risks from systematic failures and random hardware failures. ISO 26262 includes guidance to
avoid these risks by providing appropriate requirements and processes.
System safety is achieved through a number of safety measures, which are implemented in a variety of
technologies (e.g. mechanical, hydraulic, pneumatic, electrical, electronic, programmable electronic) and
applied at the various levels of the development process. Although ISO 26262 is concerned with functional
safety of E/E systems, it provides a framework within which safety-related systems based on other
technologies can be considered. ISO 26262:
a) provides an automotive safety lifecycle (management, development, production, operation, service,
decommissioning) and supports tailoring the necessary activities during these lifecycle phases;
b) provides an automotive-specific risk-based approach to determine integrity levels [Automotive Safety
Integrity Levels (ASIL)];
c) uses ASILs to specify applicable requirements of ISO 26262 so as to avoid unreasonable residual risk;
d) provides requirements for validation and confirmation measures to ensure a sufficient and acceptable
level of safety being achieved;
e) provides requirements for relations with suppliers.
Functional safety is influenced by the development process (including such activities as requirements
specification, design, implementation, integration, verification, validation and configuration), the production
and service processes and by the management processes.
Safety issues are intertwined with common function-oriented and quality-oriented development activities and
work products. ISO 26262 addresses the safety-related aspects of development activities and work products.
Figure 1 shows the overall structure of this edition of ISO 26262. ISO 26262 is based upon a V-model as a
reference process model for the different phases of product development. Within the figure:
 the shaded “V”s represent the interconnection between ISO 26262-3, ISO 26262-4, ISO 26262-5,
ISO 26262-6 and ISO 26262-7;
 the specific clauses are indicated in the following manner: “m-n”, where “m” represents the number of the
particular part and “n” indicates the number of the clause within that part.
EXAMPLE “2-6” represents Clause 6 of ISO 26262-2.
vi © ISO 2011 – All rights reserved

Figure 1 — Overview of ISO 26262

1. Vocabulary
2. Management of functional safety
2-6 Safety management during the concept phase 2-7 Safety management after the item´s release
2-5 Overall safety management
and the product development for production
4. Product development at the system level
3. Concept phase 7. Production and operation
4-5 Initiation of product
4-11 Release for production
3-5 Item definition 7-5 Production
development at the system level
4-10 Functional safety assessment
7-6 Operation, service
3-6 Initiation of the safety lifecycle
4-6 Specification of the technical
(maintenance and repair), and
safety requirements
decommissioning
4-9 Safety validation
3-7 Hazard analysis and risk
assessment
4-7 System design 4-8 Item integration and testing
3-8 Functional safety
concept
5. Product development at the 6. Product development at the
hardware level software level
5-5 Initiation of product 6-5 Initiation of product
development at the hardware level
development at the software level
5-6 Specification of hardware
safety requirements
5-7 Hardware design 6-7 Software architectural design
5-8 Evaluation of the hardware 6-8 Software unit design and
architectural metrics implementation
5-9 Evaluation of the safety goal
6-9 Software unit testing
violations due to random hardware
failures
6-10 Software integration and
5-10 Hardware integration and
testing
testing
6-11 Verification of software safety
requirements
8. Supporting processes
8-5 Interfaces within distributed developments 8-10 Documentation
8-6 Specification and management of safety requirements 8-11 Confidence in the use of software tools
8-7 Configuration management 8-12 Qualification of software components
8-8 Change management 8-13 Qualification of hardware components
8-9 Verification 8-14 Proven in use argument
9. ASIL-oriented and safety-oriented analyses
9-5 Requirements decomposition with respect to ASIL tailoring 9-7 Analysis of dependent failures
9-6 Criteria for coexistence of elements 9-8 Safety analyses
10. Guideline on ISO 26262
INTERNATIONAL STANDARD ISO 26262-8:2011(E)

