This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.

se/std-904566

INTERNATIONAL ISO/IEC
STANDARD 90003

First edition
2004-02-15

Software engineering — Guidelines for

the application of ISO 9001:2000 to
computer software
Ingénierie du logiciel — Lignes directrices pour l'application de
l'ISO 9001:2000 aux logiciels informatiques

Reference number
ISO/IEC 90003:2004(E)

© ISO/IEC 2004
 This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-904566

ISO/IEC 90003:2004(E)

PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.

Adobe is a trademark of Adobe Systems Incorporated.

Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

© ISO/IEC 2004

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/IEC 2004 – All rights reserved

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-904566

ISO/IEC 90003:2004(E)

Contents Page

1 Scope .................................................................................................................................................... 1
1.1 General ................................................................................................................................................. 1
1.2 Application ........................................................................................................................................... 1
2 Normative references .......................................................................................................................... 2
3 Terms and definitions .......................................................................................................................... 2
4 Quality management system .............................................................................................................. 5
4.1 General requirements ......................................................................................................................... 5
4.2 Documentation requirements ............................................................................................................ 6
4.2.1 General .............................................................................................................................................. 6
4.2.2 Quality manual .................................................................................................................................. 6
4.2.3 Control of documents ...................................................................................................................... 7
4.2.4 Control of records ............................................................................................................................ 7
5 Management responsibility ................................................................................................................ 8
5.1 Management commitment .................................................................................................................. 8
5.2 Customer focus ................................................................................................................................... 8
5.3 Quality policy ....................................................................................................................................... 9
5.4 Planning ............................................................................................................................................... 9
5.4.1 Quality objectives ............................................................................................................................. 9
5.4.2 Quality management system planning ........................................................................................... 9
5.5 Responsibility, authority and communication ................................................................................ 10
5.5.1 Responsibility and authority ......................................................................................................... 10
5.5.2 Management representative .......................................................................................................... 10
5.5.3 Internal communication ................................................................................................................. 11
5.6 Management review .......................................................................................................................... 11
5.6.1 General ............................................................................................................................................ 11
5.6.2 Review input ................................................................................................................................... 11
5.6.3 Review output ................................................................................................................................. 12
6 Resource management ..................................................................................................................... 12
6.1 Provision of resources ...................................................................................................................... 12
6.2 Human resources .............................................................................................................................. 12
6.2.1 General ............................................................................................................................................ 12
6.2.2 Competence, awareness and training .......................................................................................... 13
6.3 Infrastructure ..................................................................................................................................... 13
6.4 Work environment ............................................................................................................................. 14
7 Product realization ............................................................................................................................. 14
7.1 Planning of product realization ........................................................................................................ 14
7.1.1 Software life cycle .......................................................................................................................... 15
7.1.2 Quality planning ............................................................................................................................. 15
7.2 Customer-related processes ............................................................................................................ 16

© ISO/IEC 2004 – All rights reserved iii

 This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-904566

ISO/IEC 90003:2004(E)

7.2.1 Determination of requirements related to the product ............................................................... 16

