Safety Reports Series No · quality standards: comparison between iaea 50-c/sg-q and iso 9001:2000...

S a f e t y R e p o r t s S e r i e sNo. 22

Q u a l i t y S t a n d a r d s :C o m p a r i s o n b e t w e e nI A E A 5 0 - C / S G - Q a n d

I S O 9 0 0 1 : 2 0 0 0

I n te rnat iona l A tomic Energ y A genc y, V ienna, 2002

QUALITY STANDARDS: COMPARISONBETWEEN IAEA 50-C/SG-Q

AND ISO 9001:2000

The following States are Members of the International Atomic Energy Agency:

AFGHANISTANALBANIAALGERIAANGOLAARGENTINAARMENIAAUSTRALIAAUSTRIAAZERBAIJANBANGLADESHBELARUSBELGIUMBENINBOLIVIABOSNIA AND HERZEGOVINABRAZILBULGARIABURKINA FASOCAMBODIACAMEROONCANADACENTRAL AFRICAN

REPUBLICCHILECHINACOLOMBIACOSTA RICACÔTE D’IVOIRECROATIACUBACYPRUSCZECH REPUBLICDEMOCRATIC REPUBLIC

OF THE CONGODENMARKDOMINICAN REPUBLICECUADOREGYPTEL SALVADORESTONIAETHIOPIAFINLANDFRANCEGABONGEORGIAGERMANYGHANA

GREECEGUATEMALAHAITIHOLY SEEHUNGARYICELANDINDIAINDONESIAIRAN, ISLAMIC REPUBLIC OF IRAQIRELANDISRAELITALYJAMAICAJAPANJORDANKAZAKHSTANKENYAKOREA, REPUBLIC OFKUWAITLATVIALEBANONLIBERIALIBYAN ARAB JAMAHIRIYALIECHTENSTEINLITHUANIALUXEMBOURGMADAGASCARMALAYSIAMALIMALTAMARSHALL ISLANDSMAURITIUSMEXICOMONACOMONGOLIAMOROCCOMYANMARNAMIBIANETHERLANDSNEW ZEALANDNICARAGUANIGERNIGERIANORWAYPAKISTANPANAMA

PARAGUAYPERUPHILIPPINESPOLANDPORTUGALQATARREPUBLIC OF MOLDOVAROMANIARUSSIAN FEDERATIONSAUDI ARABIASENEGALSIERRA LEONESINGAPORESLOVAKIASLOVENIASOUTH AFRICASPAINSRI LANKASUDANSWEDENSWITZERLANDSYRIAN ARAB REPUBLICTAJIKISTANTHAILANDTHE FORMER YUGOSLAV

REPUBLIC OF MACEDONIATUNISIATURKEYUGANDAUKRAINEUNITED ARAB EMIRATESUNITED KINGDOM OF

GREAT BRITAIN AND NORTHERN IRELAND

UNITED REPUBLICOF TANZANIA

UNITED STATES OF AMERICAURUGUAYUZBEKISTANVENEZUELAVIET NAMYEMENYUGOSLAVIA,

FEDERAL REPUBLIC OFZAMBIAZIMBABWE

The Agency’s Statute was approved on 23 October 1956 by the Conference on the Statute of theIAEA held at United Nations Headquarters, New York; it entered into force on 29 July 1957. TheHeadquarters of the Agency are situated in Vienna. Its principal objective is “to accelerate and enlarge thecontribution of atomic energy to peace, health and prosperity throughout the world’’.

© IAEA, 2002

Permission to reproduce or translate the information contained in this publication may beobtained by writing to the International Atomic Energy Agency, Wagramer Strasse 5, P.O. Box 100,A-1400 Vienna, Austria.

Printed by the IAEA in AustriaMarch 2002

STI/PUB/1127

QUALITY STANDARDS: COMPARISONBETWEEN IAEA 50-C/SG-Q

AND ISO 9001:2000

SAFETY REPORTS SERIES No. 22

INTERNATIONAL ATOMIC ENERGY AGENCYVIENNA, 2002

VIC Library Cataloguing in Publication Data

Quality standards : comparison between IAEA 50-C/SG-Q and ISO 9001:2000.— Vienna : International Atomic Energy Agency, 2002.

p. ; 24 cm. — (Safety reports series, ISSN 1020–6450 ; no. 22)STI/PUB/1127ISBN 92–0–111102–9Includes bibliographical references.

1. Nuclear reactors — Safety measures. 2. Quality control — Standards.3. Quality assurance — Standards. I. International Atomic Energy Agency.II. Series.

VICL 02–00281

FOREWORD

The International Atomic Energy Agency (IAEA) has the statutory mandate toseek to accelerate and enlarge the contribution of atomic energy to peace, health andprosperity throughout the world. As part of the activities to achieve its objectives, theIAEA is authorized to establish standards of safety for the protection of health and theminimization of danger to life and property. The standards of safety developed by theIAEA are recommendations for use by its Member States in the framework ofnational regulations for the safe utilization of nuclear energy. Such standards shouldbe considered as nuclear safety regulatory documents. The standards developed bythe International Organization for Standardization (ISO) are complementary technicaldocuments emphasizing industrial application and contractual aspects. Regarding thequality assurance topic, the IAEA developed the publication Safety Series No. 50-C/SG-Q, Quality Assurance for Safety in Nuclear Power Plants and otherNuclear Installations, which is mostly used directly or indirectly to establish thenuclear safety requirements at the nuclear utility–regulator interface. TheISO 9001:2000 standard, Quality Management Systems — Requirements, is oftenused to define the quality management system requirements at the utility–supplierinterface.

