9001 Updates

Safety Reports Series
N o. 6 9
Management System
Standards:
Comparison between
IAEA GS-R-3 and
ISO 9001:2008
IAEA SAFETY STANDARDS AND RELATED PUBLICATIONS
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MANAGEMENT SYSTEM STANDARDS:
COMPARISON BETWEEN
IAEA GS-R-3 AND ISO 9001:2008
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SAFETY REPORTS SERIES No. 69
MANAGEMENT SYSTEM
STANDARDS:
COMPARISON BETWEEN
IAEA GS-R-3 AND ISO 9001:2008
INTERNATIONAL ATOMIC ENERGY AGENCY

VIENNA, 2012
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STI/PUB/1529
IAEA Library Cataloguing in Publication Data

Management system standards : comparison between IAEA GS-R-3 and ISO
9001:2008. — Vienna : International Atomic Energy Agency, 2012.
p. ; 24 cm. — (Safety reports series, ISSN 1020–6450 ; no. 69)
STI/PUB/1529
ISBN 978–92–0–120710–4
Includes bibliographical references.
1. Nuclear power plants — Safety measures. — 2. Nuclear facilities —

Management — Quality control — Standards. 3. Industrial organization for
standardization — Quality control — Standards. — 4. Safety series. IAEA
safety standards — Quality control — Standards. I. International Atomic
Energy Agency. II. Series.
IAEAL 12–00727
FOREWORD
IAEA safety standards reflect an international consensus on what

constitutes a high level of safety for protecting people and the environment. They
often serve as safety regulatory documents. In practice, to be fully effective the
IAEA safety standards need to be complemented by industry standards and must
be implemented within an appropriate national regulatory infrastructure. The
IAEA produces a wide range of technical publications and reports to help
Member States in developing this national infrastructure and the associated
standards. Regarding management systems and integrated management systems,
IAEA Safety Standards Series No. GS-R-3, The Management System for
Facilities and Activities (IAEA GS-R-3), defines the requirements for
establishing, implementing, assessing and continually improving a management
system. IAEA GS-R-3, together with its supporting Safety Guides, supersedes
Safety Series No. 50-C/SG-Q, Quality Assurance for Safety in Nuclear Power
Plants and other Nuclear Installations.
IAEA GS-R-3 establishes management system requirements for nuclear
facilities and activities for operating organizations, but also for other interested
parties, such as regulatory bodies, suppliers and customers.
Where International Organization for Standardization (ISO) and other
standards are used, an appropriate and adequate safety management system can
be achieved by imposing additional requirements on an organization, over and
above those contained within the ISO 9001:2008 standard on Quality
Management Systems.
Differences between IAEA GS-R-3 and ISO 9001:2008 exist, as the
objectives, approaches and perspectives adopted in developing the requirements
in each standard are different. IAEA GS-R-3 requires that health, environmental,
security, quality and economic requirements be considered in conjunction with
safety requirements, to help preclude possible negative impacts on safety. The
approach used in the ISO standards is to develop requirements specific to a given
area (e.g. quality management or environmental management) and leave it to an
organization to select and use the set of ISO standards relevant to its areas of
operation. Comparing the requirements of one such standard with those of an
integrated management system standard will reveal inherent differences between
them.
The IAEA has provided guidance to support practical measures for
achieving safety when ISO 9001:2008 is used in nuclear installations. The
publication Quality Standards: Comparison between IAEA 50-C/SG-Q and ISO
9001:2000, Safety Reports Series No. 22, was published in 2002 to update
IAEA-TECDOC-1182, Quality Assurance Standards: Comparison between
IAEA 50-C/SG-Q and ISO 9001:1994. After the publication of IAEA GS-R-3,
prescribing the new IAEA management system requirements, there was a need to
update the comparison of IAEA and ISO management system standards. The
result is presented in this publication, which provides information and guidance
that may be considered when ISO 9001:2008 is used by the nuclear industry.
In this publication, ‘should’ statements are used to provide guidance based
on expert judgement; they do not stem from a consensus of IAEA Member States.
The guidance provided does not relieve the users of their responsibility to comply
with the requirements of the standards.
The IAEA wishes to thank all of the contributors to this Safety Report,
especially the members of the FORATOM Management System Task Force,
M. Hille (Germany) and J. Majola (Canada), for their efforts and valuable
assistance. The IAEA officers responsible for this publication were P. Vincze,
C.R. Clark and J.P. Boogaard of the Division of Nuclear Power, and
C. Viktorsson of the Division of the Nuclear Safety of Nuclear Installations.
EDITORIAL NOTE
Although great care has been taken to maintain the accuracy of information contained in
this publication, neither the IAEA nor its Member States assume any responsibility for
consequences which may arise from its use.
The use of particular designations of countries or territories does not imply any
judgement by the publisher, the IAEA, as to the legal status of such countries or territories, of
their authorities and institutions or of the delimitation of their boundaries.
The mention of names of specific companies or products (whether or not indicated as
registered) does not imply any intention to infringe proprietary rights, nor should it be
construed as an endorsement or recommendation on the part of the IAEA.
CONTENTS
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1. Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2. Objective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.4. Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. APPLICATION OF IAEA GS-R-3 AND ISO 9001:2008

STANDARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3. MAJOR DIFFERENCES AND CORRELATIONS . . . . . . . . . . . . . . 6
3.1. General approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3.1.1. Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.1.2. Management principles . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.1.3. Focus and structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.1.3.1. Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.1.3.2. Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.1.4. Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.2. Management system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.2.1. General requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.2.1.1. Level of detail of requirements . . . . . . . . . . . . 10
3.2.1.2. Integration of requirements from other
standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.2.2. Safety culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2.3. Grading the application of management system
requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2.3.1. Exclusion of requirements . . . . . . . . . . . . . . . 11
3.2.4. Documentation of the system . . . . . . . . . . . . . . . . . . . . . 11
3.3. Management responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.3.1. Management commitment . . . . . . . . . . . . . . . . . . . . . . . 13
3.3.2. Satisfaction of interested parties . . . . . . . . . . . . . . . . . . 14
3.4. Resource management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.4.1. Provision of resources . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.4.1.1. Management of information
and knowledge . . . . . . . . . . . . . . . . . . . . . . . . 14
3.4.2. Human resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.4.3. Infrastructure and the working environment . . . . . . . . . 15
3.5. Process implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.5.1. Process development and management . . . . . . . . . . . . . 16
3.5.1.1. Process and product focus . . . . . . . . . . . . . . . . 16
3.5.1.2. Process owner . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.5.1.3. Process models . . . . . . . . . . . . . . . . . . . . . . . . 16
3.5.2. Generic management system processes . . . . . . . . . . . . . 17
3.5.2.1. Control of products . . . . . . . . . . . . . . . . . . . . . 17
3.5.2.2. Planning of product realization . . . . . . . . . . . 17
3.5.2.3. Determination of interested party
requirements . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.5.2.4. Specification of requirements . . . . . . . . . . . . . 17
3.5.2.5. Review of requirements . . . . . . . . . . . . . . . . . 18
3.5.2.6. Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.5.2.7. Other stages of product realization . . . . . . . . . 18
3.5.2.8. Control of monitoring and measuring
devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.5.2.9. Customer property . . . . . . . . . . . . . . . . . . . . . 18
3.5.2.10. Communication . . . . . . . . . . . . . . . . . . . . . . . . 19
3.5.2.11. Managing organizational change . . . . . . . . . . 19
3.6. Measurement, assessment and improvement . . . . . . . . . . . . . . . 19
3.6.1. Monitoring and measurement . . . . . . . . . . . . . . . . . . . . 19
3.6.2. Self-assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.6.3. Independent assessment . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.6.4. Management system review . . . . . . . . . . . . . . . . . . . . . . 20
4. NOTES TO AID USERS IN MEETING ADDITIONAL

REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
APPENDIX: CORRELATION BETWEEN THE REQUIREMENTS 

OF IAEA GS-R-3 AND THOSE OF ISO 9001:2008 . . . . 51
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
CONTRIBUTORS TO DRAFTING AND REVIEW . . . . . . . . . . . . . . . . . 55
1. INTRODUCTION
1.1. BACKGROUND
The IAEA Safety Requirements publication on The Management System

for Facilities and Activities, IAEA Safety Standards Series No. GS-R-3 [1]
(IAEA GS-R-3), defines the requirements for establishing, implementing,
assessing and continually improving a management system for facilities and
activities that integrates safety, health, environmental, security, quality and
economic elements. The IAEA Safety Guides on the Application of the
Management System for Facilities and Activities [2] and on The Management
System for Nuclear Installations [3], as well as other IAEA Safety Guides
specific to technical areas, provide recommendations on how to fulfil the
requirements specified in IAEA GS-R-3.
The management systems of operators or organizations that provide nuclear
items or products and services must comply with safety requirements, including
those prescribed in IAEA safety standards (e.g. IAEA GS-R-3) that are adopted
by Member States. The utility or the owner/operator of a nuclear facility or
installation has the ultimate responsibility to ensure that the management system
implemented provides for an adequate level of safety. IAEA GS-R-3 helps an
organization to put in place a management system that fosters a strong safety
culture and improves safety performance.
In the conduct of their operations, organizations often use other standards in
their interfaces with suppliers and other interested parties. Organizations
conducting nuclear activities and nuclear facilities frequently use the International
Organization for Standardization (ISO) 9001:2008 standard on Quality
Management Systems — Requirements [4] at the interface between the nuclear
facility owner/operator and suppliers. ISO 9001:2008 cancels and replaces ISO
9001:2000, which was amended to clarify points in the text and to enhance
compatibility with the ISO 14001:2004 standard on Environmental Management
Systems — Requirements with Guidance for Use [5].
Having a management system that complies with ISO 9001:2008 allows an
organization to demonstrate its ability to meet customer and applicable regulatory
requirements, in addition to its own organizational requirements. The IAEA
safety standards need to be complemented by industry standards to address
specific technical and regulatory requirements. The standards developed by the
ISO are complementary technical documents that emphasize industrial
application and contractual aspects.
ISO 9001:2008 [4] is often used as a complementary standard for defining
the quality management system requirements at the interface between the nuclear
1
installation owner/operator and the supplier/contractor. ISO 14001:2004 [5] is
often used as a complementary standard for defining the environmental
management system, to comply with legal and regulatory environmental
requirements. Also, some organizations use requirements from ISO 14001:2004
and other complementary standards and specifications1 to integrate
environmental aspects into their ISO 9001:2008 based management system.
Recognizing that the IAEA safety standards often need to be complemented
by industry standards for practical effect, IAEA GS-R-3 was developed taking
into account international standards such as those of the ISO as well as the
experience of Member States in developing, implementing and improving
management systems. Consequently, there are similarities between the
requirements in IAEA GS-R-3 (which integrates safety, health, environmental,
security, quality and economic elements) and those in ISO 9001:2008. However,
there are differences between them as well. This publication compares these two
standards.
This report is a follow-up of previous similar comparisons of IAEA and ISO
management system standards, such as the comparison of the IAEA 50-C/SG-Q
Code and Safety Guides [7] and the ISO standards, reported in IAEA-TECDOC-
1182 [8] and in IAEA Safety Reports Series No. 22 [9].
1.2. OBJECTIVE
The objective of this Safety Report is to compare the requirements of