7.2.2 Review of requirements related to the product ........................................................................... 18
7.2.3 Customer communication ............................................................................................................. 20
7.3 Design and development .................................................................................................................. 21
7.3.1 Design and development planning ............................................................................................... 21
7.3.2 Design and development inputs ................................................................................................... 23
7.3.3 Design and development outputs ................................................................................................. 24
7.3.4 Design and development review ................................................................................................... 25
7.3.5 Design and development verification ........................................................................................... 26
7.3.6 Design and development validation ............................................................................................. 26
7.3.7 Control of design and development changes .............................................................................. 28
7.4 Purchasing ......................................................................................................................................... 28
7.4.1 Purchasing process ....................................................................................................................... 28
7.4.2 Purchasing information ................................................................................................................. 30
7.4.3 Verification of purchased product ................................................................................................ 30
7.5 Production and service provision .................................................................................................... 31
7.5.1 Control of production and service provision ............................................................................... 31
7.5.2 Validation of processes for production and service provision .................................................. 34
7.5.3 Identification and traceability ........................................................................................................ 34
7.5.4 Customer property ......................................................................................................................... 35
7.5.5 Preservation of product ................................................................................................................. 36
7.6 Control of monitoring and measuring devices ............................................................................... 37
8 Measurement, analysis and improvement ....................................................................................... 38
8.1 General ............................................................................................................................................... 38
8.2 Monitoring and measurement .......................................................................................................... 38
8.2.1 Customer satisfaction .................................................................................................................... 38
8.2.2 Internal audit ................................................................................................................................... 39
8.2.3 Monitoring and measurement of processes ................................................................................ 40
8.2.4 Monitoring and measurement of product ..................................................................................... 40
8.3 Control of nonconforming product .................................................................................................. 41
8.4 Analysis of data ................................................................................................................................. 42
8.5 Improvement ...................................................................................................................................... 42
8.5.1 Continual improvement .................................................................................................................. 42
8.5.2 Corrective action ............................................................................................................................ 43
8.5.3 Preventive action ............................................................................................................................ 43
Annex A (informative) Additional guidance in the implementation of ISO 9001:2000 available in
ISO/IEC JTC 1/SC 7 and ISO/TC 176 standards ....................................................................................... 44
Annex B (informative) Planning in ISO/IEC 90003 and ISO/IEC 12207 ................................................... 49
Bibliography ............................................................................................................................................... 53

iv © ISO/IEC 2004 – All rights reserved

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-904566

ISO/IEC 90003:2004(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

In the field of information technology, ISO and IEC have established a joint technical committee, ISO/IEC
JTC 1. 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.

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 90003 was prepared by Joint Technical Committee ISO/IEC JTC 1, Information technology,
Subcommittee SC 7, Software and system engineering.

This first edition of ISO/IEC 90003 cancels and replaces ISO 9000-3:1997, which has been updated for
conformity with ISO 9001:2000. ISO 9000-3:1997 was under the responsibility of ISO/TC 176/SC 2.

© ISO/IEC 2004 – All rights reserved v

 This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-904566

ISO/IEC 90003:2004(E)

Introduction
This International Standard provides guidance for organizations in the application of ISO 9001:2000 to the
acquisition, supply, development, operation and maintenance of computer software.

It identifies the issues which should be addressed and is independent of the technology, life cycle models,
development processes, sequence of activities and organizational structure used by an organization. The
guidance and identified issues are intended to be comprehensive but not exhaustive. Where the scope of an
organization’s activities includes areas other than computer software development, the relationship between
the computer software elements of that organization’s quality management system and the remaining aspects
should be clearly documented within the quality management system as a whole.

Clauses 4, 5 and 6 and parts of clause 8 of ISO 9001:2000 are applied mainly at the “global” level in the
organization, although they do have some effect at the “project/product level”. Each project or product
development may tailor the associated parts of the organization’s quality management system, to suit
project/product-specific requirements.

Throughout ISO 9001:2000, “shall” is used to express a provision that is binding between two or more parties,
“should” to express a recommendation among possibilities and “may” to indicate a course of action permissible
within the limits of ISO 9001:2000. In this International Standard (ISO/IEC 90003), “should” and “may” have the
same meaning as in ISO 9001:2000, i.e. “should” to express a recommendation among possibilities and “may”
to indicate a course of action permissible within the limits of this International Standard.