The relationship between the IAEA and ISO quality standards is growing insignificance owing to their increasing impact upon utilities (owners/operators ofnuclear facilities) and their contractors/suppliers. The relationship between the IAEA and ISO standards is considered critical in particular with respect to contractors/suppliers with a small range of nuclear supplies. These contractors/suppliers are not always willing to prepare special quality assurance programmesbased on nuclear safety standards. On the other hand, these contractors/suppliers maybe qualified on the basis of the ISO quality standard. In any case, for deliveringnuclear items and services the contractors/suppliers’ quality assurance programmemust comply with the nuclear safety requirements. The utility/owner/operator has theultimate responsibility to ensure that an acceptable degree of quality assurance inrelation to nuclear safety has been achieved. This can be done by imposing additionalrequirements on the contractors/suppliers over and above those contained within theISO 9001:2000 standard.

In order to provide a description of the differences between the IAEA and ISOquality standards when applied in nuclear installations, and to support practicalmeasures for achieving nuclear safety, the IAEA established a project for producinga guidance report. A first effort to compare the IAEA and ISO quality standards wasconducted during the years 1999 and 2000. The comparison was made using the 1994edition of the ISO:9001 standard despite the fact that the ISO 9000:2000 series ofstandards was in its final phase of discussion and approval. This effort was considered

to be worth while and remains valid since the two versions will co-exist during theperiod from 15 December 2000 to 15 December 2003, during which ISO users willhave to upgrade their quality management systems to meet the requirements of ISO9001:2000. The result of the first comparison was published in IAEA-TECDOC-1182, Quality Assurance Standards: Comparison between IAEA 50-C/SG-Q and ISO9001:1994.

After the publication of ISO 9001:2000 a new effort was initiated in 2001 toupdate the comparison mentioned above. The result is presented in this publication,which provides information and guidance that may be considered when ISO9001:2000 and also ISO 9004:2000 are utilized by the nuclear industry.

In thanking the contributors to this Safety Report, who are listed at the end ofthis publication, the IAEA wishes to especially acknowledge the efforts and valuableassistance of the FORATOM Quality Management Working Group. The ScientificSecretary responsible for the preparation of this publication was C.R. Clark of theDivision of Nuclear Power.

CONTENTS

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.1. Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.2. Objective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.3. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.4. Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

2. STANDARDS USED IN THE COMPARISON . . . . . . . . . . . . . . . . . . . . 2

2.1. IAEA 50-C/SG-Q Code and Safety Guides on quality assurance . . . 22.1.1. IAEA Code 50-C-Q . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22.1.2. IAEA Safety Guides 50-SG-Q1 to Q14 . . . . . . . . . . . . . . . . . 3

2.1.2.1. Basic requirement related Safety Guides . . . . . . . . . 32.1.2.2. Stage related Safety Guides . . . . . . . . . . . . . . . . . . . 4

2.2. ISO 9000:2000 standards on quality management systems . . . . . . . 4

3. APPLICATION OF IAEA 50-C-Q AND ISO 9001:2000 STANDARDS . . 5

4. MAJOR DIFFERENCES AND CORRELATIONS . . . . . . . . . . . . . . . . . . 6

4.1. Structure and focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64.2. Major changes in ISO 9001:2000 with respect to ISO 9001:1994 . . . 64.3. Correlation between the basic requirements of the IAEA Code

50-C-Q and IAEA Safety Guides 50-SG-Q1 to Q14 . . . . . . . . . . . . . 94.4. Correlation between the basic requirements of the IAEA Code

50-C-Q and the requirements of ISO 9001:2000 . . . . . . . . . . . . . . . . 94.4.1. Underlying approaches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104.4.2. Additional conceptual requirements of the

IAEA Code 50-C-Q . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104.4.2.1. Grading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104.4.2.2. Independence of inspection and testing personnel . . 11

5. GUIDANCE FOR THE USE OF ISO 9001:2000 . . . . . . . . . . . . . . . . . . . 11

5.1. IAEA 50-C-Q requirements not contained in ISO 9001:2000 . . . . . . 125.2. Additional guidance in IAEA Safety Guides 50-C-SG1 to SG14

not covered in ISO 9001:2000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145.3. ISO 9001:2000 clauses with no corresponding requirements and

guidance in the IAEA documents . . . . . . . . . . . . . . . . . . . . . . . . . . 33

APPENDIX I: COVERAGE OF IAEA CODE 50-C-Q BASIC REQUIREMENTS IN IAEA SAFETY GUIDES 50-SG-Q1 TO Q14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