IAEA GS-R-3 with those of ISO 9001:2008, in order to identify the main
differences between them. This report also provides information and guidance
that may be considered when ISO 9001:2008 is used by the nuclear industry to
complement safety specific management system standards or quality
management system standards.
1
For example, the OHSAS 18001 Occupational Health and Safety Management
Systems Requirements Standard (OHSAS 18001:2007) [6] establishes requirements for an
occupational health and safety management system, to enable an organization to control its
occupational health and safety risks and improve its performance. OHSAS 18001:2007 was
developed to be compatible with ISO 9001:2000, which has been replaced by the
ISO 9001:2008 [4] and ISO 14001:2004 [5] management system standards, to facilitate the
integration of quality, environmental, and occupational health and safety management systems
by organizations, should they wish to do so.
2
1.3. SCOPE
This report compares the requirements in the following publications:
— IAEA Safety Standards Series No. GS-R-3, The Management System for
Facilities and Activities [1];
— ISO 9001:2008, Quality Management Systems – Requirements [4].
The recommendations provided in Ref. [2] and the fundamentals and

vocabulary contained in ISO 9000:2005, Quality Management Systems —
Fundamentals and Vocabulary [10], have been used, as necessary and
appropriate, to inform and facilitate the comparison.
1.4. USERS
This Safety Report is intended primarily for the use of owners, operators
and employees of nuclear facilities and installations, regulatory bodies, suppliers,
research and development organizations, and other interested parties. It will be of
particular interest to organizations wishing to procure items, products or services
for use in the nuclear industry as a source of guidance on specifying additional
management system requirements to suppliers with management systems that
comply with ISO 9001:2008.
2. APPLICATION OF IAEA GS-R-3

AND ISO 9001:2008 STANDARDS
Figure 1 illustrates the use of IAEA GS-R-3 and ISO 9001:2008

requirements by an operator of a nuclear facility, or by an organization
conducting a nuclear activity, at the interfaces between the operator, the nuclear
regulatory body and a supplier. The figure also illustrates how a regulatory body
might use IAEA GS-R-3 at the interfaces between the regulatory body, an
operator of a nuclear facility or an organization conducting a nuclear activity, and
the government.
3
GOVERNMENT
Legal and statutory

requirements
(e.g. national laws)
REGULATORY BODY SUPPLIER
IAEA GS-R-3
ISO 9001:2008
and other national or area
additional requirements
specific requirements
NUCLEAR FACILITY
OR ACTIVITY
Requirement path
Satisfaction path
FIG. 1. Application of IAEA GS-R-3 and ISO 9001:2008. See Table 1 for examples of
additional requirements.
4
Through governmental policy and legal or statutory instruments, a Member
State might require a regulatory body to put in place regulatory and management
systems for establishing policies and objectives, and for implementing them such
that objectives are achieved in an efficient and effective way. Figure 1 also
illustrates the use of IAEA GS-R-3 in addition to the legal, statutory and other
requirements of the Member State to be imposed on a regulated organization such
as an operator of a nuclear facility. It is the responsibility of the operator to put in
place a management system that satisfies these requirements. At the interface
between the nuclear facility operator and a supplier of items and services, the
operator may require the supplier to put in place a management system for the
delivery of items and services that satisfies requirements imposed by the
regulatory body; these requirements may include IAEA GS-R-3 requirements. A
supplier with a management system based on ISO 9001:2008 would then have to
ensure that its management system satisfies these additional requirements.
Figure 1 illustrates such a situation.
The development of a management system which complies with the IAEA
GS-R-3 requirements involves the participation of regulatory bodies with
oversight of nuclear facilities as a matter of course, while the development of a
management system based on ISO 9001:2008 does not require their involvement.
However, a supplier may incorporate product related regulatory requirements set
by a regulatory body or the government when establishing a management system
based on ISO 9001:2008.
Both standards specify requirements for use by an organization internally,
or for contractual purposes, to enhance and demonstrate the effectiveness of its
management system. Both standards can be used by external parties as the basis
of assessing the organization’s management system.
Unlike IAEA GS-R-3, however, ISO 9001:2008 also can be used by
external parties, such as certification bodies, for certification purposes. The IAEA
does not encourage the certification of an organization’s management system
against the requirements of IAEA GS-R-3. The compliance of a management
system with IAEA GS-R-3 requirements is normally assessed and enforced by
the regulatory bodies of Member States that have adopted IAEA GS-R-3 for use
in their regulatory systems.
5
3. MAJOR DIFFERENCES AND CORRELATIONS
This section provides a summary comparing and contrasting the approaches

of IAEA GS-R-3 and ISO 9001:2008 in the major areas of interest. A more
detailed comparison is provided in the Appendix to this publication.
3.1. GENERAL APPROACH
3.1.1. Objectives
IAEA GS-R-3 presents the requirements for organizations to establish,

implement, assess and continually improve a management system that integrates
safety, health, environmental, security, quality and economic elements, to foster a
strong safety culture and improve safety performance in all the activities of the
organization. In IAEA GS-R-3, safety is of primary importance, overriding all
other demands.
ISO 9001:2008 allows an organization to demonstrate its ability to meet
customer and applicable statutory and regulatory requirements2, in addition to its
own organizational requirements, and to enhance customer satisfaction. It does
not include requirements to ensure safety or requirements specific to other
management system aspects, such as those particular to environmental
management, occupational health and safety management, financial management
or risk management.
3.1.2. Management principles
Both IAEA GS-R-3 and ISO 9001:2008 are based on the following
common management principles, which reflect good management practices:
— Customer focus;
— Leadership;
— Involvement of people;
— Process approach;
2
ISO 9001:2008 refers to statutory and regulatory requirements as legal requirements.
IAEA GS-R-3 makes a distinction between them, making reference in one of its requirements
to statutory, regulatory and legal requirements.
6
— Systematic approach to management;
— Continual improvement;
— Factual approach to decision making;
— Mutually beneficial supplier relationships.
IAEA GS-R-3 is also based on the principle of an integrated management

system, which includes all factors affecting the activities and safety performance
of an organization. Safety culture and human performance are important
management principles in IAEA GS-R-3 and are part of the focus of the standard.
Risk management is another important management principle included in IAEA
GS-R-3.
IAEA GS-R-3 requires proactive strategic thinking and planning,
integrating all goals, strategies and objectives, while the emphasis of ISO
9001:2008 is on the operational level of product and ‘quality management’
requirements. Consequently, the scope of application and integration of
management principles is much greater in IAEA GS-R-3 than in ISO 9001:2008.
ISO 9001:2008 has no requirement to integrate safety, health,
environmental, security, quality and economic elements of the management
system to ensure that safety is properly taken into account in all activities of the
organization.
3.1.3. Focus and structure
Figure 2 illustrates the differences of focus and the similarities of structure

between IAEA GS-R-3 and ISO 9001:2008.
3.1.3.1. Focus
IAEA GS-R-3 is a safety standard, whereas ISO 9001:2008 is not. IAEA

GS-R-3 is a standard specific to the nuclear industry, and its focus is on achieving
and enhancing safety. It establishes requirements designed to achieve and enhance
safety, while enhancing the satisfaction of interested parties. IAEA GS-R-3 is
applicable to the establishment, implementation, assessment and continual
improvement of management systems for:
— Nuclear facilities;
— Activities using sources of ionizing radiation;
— Radioactive waste management;
— Transport of radioactive material;
— Radiation protection activities;
7
IAEA GS-R-3 ISO 9001:2008
Integrated Management
Quality Management System
System
Safety Culture
General Requirements
Grading
Documentation Requirements
Documentation
Management Responsibility Management Responsibility
Management Commitment
Management Commitment
Customer Focus
Satisfaction of Interested
Quality Policy
Parties (i.e. Stakeholders)
Planning
Policies
Responsibility, Authority &
Planning
Communication
Responsibility & Authority
Management Review
Resource Management Resource Management
Provision of Resources Provision of Resources

Human Resources Human Resources
Infrastructure & Working Infrastructure
Environment Working Environment
Process Implementation Product Realization
Planning of Product
Realization
Developing Processes Customer-Related Processes
Process Management Design & Development
Generic Management Purchasing
System Processes Production & Service Provision
Control of Monitoring &
Measuring Equipment
Measurement, Assessment Measurement, Analysis

and Improvement and Improvement
Monitoring & Measurement General

Self-Assessment Monitoring & Measurement
Independent Assessment Control of Nonconforming
Management System Review Product
Non-conformances and Analysis of Data
Corrective & Preventive Improvement
Actions
Improvement
Focus on
Focus on
Customer
Safety Multiple similarities Satisfaction
One to one similarity
FIG. 2. Differences of focus and similarities of structure between IAEA GS-R-3 and
ISO 9001:2008.
8
— Any other practices or circumstances in which people may be exposed to
radiation from naturally occurring or artificial sources;
— Regulation of such facilities and activities.
ISO 9001:2008 is a general quality management system standard applicable

to any organization. Its focus is on providing products and services that meet
customer and applicable statutory and regulatory requirements, and on enhancing
customer satisfaction. It concentrates on the effectiveness of the quality
management system in meeting these objectives, not on enhancing safety. ISO
9001:2008 states that it does not include requirements specific to other
management systems, such as those particular to environmental management,
occupational health and safety management, financial management or risk
management. It specifies requirements designed to demonstrate an organization’s
ability to consistently provide products that meet customer and applicable
statutory and regulatory requirements, and 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 statutory and regulatory requirements [4].
3.1.3.2. Structure
There are similarities in structure between IAEA GS-R-3 and ISO

9001:2008, in spite of the differences in focus and overall objective. The
requirements in both standards have been structured in terms of the following
main categories:
— Management system versus quality management system;

— Management responsibility;
— Resource management;
— Process implementation versus product realization;
— Measurement, assessment and improvement versus measurement, analysis
and improvement.
However, there are differences in emphasis and detail within these main
categories of requirements.
3.1.4. Terminology
There are some differences in terminology between IAEA GS-R-3 and ISO
9001:2008. The vocabulary used in IAEA GS-R-3 is defined in the IAEA Safety
Glossary [11], and terms relating to the management system are included in a
9
glossary of terms in IAEA GS-R-3 [1]. The vocabulary for ISO 9001:2008 is
contained in ISO 9000:2005 [10].
Note that both standards use the concept of ‘product’ to mean both items
and services. Also, IAEA GS-R-3 makes reference to interested parties, while
ISO 9001:2008 restricts its focus to suppliers, organizations and customers, and
points to ISO 9004:2009 [12] for a wider focus on quality management that
addresses the needs and expectations of all interested parties, and their
satisfaction, by the systematic and continual improvement of the organization’s
performance.
3.2. MANAGEMENT SYSTEM
3.2.1. General requirements
3.2.1.1. Level of detail of requirements
There are differences in the level of detail in topics common to both

standards. IAEA GS-R-3 is supported by Refs [2] and [3] and by similar guides,
which provide recommendations on the implementation of the requirements in
IAEA GS-R-3. ISO 9001:2008 does not provide such separate guidance on the
implementation of its requirements.
3.2.1.2. Integration of requirements from other standards
IAEA GS-R-3 requires an integrated management system. It makes specific

provision for the integration of requirements of regulatory bodies and of other
interested parties into the management system. It also provides an explicit
mechanism for integrating requirements from other codes and standards into the
management system.
ISO 9001:2008 focuses on quality management. It does not include a
requirement to integrate the requirements of other management system standards
but states that an organization can use ISO 9001:2008 to align or integrate its
quality management system with related management system requirements. ISO
9001:2008 considers statutory and regulatory requirements, but only those
applicable to the product, as well as additional requirements identified by the
organization. The application of statutory and regulatory requirements to the
totality of the quality management system is not considered.
10
3.2.2. Safety culture
The promotion of and support for a strong safety culture is an integral part
of the integrated management system described in IAEA GS-R-3. A safety
culture is not a requirement of ISO 9001:2008.
3.2.3. Grading the application of management system requirements
IAEA GS-R-3 states that the application of management system

requirements shall be graded so as to deploy appropriate resources, but this is not
a stated requirement in ISO 9001:2008. In the latter, however, there is the implied
use of the concept of a graded approach in the application of a few specific
requirements, for instance, by the use of wording such as “as appropriate”,
“where appropriate”, “where applicable”, “as necessary” or “where necessary” in
the text or explanatory notes of these requirements.
A graded approach to the application of requirements allows an
organization to deploy resources and to determine the types and extent of controls
to be applied to specific items, services and processes in a manner that is
commensurate with the significance and complexity of, and risks (hazards and
consequences) associated with, these items, products or services, to ensure that
they are produced and/or delivered correctly and safely.
3.2.3.1. Exclusion of requirements
IAEA GS-R-3 does not make provision for the exclusion of any of its
requirements; it makes provision only for varying degrees of application of the
requirements through the graded approach.
ISO 9001:2008 allows the exclusion of requirements within clause 7, where
such exclusions do not affect the organization’s ability, or responsibility, to
provide products or services that meet customer and applicable statutory and
regulatory requirements.
3.2.4. Documentation of the system
IAEA GS-R-3 does not specify the processes to be documented, but

requires the management system to include the following:
— The policy statements of the organization.