Road vehicles — Functional safety —
Part 8:
Supporting processes
1 Scope
ISO 26262 is intended to be applied to safety-related systems that include one or more electrical and/or
electronic (E/E) systems and that are installed in series production passenger cars with a maximum gross
vehicle mass up to 3 500 kg. ISO 26262 does not address unique E/E systems in special purpose vehicles
such as vehicles designed for drivers with disabilities.
Systems and their components released for production, or systems and their components already under
development prior to the publication date of ISO 26262, are exempted from the scope. For further
development or alterations based on systems and their components released for production prior to the
publication of ISO 26262, only the modifications will be developed in accordance with ISO 26262.
ISO 26262 addresses possible hazards caused by malfunctioning behaviour of E/E safety-related systems,
including interaction of these systems. It does not address hazards related to electric shock, fire, smoke, heat,
radiation, toxicity, flammability, reactivity, corrosion, release of energy and similar hazards, unless directly
caused by malfunctioning behaviour of E/E safety-related systems.
ISO 26262 does not address the nominal performance of E/E systems, even if dedicated functional
performance standards exist for these systems (e.g. active and passive safety systems, brake systems,
Adaptive Cruise Control).
This part of ISO 26262 specifies the requirements for supporting processes, including the following:
 interfaces within distributed developments,
 overall management of safety requirements,
 configuration management,
 change management,
 verification,
 documentation,
 confidence in the use of software tools,
 qualification of software components,
 qualification of hardware components, and
 proven in use argument.
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 26262-1:2011, Road vehicles — Functional safety — Part 1: Vocabulary
ISO 26262-2:2011, Road vehicles — Functional safety — Part 2: Management of functional safety
ISO 26262-3:2011, Road vehicles — Functional safety — Part 3: Concept phase
ISO 26262-4:2011, Road vehicles — Functional safety — Part 4: Product development at the system level
ISO 26262-5:2011, Road vehicles — Functional safety — Part 5: Product development at the hardware level
ISO 26262-6:2011, Road vehicles — Functional safety — Part 6: Product development at the software level
ISO 26262-7:2011, Road vehicles — Functional safety — Part 7: Production and operation
ISO 26262-9:2011, Road vehicles — Functional safety — Part 9: Automotive Safety Integrity Level
(ASIL)-oriented and safety-oriented analyses
ISO/IEC 12207, Systems and software engineering — Software life cycle processes
3 Terms, definitions and abbreviated terms
For the purposes of this document, the terms, definitions and abbreviated terms given in ISO 26262-1:2011
apply.
4 Requirements for compliance
4.1 General requirements
When claiming compliance with ISO 26262, each requirement shall be complied with, unless one of the
following applies:
a) tailoring of the safety activities in accordance with ISO 26262-2 has been planned and shows that the
requirement does not apply, or
b) a rationale is available that the non-compliance is acceptable and the rationale has been assessed in
accordance with ISO 26262-2.
Information marked as a “NOTE” or “EXAMPLE” is only for guidance in understanding, or for clarification of
the associated requirement, and shall not be interpreted as a requirement itself or as complete or exhaustive.
The results of safety activities are given as work products. “Prerequisites” are information which shall be
available as work products of a previous phase. Given that certain requirements of a clause are
ASIL-dependent or may be tailored, certain work products may not be needed as prerequisites.
“Further supporting information” is information that can be considered, but which in some cases is not required
by ISO 26262 as a work product of a previous phase and which may be made available by external sources
that are different from the persons or organizations responsible for the functional safety activities.
2 © ISO 2011 – All rights reserved