APPENDIX II: CORRELATION BETWEEN THE BASIC REQUIREMENTS OF IAEA CODE 50-C-Q AND THE REQUIREMENTS IN ISO 9001:2000 . . . . . . . . . . . . . . . . . . . 40

APPENDIX III: CORRELATION BETWEEN IAEA SAFETY GUIDES 50-SG-Q1 TO Q14 AND THE REQUIREMENTS IN ISO 9001:2000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47CONTRIBUTORS TO DRAFTING AND REVIEW . . . . . . . . . . . . . . . . . . . . . 48

1. INTRODUCTION

1.1. BACKGROUND

The International Atomic Energy Agency (IAEA) Code and Safety Guidescontained in Safety Series No. 50-C/SG-Q [1] define basic quality assurancerequirements (in the Code) which must be considered to ensure safety, and providerecommendations (in the Safety Guides) on how to fulfil these basic requirements.The IAEA 50-C/SG-Q Code and Safety Guides reflect a performance based approachto quality assurance covering all aspects of plant safety, economics and efficiency.The IAEA requirements and recommendations are generally used at the nuclearutility–regulator interface.

The International Organization for Standardization (ISO) International Stan-dard ISO 9001:2000 [2] specifies quality management system requirements where asupplier needs to:

(a) Demonstrate its ability to consistently provide a product that meets customerand applicable regulatory requirements;

(b) Enhance customer satisfaction through the effective application of the system,including processes for continual improvement of the system and the assuranceof conformity to customer and applicable regulatory requirements.

The ISO 9001:2000 standard is sometimes used at the nuclear utility–supplierinterface. The earlier version, ISO 9001:1994, was used in a previous comparisonwith IAEA 50-C/SG-Q, and the results were issued as IAEA-TECDOC-1182 [3].

1.2. OBJECTIVE

The objective of this Safety Report is to compare the requirements of IAEA 50-C/SG-Q with ISO 9001:2000 in order to identify the main differences between theISO quality standards and the additional requirements and guidance contained with-in the IAEA standard. This report also provides information and guidance that maybe considered when ISO 9001:2000 and ISO 9004:2000 [4] are utilized by the nuclearindustry.

1.3. SCOPE

The comparison is made between the following publications:

1

— IAEA Safety Series No. 50-C/SG-Q, Quality Assurance for Safety in NuclearPower Plants and other Nuclear Installations, Code and Safety GuidesQ1–Q14 [1];

— ISO 9001:2000, Quality Management Systems — Requirements [2].

The guidelines contained in ISO 9004:2000 [4] and the fundamentals andvocabulary contained in ISO 9000:2000 [5] were considered where appropriate.

1.4. USERS

This Safety Report is intended for use by nuclear utilities, regulatory bodies,suppliers, and research and development organizations. They could use the informa-tion provided when procuring items and services for use in the nuclear industry. Also,they could use this report as a source of guidance on specifying additional qualitymanagement system requirements to their suppliers when their quality managementsystems comply with ISO 9001:2000.

2. STANDARDS USED IN THE COMPARISON

2.1. IAEA 50-C/SG-Q CODE AND SAFETY GUIDES ON QUALITYASSURANCE

2.1.1. IAEA Code 50-C-Q

The IAEA Safety Series includes one Code on quality assurance, 50-C-Q, and14 related Safety Guides, 50-SG-Q1 to Q14. The quality assurance Code 50-C-Qestablishes the basic requirements that must be met to ensure adequate safety ofnuclear power plants and other nuclear installations. The Code consists of ten basicrequirements (BRs) as the foundation for establishing and implementing a compre-hensive quality assurance programme related to the safety of nuclear power plants.The basic requirements are presented in three functional categories:

I. ManagementBR 1: Quality assurance programmeBR 2: Training and qualificationBR 3: Non-conformance control and corrective actionsBR 4: Document control and records

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II. PerformanceBR 5: WorkBR 6: DesignBR 7: ProcurementBR 8: Inspection and testing for acceptance

III. AssessmentBR 9: Management self-assessmentBR 10: Independent assessment

The Code includes an Annex, which provides guidance to aid in the under-standing and implementation of the basic requirements. The content of this Annexwas also taken into account in this comparison.

2.1.2. IAEA Safety Guides 50-SG-Q1 to Q14

The IAEA Safety Guides 50-SG-Q1 to Q14 provide detailed and comprehen-sive guidance and recommendations on how to implement the basic requirements ofthe IAEA Code. The Safety Guides also describe acceptable methods of implement-ing particular parts of the Code. The Safety Guides 50-SG-Q1 to Q14 are of twotypes:

— Basic requirement related Safety Guides,— Stage related Safety Guides.