— A description of the management system.
— A description of the structure of the organization.
11
— A description of the functional responsibilities, accountability, levels of
authority and interactions of those managing, performing and assessing
work.
— A description of the processes and supporting information explaining how
work is to be prepared, reviewed, carried out, recorded, assessed and
improved.
— Records, specified in the process documentation, that are required to
demonstrate that the process results have been achieved. It should be noted
that IAEA GS-R-3 treats records as outputs of processes, and not as
documentation of the management system.
Also, IAEA GS-R-3 requires the documentation of the management system

to reflect the characteristics of the organization and its activities, and the
complexities of processes and their interactions.
ISO 9001:2008 requires the quality management system documentation to
include:
— Documented statements of a quality policy and quality objectives.

— A quality manual.
— Documented procedures and records, including documented procedures
for:
• Control of documents;
• Control of records;
• Internal audit;
• Control of non-conforming product;
• Corrective action;
• Preventive action.
— Documents, including records, needed to ensure the effective planning,
operation and control of processes.
ISO 9001:2008 recognizes that the extent of the documentation will depend
on the size of the organization, the types of activity being undertaken, the
complexity of the processes and their interactions, and the competence of
personnel.
12
3.3. MANAGEMENT RESPONSIBILITY
3.3.1. Management commitment
IAEA GS-R-3 places requirements on all levels of management, while ISO

9001:2008 places requirements only on top management.
In IAEA GS-R-3, senior management3 has a number of responsibilities not
specified in ISO 9001:2008; they include:
— Developing individual values, institutional values and behavioural

expectations for the organization to support the implementation of the
management system, and acting as role models in the promulgation of these
values and expectations.
— Communicating to individuals the need to adopt these values and
expectations.
— Fostering the involvement of all individuals in the implementation and
continual improvement of the management system.
— Developing organizational policies not limited to the quality policy; as ISO
9001:2008 is a quality management system standard, states that top
management is responsible only for the quality policy.
— Establishing goals, strategies, plans and objectives that are consistent with
the policies of the organization.
— Developing the goals, strategies, plans and objectives of the organization in
an integrated manner so that their collective impact on safety is understood
and managed.
Senior management has the responsibility of carrying out self-assessment

to evaluate the performance of work and the improvement of the safety culture;
this responsibility is shared with management at all other levels of the
organization.
IAEA GS-R-3 has a broader view of leadership and management
responsibility than does ISO 9001:2008. The latter addresses leadership in its
requirements, but does not explicitly address the particular aspects listed above.
3
‘Senior management’ means the person who, or group of people which, directs,
controls and assesses an organization at the highest level. Many different terms are used;
ISO 9001:2008 uses the term ‘top management’.
13
3.3.2. Satisfaction of interested parties
IAEA GS-R-3 requires senior management to consider the expectations and

the satisfaction of interested parties in the processes of its management system,
while ISO 9001:2008 focuses only on customers. Thus, the focus in IAEA
GS-R-3 is on safety but with due consideration of the requirements and
expectations of interested parties as far as they directly or indirectly affect the
activities of an organization. IAEA GS-R-3 focuses on a broader range of
interested parties than does ISO 9001:2008.
IAEA GS-R-3 addresses customer satisfaction by requiring the enhancement
of interested party satisfaction, as long as safety is not compromised, in the
activities and interactions of the organization. ISO 9001:2008 establishes the
requirement for customer satisfaction as part of the monitoring and measurement of
the performance of the quality management system.
3.4. RESOURCE MANAGEMENT
3.4.1. Provision of resources
IAEA GS-R-3 places the responsibility specifically on senior management

to provide the resources necessary to carry out the activities of the organization
and to establish, implement, assess and continually improve the management
system. ISO 9001:2008 places this responsibility on the organization, but requires
top management to ensure that responsibilities and authorities are defined for this
and other activities.
3.4.1.1. Management of information and knowledge
IAEA GS-R-3 highlights the requirement to manage information and

knowledge as a resource. ISO 9001:2008 has several requirements to manage
information, but it has no requirement for knowledge management.
3.4.2. Human resources
Both IAEA GS-R-3 and ISO 9001:2008 have requirements to determine the
necessary competence of personnel performing work, and to provide training
and/or take other actions to satisfy these needs and achieve the required level of
competence.
14
Both standards also have requirements to evaluate the effectiveness of the
actions taken, to ensure that suitable proficiency is achieved; IAEA GS-R-3 also
requires that the proficiency be maintained.
IAEA GS-R-3 requires senior management to ensure not only that
individuals are competent to perform their assigned work, but also that they
understand the consequences for safety of their activities. It requires individuals
to receive appropriate education and training and to acquire suitable skills,
knowledge and experience, to ensure their competence and to promote
compliance with the requirements of the management system and adoption of the
values and expectations promulgated by management. Consequently, the training
provided is required to ensure that individuals are aware of the relevance and
importance of their activities, and of how their activities contribute to safety in
the achievement of the organization’s objectives.
Except for a specific requirement for the process owner4 to ensure that the
process documentation specifies the records required to demonstrate that the
process results have been achieved, IAEA GS-R-3 does not explicitly set a
requirement for training records to be maintained. Retention of records is
addressed in annex II of the companion Safety Guide [2].
ISO 9001:2008 requires the organization to ensure that its personnel are
aware of the relevance and importance of their activities, and of how these activities
contribute to the achievement of the quality objectives. IAEA GS-R-3 requires the
organization to ensure that its personnel are competent to perform their assigned
work and that they understand the consequences for safety of their activities. Also
in this area, ISO 9001:2008 focuses on the quality aspects, in contrast to the strong
focus on safety in IAEA GS-R-3. The organization is also required to maintain
appropriate records of education, training, skills and experience.
3.4.3. Infrastructure and the working environment
IAEA GS-R-3 does not set detailed requirements regarding infrastructure;

however, guidance is provided in Ref. [2]. IAEA GS-R-3 requires senior
management to determine, provide, maintain and re-evaluate the infrastructure
and the working environment necessary for requirements to be met and for work
to be carried out in a safe manner.
ISO 9001:2008 contains more requirements for infrastructure than does
IAEA GS-R-3, but with a focus on the infrastructure needed to achieve
conformity to product requirements.
4
The individual designated as having the authority and responsibility for a process is
often referred to as the ‘process owner’.
15
3.5. PROCESS IMPLEMENTATION
3.5.1. Process development and management
3.5.1.1. Process and product focus
Both standards adopt the process approach, based on the concept that work may
be structured and interpreted as a set of interacting processes. IAEA GS-R-3 puts a
strong focus on processes, requiring a graded application of management system
requirements to the products and activities of each process. ISO 9001:2008 considers
processes needed for product realization and focuses mainly on product quality.
3.5.1.2. Process owner
IAEA GS-R-3 has a specific requirement for a designated individual with

the authority and responsibility for developing, documenting, monitoring and
promoting improvement of each process, while ISO 9001:2008 does not.
3.5.1.3. Process models
IAEA GS-R-3 does not specify or rely on a particular process model to

present process implementation requirements. It provides generic requirements
for developing and managing processes, focusing on a number of generic
management system processes for the control of documents, products, records
and purchasing, and for communication and managing organizational change,
without reference to any particular model.
However, IAEA GS-R-3 process development requirements explicitly
include the specification and addressing of applicable regulatory, statutory, legal,
safety, health, environmental, security, quality and economic requirements. There
is also a requirement to identify hazards and risks, along with actions to mitigate
them. ISO 9001:2008 only requires that statutory and regulatory requirements
applicable to the product be addressed.
ISO 9001:2008 includes a process model that identifies the importance of
understanding and meeting requirements, the need to consider processes in terms
of added value, the need to monitor performance and effectiveness, and the need
for continual improvement based on objective measurement. The model
emphasizes the responsibility of management to manage resources, establish
product realization processes and monitor process effectiveness in delivering
products and services conforming to applicable requirements. Although IAEA
GS-R-3 does not discuss a particular process model, it also specifies requirements
discussed in the process model of ISO 9001:2008.
16
3.5.2. Generic management system processes
3.5.2.1. Control of products
There are differences between IAEA GS-R-3 and ISO 9001:2008 in the
way in which the requirements for control of products are presented.
3.5.2.2. Planning of product realization
IAEA GS-R-3 does not establish detailed and specific requirements on

product realization planning, while ISO 9001:2008 does.
3.5.2.3. Determination of interested party requirements
IAEA GS-R-3 requires the management system to identify and integrate

any requirements formally agreed with interested parties. It also requires senior
management to consider the expectations of interested parties in process activities
and interactions, with the aim of enhancing the satisfaction of interested parties
while ensuring that safety is not compromised.
IAEA GS-R-3 makes reference to applicable requirements of interested
parties without specifying the source of those requirements at the product level;
however, the scope of the interested party requirements considered is larger, since
the scope of interested parties considered in IAEA GS-R-3 extends beyond those
specified in ISO 9001:2008.5
ISO 9001:2008 explicitly addresses the input of customers, the organization
and regulatory or statutory bodies in the determination of requirements that only
relate to the product. It sets out detailed requirements for determining customer
requirements relating to the product, but without mentioning safety, as this
standard was not developed for safety applications.
3.5.2.4. Specification of requirements
IAEA GS-R-3 requirements for process development, product control and

purchasing are not as detailed, or as specific, as the explicit requirements for
product realization in ISO 9001:2008.
5
Customers, as addressed by the requirements of ISO 9001:2008, are included among
the interested parties addressed by IAEA GS-R-3.
17
3.5.2.5. Review of requirements
IAEA GS-R-3 requirements for product control and purchasing as part of

the generic management processes are not as detailed as the requirements in
ISO 9001:2008 for review of the requirements related to the product.
3.5.2.6. Design
The focus of IAEA GS-R-3 on processes means that the requirements are
sufficiently generic to be applicable to design.
ISO 9001:2008 includes specific requirements relating to design and
development planning, the determination of design inputs and outputs, design
review, verification and validation, and the control of design changes.
3.5.2.7. Other stages of product realization
The focus on processes in IAEA GS-R-3 means that the requirements are
sufficiently generic to be applicable to all processes without regard to what a
given process is designed to achieve. IAEA GS-R-3 requirements apply equally
at the design stage as at subsequent developmental, implementation, or product
obsolescence and decommissioning or disposition stages; the requirements are
addressed only in a generic way in IAEA GS-R-3, without reference to the
developmental phases of products.
ISO 9001:2008 includes generic requirements for processes that control
production and service provision, and for the validation of such processes. In
general, ISO 9001:2008 requirements in relation to product realization are more
specific than those in IAEA GS-R-3.
3.5.2.8. Control of monitoring and measuring devices
IAEA GS-R-3 requires the tools and equipment used in activities for
inspection, testing, verification and validation of products to be of the proper
range, type, accuracy and precision. ISO 9001:2008 establishes similar
requirements but provides more detail.
3.5.2.9. Customer property
Customer property is not addressed in IAEA GS-R-3, but is explicitly

addressed in ISO 9001:2008.
18
3.5.2.10. Communication
IAEA GS-R-3 focuses on internal communication and communication with