4.2 Interpretations of tables
Tables are normative or informative depending on their context. The different methods listed in a table
contribute to the level of confidence in achieving compliance with the corresponding requirement. Each
method in a table is either
a) a consecutive entry (marked by a sequence number in the leftmost column, e.g. 1, 2, 3), or
b) an alternative entry (marked by a number followed by a letter in the leftmost column, e.g. 2a, 2b, 2c).
For consecutive entries, all methods shall be applied as recommended in accordance with the ASIL. If
methods other than those listed are to be applied, a rationale shall be given that these fulfil the corresponding
requirement.
For alternative entries, an appropriate combination of methods shall be applied in accordance with the ASIL
indicated, independent of whether they are listed in the table or not. If methods are listed with different
degrees of recommendation for an ASIL, the methods with the higher recommendation should be preferred. A
rationale shall be given that the selected combination of methods complies with the corresponding
requirement.
NOTE A rationale based on the methods listed in the table is sufficient. However, this does not imply a bias for or
against methods not listed in the table.
For each method, the degree of recommendation to use the corresponding method depends on the ASIL and
is categorized as follows:
 “++” indicates that the method is highly recommended for the identified ASIL;
 “+” indicates that the method is recommended for the identified ASIL;
 “o” indicates that the method has no recommendation for or against its usage for the identified ASIL.
4.3 ASIL-dependent requirements and recommendations
The requirements or recommendations of each subclause shall be complied with for ASIL A, B, C and D, if not
stated otherwise. These requirements and recommendations refer to the ASIL of the safety goal. If ASIL
decomposition has been performed at an earlier stage of development, in accordance with ISO 26262-9:2011,
Clause 5, the ASIL resulting from the decomposition shall be complied with.
If an ASIL is given in parentheses in ISO 26262, the corresponding subclause shall be considered as a
recommendation rather than a requirement for this ASIL. This has no link with the parenthesis notation related
to ASIL decomposition.
5 Interfaces within distributed developments
5.1 Objectives
The objective of this clause is to describe the procedures and to allocate associated responsibilities within
distributed developments for items and elements.
5.2 General
The customer (e.g. vehicle manufacturer) and the suppliers for item developments jointly comply with the
requirements specified in ISO 26262. Responsibilities are agreed between the customer and the suppliers.
Subcontractor relationships are permitted. Just as with the customer's safety-related specifications concerning
planning, execution and documentation for in-house item developments, comparable procedures are to be
agreed for co-operation with the supplier on distributed item developments, or item developments where the
supplier has the full responsibility for safety.
NOTE This clause is not relevant for the procurement of standard components and parts or development
commissions which do not place any responsibility for safety on the supplier.
5.3 Inputs to this clause
5.3.1 Prerequisites
See applicable prerequisites of the relevant phases of the safety lifecycle for which a distributed development
is planned and carried out.
5.3.2 Further supporting information
The following information can be considered:
 the draft version of development interface agreement (DIA) (from external source);
 the supplier’s tender based on a request for quotation (RFQ) (from external source).
5.4 Requirements and recommendations
5.4.1 Application of requirements
5.4.1.1 The requirements of Clause 5 shall apply to each item and element developed according to
ISO 26262, except for off-the-shelf hardware parts, if either of the following applies:
a) there are no specific hardware safety requirements allocated to the hardware parts, or
b) the off-the-shelf hardware parts are qualified according to well-established procedures based on
worldwide quality standards (e.g. AEC standards for electronic components), and the qualification of the
off-the-shelf hardware parts covers ranges of parameters with regard to the intended application.
5.4.1.2 Requirements on the customer-supplier relationship (interfaces and interactions) shall apply to
each level of the customer-supplier relationship.
NOTE 1 This includes subcontracts taken out by the top level supplier, subcontracts taken out by those subcontractors,
etc.
NOTE 2 Internal suppliers can be managed in the same way as external suppliers.
5.4.2 Supplier selection criteria
5.4.2.1 The supplier selection criteria shall include an evaluation of the supplier's capability to develop
and produce items and elements of comparable complexity and ASIL according to ISO 26262.
NOTE Supplier selection criteria includes:
 evidence of the supplier's quality management system;
 the supplier's past performance and quality;
 the confirmation of the supplier's capability concerning functional safety as part of the supplier's tender;
 results of previous safety assessments according to ISO 26262-2:2011, 6.4.9;
 recommendations from the development, production, quality and logistics departments of the vehicle manufacturer as
far as they impact functional safety.
4 © ISO 2011 – All rights reserved