2.1.2.1. Basic requirement related Safety Guides

The basic requirement related Safety Guides provide recommendations andguidance on how to fulfil the basic requirements of the Code that are relevant in allof the life cycle stages of nuclear power plants and other nuclear installations. Thebasic requirement related Safety Guides are:

50-SG-Q1: Establishing and Implementing a Quality Assurance Programme50-SG-Q2: Non-conformance Control and Corrective Actions50-SG-Q3: Document Control and Records50-SG-Q4: Inspection and Testing for Acceptance50-SG-Q5: Assessment of the Implementation of the Quality Assurance

Programme50-SG-Q6: Quality Assurance in Procurement of Items and Services50-SG-Q7: Quality Assurance in Manufacturing

3

2.1.2.2. Stage related Safety Guides

The stage related Safety Guides provide specific recommendations and guid-ance on how to implement the Code during the different life cycle stages of nuclearpower plants and other nuclear installations. The stage related Safety Guides are:

50-SG-Q8: Quality Assurance in Research and Development 50-SG-Q9: Quality Assurance in Siting50-SG-Q10: Quality Assurance in Design 50-SG-Q11: Quality Assurance in Construction50-SG-Q12: Quality Assurance in Commissioning50-SG-Q13: Quality Assurance in Operation50-SG-Q14: Quality Assurance in Decommissioning

2.2. ISO 9000:2000 STANDARDS ON QUALITY MANAGEMENT SYSTEMS

The ISO 9000:2000 family includes three primary standards:

ISO 9000: Quality Management Systems — Fundamentals and VocabularyISO 9001: Quality Management Systems — RequirementsISO 9004: Quality Management Systems — Guidelines for Performance

Improvement

The ISO 9001:2000 and ISO 9004:2000 standards were developed as a ‘con-sistent pair’ of standards. ISO 9001:2000 addresses the quality management systemrequirements that an organization must fulfil to demonstrate its capability to meetcustomer requirements and enhance customer satisfaction. ISO 9004:2000 givesguidance on a wider range of objectives of a quality management system than doesISO 9001:2000. These objectives include the satisfaction of interested parties, inaddition to customers, and improving the performance of the organization.

The ISO 9001:2000 and 9004:2000 standards are based on eight quality man-agement principles that reflect good management practices. These eight principlesare:

— Customer focus,— Leadership,— Involvement of people,— Process approach,— System approach to management,— Continual improvement,

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— Factual approach to decision making,— Mutually beneficial supplier relationships.

3. APPLICATION OF IAEA 50-C-Q AND ISO 9001:2000 STANDARDS

Figure 1 illustrates where IAEA 50-C-Q and ISO 9001:2000 are applicable atthe interfaces between the regulator, utility and suppliers.

A nuclear utility has two different interfaces where quality management systemstandards are applied. The primary interface is between the utility and the regulator,and in this case the regulator has the expectation (in some Member States it isspecified as a licensing requirement) that the utility will develop and implement aquality management system which satisfies the IAEA 50-C-Q requirements.

The utility also has a secondary interface with the suppliers of items andservices. In some cases the utility requires its suppliers to have developed and imple-mented a quality management system for the supply and delivery of items andservices that satisfies the requirements of IAEA 50-C-Q.

5

IAEA Code 50-C-Q ISO 9001:2000

+ additional

requirements

Regulator Supplier

Nuclear utility

Requirement path

Satisfaction path

FIG. 1. Application of IAEA 50-C-Q and ISO 9001:2000.

Where a supplier has developed a management system that complies with ISO9001:2000, it may be necessary for the utility to consider including additional quali-ty management system requirements to address nuclear safety issues as part of thespecification to the supplier. Guidance on the additional quality management systemrequirements is contained in this publication.

4. MAJOR DIFFERENCES AND CORRELATIONS

4.1. STRUCTURE AND FOCUS

Figure 2 highlights the similarities of structure and the differences of focusbetween IAEA 50-C-Q and ISO 9001:2000. Both standards show a process structurethe elements of which are overlapping in scope. The IAEA standard distinguishesbetween management, performance and assessment, the ISO standard between man-agement responsibility, resource management, product realization, and measurement,analysis and improvement.

The focus of IAEA 50-C-Q is on achieving nuclear safety, the focus of ISO9001:2000 on achieving customer satisfaction.

In IAEA 50-C-Q the terms ‘quality assurance’ and ‘quality assurance pro-gramme’ are used. The term ‘quality assurance’ is no longer used in ISO 9001:2000.The term ‘quality management system’ used in ISO 9001:2000 is equivalent to theterm ‘quality assurance programme’ as used in IAEA 50-C-Q.

IAEA 50-C-Q and ISO 9001:2000 both utilize a quality management systemapproach. Both IAEA 50-C-Q and ISO 9001:2000 require that the quality manage-ment system shall focus on continual improvement.

4.2. MAJOR CHANGES IN ISO 9001:2000 WITH RESPECT TO ISO 9001:1994

The ISO 9001:1994 version was used in a previous comparison with IAEA 50-C/SG-Q [3]. The major changes in ISO 9001:2000 with respect to ISO 9001:1994are the increased focus on top management commitment, and an emphasis on theprocess approach within the organization, on continual improvement and on enhanc-ing satisfaction for customers.

(a) Quality management principles

Eight quality management principles were introduced by the ISO to form thebasis for ISO 9001:2000 and 9004:2000. These principles are listed in Section 2.2.