other interested parties, as necessary.
ISO 9001:2008 focuses on communication with the customer and on
internal communication regarding the effectiveness of the quality management
system. The requirements for customer focused communication in ISO
9001:2008 are equivalent to the IAEA GS-R-3 requirements for communication
with internal and external interested parties as well as those for reporting and
resolving product non-conformances.
3.5.2.11. Managing organizational change
IAEA GS-R-3 has specific requirements for: evaluating and classifying

organizational changes according to their importance to safety; justifying each
change; and planning, controlling, communicating, monitoring, tracking and
recording the implementation of such changes to ensure that safety is not
compromised.
ISO 9001:2008 has several explicit requirements for managing changes to
product realization and other elements of a quality management system, but not
for managing organizational change.
3.6. MEASUREMENT, ASSESSMENT AND IMPROVEMENT
3.6.1. Monitoring and measurement
IAEA GS-R-3 provides high level requirements for monitoring and

measuring the effectiveness of the management system in achieving intended
results, and for identifying opportunities for improvement.
ISO 9001:2008 requires the organization to monitor information relating to
customer perception as to whether the organization has met customer
requirements as one of the measurements of the performance of the management
system. It also requires the organization to determine the methods for obtaining
and using such information. IAEA GS-R-3 does not specify such requirements.
ISO 9001:2008 establishes more detailed requirements, including the
requirements to determine applicable monitoring and measuring methods that
include statistical techniques, and to determine the extent of their use.
19
3.6.2. Self-assessment
IAEA GS-R-3 requires senior management and management at all other

levels of the organization to carry out self-assessments to evaluate not just the
performance of work but also the improvement of the safety culture. ISO
9001:2008 has no equivalent requirements for self-assessment.
3.6.3. Independent assessment
IAEA GS-R-3 requires independent assessments to be conducted to:

determine, among other things, effectiveness in achieving goals, strategies, plans
and objectives; determine the adequacy of work performance and leadership; and
evaluate the organization’s safety culture.
It also requires the establishment of an organizational unit with the
responsibility for conducting independent assessments. Senior management is
required to evaluate the results of the independent assessments and to take any
necessary steps to address those results, with the decisions and reasons for them
recorded and communicated.
There are no similar requirements for independent assessment in ISO
9001:2008; however, audits can be conducted by an independent organization, as
it is left to the organization to assign responsibility for audits in a documented
procedure.
ISO 9001:2008 requires internal audits of the quality management system
to be conducted in order to determine the effectiveness of its implementation and
whether it conforms to the planned arrangements, the requirements of ISO
9001:2008 and any other requirements established by the organization. It also
requires assessment of the effectiveness of processes and of the product to verify
that product requirements have been met.
ISO 9001:2008 does not specifically place the responsibility for audits on
management, but it requires the responsibilities and requirements for planning
and conducting audits, and for reporting results and maintaining records, to be
defined in a documented procedure.
3.6.4. Management system review
In IAEA GS-R-3, management system review is considered to be part of the

measurement, assessment and improvement of the management system. IAEA
GS-R-3 requires the management system review to cover: outputs from all forms
of assessment; results delivered and objectives achieved; non-conformances, and
corrective and preventive actions; lessons learned from other organizations; and
opportunities for improvement.
20
Key outputs from such reviews are the identification of obstacles and of the
need to make changes or improvements to policies, goals, strategies, plans,
objectives and processes.
IAEA GS-R-3 does not explicitly state who is responsible for conducting
the review of the management system.
In ISO 9001:2008, management system review is addressed in the context
of management responsibility. ISO 9001:2008 establishes detailed requirements
for reviews of the quality management system with inputs that are similar to those
in IAEA GS-R-3, except for the IAEA GS-R-3 requirement to address lessons
learned from other organizations.
Key outputs from ISO 9001:2008 reviews relate to: improvement of the
effectiveness of the quality management system and its processes; improvement
of product relating to customer requirements; and resource needs. ISO 9001:2008
explicitly requires top management to conduct such reviews.
4. NOTES TO AID USERS

IN MEETING ADDITIONAL REQUIREMENTS
Table 1 identifies requirements on the management system established in

IAEA GS-R-3 that are not addressed in ISO 9001:2008. The table provides notes
to aid users of ISO 9001:2008 in meeting these additional IAEA GS-R-3
requirements. Table 2 identifies requirements on the quality management system
established in ISO 9001:2008 that are not addressed in IAEA GS-R-3. The table
provides notes to aid users of IAEA GS-R-3 in meeting these additional
ISO 9001:2008 requirements.
The tables identify the additional requirements to be met in circumstances
where only one standard is currently implemented. It should be noted that there
may be alternate approaches to satisfy the requirements of one standard or the
other, and the notes present only one viable approach to meeting the
requirements.
In Tables 1 and 2, the notes to aid users in meeting the requirements relate
to the text in italics. For those sections in each of the standards that are not
addressed in these tables, the requirements are considered to be equivalent.
In the tables, ‘should’ statements are used to provide guidance based on
expert judgement; they do not stem from a consensus of IAEA Member States.
The guidance provided does not relieve the users of their responsibility to comply
with the requirements of the standards.
21
TABLE 1. IAEA GS-R-3 REQUIREMENTS NOT CONTAINED IN
ISO 9001:2008 
(Notes to aid users in meeting the requirements relate to the text in italics.)
Notes to aid users of ISO 9001:2008

Paragraph IAEA GS-R-3 requirements in meeting the IAEA GS-R-3
requirements
2.1–2.10 Management system
General requirements
2.1 A management system shall be established, A management system should be

implemented, assessed and continually improved. established that integrates safety,
It shall be aligned with the goals of the organization health, environmental, security and
and shall contribute to their achievement. The main economic requirements with the
aim of the management system shall be to achieve ISO 9001:2008 quality
and enhance safety by: management system requirements.
– Bringing together in a coherent manner all the
requirements for managing the organization;
– Describing the planned and systematic actions
necessary to provide adequate confidence that all
these requirements are satisfied;
– Ensuring that health, environmental, security,
quality and economic requirements are not
considered separately from safety requirements,
to help preclude their possible negative impact
on safety.
2.2 Safety shall be paramount within the management Safety needs to be ensured when
system, overriding all other demands. using ISO 9001:2008 in a nuclear
environment. For example, safety
should be made a priority in
policies, processes, procedures,
training and communication; a
strong safety culture should be
promoted and supported; and the
values and expectations supporting
safety should be developed,
established, stated and clearly
communicated.
22
ISO 9001:2008 (cont.) 

requirements
2.3 The management system shall identify and The organization should identify
integrate with the requirements contained within all formally agreed requirements of
[IAEA GS-R-3]: interested parties and integrate
– The statutory and regulatory requirements of the them into the management system.
Member State;
– Any requirements formally agreed with The organization should identify
interested parties (also known as the relevant IAEA requirements
‘stakeholders’); and integrate them into the
– All other relevant IAEA Safety Requirements management system.
publications, such as those on emergency
preparedness and response and safety The organization should identify
assessment; requirements from other relevant
– Requirements from other relevant codes and codes and standards and integrate
standards adopted for use by the organization. them into the management system.
Safety culture
2.5 The management system shall be used to promote Safety culture is not addressed in
and support a strong safety culture by: ISO 9001:2008 but should be
– Ensuring a common understanding of the key promoted and supported by the
aspects of safety culture within the organization; management system.
– Providing the means by which the organization
supports individuals and teams in carrying out
their tasks safely and successfully, taking into
account the interaction between individuals,
technology and the organization;
– Reinforcing a learning and questioning attitude
at all levels of the organization;
– Providing the means by which the organization
continually seeks to develop and improve its
safety culture.
23
ISO 9001:2008 (cont.) 

requirements
Grading the application of management system requirements
2.6 The application of management system The resources and effort expended,
requirements shall be graded so as to deploy and the extent to which
appropriate resources, on the basis of the management system requirements
consideration of: are applied to a particular product,
– The significance and complexity of each product activity or process, should be
or activity; commensurate with:
– The hazards and the magnitude of the potential – The importance and complexity
impact (risks) associated with the safety, health, of the product, activity or
environmental, security, quality and economic process;
elements of each product or activity; – The potential impact of that
– The possible consequences if a product fails or product, activity or process on
an activity is carried out incorrectly. safety, health, environmental,
security, quality and economic
priorities of the organization;
– The consequences of mistakes or
product, activity or process
failure.
2.7 Grading of the application of management system See the note to aid users relating to
requirements shall be applied to the products and Requirement 2.6 above.
activities of each process.
Documentation of the management system
2.8 The documentation of the management system shall In the documentation of the
include the following: management system, all
– The policy statements of the organization; requirements should be addressed,
– A description of the management system; that is, safety, health,
– A description of the structure of the environmental, security, quality
organization; and economic requirements.
– A description of the functional responsibilities,
accountability, levels of authority and
interactions of those managing, performing and
assessing work;
– A description of the processes and supporting
information that explain how work is to be
prepared, reviewed, carried out, recorded,
assessed and improved.
24
ISO 9001:2008 (cont.) 

requirements
2.9 The documentation of the management system shall When preparing documentation of
be developed to be understandable to those who use the management system,
it. Documents shall be readable, readily identifiable consideration should be given to
and available at the point of use. the accessibility and ease of use of
documents, with particular
attention to, for instance,
appropriate language and format,
avoidance of jargon, and provision
of clear definitions.
3.1–3.14 Management responsibility
Management commitment
3.1 Management at all levels shall demonstrate its The principle of management
commitment to the establishment, implementation, commitment should be extended to
assessment and continual improvement of the all levels of management.
management system and shall allocate adequate
resources to carry out these activities.
3.2 Senior management shall develop individual Management at all levels should
values, institutional values and behavioural develop, establish, state, clearly
expectations for the organization to support the communicate and foster a culture
implementation of the management system and of shared values and expectations
shall act as role models in the promulgation of by developing individual and
these values and expectations. institutional or corporate values, as
well as behavioural expectations
for the individuals in the
organization. Management should
then lead by example to
promulgate these values and
expectations throughout the
organization.
3.3 Management at all levels shall communicate to See the notes to aid users relating
individuals the need to adopt these individual to Requirement 3.2 above.
values, institutional values and behavioural
expectations as well as to comply with the
requirements of the management system.
25
ISO 9001:2008 (cont.) 

requirements
3.4 Management at all levels shall foster the The basic quality management
involvement of all individuals in the principle of ISO 9000:2005 item
implementation and continual improvement of the 0.2(c), “involvement of people”
management system. [10], should be implemented by
involving all individuals in the
implementation and continual
improvement of the management
system.
3.5 Senior management shall ensure that it is clear Responsibilities and authorities for
when, how and by whom decisions are to be made making decisions should be clear.
within the management system.
Satisfaction of interested parties
3.6 The expectations of interested parties shall be Senior management should expand
considered by senior management in the activities the customer focus to all interested
and interactions in the processes of the parties while ensuring that safety is
management system, with the aim of enhancing the not compromised.
satisfaction of interested parties while at the same
time ensuring that safety is not compromised.
Organizational policies
3.7 Senior management shall develop the policies of Top management should develop
the organization. The policies shall be appropriate policies in addition to, or should
to the activities and facilities of the organization. extend, the existing quality policy
to cover all elements of the
management system, including
safety, health, the environment,
security and economics, as
appropriate.
Planning
3.8 Senior management shall establish goals, Top management should extend
strategies, plans and objectives that are consistent the existing quality objectives to
with the policies of the organization. cover all elements of the
management system, including
safety, health, the environment,
security and economics, as
appropriate.
26
ISO 9001:2008 (cont.) 