Organizations with quality management systems for developing, operating or maintaining software based on
this International Standard may choose to use processes from ISO/IEC 12207 and
ISO/IEC 12207:1995/Amd.1:2002 to support or complement the ISO 9001:2000 process model. It should be
noted that the quality management process defined in ISO/IEC 12207:1995/Amd.1:2002, F.3.1.4 is not
consistent with the definition of quality management in ISO 9000, ISO 9001 and other ISO/TC 176 standards.
The related paragraphs of ISO/IEC 12207:1995/Amd.1:2002 are referenced in each clause of this International
Standard; however, they are not intended to imply requirements additional to those in ISO 9001:2000. Further
guidance to the use of ISO/IEC 12207 may be found in ISO/IEC TR 15271. For additional guidance, frequent
references are provided to the International Standards for software engineering defined by ISO/IEC JTC 1/SC 7
and in particular ISO/IEC 9126-1, ISO/IEC TR 9126-2, ISO/IEC TR 9126-3, ISO/IEC TR 9126-4,
ISO/IEC 15939 and ISO/IEC 15504 (all parts). Where these references are specific to a clause or subclause of
ISO 9001:2000 they appear after the guidance for that clause or subclause. Where they apply generally across
the parts of a clause or subclause, the references are included at the end of the last part of the clause or
subclause.

Where text has been quoted from ISO 9001:2000, that text is enclosed in a box, for ease of identification.

vi © ISO/IEC 2004 – All rights reserved

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-904566

INTERNATIONAL STANDARD ISO/IEC 90003:2004(E)

Software engineering — Guidelines for the application of

ISO 9001:2000 to computer software

1 Scope

1.1 General

ISO 9001:2000, Quality management systems — Requirements

1.1 General
This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory
requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for
continual improvement of the system and the assurance of conformity to customer and applicable regulatory
requirements.
NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.

This International Standard provides guidance for organizations in the application of ISO 9001:2000 to the
acquisition, supply, development, operation and maintenance of computer software and related support
services. It does not add to or otherwise change the requirements of ISO 9001:2000.

Annex A (informative) provides a table pointing to additional guidance in the implementation of ISO 9001:2000
available in ISO/IEC JTC 1/SC 7 and ISO/TC 176 standards.

The guidelines provided in this International Standard are not intended to be used as assessment criteria in
quality management system registration/certification.

1.2 Application

ISO 9001:2000, Quality management systems — Requirements

1.2 Application

All requirements of this International Standard are generic and are intended to be applicable to all organizations,
regardless of type, size and product provided.

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and
its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these
exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or
responsibility, to provide product that meets customer and applicable regulatory requirements.

© ISO/IEC 2004 – All rights reserved 1

 This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-904566

ISO/IEC 90003:2004(E)

The application of this International Standard is appropriate to software that is

— part of a commercial contract with another organization,
— a product available for a market sector,
— used to support the processes of an organization,
— embedded in a hardware product, or
— related to software services.

Some organizations may be involved in all of the above activities; others may specialize in one area. Whatever
the situation, the organization’s quality management system should cover all aspects (software related and non-
software related) of the business.

2 Normative references

ISO 9001:2000, Quality management systems — Requirements

2 Normative reference

The following normative document contains provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent edition of the normative document indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.

ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.

3 Terms and definitions

ISO 9001:2000, Quality management systems — Requirements

3 Terms and definitions

For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.

The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the
vocabulary currently used:

supplier organization customer

The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this
International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.

Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.

For the purposes of this document, the terms and definitions given in ISO 9001:2000, and certain terms
(repeated here for convenience) given in ISO/IEC 12207 apply.

However, in the event of a conflict in terms and definitions, the terms and definitions specified in ISO 9000:2000
apply.

NOTE ISO/IEC 12207:1995 provides detailed provisions for seventeen software life cycle processes.
ISO/IEC 12207:1995/Amd.1:2002 provides high-level provisions for many additional processes. This International Standard
will make reference to terms defined in both.

2 © ISO/IEC 2004 – All rights reserved

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-904566

ISO/IEC 90003:2004(E)

3.1
activity
collection of related tasks

3.2
baseline
formally approved version of a configuration item, regardless of media, formally designated and fixed at a
specific time during the configuration item’s life cycle

[ISO/IEC 12207:1995, definition 3.5]

3.3
configuration item
entity within a configuration that satisfies an end use function and that can be uniquely identified at a given
reference point

[ISO/IEC 12207:1995, definition 3.6]

3.4
COTS
Commercial-Off-The-Shelf (acronym)
〈software product〉 available for purchase and use without the need to conduct development activities

3.5
development
software life cycle process that contains the activities of requirements analysis, design, coding, integration,
testing, installation and support for acceptance of software products

3.6
life cycle model
framework containing the processes, activities, and tasks involved in the development, operation, and
maintenance of a software product, spanning the life of the system from the definition of its requirements to the
termination of its use

[ISO/IEC 12207:1995, definition 3.11]

NOTE The requirements of ISO 9001:2000 would apply to maintenance, only if contractually required, after acceptance of
the product by the customer. However, generally the requirements do not apply to maintenance.