6

7

One to one similarity

Multiple similarities

Management

Management

responsibility

Performance

Resource

management

Product

realization

Assessment

Measurement,

analysis and

improvement

Focus on

nuclear safety

Focus on

customer

satisfaction

IAEA 50-C-Q ISO 9001:2000

FIG. 2. Similarities of structure and differences of focus between IAEA 50-C-Q and ISO9001:2000.

(b) Structure

The ISO 2000 version of the ISO quality management system standardsincludes a radical change to the structure of ISO 9001 and ISO 9004. While retainingthe essence of the original requirements, the ISO 2000 version has repositioned the20 elements of ISO 9001:1994 into five main chapters:

— Quality management system,— Management responsibility,— Resource management,— Product realization,— Measurement, analysis and improvement.

(c) Process approach

The standard promotes the adoption of a process approach as opposed to theprocedural approach described in the 1994 version.

(d) Top management role

More emphasis is placed on the role of top management, which includes itscommitment to the development, implementation, improvement and review of thequality management system. In addition, emphasis is also placed on customer focus,consideration of statutory and regulatory requirements, and the establishment ofmeasurable objectives for relevant functions and levels.

(e) Continual improvement

An enhanced requirement for continual improvement is introduced into ISO9001:2000, defining a complete cycle to improve the effectiveness of the qualitymanagement system.

(f) Application

The concept of exclusions to the requirements of ISO 9001:2000 is introduced asa way to cope with the wide spectrum of organizations and activities using the standard.

(g) Customer satisfaction

An item introduced into ISO 9001:2000 is the requirement for the organizationto monitor information on customer satisfaction as a measure of system performance.

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(h) Resources

Emphasis is placed on top management commitment to making the necessaryresources available. Requirements now relate to evaluation of the effectiveness oftraining and other actions taken, provision of relevant information, internal and exter-nal communication, infrastructure and work environment.

(i) Terminology

There are also changes in terminology. The most important changes concern theuse of the term ‘organization’ instead of ‘supplier’, and the use of the term ‘supplier’instead of ‘subcontractor’. These changes respond to the need for greater consistencyand compatibility with the normal use and meaning of the words.

(j) Documentation

The number of requirements for documented procedures has been reduced inISO 9001:2000, and the emphasis has been placed on the organization demonstratingeffective operation.

4.3. CORRELATION BETWEEN THE BASIC REQUIREMENTS OF THEIAEA CODE 50-C-Q AND IAEA SAFETY GUIDES 50-SG-Q1 TO Q14

While the IAEA Code 50-C-Q specifies the ten basic requirements for qualityassurance in nuclear power plants and other nuclear installations, the Safety Guidesprovide recommendations relative to the fulfilment of these basic requirements fordifferent life cycle stages. An overview showing how each Safety Guide addresses thebasic requirements is given in Appendix I.

4.4. CORRELATION BETWEEN THE BASIC REQUIREMENTS OF THEIAEA CODE 50-C-Q AND THE REQUIREMENTS OF ISO 9001:2000

The correlation between the ten basic requirements of the IAEA Code 50-C-Qand the requirements of ISO 9001:2000 is shown in Appendix II.

In general the basic requirements of the IAEA Code 50-C-Q are addressed byone or more clauses of ISO 9001:2000. The following clauses of ISO 9001:2000 arenot specifically addressed within IAEA 50-C-Q:

9

— Clause 5.2: Customer focus— Clause 5.5.3: Internal communication— Clause 7.5.4: Customer property— Clause 8.2.1: Customer satisfaction

4.4.1. Underlying approaches

The IAEA Code 50-C-Q provides the basic requirements to be adopted forestablishing and implementing quality assurance programmes/quality managementsystems related to the safety of nuclear power plants and other nuclear installations.These basic requirements apply to the overall quality assurance programme/qualitymanagement system of the responsible organization, i.e. the organization havingoverall responsibility for the nuclear power plant, as well as to any other separatequality assurance programme/quality management system in each stage of the life ofa nuclear power plant.

The objective of the IAEA Code is to establish basic requirements for qualityassurance in order to enhance nuclear safety by continually improving the methodsemployed to achieve quality. The Code recognizes that all work is a process that canbe planned, performed, assessed and improved.

ISO 9001:2000 specifies requirements for a quality management system thatcan be used for internal application by organizations, or for certification or contrac-tual purposes. It focuses on the effectiveness of the quality management system inmeeting customer requirements.

In summary, the IAEA Code 50-C-Q is focused on meeting the overall safetyrequirements for the plant, personnel and society in general, whilst ISO 9001:2000 isfocused on satisfying the requirements of the customer.

4.4.2. Additional conceptual requirements of the IAEA Code 50-C-Q

4.4.2.1. Grading

The IAEA Code 50-C-Q recommends a graded approach for the application ofquality assurance during the various stages of a nuclear power plant life cycle. Allitems, services and processes require various controls to ensure that they performcorrectly. The grading process is a means of determining the types and extent of controls to be applied to specific items, services and processes. Safety Guide 50-SG-Q1 explains what the graded approach means in relation tonuclear safety.

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ISO 9001:2000 does not specifically address a graded approach for applyingthe controls specified in the quality system.