requirements
3.9 Senior management shall develop the goals, A leading principle of the
strategies, plans and objectives of the organization management system should be
in an integrated manner so that their collective strategic planning that focuses on
impact on safety is understood and managed. safety. Senior management should
develop the goals, strategies, plans
and objectives of the organization
in an integrated manner so that
their collective impact on safety
is understood and managed. In
addition, see the notes to aid users
relating to Requirements 2.1 and
2.2 above.
Responsibility and authority for the management system
3.12 Senior management shall be ultimately responsible Top management should retain the
for the management system and shall ensure that it responsibility and authority for the
is established, implemented, assessed and management system.
continually improved.
3.13 An individual reporting directly to senior Top management should assign an

management shall have specific responsibility and individual to report directly to top
authority for: management on the performance of
– Coordinating the development and the whole management system,
implementation of the management system, and including its influence on safety
its assessment and continual improvement; and safety culture.
– Reporting on the performance of the
management system, including its influence on
safety and safety culture, and any need for
improvement;
– Resolving any potential conflicts between
requirements and within the processes of the
management system.
4.1–4.5 Resource management
Provision of resources
4.2 The information and knowledge of the organization The organization should manage
shall be managed as a resource. information and knowledge as a
resource.
27
ISO 9001:2008 (cont.) 

requirements
Human resources
4.4 Senior management shall ensure that individuals See the notes to aid users relating
are competent to perform their assigned work and to Requirement 2.2 above.
that they understand the consequences for safety of
their activities. Individuals shall have received
appropriate education and training, and shall have
acquired suitable skills, knowledge and experience
to ensure their competence. Training shall ensure
that individuals are aware of the relevance and
importance of their activities and of how their
activities contribute to safety in the achievement of
the organization’s objectives.
Infrastructure and the working environment
4.5 Senior management shall determine, provide, See the notes to aid users relating
maintain and re-evaluate the infrastructure and the to Requirement 2.2 above.
working environment necessary for work to be
carried out in a safe manner and for requirements
to be met.
5.1–5.29 Process implementation
Developing processes
5.4 The development of each process shall ensure that All requirements (for product and
the following are achieved: processes) should be identified and
– Process requirements, such as applicable addressed in the management
regulatory, statutory, legal, safety, health, system.
environmental, security, quality and economic
requirements, are specified and addressed. Risk management should be
– Hazards and risks are identified, together with included in the management
any necessary mitigatory actions. system of the organization.
– Interactions with interfacing processes are
identified.
– Process inputs are identified.
– The process flow is described.
– Process outputs (products) are identified.
– Process measurement criteria are established.
28
ISO 9001:2008 (cont.) 

requirements
5.5 The activities of and interfaces between different The organization should apply the
individuals or groups involved in a single process requirement from clause 7.3.1
shall be planned, controlled and managed in a (“The organization shall manage
manner that ensures effective communication and the interfaces between different
the clear assignment of responsibilities. groups involved in design and
development to ensure effective
communication and clear
assignment of responsibility”) to
all processes.
Process management
5.6 For each process a designated individual shall be The organization should explicitly
given the authority and responsibility for: identify a designated individual
– Developing and documenting the process and (the process owner) to be
maintaining the necessary supporting responsible and accountable for
documentation; each process.
– Ensuring that there is effective interaction
between interfacing processes;
– Ensuring that process documentation is
consistent with any existing documents;
– Ensuring that the records required to
demonstrate that the process results have been
achieved are specified in the process
documentation;
– Monitoring and reporting on the performance of
the process;
– Promoting improvement in the process;
– Ensuring that the process, including any
subsequent changes to it, is aligned with the
goals, strategies, plans and objectives of the
organization.
5.10 The control of processes contracted to external The requirements of

organizations shall be identified within the ISO 9001:2008 on outsourcing
management system. The organization shall retain should be extended to all types
overall responsibility when contracting any of contract.
processes.
29
ISO 9001:2008 (cont.) 

requirements
Generic management system processes
5.12 Control of documents

Documents shall be controlled. All individuals When preparing documentation of
involved in preparing, revising, reviewing or the management system,
approving documents shall be specifically assigned consideration should be given to
this work, shall be competent to carry it out and the use of appropriate language and
shall be given access to appropriate information on format, avoidance of jargon, and
which to base their input or decisions. It shall be the provision of clear definitions.
ensured that document users are aware of and use
appropriate and correct documents.
5.14 Control of products

Specifications and requirements for products, The requirements of clause 7.4.1
including any subsequent changes, shall be in of ISO 9001:2008 (purchasing
accordance with established standards and shall process requirements) should be
incorporate applicable requirements. Products that extended in order to cover internal
interface or interact with each other shall be products so that products that
identified and controlled. interface or interact with each other
are identified and controlled.
5.28 Managing organizational change

Organizational changes shall be evaluated and The organization should classify
classified according to their importance to safety and prioritize organizational
and each change shall be justified. changes according to their
importance, especially their impact
on or significance to safety, and
should justify each organizational
change.
5.29 The implementation of such changes shall be Organizational changes, including

planned, controlled, communicated, monitored, changes to the management
tracked and recorded to ensure that safety is not system, should include provision
compromised. for control, communication,
monitoring, tracking and recording
to ensure that safety is not
compromised.
30
ISO 9001:2008 (cont.) 

requirements
6.1–6.18 Measurement, assessment and improvement
Self-assessment
6.2 Senior management and management at all other Self-assessment to evaluate the
levels of the organization shall carry out self- performance of work and the
assessment to evaluate the performance of work improvement of the safety culture
and the improvement of the safety culture. should be included in the
management system.
Independent assessment
6.3 Independent assessments shall be conducted The organization should include

regularly on behalf of senior management: the safety culture and leadership in
– To evaluate the effectiveness of processes in the internal audit programme.
meeting and fulfilling goals, strategies, plans and
objectives;
– To determine the adequacy of work performance
and leadership;
– To evaluate the organization’s safety culture;
– To monitor product quality;
– To identify opportunities for improvement.
6.4 An organizational unit shall be established with the An independent assessment unit
responsibility for conducting independent should be established.
assessments. This unit shall have sufficient
authority to discharge its responsibilities.
Management system review
6.8 The review shall cover but shall not be limited to: Management system reviews
– Outputs from all forms of assessment; should include lessons learned
– Results delivered and objectives achieved by the from other organizations.
organization and its processes;
– Non-conformances and corrective and
preventive actions;
– Lessons learned from other organizations;
– Opportunities for improvement.
31
ISO 9001:2008 (cont.) 

requirements
Non-conformances and corrective and preventive actions
6.12 Products and processes that do not conform to the Non-conformances should be
specified requirements shall be identified, reported to an appropriate level of
segregated, controlled, recorded and reported to an management within the
appropriate level of management within the organization.
organization. The impact of non-conformances
shall be evaluated, and non-conforming products or
processes shall be either:
– Accepted;
– Reworked or corrected within a specified time
period; or
– Rejected and discarded or destroyed to prevent
their inadvertent use.
6.15 The status and effectiveness of all corrective and In addition to reviewing the
preventive actions shall be monitored and reported effectiveness of corrective and
to management at an appropriate level of the preventive actions taken,
organization. monitoring of the status as well as
the effectiveness of corrective and
preventive actions should also be
included in the documented
procedures for corrective and
preventive actions.
6.16 Potential non-conformances that could detract The documented procedure for
from the organization’s performance shall be preventive action should include
identified. This shall be done: by using feedback the identification of potential non-
from other organizations, both internal and conformances through feedback
external; through the use of technical advances and from other organizations, both
research; through the sharing of knowledge and internal and external; through the
experience; and through the use of techniques that use of technical advances and
identify best practices. research; through the sharing of
knowledge and experience; and
through the use of techniques that
identify best practices.
Improvement
6.18 Improvement plans shall include plans for the A requirement to check the
provision of adequate resources. Actions for effectiveness of any improvement
improvement shall be monitored through to their should be included in the
completion and the effectiveness of the management system.
improvement shall be checked.
32
TABLE 2. ISO 9001:2008 REQUIREMENTS NOT CONTAINED IN IAEA
GS-R-3 
(ISO 9001:2008 requirements are reproduced in unedited form;
notes to aid users in meeting the requirements relate to the text in italics.)
Notes to aid users of GS-R-3

Clause ISO 9001:2008 requirements in meeting the ISO 9001:2008
requirements
4.1–4.2 Quality management system
4.2 Documentation requirements
4.2.1 General IAEA GS-R-3 requires a

The quality management system documentation documented management system
shall include: that addresses ‘quality’ or quality
(a) documented statements of a quality policy and principles, but it does not explicitly
quality objectives, mention or use the expression
(b) a quality manual, ‘quality manual’. Producing all the
(c) documented procedures and records required by documentation required under
this International Standard, and IAEA GS-R-3 will normally
(d) documents, including records, determined by address the ISO 9001:2008
the organization to be necessary to ensure the requirement for a quality manual
effective planning, operation and control of its adequately. A quality manual can
processes. be readily prepared from existing
documentation, if explicitly
required.
4.2.2 Quality manual See the notes to aid users in meeting

The organization shall establish and maintain a requirement 4.2.1.
quality manual that includes There is no explicit and specific
(a) the scope of the quality management system, requirement for a quality manual
including details of and justification for any in IAEA GS-R-3. Since quality
exclusions (see 1.2), management is one part of an
(b) the documented procedures established for integrated management system,
the quality management system, or reference fulfilling the management system
to them, and documentation requirements of
(c) a description of the interaction between the IAEA GS-R-3 (e.g. producing a
processes of the quality management system. description of the management
system along with the other
documentation of the management
system stipulated in IAEA GS-R-3)
will normally satisfy the
requirements for a quality manual.
A quality manual can be readily
prepared from existing
documentation, if explicitly
required.
33
GS-R-3 (cont.) 

requirements
4.2.4 Control of records IAEA GS-R-3 does not specify the

Records established to provide evidence of processes that are required to be
conformity to requirements and of the effective documented. It gives the authority
operation of the quality management system shall and responsibility for
be controlled. documentation of processes to
The organization shall establish a documented management.
procedure to define the controls needed for the A procedure describes a specific
identification, storage, protection, retrieval, way to carry out an activity or a
retention and disposition of records. process. IAEA GS-R-3 has a
Records shall remain legible, readily identifiable generic requirement for
and retrievable. documented processes, including
maintaining their related
supporting documentation, which
may include approved current
procedures, instructions, drawings,
records, etc. Furthermore, IAEA
GS-R-3 requires the development,
implementation and management
of processes for control of
documents and records.
Developing such processes for
control of documents and records
will normally ensure that this
requirement of ISO 9001:2008
is met.
5.1–5.4 Management responsibility
5.1 Management commitment
5.1 Top management shall provide evidence of its Customers are included among
commitment in the development and interested parties. Therefore these
implementation of the quality management system requirements are addressed in
and continually improving its effectiveness by: IAEA GS-R-3.
(a) communicating to the organization the
importance of meeting customer as well as
statutory and regulatory requirements,
(b) establishing the quality policy,
(c) ensuring that quality objectives are established,
(d) conducting management reviews, and
(e) ensuring the availability of resources.
34
GS-R-3 (cont.) 

requirements
5.2 Customer focus
5.2 Top management shall ensure that customer Customers are included among
requirements are determined and are met with the interested parties. Therefore these
aims of enhancing customer satisfaction (see 7.2.1 requirements are addressed in
and 8.2.1). IAEA GS-R-3.
5.3 Quality policy
5.3 Top management shall ensure that the quality IAEA GS-R-3 does not specify the
policy: content of policies, but it does
(a) is appropriate to the purpose of the require policy statements of the
organization, organization that address ‘quality’,
(b) includes a commitment to comply with although IAEA GS-R-3 does not
requirements and continually improve the mention or use the term ‘quality
effectiveness of the quality management policy’. 
system, IAEA GS-R-3 makes provision for
(c) provides a framework for establishing and integrating requirements from
reviewing quality objectives, other relevant codes and standards
(d) is communicated, and understood within the adopted for use by an organization.
organization, and The ISO 9001:2008 requirements
(e) is reviewed for continuing suitability. on policy content can be
incorporated into an IAEA GS-R-3
based management system through
this mechanism or provision.
5.4 Planning
5.4.1 Quality objectives IAEA GS-R-3 requires senior