5.4.2.2 The RFQ from the customer to the supplier candidates shall include:
a) a formal request to comply with ISO 26262,
b) the item definition or functional specification of the element, and
c) the safety goals, the functional safety requirements or the technical safety requirements, including their
respective ASIL if already available, depending on what the supplier is quoting for.
NOTE If the ASIL is not known at the time of supplier selection, a conservative assumption is made.
5.4.3 Initiation and planning of distributed development
5.4.3.1 The customer and the supplier shall specify a DIA including the following:
NOTE An example of a DIA is given in Annex B.
a) the appointment of the customer’s and the supplier’s safety managers,
b) the joint tailoring of the safety lifecycle in accordance with ISO 26262-2:2011, 6.4.5,
c) the activities and processes to be performed by the customer and the activities and processes to be
performed by the supplier,
d) the information and the work products to be exchanged,
NOTE 1 This includes an agreement on the documentation to be provided for the completion of the customer's and
supplier's safety cases.
NOTE 2 The information exchanged includes the safety-related special characteristics.
NOTE 3 In the case of a distributed development, the relevant parts of the work products necessary for the activities
of the development parties involved can be identified and exchanged.
e) the parties or persons responsible for the activities,
f) the communication of the target values, derived from the system level targets, to each relevant party in
order for them to meet the target values for single-point faults metric and latent faults metric in
accordance with the evaluation of the hardware architectural metrics and the evaluation of safety goal
violations due to random hardware failures (see ISO 26262-5), and
g) the supporting processes and tools, including interfaces, to assure compatibility between customer and
supplier.
5.4.3.2 If the supplier conducts the hazard analysis and risk assessment, then the hazard analysis and
risk assessment shall be provided to the customer for verification.
5.4.3.3 The party responsible for the item development shall create the functional safety concept in
accordance with ISO 26262-3. The functional safety requirements shall be agreed between the customer and
the supplier.
5.4.4 Execution of distributed development
5.4.4.1 The supplier shall report to the customer each issue which increases the risk of not conforming to
the project plan, the safety plan, integration and testing plan in accordance with ISO 26262-4 or the software
verification plan in accordance with ISO 26262-6, or other provisions of the DIA.
5.4.4.2 The supplier shall report to the customer each anomaly which occurs during the development
activities in their area of responsibility or in that of their subcontractors.
5.4.4.3 The supplier shall determine whether each safety requirement can be complied with. If not, the
safety concept shall be re-examined and, if necessary, modified to yield safety requirements that will be met.
5.4.4.4 Each change potentially affecting the safety of the item or the planned activities to demonstrate
compliance with ISO 26262 shall be communicated to the other party to support the impact analysis in
accordance with Clause 8.
5.4.4.5 Both parties should consider previous experience gained in similar developments in accordance
with ISO 26262-2:2011, 5.4.2.7, when deriving safety requirements for the current development.
5.4.4.6 The supplier shall report to the customer's safety manager the progress achieved against the
tasks and milestones defined in the safety plan. The format of the report and the delivery dates shall be
agreed between the supplier and the customer.
EXAMPLE At regular intervals, or when the milestones specified in the framework of the schedule have been
reached, the customer inspects the released quality management reports compiled by the supplier.
5.4.4.7 An agreement shall be reached on which party (supplier or customer) shall perform the safety
validation in accordance with ISO 26262-4.
NOTE If the supplier performs the integration and validation, an agreement on the capabilities and resources needed
by the supplier is important since safety validation requires the integrated vehicle (see ISO 26262-4).
5.4.4.8 This requirement applies to ASIL D in accordance with 4.3. The customer shall be allowed to
perform additional functional safety audits at the supplier's premises at any appropriate time.
5.4.5 Functional safety assessment at supplier's premises
5.4.5.1 This requirement applies to ASILs (B), C, D in accordance with 4.3. One or more functional safety
assessments shall be carried out upon reaching defined milestones, these assessments shall include each
phase of the item development. The functional safety assessments shall be at the level of detail appropriate
for the complexity of the item and the ASILs of its safety goals. The functional safety assessment shall be
performed in accordance with ISO 26262-2:2011, 6.4.9.
5.4.5.2 This requirement applies to ASIL B in accordance with 4.3. A functional safety assessment should
be carried out.
NOTE This can be done by the customer, another organization or by the supplier itself.
5.4.5.3 This requirement applies to ASILs C and D in accordance with 4.3. A functional safety
assessment in accordance with ISO 26262-2:2011, 6.4.9, shall be carried out at the supplier's premises by the
customer, or by an organization or person designated by the customer.
NOTE This can be done by the supplier itself.
5.4.5.4 This requirement applies to ASILs (B), C and D in accordance with 4.3. The functional safety
assessment report shall be available at the customer's and at the supplier's premises.
5.4.5.5 This requirement applies to ASILs (B), C and D in accordance with 4.3. Each anomaly identified,
that potentially impacts the deliverables from the supplier, shall be analyzed and actions shall be derived to
resolve them. An agreement between both parties shall be reached on who performs the actions required.
5.4.6 After release for production
5.4.6.1 The supplier shall provide evidence to the customer that the process capability is being met and
maintained in accordance with ISO 26262-2:2011, Clause 7, and ISO 26262-7:2011, Clause 5.
5.4.6.2 A supply agreement between the customer and the supplier shall address the responsibilities for
functional safety in accordance with ISO 26262-2:2011, 7.4.2.1, and define the safety activities for each party.
6 © ISO 2011 – All rights reserved