3.7
measure, verb
make a measurement

[ISO/IEC 14598-1:1999, definition 4.17]

3.8
measure, noun
variable to which a value is assigned as the result of measurement

[ISO/IEC 15939:2002, definition 3.14]

3.9
measurement
set of operations having the object of determining a value of a measure

[ISO/IEC 15939:2002, definition 3.17]

© ISO/IEC 2004 – All rights reserved 3

 This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-904566

ISO/IEC 90003:2004(E)

3.10
process
set of interrelated or interacting activities which transforms inputs into outputs

NOTE 1 Inputs to a process are generally outputs of other processes.

NOTE 2 Adapted from ISO 9000:2000, definition 3.4.1.

3.11
regression testing
testing required to determine that a change to a system component has not adversely affected functionality,
reliability or performance and has not introduced additional defects

3.12
release
particular version of a configuration item that is made available for a specific purpose

EXAMPLE A test release.

[ISO/IEC 12207:1995, definition 3.22]

NOTE The term “release” used in the ISO 9001:2000 text quoted in this International Standard is used in the context of the
definition provided in ISO 9000:2000, 3.6.13, which is different from the ISO/IEC 12207 definition quoted above.

3.13
replication
copying a software product from one medium to another

3.14
software item
identifiable part of a software product

3.15
software product
set of computer programs, procedures, and possibly associated documentation and data

[ISO/IEC 12207:1995, definition 3.26]

NOTE 1 A software product may be designated for delivery, an integral part of another product, or used in development.

NOTE 2 This is different from a product in ISO 9000 [2].

NOTE 3 For the purposes of this International Standard, “software” is synonymous with “software product”.

3.16
software service
performance of activities, work, or duties connected with a software product, such as its development,
maintenance and operation

[ISO/IEC 12207:1995, definition 3.27]

4 © ISO/IEC 2004 – All rights reserved

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-904566

ISO/IEC 90003:2004(E)

4 Quality management system

4.1 General requirements

ISO 9001:2000, Quality management systems — Requirements

4.1 General requirements

The organization shall establish, document, implement and maintain a quality management system and continually
improve its effectiveness in accordance with the requirements of this International Standard.

The organization shall

a) identify the processes needed for the quality management system and their application throughout the
organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes are
effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of these
processes,
e) monitor, measure and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International
Standard.

Where an organization chooses to outsource any process that affects product conformity with requirements, the
organization shall ensure control over such processes. Control of such outsourced processes shall be identified
within the quality management system.

NOTE Processes needed for the quality management system referred to above should include processes for management
activities, provision of resources, product realization and measurement.

Guidance is provided for items a) and b) of ISO 9001:2000, 4.1, in relation to the organizational processes as
follows (see 5.4.2, and 7.4.1 for additional guidance on outsourcing).

a) Process identification and application

The organization should also identify the processes for software development, operation or maintenance.

b) Process sequence and interaction

The organization should also define the sequence and interaction of the processes in

1) life cycle models for software development, e.g. waterfall, incremental and evolutionary, and

2) quality and development planning, which should be based upon a life cycle model.

NOTE For further information, see the following:

— ISO/IEC 12207 [11] and ISO/IEC 12207:1995/Amd.1:2002 [12] (software life cycle processes) which define a set of
software life cycle processes that may be used for reference;

— ISO/IEC TR 15271:1998 [21], Annex C (guide to ISO/IEC 12207) which provides guidance on how to use processes
from ISO/IEC 12207 in different life cycles.

© ISO/IEC 2004 – All rights reserved 5