Top management shall ensure that quality management to establish goals,
objectives, including those needed to meet strategies, plans and objectives that
requirements for product [see 7.1a)], are are consistent with the policies of
established at relevant functions and levels within the organization. This includes
the organization. The quality objectives shall be ‘quality’ as well, even though the
measurable and consistent with the quality policy. expression ‘quality objectives’ is
not explicitly mentioned.
35
GS-R-3 (cont.) 

requirements
5.4.2 Quality management system planning See the notes to aid users in meeting
Top management shall ensure that: requirement 5.4.1.
(a) the planning of the quality management system IAEA GS-R-3 does not contain
is carried out in order to meet the requirement direct reference to management
given in 4.1, as well as the quality objectives, system planning including
and maintaining the integrity of the
(b) the integrity of quality management system is management system when changes
maintained when changes to the quality are made to the system.
management system are planned and The requirements in IAEA GS-R-3
implemented. relating to planning should be taken
to include planning of the quality
management system. There is a
requirement on senior management
to review the implementation of
plans and to take corrective or
preventive action as needed.
Processes to manage organizational
change should be taken to include
processes to maintain the integrity
of the management system when
changes to the organization or the
management system are planned
and implemented.
5.5 Responsibility, authority and communication

5.5.2 Management representative The appointed individual (see
Top management shall appoint a member of the para. 3.13 of GS-R-3) should be
organization’s management who, irrespective of a member of the organization’s
other responsibilities, shall have responsibility and management.
authority that includes: Customers are included among
(a) ensuring that processes needed for the quality interested parties. Therefore these
management system are established, requirements are addressed in
implemented and maintained, IAEA GS-R-3.
(b) reporting to top management on the performance
of the quality management system, and any need
for improvement, and
(c) ensuring the promotion of awareness of customer
requirements through the organization.
Note: The responsibility of a management
representative can include liaison with external parties
on matters relating to the quality management system
36
GS-R-3 (cont.) 

requirements
5.5.3 Internal communication IAEA GS-R-3 requires internal
Top management shall ensure that appropriate communication between the
communication processes are established within various levels and functions of the
the organization and that communication takes organization regarding the
place regarding the effectiveness of the quality implementation and effectiveness
management system. of the management system. The
expression ‘effectiveness of the
quality management system’ is not
explicitly mentioned. Thus, there is
no need for a special
recommendation, as this
requirement is implicitly covered
in IAEA GS-R-3.
5.6 Management review
5.6.1 General Although IAEA GS-R-3 does not
Top management shall review the organization’s contain any explicit reference to
quality management system, at planned intervals, such records, they are implicitly
to ensure its continued suitability, adequacy and included, as they would normally
effectiveness. This review shall include assessing be specified in process
opportunities for improvement and the need for documentation for the
changes to the quality management system, management system review
including the quality policy and quality objectives. activity or process. Records from
Records from management review shall be management review should be
maintained (see 4.2.4). maintained.
5.6.2 Review input Customer feedback should
The input to management review shall include be included as an input to
information on management review in
(a) results of audits, IAEA GS-R-3.
(b) customer feedback,
(c) process performance and product conformity,
(d) status of preventive and corrective actions,
(e) follow-up actions from previous management
reviews,
(f) changes that could affect the quality
management system,
(g) recommendations for improvement.
37
GS-R-3 (cont.) 

requirements
5.6.3 Review output Any decisions and actions relating

The output from the management review shall to improvement of products
include any decisions and actions related to relating to customer requirements
(a) improvement of the effectiveness of the quality should be included as an output
management system and its processes, from management review in
(b) improvement of product related to customer IAEA GS-R-3.
requirements,
(c) resource needs.
6.1–6.4 Resource management
6.1 Provision of resources
6.1 The organization shall determine and provide the Customers are included among
resources needed interested parties. Therefore these
(a) to implement and maintain the quality requirements are addressed in
management system and continually improve IAEA GS-R-3.
its effectiveness, and
(b) to enhance customer satisfaction by meeting
customer requirements.
6.2 Human resources
6.2.2 Competence, training and awareness IAEA GS-R-3 does not explicitly
The organization shall mention records of education,
(a) determine the necessary competence for training, skills and experience. It
personnel performing work affecting requires records to be specified in
conformity to product requirements, the process documentation and
(b) where applicable, provide training or take other control of the specified records.
actions to achieve the necessary competence, Records of education, training,
(c) evaluate the effectiveness of the actions taken, skills and experience in their
(d) ensure that its personnel are aware of the respective processes should be
relevance and importance of their activities and maintained.
how they contribute to the achievement of the
quality objectives, and
(e) maintain appropriate records of education,
training, skills and experience (see 4.2.4).
38
GS-R-3 (cont.) 

requirements
6.3 Infrastructure
6.3 The organization shall determine, provide and IAEA GS-R-3 does not explicitly
maintain the infrastructure needed to achieve mention the information given in
conformity to product requirements. Infrastructure ISO 9001:2008 clauses 6.3 (a), (b)
includes, as applicable and (c). The detail provided in
(a) buildings, workspace and associated utilities, ISO 9001:2008 should be
(b) process equipment (both hardware and integrated into an IAEA GS-R-3
software), and based management system,
(c) supporting services (such as transport, together with the recommendations
communication, or information systems). provided in Ref. [2].
7.1–7.6 Product realization
7.1 Planning of product realization
7.1 The organization shall plan and develop the GS-R-3 requires senior
processes needed for product realization. Planning management to establish goals,
of product realization shall be consistent with the strategies, plans and objectives that
requirements of the other processes of the quality are consistent with the policies of
management system (see 4.1). the organization. This includes
In planning product realization, the organization ‘quality’ as well, even if there is no
shall determine the following, as appropriate: explicit mention of the expression
(a) quality objectives and requirements for the ‘quality objectives’ in GS-R-3.
product;
(b) the need to establish processes and documents,
and to provide resources specific to the product;
(c) required verification, validation, monitoring,
measurement, inspection and test activities
specific to the product and the criteria for
product acceptance;
(d) records needed to provide evidence that the
realization processes and resulting product meet
requirements (see 4.2.4).
The output of this planning shall be in a form
suitable for the organization’s method of
operations.
39
GS-R-3 (cont.) 

requirements
7.2 Customer related processes
7.2.1 Determination of requirements related to the Customers are included among

product interested parties. Therefore these
The organization shall determine requirements are addressed in
(a) requirements specified by the customer, IAEA GS-R-3.
including the requirements for delivery and
post-delivery activities,
(b) requirements not stated by the customer but
necessary for specified or intended use, where
known,
(c) statutory and regulatory requirements
applicable to the product, and any additional
requirements considered necessary by the
organization.
7.2.2 Review of requirements related to the product Customers are included among
The organization shall review the requirements interested parties. Where the
related to the product. This review shall be customer provides no documented
conducted prior to the organization’s commitment statement of requirement, the
to supply a product to the customer (e.g. customer requirements should be
submission of tenders, acceptance of contracts confirmed by the organization
or orders, acceptance of changes to contracts or before acceptance.
orders) and shall ensure that
(a) product requirements are defined,
(b) contract or order requirements differing from
those previously expressed are resolved, and
(c) the organization has the ability to meet the
defined requirements.
Records of the results of the review and actions
arising from the review shall be maintained
(see 4.2.4).
Where the customer provides no documented
statement of requirement, the customer
requirements shall be confirmed by the
organization before acceptance.
Where product requirements are changed, the
organization shall ensure that relevant documents
are amended and that relevant personnel are made
aware of the changed requirements
40
GS-R-3 (cont.) 

requirements
7.2.3 Customer communication Customers are included among
The organization shall determine and implement interested parties. Therefore these
effective arrangements for communicating with requirements are addressed in
customers in relation to IAEA GS-R-3.
(a) product information,
(b) enquiries, contracts or order handling, including
amendments, and
(c) customer feedback, including customer
complaints.
7.3 Design and development

7.3.1 Design and development planning IAEA GS-R-3 contains generic
The organization shall plan and control the design requirements for all processes,
and development of product. including design processes. The
During the design and development planning, the organization should determine the
organization shall determine design and development stages.
(a) the design and development stages,
(b) the review, verification and validation that are
appropriate to each design and development
stage, and
(c) the responsibilities and authorities for design
and development.
The organization shall manage the interfaces
between different groups involved in design and
development to ensure effective communication
and clear assignment of responsibility.
Planning output shall be updated, as appropriate, as
the design and development progresses.
7.3.2 Design and development inputs Inputs to design and development
Inputs relating to product requirements shall be should include functional and
determined and records maintained (see 4.2.4). performance requirements where
These inputs shall include applicable, information derived
(a) functional and performance requirements, from previous similar designs, and
(b) applicable statutory and regulatory requirements, other requirements essential for
(c) where applicable, information derived from design and development.
previous similar designs, and
(d) other requirements essential for design and
development.
The inputs shall be reviewed for adequacy.
Requirements shall be complete, unambiguous and
not in conflict with each other.
41
GS-R-3 (cont.) 

requirements
7.3.3 Design and development outputs Outputs of design and development

The outputs of design and development shall be in should provide appropriate
a form suitable for verification against the design information for purchasing,
and development input and shall be approved prior production and service provision.
to release. Design and development outputs shall
(a) meet the input requirements for design and
development,
(b) provide appropriate information for
purchasing, production and service provision,
(c) contain or reference product acceptance criteria,
and
(d) specify the characteristics of the product that
are essential for its safe and proper use.
7.3.4 Design and development review IAEA GS-R-3 contains generic

At suitable stages, systematic reviews of design and requirements for all processes,
development shall be performed in accordance with including design processes. The
planned arrangements (see 7.3.1) requirements are therefore
(a) to evaluate the ability of the results of design addressed.
and development to meet requirements, and
(b) to identify any problems and propose necessary
actions.
Participants in such reviews shall include
representatives of functions concerned with the
design and development stage(s) being reviewed.
Records of the results of the reviews and any
necessary actions shall be maintained (see 4.2.4).
7.3.5 Design and development verification IAEA GS-R-3 contains generic

Verification shall be performed in accordance with requirements for all processes,
planned arrangements (see 7.3.1) to ensure that the including design processes. The
design and development outputs have met the requirements are therefore
design and development input requirements. addressed.
Records of the results of the verification and any
necessary actions shall be maintained (see 4.2.4).
42
GS-R-3 (cont.) 

requirements
7.3.6 Design and development validation IAEA GS-R-3 contains generic

Design and development validation shall be requirements for all processes,
performed in accordance with planned including design processes. The
arrangements (see 7.3.1) to ensure that the resulting requirements are therefore
product is capable of meeting the requirements for addressed.
the specified application or intended use, where
known. Wherever practicable, validation shall be
completed prior to the delivery or implementation
of the product. Records of the results of validation
and any necessary actions shall be maintained
(see 4.2.4).
7.3.7 Control of design and development changes IAEA GS-R-3 contains generic
Design and development changes shall be requirements for all processes,
identified and records maintained. The changes including design processes. The
shall be reviewed, verified and validated, as requirements are therefore
appropriate, and approved before implementation. addressed.
The review of design and development changes
shall include evaluation of the effect of the changes
on constituent parts and product already delivered.
Records of the results of the review of changes and
any necessary actions shall be maintained
(see 4.2.4).
7.4 Purchasing
7.4.1 Purchasing process IAEA GS-R-3 includes

The organization shall ensure that purchased requirements for the control of
product conforms to specified purchase records. It is the responsibility of
requirements. The type and extent of control the process owner to define the
applied to the supplier and the purchased product records required as part of the
shall be dependent upon the effect of the purchased process documentation (see para.
product on subsequent product realization or the 5.6 of IAEA GS-R-3). The process
final product. should include records of the
The organization shall evaluate and select suppliers results of evaluations of suppliers
based on their ability to supply product in and any necessary actions arising
accordance with the organization’s requirements. from the evaluation.
Criteria for selection, evaluation and re-evaluation
shall be established. Records of the results of
evaluations and any necessary actions arising from
the evaluation shall be maintained (see 4.2.4).
43
GS-R-3 (cont.) 