5.4.6.3 The supply agreement shall state the access to, and exchange of, production monitoring records
between the parties for the safety-related special characteristics.
5.4.6.4 Each party that becomes aware of a safety-related event shall report this in a timely manner and
according to the supply agreement. If a safety-related event occurs, an analysis of that event shall be
performed. This analysis should include similar items and related parties which are potentially affected by a
similar event.
5.5 Work products
5.5.1 Supplier selection report resulting from requirements 5.4.2.1 and 5.4.2.2.
5.5.2 Development interface agreement (DIA) resulting from requirement 5.4.3.
5.5.3 Supplier's project plan resulting from requirement 5.4.3.
5.5.4 Supplier's safety plan resulting from requirement 5.4.3.
5.5.5 Functional safety assessment report resulting from requirements 5.4.5.1 to 5.4.5.5.
5.5.6 Supply agreement resulting from requirements 5.4.6.2 to 5.4.6.3.
6 Specification and management of safety requirements
6.1 Objectives
The first objective is to ensure the correct specification of safety requirements with respect to their attributes
and characteristics.
The second objective is to ensure consistent management of safety requirements throughout the entire safety
lifecycle.
6.2 General
Safety requirements constitute all requirements aimed at achieving and ensuring the required ASILs.
During the safety lifecycle, safety requirements are specified and detailed in a hierarchical structure. The
structure and dependencies of safety requirements used in ISO 26262 are illustrated in Figure 2. The safety
requirements are allocated or distributed among the elements.
3-7 Hazard analysis and
risk assessment
Hazard analysis and risk
assessment
3-7 Hazard analysis and
risk assessment
Specification of safety goals
3-8 Functional safety
concept
Specification of functional safety
requirements
4-6 Specification of
technical safety requirements
Specification of technical safety
requirements
5-6 Specification of hardware 6-6 Specification of software
safety requirements safety requirements
Hardware safety requirements Software safety requirements