4.4.2.2. Independence of inspection and testing personnel

The IAEA Code 50-C-Q requires that inspection and testing of specified items,services and processes shall be conducted using established acceptance and perform-ance criteria. The level of inspection and testing and the degree of independence ofpersonnel shall be established.

ISO 9001:2000 does not specifically cover the independence of inspection andtesting personnel.

5. GUIDANCE FOR THE USE OF ISO 9001:2000

Through the process of grading its management system requirements, the util-ity should be able to identify where in the procurement of items and services itrequires a supplier’s management system to meet specific requirements.

In cases where the supplier has a management system which meets the require-ments of ISO 9001:2000, the utility should consider whether any additional require-ments need to be included to satisfy the requirements of IAEA 50-C-Q. These addi-tional management system requirements should be included in procurementdocumentation.

Sections 5.1 and 5.2 identify management system requirements and guidance inthe IAEA documents that are not contained within ISO 9001:2000 and providerecommendations on what requirements additional to those of ISO 9001:2000 mightneed to be specified. No recommendations are provided in cases where the implica-tions of the guidance within the Safety Guides are considered to be self-explanatory.Section 5.3 identifies clauses of the ISO standards that do not have correspondingrequirements and guidance in the IAEA documents.

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5.1. IAEA-50-C-Q REQUIREMENTS NOT CONTAINED IN ISO 9001:2000

A comparison was made between the ten basic requirements of the IAEA Code50-C-Q and ISO 9001:2000, Chapters 4–8. The table below presents the requirementsnot covered in the ISO document, along with recommendations for satisfying theserequirements.

12

104

204

206

The responsible organization hasto demonstrate the effective ful-filment of the quality assurancerequirements to the satisfactionof the regulatory body.

Nuclear safety shall be the funda-mental consideration in the identi-fication of the items, services andprocesses to which the qualityassurance programme applies. A graded approach based on therelative importance to nuclearsafety of each item, service orprocess shall be used. The gradedapproach shall reflect a plannedand recognized difference in theapplications of specific qualityassurance requirements.

Personnel shall be trained andqualified so that they are com-petent to perform their assignedwork and understand the safetyconsequences of their activities.

The utility should require its sup-pliers to apply any additionalrequirements in order to satisfythe utility, who has the respon-sibility to satisfy the regulatorybody, where necessary.

The graded approach is describedwithin the utility quality systemdocumentation as part of qualityplanning and procurement activ-ities. The utility should ensurethat any grading requirements areincluded within procurementdocuments. It may be necessaryto ensure that the supplier under-stands the safety significance ofthe procured items and services.

The utility should ensure thatsuppliers identify personnel con-cerned with safety matters. Thesupplier should be required toensure that these personnel are

101–108 Introduction

Section IAEA 50-C-Q requirements Recommendations

201–205 BR 1: Quality assurance programme

206 BR 2: Training and qualification

13

206 (cont.)

305

Annex

309

The adequacy of design, includ-ing design tools and design inputsand outputs, shall be verified orvalidated by individuals or groupsother than those who originallyperformed the work. Verification,validation and approval shall becompleted before implementationof the design.

Design inputs include all require-ments for the design, such as thetechnical bases for the design(design basis), performancerequirements, reliability require-ments, and safety and securityrequirements.

Computer programs used indesign are validated through test-ing or simulation prior to use ifnot proven through previous use.

Inspection and testing of speci-fied items, services and processesshall be conducted using estab-lished acceptance and perform-ance criteria. The level of inspec-tion and testing and the degree ofindependence of personnel shallbe established.

properly trained. In some casesthe utility can provide training tosupplier staff.

The utility should require thatsupplier staff involved in safetyrelated design verification andvalidation be different from thoseperforming the work. Designverification and approval shouldbe performed before implementation of the design.

The utility should require thedesign organization to validatethe computer codes used forsafety design prior to use.

The utility should specify therequired degree of independencefor supplier personnel involved ininspection and test activities.

304–305 BR 6: Design

Section IAEA 50-C-Q requirements Recommendations

309–310 BR 8: Inspection and testing for acceptance

5.2. ADDITIONAL GUIDANCE IN IAEA SAFETY GUIDES 50-C-SG1 TOSG14 NOT COVERED IN ISO 9001:2000

A comparison was made between the additional guidance in the IAEA SafetyGuides 50-SG-Q1 to Q14 and ISO 9001:2000. The following table presents the guid-ance not covered in the ISO document, along with recommendations for additionalrequirements that might need to be specified.

Safety Guide 50-SG-Q1: Establishing and Implementing a Quality Assurance Programme

14

209

211

307

Whilst the quality assurance(QA) principles remain the same,the extent to which the QArequirements are to be appliedshall be consistent with theimportance to nuclear safety ofthe item, service or process. A graded approach which cansatisfy the necessary require-ments and ensure the requiredquality and safety shall be used.

When items, processes orservices are modified, theassigned grade of QA require-ments could become more strin-gent or less stringent dependingon whether a change in nuclearsafety significance has occurred.

The QA programmes should takeaccount of the details containedin the corresponding SafetyGuides and should also recognize that the planning and

The suppliers’ quality systemsshould meet the QA requirementsnotified by the utility, includingprovisions for grading their ownQA requirements to their ownsub-suppliers where necessary.The suppliers’ graded approachshould be acceptable to theutility.