requirements
7.4.2 Purchasing information IAEA GS-R-3 does not specifically
Purchasing information shall describe the product address purchasing information;
to be purchased, including where appropriate rather, it uses the expression
(a) requirements for approval of product, ‘procurement documents’ and
procedures, processes and equipment, requires purchasing requirements
(b) requirements for qualification of personnel, and to be developed and specified in
(c) quality management system requirements. the procurement documents.
The organization shall ensure the adequacy of
specified purchase requirements prior to their
communication to the supplier.
7.4.3 Verification of purchased product IAEA GS-R-3 does not specifically
The organization shall establish and implement the require that intended verification
inspection or other activities necessary for ensuring arrangements and the method of
that purchased product meets specified purchase product release be addressed in the
requirements. procurement documents.
Where the organization or its customer intends to Verification of products, including
perform verification at the supplier’s premises, the purchased products, is covered in
organization shall state the intended verification para. 5.15 of IAEA GS-R-3.
arrangements and method of product release in the
purchasing information.
7.5 Production and service provision
7.5.2 Validation of processes for production and service IAEA GS-R-3 provides
provision requirements on validation but
The organization shall validate any processes for does not provide details of the
production and service provision where the validation process. Validation of
resulting output cannot be verified by subsequent processes is covered in paras 5.3
monitoring or measurement and, as a consequence, and 5.8 of IAEA GS-R-3.
deficiencies become apparent only after the product
is in use or the service has been delivered.
Validation shall demonstrate the ability of these
processes to achieve planned results.
The organization shall establish arrangements for
these processes including, as applicable
(a) defined criteria for review and approval of the
processes,
(b) approval of equipment and qualification of
personnel,
(c) use of specific methods and procedures,
(d) requirements for records (see 4.2.4), and
(e) revalidation.
44
GS-R-3 (cont.) 

requirements
7.5.4 Customer property This requirement should be

The organization shall exercise care with customer integrated into a management
property while it is under the organization’s control system based on IAEA GS-R-3;
or being used by the organization. The organization this could be done in the section
shall identify, verify, protect and safeguard dealing with requirements for
customer property provided for use or processes regarding the control of
incorporation into the product. If any customer products.
property is lost, damaged or otherwise found to be
unsuitable for use, the organization shall report this
to the customer and maintain records (see 4.2.4).
7.6 Control of monitoring and measurement equipment
7.6 The organization shall determine the monitoring IAEA GS-R-3 requires the tools
and measurement to be undertaken and the and equipment used for these
monitoring and measuring equipment needed to activities to be of the proper range,
provide evidence of conformity of product to type, accuracy and precision, but
determined requirements. does not provide details relating to
The organization shall establish processes to ‘control of monitoring and
ensure that monitoring and measurement can be measurement devices’.
carried out and are carried out in a manner that is The ISO 9001:2008 requirements
consistent with the monitoring and measurement in this area should be integrated
requirements. into a management system based
Where necessary to ensure valid results, measuring on IAEA GS-R-3, with the
equipment shall appropriate adaptation or changes
(a) be calibrated or verified, or both, at specified to the ISO 9001:2008 terminology
intervals, or prior to use, against measurement to harmonize it with IAEA GS-R-3
standards traceable to international or national language.
measurement standards; where no such
standards exist, the basis used for calibration or
verification shall be recorded (see 4.2.4);
(b) be adjusted or re-adjusted as necessary;
(c) have identification in order to determine its
calibration status;
(d) be safeguarded from adjustments that would
invalidate the measurement result;
(e) be protected from damage and deterioration
during handling, maintenance and storage.
45
GS-R-3 (cont.) 

requirements
7.6 In addition, the organization shall assess and

(cont.) record the validity of the previous measuring
results when the equipment is found not to conform
to requirements. The organization shall take
appropriate action on the equipment and any
product affected.
Records of the results of calibration and
verification shall be maintained (see 4.2.4).
When used in the monitoring and measurement of
specified requirements, the ability of computer
software to satisfy the intended application shall be
confirmed. This shall be undertaken prior to initial
use and reconfirmed as necessary.
8.1–8.5 Measurement, analysis and improvement
8.2 Monitoring and measurement
8.2.1 Customer satisfaction Customers are included among

As one of the measurements of the performance of interested parties. Therefore these
the quality management system, the organizations requirements are addressed in
shall monitor information relating to customer IAEA GS-R-3.
perception as to whether the organization has met
customer requirements. The methods for obtaining
and using this information shall be determined.
8.2.2 Internal audit IAEA GS-R-3 assessments include

The organization shall conduct internal audits at audits. The management system
planned intervals to determine whether the quality should include an audit programme
management system as part of independent assessment.
(a) conforms to the planned arrangements (see 7.1),
to the requirements of this International Standard IAEA GS-R-3 focuses on
and to the quality management system processes, but it does not specify
requirements established by the organization, and the processes to be documented. It
(b) is effectively implemented and maintained. gives the authority and
An audit programme shall be planned, taking into responsibility for documenting
consideration the status and importance of the processes to management.
processes and areas to be audited, as well as the
results of previous audits. The audit criteria, scope,
frequency and methods shall be defined. The
selection of auditors and conduct of audits shall
ensure objectivity and impartiality of the audit
process. Auditors shall not audit their own work.
46
GS-R-3 (cont.) 

requirements
8.2.2 A documented procedure shall be established to There should be a documented

define the responsibilities and requirements for procedure that defines the
planning and conducting audits, establishing responsibilities and requirements
records and reporting results. for planning and conducting audits,
Records of the audits and their results shall be establishing records and reporting
maintained (see 4.2.4). results.
The management responsible for the area being
audited shall ensure that any necessary corrections
and corrective actions are taken without undue
delay to eliminate detected nonconformities and
their causes. Follow-up activities shall include the
verification of the actions taken and the reporting of
verification results (see 8.5.2).
8.2.4 Monitoring and measurement of product IAEA GS-R-3 does not have
The organization shall monitor and measure the explicit requirements for the
characteristics of the product to verify that product maintenance of evidence of
requirements have been met. This shall be carried conformity, nor does it require the
out at appropriate stages of the product realization explicit recording of the identity of
process in accordance with the planned the person(s) authorizing the
arrangements (see 7.1). Evidence of conformity release of product for delivery to
with the acceptance criteria shall be maintained. the customer.
Records shall indicate the person(s) authorizing
release of product for delivery to the customer However, there are IAEA GS-R-3
(see 4.2.4). requirements relating to non-
The release of product and delivery of service to the conformances and corrective and
customer shall not proceed until the planned preventive actions that address
arrangements (see 7.1) have been satisfactorily products and processes not
completed, unless otherwise approved by a relevant conforming to specified
authority and, where applicable, by the customer. requirements. Evidence of
conformity with the acceptance
criteria should be maintained.
Records should indicate the
person(s) authorizing release of
product for delivery to the
customer.
47
GS-R-3 (cont.) 

requirements
8.3 Control of nonconforming product
8.3 The organization shall ensure that product which IAEA GS-R-3 does not specify the
does not conform to product requirements is processes that are required to be
identified and controlled to prevent its unintended documented, because it is up to
use or delivery. A documented procedure shall be each organization to determine the
established to define the controls and related processes that are needed to
responsibilities and authorities for dealing with achieve organizational goals, to
nonconforming product. provide the means to meet all
Where applicable, the organization shall deal with requirements and to deliver the
nonconforming product by one or more of the products of the organization.
following ways: Control of non-conformities
(a) by taking action to eliminate the detected should be defined in a documented
nonconformity; procedure.
(b) by authorizing its use, release or acceptance
under concession by a relevant authority and,
where applicable, by the customer;
(c) by taking action to preclude its original
intended use or application;
(d) by taking action appropriate to the effects, or
potential effects, of the nonconformity when
nonconforming product is detected after
delivery or use has started.
When nonconforming product is corrected it shall
be subject to re-verification to demonstrate
conformity to the requirements.
Records of the nature of nonconformities and any
subsequent actions taken, including concessions
obtained, shall be maintained (see 4.2.4).
8.4 Analysis of data
8.4 The organization shall determine, collect and IAEA GS-R-3 does not have
analyse appropriate data to demonstrate the specific requirements on collection
suitability and effectiveness of the quality and analysis of data to monitor the
management system and to evaluate where effectiveness of the management
continual improvement of the effectiveness of the system.
quality management system can be made. This shall
include data generated as a result of monitoring
and measurement and from other relevant sources.
48
GS-R-3 (cont.) 

requirements
8.4 The analysis of data shall provide information Paragraph 6.1 of IAEA GS-R-3 does
relating to: in general terms require that the
(a) customer satisfaction (see 8.2.1), effectiveness of the management
(b) conformity to product requirements (see 8.2.4), system be monitored and measured.
(c) characteristics and trends of processes and The detailed or specific
products including opportunities for preventive ISO 9001:2008 requirements should
action (see 8.2.3 and 8.2.4), and be integrated into a management
(d) suppliers (see 7.4). system based on IAEA GS-R-3,
as necessary.
8.5 Improvement
8.5.2 Corrective action Arrangements for corrective action

The organization shall take action to eliminate the should be documented.
causes of nonconformities in order to prevent
recurrence. Corrective actions shall be appropriate
to the effects of the nonconformities encountered.
A documented procedure shall be established to
define requirements for
(a) reviewing nonconformities (including customer
complaints),
(b) determining the causes of nonconformities,
(c) evaluating the need for action to ensure that
nonconformities do not recur,
(d) determining and implementing action needed,
(e) records of the results of action taken (see 4.2.4),
and
(f) reviewing the effectiveness of the corrective
action taken.
49
GS-R-3 (cont.) 

requirements
8.5.3 Preventive action Arrangements for preventive

The organization shall take action to eliminate the action should be documented.
cause of nonconformities in order to prevent their
occurrence. Preventive actions shall be appropriate
to the effects of the potential problems.
A documented procedure shall be established to
define requirements for
(a) determining potential nonconformities and their
causes,
(b) evaluating the need for action to prevent
occurrences of nonconformities,
(c) determining and implementing action needed,
(d) records of results of action taken (see 4.2.4),
and
(e) reviewing the effectiveness of the preventive
action taken.
50
IAEA GS-R-3
6. Measurement,
4. Resource 3. Management 2. Management
Assessment and 5. Process Implementation
Management Responsibility System
Improvement
Safety culture (2.5)
Planning (3.8–3.11)
Self-assessment (6.2)
Purchasing (5.23-5.25)
Improvement (6.17–6.18)
Communication (5.26-5.27)
Human resources (4.3–4.4)
Organizational policies (3.7)
Control of records (5.21-5.22)

Control of products (5.14-5.20)
General requirements (2.1–2.4)
Developing processes (5.1–5.5)

Provision of resources (4.1–4.2)
Process management (5.6–5.10)
Control of documents (5.12-5.13)
Monitoring and measurement (6.1)

X = Correlation
Independent assessment (6.3–6.6)

Management commitment (3.1–3.5)
2. Management System (title only)
Satisfaction of interested parties (3.6)
4. Resource Management (title only)

Grey = No correlation
Management system review (6.7–6.10)

Blank = No correlation
5. Process Implementation (title only)

(X) = Weak correlation
3. Management Responsibility (title only)
Managing organizational change (5.28-5.29)

Infrastructure and the working environment (4.5)
Documentation of the management system (2.8–2.10)
Grading the application of management system (2.6–2.7)
6. Measurement, Assessment and Improvement (title only)

Generic Management System Processes (5.11–5.29) (title only)
Responsibility and authority for the management system (3.12–3.14)
Non-conformances and corrective and preventive actions (6.11–6.16)

X
X
X
X
4.1 General requirements
4.2 Documentation requirements (title only)
4.2.1 General
(X)
4.2.2 Quality manual

(X)
X
4.2.3 Control of documents
4 Quality Management System
X
4.2.4 Control of records
X
X
X
5.1 Management commitment
5.2 Customer focus