NOTE Within the figure, the specific clauses of each part of ISO 26262 are indicated in the following manner: “m-n”,
where “m” represents the number of the part and “n” indicates the number of the clause, e.g. “3-7” represents Clause 7 of
ISO 26262-3.
Figure 2 — Structure of safety requirements
The management of safety requirements includes managing requirements, obtaining agreement on the
requirements, obtaining commitments from those implementing the requirements, and maintaining traceability.
In order to support the management of safety requirements, the use of suitable requirements management
tools is recommended.
This clause includes requirements on the specification and management of safety requirements (see Figure 3).
The specific requirements concerning the content of the safety requirements at different hierarchical levels are
listed in ISO 26262-3, ISO 26262-4, ISO 26262-5 and ISO 26262-6.
8 © ISO 2011 – All rights reserved

after release for
Product development Concept phase
production
8-6 Specification and management of safety requirements
Specification and management of safety requirements

Specification and management of safety requirements
Hierarchical structure
Traceability
Completeness
External consistency

Safety requirement 1
unambiguous
comprehensible
atomic
internal consistent
feasible
verifiable

Safety requirement 2
unambiguous
comprehensible
atomic
internal consistent
feasible
verifiable

Figure 3 — Relationship between management of safety
requirements and particular safety requirements
6.3 Inputs to this clause
6.3.1 Prerequisites
See applicable prerequisites of the relevant phases of the safety lifecycle in which safety requirements are
specified or managed.
6.3.2 Further supporting information
See applicable further supporting information of the relevant phases of the safety lifecycle in which safety
requirements are specified or managed.
6.4 Requirements and recommendations
6.4.1 Specification of safety requirements
6.4.1.1 To achieve the characteristics of safety requirements listed in 6.4.2.4, safety requirements shall
be specified by an appropriate combination of:
a) natural language, and
b) methods listed in Table 1.
NOTE For higher level safety requirements (e.g. functional and technical safety requirements) natural language is
more appropriate while for lower level safety requirements (e.g. software and hardware safety requirements) notations
listed in Table 1 are more appropriate.
Table 1 — Specifying safety requirements
ASIL
Methods
A B C D
1a Informal notations for requirements specification ++ ++ + +
1b Semi-formal notations for requirements specification + + ++ ++
1c Formal notations for requirements specification + + + +

6.4.2 Attributes and characteristics of safety requirements
6.4.2.1 Safety requirements shall be unambiguously identifiable as safety requirements.
NOTE In order to comply with this requirement, safety requirements can be listed in a separate document. If safety
requirements and other requirements are administered in the same document, safety requirements can be identified
explicitly by using a special attribute as described in 6.4.2.5.
6.4.2.2 Safety requirements shall inherit the ASIL from the safety requirements from which they are
derived, except if ASIL decomposition is applied in accordance with ISO 26262-9.
NOTE As safety goals are the top level safety requirements, the inheritance of ASILs starts at the safety goal level
(see ISO 26262-1:2011, definition 1.108).
6.4.2.3 Safety requirements shall be allocated to an item or an element.
6.4.2.4 Safety requirements shall have the following characteristics:
a) unambiguous and comprehensible,
NOTE 1 A requirement is unambiguous if there is common understanding of the meaning of the requirement.
NOTE 2 A requirement is comprehensible if the reader at an adjacent abstraction level (i.e. either the stakeholder
or the consumer of that requirement) understands its meaning.
b) atomic,
NOTE Safety requirements at one hierarchical level are atomic when they are formulated in such a way that
they can not be divided into more than one safety requirement at the considered level.
c) internally consistent,
NOTE Unlike external consistency, in which multiple safety requirements do not contradict each other, internal
consistency means that each individual safety requirement contains no contradictions within itself.
d) feasible, and
NOTE A requirement is feasible if it can be implemented within the constraints of the item development
(resources, state-of-the-art, etc.).
e) verifiable.
6.4.2.5 Safety requirements shall have the following attributes:
a) a unique identification remaining unchanged throughout the safety lifecycle,
EXAMPLE A unique identification of a requirement can be achieved in a variety of ways, such as subscripting
each instance of the word “shall”, e.g. “The system shall check …”, or numbering consecutively each sentence
containing the word “shall”, e.g. “ In the case of . the system shall check .”.
10 © ISO 2011 – All rights reserved

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