Self-explanatory.

The utility should ensure that anyrequirements for subsequentstages are identified and com-municated to suppliers. Also seeclause 313 of Safety Guide Q3.

209–211 Grading

Section Additional guidance Recommendations

301–319 Documentation of the quality assurance programme

15

307 (cont.)

308

312

development of the later stageQA programmes commencesduring the early stages of a proj-ect, for example design reviewrequires consideration ofinspectability, constructability,operability, maintainability andALARA requirements beforefinalization of the design. To dothis effectively, the advice ofconstructors and operators shouldbe sought early in the designstage.

The requirements and needs ofthe QA programme for a partic-ular stage should be consideredduring earlier stages so that theyare fully established prior to thecommencement of the stage. Forexample, establishing the QAprogramme for operationsincludes: providing fully documented detailed workingdocuments; having a trained andqualified workforce; and ensur-ing that workshops, facilities,tools and suitable workingenvironments are in place.

The following should be included in the QA programmedescription:

(1) Management’s quality pol-icy statement;

(2) The mission and objectiveof the organization;

The utility should identify wheresuppliers are required todocument and work to specificprocedures/instructions. The QA programme for asupplier appointed as principaldesigner for a nuclear powerplant is required to be developedin accordance with therequirements of IAEA 50-C-Q.

Self-explanatory.

This is basically equivalent to therequirements of ISO 9001:2000,but it may be useful to considerif any of the guidance is helpfulto the supplier.


16

312(cont.)

401–413

(3) The organizational structureand outline of the manage-ment procedures;

(4) The level of authority andthe responsibilities andaccountabilities of personsand organizational units;

(5) The lines of internal andexternal communicationsand interface arrangements;

(6) The responsibilities of eachorganization involved in thework;

(7) Requirements for training,facilities and workingenvironment;

(8) Requirements for the devel-opment of detailed workingdocuments for the perform-ance and assessment ofwork;

(9) The arrangements forestablishing a gradedapproach to nuclear safety;

(10) The arrangements formeasuring effectiveness and management self-assessment of the QAprogramme.

Implementing the qualityassurance programme

Plans mentioned in the SafetyGuide should be handled throughquality planning.


Safety Guide 50-SG-Q2: Non-conformance Control and Corrective Actions

17

303

305

308

309

Non-conformances may bediscovered during regulatoryinspections.

On being advised of a non-conformance, the line manage-ment should promptly inform theregulatory body and othernuclear power plants if necessary.

Non-conformances should bereviewed as soon as practicableby appropriate personnel whoshould be selected by taking thefollowing into account:

— The QA grade or classifica-tion of the affected item,service or process;

— The need for the safetyimplications of the non-conformance to beindependently reviewed;

— The need to involve theregulatory body.

The review should determine:

— The cause of the identifiednon-conformance, whichcould include failures, mal-functions, incorrect materials,tools, equipment, procedures,

Utilities should include therequirement for the right ofaccess for regulatory bodies’representatives for inspectionwhere applicable.

The utility should establish crite-ria with the supplier for identify-ing non-conformances thatshould be brought to the attentionof the regulator via the utilityrepresentative.

A formal process related toreview and acceptance of thenon-conformance which affectsdesign intent, by utility represen-tatives or by the regulatory body,should be established.

Self-explanatory.

301–313 Non-conformance control


18

309(cont.)

311

313

406

information, training orhuman error. Root causeanalysis techniques should beutilized.

— Any safety implications ofthe non-conformance.

During the review additionalinformation about the nature ofthe non-conformance and restric-tions to be imposed on furtherprocessing or operation should bemade available to involvedorganizations, including the regu-latory body and other nuclearpower plants if required.

Relevant information on the statusof non-conformances should bereported to management and theregulatory body, where required.

Implementation of preventiveactions may proceed in stages. Insuch cases each stage should beclearly defined and specify themeans of verification that assuresthat the actions have been effec-tive. Prior to implementation, allproposed actions should havebeen agreed, documented andauthorized by appropriatepersonnel and the regulatorybody if required.

Self-explanatory.

Self-explanatory.

Self-explanatory.


401–406 Corrective actions

Safety Guide 50-SG-Q3: Document Control and Records

19

305

313

408

425

During preparation, activitiesdescribed by the documentsshould be assessed using thegrading system, so that theappropriate controls are chosenand included.

Where acceptance by, orapproval of, the regulatory bodyis required, this should beobtained before the document isissued for use.

The method of indexing shouldbe established before receipt ofthe record. The index shouldprovide sufficient information onboth the item and the relevantrecord.

The responsible organizationshould identify who is responsi-ble for transferring or disposingof records.

Supplier documents shouldinclude all controls necessary foractivities to be properlyimplemented.

The utility should ensure thatsuppliers are aware of anyspecific documents requiringregulatory acceptance/approval.Suppliers should be made awareof situations where work cannotstart until acceptance/approval ofthe specific documents isobtained. The utility shouldobtain any acceptance/approvalrequired by the regulatory body.