(X)
X
5.3 Quality policy
51
5.4 Planning (title only)
X
5.4.1 Quality objectives
X
X
5.4.2 Quality management system planning
5.5 Responsibility, authority and

communication (title only)
X
X
X
X
X
X
X
5.5.1 Responsibility and authority

X
5.5.2 Management representative

5 Management Responsibility
X
X
X
X
X
5.5.3 Internal communication
5.6 Management review (title only)
X
X
X
5.6.1 General
X
5.6.2 Review input
X
5.6.3 Review output
X
X
6.1 Provision of resources
6.2 Human resources (title only)

X
6.2.1 General
APPENDIX: CORRELATION BETWEEN THE REQUIREMENTS OF IAEA GS-R-3 AND THOSE OF ISO 9001:2008
6.2.2 Competence, training and awareness

X
6.3 Infrastructure
6 Resource Management
6.4 Work environment

X
X
7.1 Planning of product realization
7.2 Customer related processes (title only)
7.2.1 Determination of requirements related to

X
X
X
the product
7.2.2 Review of requirements related to
X
the product
X
7.2.3 Customer communication
7.3 Design and development (title only)

ISO 9001:2008
7.3.1 Design and development planning

(X)
7.3.2 Design and development inputs

(X)
7.3.3 Design and development outputs

(X)
7.3.4 Design and development review

(X)
7.3.5 Design and development verification

(X)
7.3.6 Design and development validation

(X)
7.3.7 Control of design and

(X)
development changes
7.4 Purchasing (title only)

7 Product Realization
7.4.1 Purchasing process

(X)
X
X
7.4.2 Purchasing information

X
7.4.3 Verification of purchased product
7.5 Production and service provision (title only)
7.5.1 Control of production and

X
X
service provision
7.5.2 Validation of processes for production
X
X
and service provision

X
7.5.3 Identification and traceability
7.5.4 Customer property

X
7.5.5 Preservation of product
7.6 Control of monitoring and

X
X
measuring equipment
X
X
X
8.1 General
8.2 Monitoring and measurement (title only)
8.2.1 Customer satisfaction

(X)
(X)
(X)
X
X
X
X
8.2.2 Internal audit

(X)
8.2.3 Monitoring and measurement of

X
X
X
X
processes
X
X
X
8.2.4 Monitoring and measurement of product

X
X
8.3 Control of nonconforming product

X
X
X
8.4 Analysis of data
8.5 Improvement (title only)

X
X
X
X
X
8 Measurement, analysis and improvement
8.5.1 Continual improvement

(X)
8.5.2 Corrective action

X
8.5.3 Preventive action

.
REFERENCES
[1] INTERNATIONAL ATOMIC ENERGY AGENCY, The Management System for
Facilities and Activities, IAEA Safety Standards Series No. GS-R-3, IAEA, Vienna (2006).
[2] INTERNATIONAL ATOMIC ENERGY AGENCY, Application of the Management
System for Facilities and Activities, IAEA Safety Standards Series No. GS-G-3.1,
IAEA, Vienna (2006).
[3] INTERNATIONAL ATOMIC ENERGY AGENCY, The Management System for
Nuclear Installations, IAEA Safety Standards Series No. GS-G-3.5, IAEA, Vienna (2009).
[4] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Quality
Management Systems — Requirements, ISO 9001:2008, ISO, Geneva (2008).
[5] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Environmental
Management Systems — Requirements with Guidance for Use, ISO 14001:2004, ISO,
Geneva (2004).
[6] BRITISH STANDARDS INSTITUTION, Occupational Health and Safety Management
Systems: Requirements, OHSAS 18001:2007, BSI, London (2007).
[7] INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Assurance for Safety in
Nuclear Power Plants and other Nuclear Installations: Code and Safety Guides Q1–Q14,
Safety Series No. 50-C/SG-Q, IAEA, Vienna (1996).
[8] INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Assurance Standards:
Comparison between IAEA 50-C/SG-Q and ISO 9001:1994, IAEA-TECDOC-1182,
IAEA, Vienna (2000).
[9] INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Standards: Comparison
between IAEA 50-C/SG-Q and ISO 9001:2000, Safety Reports Series No. 22, IAEA,
Vienna (2002).
[10] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Quality
Management Systems — Fundamentals and Vocabulary, ISO 9000:2005, ISO, Geneva
(2005).
[11] INTERNATIONAL ATOMIC ENERGY AGENCY, IAEA Safety Glossary:
Terminology Used in Nuclear Safety and Radiation Protection, 2007 Edition, IAEA,
Vienna (2007).
[12] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Managing for the
Sustained Success of an Organization — A Quality Management Approach, ISO
9004:2009, ISO, Geneva (2009).
53
CONTRIBUTORS TO DRAFTING AND REVIEW
Beher, M. AREVA NP GmbH, Germany
Boogaard, J.P. International Atomic Energy Agency
Clark, C.R. International Atomic Energy Agency
Cohn, Y. Forsmark Kraftgrupp Vattenfall, Sweden
Dahlgren Persson, K. International Atomic Energy Agency
Florescu, N. Societatea Nationala ‘Nuclearelectrica’ SA, Romania
Hille, M. AREVA NP GmbH, Germany
Kerhoas, A. International Atomic Energy Agency
Majola, J. Gennessys Corporation, Canada
McCabe, E. International Atomic Energy Agency
Perez Alonso, O. Tecnatom, S.A., Spain
Vanbrabant, R. BELGOPROCESS, Belgium
Viktorsson, C. International Atomic Energy Agency
Vincze, P. International Atomic Energy Agency
Watson, A.G. Magnox Electric, United Kingdom
Consultants Meetings
Vienna, Austria: 11–12 February 2007, 10–12 July 2007
55
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11-39201
R E L AT ED PUBL ICAT IONS
MANAGEMENT SYSTEM STANDARDS: COMPARISON BETWEEN

IAEA GS-R-3 AND ASME NQA-1-2008 AND NQA-1A-2009 ADDENDA
Safety Reports Series No. 70
STI/PUB/1530 (61 pp.; 2012)
ISBN 978-92-0-120810-1 Price: €29.00
THE MANAGEMENT SYSTEM FOR FACILITIES AND ACTIVITIES
IAEA Safety Standards Series No. GS-R-3
STI/PUB/1252 (39 pp.; 2006)
ISBN 92–0–106506–X Price: €25.00
APPLICATION OF THE MANAGEMENT SYSTEM FOR FACILITIES
AND ACTIVITIES
IAEA Safety Standards Series No. GS-G-3.1
STI/PUB/1253 (123 pp; 2006)
ISBN 92-0-106606-6 Price: €31.00
THE MANAGEMENT SYSTEM FOR NUCLEAR INSTALLATIONS
IAEA SAFETY STANDARDS SERIES NO. GS-G-3.5
STI/PUB/1392 (139 pp; 2009)
ISBN 978-92-0-103409-0 Price: €35.00
MANAGEMENT OF CONTINUAL IMPROVEMENT FOR FACILITIES
AND ACTIVITIES: A STRUCTURED APPROACH
IAEA TECDOC Series No. 1491
IAEA-TECDOC-1491 (61 pp; 2006)
ISBN 92-0-102906-3 Price: €15.00
KEY PRACTICAL ISSUES IN STRENGTHENING SAFETY CULTURE
INSAG Series No. 15
STI/PUB/1137 (25 pp; 2002)
ISBN 92–0–112202–0 Price: €12.50
THE MANAGEMENT SYSTEM FOR TECHNICAL SERVICES
IN RADIATION SAFETY
STI/PUB/1319 (51 pp; 2008)
ISBN 978-92-0-100308-9 Price: €25.00
THE MANAGEMENT SYSTEM FOR THE PROCESSING, HANDLING
AND STORAGE OF RADIOACTIVE WASTE
STI/PUB/1329 (69 pp; 2006)
ISBN 978-92-0-102008-6 Price: €25.00
www.iaea.org/books
This Safety Report compares the requirements
o f I A E A S af ety S tan dar ds S er ie s No. GS-R -3, The
M a n a gem en t S ys tem f or Facilit i es and Acti v i ti es,
a n d I S O 9 0 0 1 : 2 0 0 8 , Q u ality Management Sy stems
— R e qu ir em en ts , an d iden tif ie s the mai n di ffer-
ences between the two standards. It provides
in f o rm ation an d g u idan ce on addi ng safety spe-
c i f ic m an ag em en t s ys tem r equ irements to the ISO
9 0 0 1 : 2 0 0 8 s tan dar d, to en s u r e that safety can be
a c h ie ved. T h e pu blication is in tended pri mari l y for
u s e b y own er s , oper ator s an d empl oy ees of nucl ear
facilities and installations, and by regulatory
b o d ie s, s u pplier s , an d r es ear c h and de v el opment
o r g a n i zation s .
INTERNATIONAL ATOMIC ENERGY AGENCY

VIENNA
ISBN 978–92–0–120710–4
ISSN 1020–6450

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Safety Reports Series

IAEA SAFETY STANDARDS

AFGHANISTAN GHANA NIGERIA

INTERNATIONAL ATOMIC ENERGY AGENCY

Marketing and Sales Unit, Publishing Section

IAEA Library Cataloguing in Publication Data

1. Nuclear power plants — Safety measures. — 2. Nuclear facilities —

IAEA safety standards reflect an international consensus on what

2. APPLICATION OF IAEA GS-R-3 AND ISO 9001:2008

3. MAJOR DIFFERENCES AND CORRELATIONS . . . . . . . . . . . . . . 6

3.1. General approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4. NOTES TO AID USERS IN MEETING ADDITIONAL

APPENDIX: CORRELATION BETWEEN THE REQUIREMENTS 

The IAEA Safety Requirements publication on The Management System

The objective of this Safety Report is to compare the requirements of

This report compares the requirements in the following publications:

The recommendations provided in Ref. [2] and the fundamentals and

2. APPLICATION OF IAEA GS-R-3

Figure 1 illustrates the use of IAEA GS-R-3 and ISO 9001:2008

Legal and statutory

REGULATORY BODY SUPPLIER

This section provides a summary comparing and contrasting the approaches

3.1. GENERAL APPROACH

IAEA GS-R-3 presents the requirements for organizations to establish,

3.1.2. Management principles

IAEA GS-R-3 is also based on the principle of an integrated management

3.1.3. Focus and structure

Figure 2 illustrates the differences of focus and the similarities of structure

IAEA GS-R-3 is a safety standard, whereas ISO 9001:2008 is not. IAEA

Management Responsibility Management Responsibility

Resource Management Resource Management

Provision of Resources Provision of Resources

Process Implementation Product Realization

Measurement, Assessment Measurement, Analysis

Monitoring & Measurement General

ISO 9001:2008 is a general quality management system standard applicable

There are similarities in structure between IAEA GS-R-3 and ISO

— Management system versus quality management system;

3.2. MANAGEMENT SYSTEM

3.2.1. General requirements

3.2.1.1. Level of detail of requirements

There are differences in the level of detail in topics common to both

3.2.1.2. Integration of requirements from other standards

IAEA GS-R-3 requires an integrated management system. It makes specific

3.2.3. Grading the application of management system requirements

IAEA GS-R-3 states that the application of management system

3.2.3.1. Exclusion of requirements

3.2.4. Documentation of the system

IAEA GS-R-3 does not specify the processes to be documented, but

— The policy statements of the organization.

Also, IAEA GS-R-3 requires the documentation of the management system

— Documented statements of a quality policy and quality objectives.

3.3.1. Management commitment

IAEA GS-R-3 places requirements on all levels of management, while ISO

— Developing individual values, institutional values and behavioural

Senior management has the responsibility of carrying out self-assessment

IAEA GS-R-3 requires senior management to consider the expectations and

3.4. RESOURCE MANAGEMENT

3.4.1. Provision of resources

IAEA GS-R-3 places the responsibility specifically on senior management