The utility should specify recordrequirements.

The utility should specifyresponsibilities for transfer anddisposal of records.

301–332 Document control


401–427 Establishment of a records system

Safety Guide 50-SG-Q4: Inspection and Testing for Acceptance

20

302

305

310

319

Items and services, includinginput material to be processed,should not be used, nor process-ing commenced, until they havebeen checked for conformance tospecified requirements. Suchchecks should be in accordancewith inspection and testing plansor procedures. Receiving inspec-tion and/or testing activitiesshould be carried out in conjunc-tion with a review of the corre-sponding documents.

Arrangements should be estab-lished to hold the item or stopfurther work until the requiredinspections and tests have beencompleted and the correspondingreports have been received andverified by designated personnel.

Items and services should not bedispatched or brought into service until all the activitiesspecified in the inspection andtesting plan have been satisfacto-rily completed. The associateddocuments and records should be available and approved asspecified.

Testing should demonstrate thatthe safety function of an item orservice has been maintained.

An Inspection and Test Plan(ITP)/Quality Plan (QP) shouldbe prepared by suppliers andapproved by the utility.

See also BR 7.

The utility should establish,where applicable, hold points(HPs) or witness points (WPs) inITPs, and communication forHPs or WPs and releasingactivities related to these pointsshould be established in theprocurement documents.

The utility or supplier responsi-bilities for acceptance inspectionand testing should be clearlyidentified.

Self-explanatory.

301–323 Inspection and testing


21

501

508

509

510

511

Systematic inspection and testingfollowing installation of majorplant systems is an essential ele-ment during the commissioningstage.

In-service inspection and testingshould be an integral part of pre-ventive maintenance aimed at theearly detection of the potentialfailure of items. It also providesdata on which to base judge-ments related to the continuedoperation and life extension ofthe plant.

In-service inspection and testingshould be concentrated on itemsthat may affect safety to ensurethat operation has not resulted inan unacceptable degradation ordeviation from the design intent.

In-service inspection and testingduring operation will compriseboth routine checks and periodicexamination that may require theplant to be shut down. Bothactivities should be defined.

Routine in-service inspection andtesting activities should confirmthe availability and reliability ofsystems and should indicate thecurrent plant status.

Suppliers may need to beinvolved in this activity.

Self-explanatory.

Self-explanatory.

Self-explanatory.

Self-explanatory.


501–514 Plant inspections and testing

22

512

513

514

For evaluation purposes, theresults of in-service inspectionand tests during plant shutdownshould be recorded using appro-priate media such as photo-graphs, videos, instrumentationprintouts and computer records.

Results of in-service inspectionsand tests should be promptlyreviewed. Non-conformancesshould be investigated to deter-mine their root cause. The result-ing data should be analysed fortrends using statistical methods.

Plant management should beperiodically appraised of all in-service inspection and testingperformed on the operating plant.Plant management should also beprovided with summary reviewsof the results. Issues requiringattention, such as problems thatcould jeopardize the safeoperation of the plant, should be highlighted.

Self-explanatory.

Self-explanatory.

Self-explanatory.


Safety Guide 50-SG-Q5: Assessment of the Implementation of the Quality Assurance Programme

23

201

202

211

Assessments are carried out todetermine that requirements aremet and that processes are ade-quate and effective, and toencourage managers to imple-ment improvements, includingsafety improvements.

The assessment activity falls intotwo broad categories:

(1) Management self-assess-ment, which is an ongoingprocess conducted by man-agement in order to evaluatethe effectiveness of perform-ance in all areas of theirresponsibility.

(2) Independent assessment,which is usually conductedby an independent organiza-tional unit in order to deter-mine the effectiveness ofmanagement processes, theadequacy of work perform-ance and the quality of itemsand services.

Managers should make arrange-ments to ensure that all personnelperforming assessment activities,including themselves, haveappropriate qualification, trainingand experience.

The internal audits of suppliersshould assist continualimprovement.

Self-explanatory.

Supplier auditors should betrained properly in auditingpractices and techniques.

201–214 General considerations


24

501

502

503

601

The purpose of managementself-assessment should be toevaluate known performanceissues, identify contributingmanagement aspects and makeimprovements.

Management self-assessmentshould be regarded as an ongoingprocess that determines how wellleadership is being provided tomeet requirements andexpectations.

Management at all levels (forexample senior, line and supervi-sory managers) perform theseself-assessments with an empha-sis on the allocation of humanand financial resources to achieveorganizational goals andobjectives.

Independent assessment, such asinternal audits, external audits,surveillance, peer evaluation andtechnical review, should befocused on safety aspects andareas where problems have beenfound. Assessment objectivesshould be reviewed periodicallyto reflect current managementconcerns and performance activi-ties. Appropriate combinations ofvarious types of assessmentshould be used to provide the best

Careful consideration should begiven to imposing this require-ment on suppliers as self-assessment is only used asguidance in ISO 9004.

Self-explanatory.

Self-explanatory.

Self-explanatory.

501–509 Management self-assessment


601–620 Independent assessment

25

601(cont.)

602

606

608

613

balanced evaluation ofperformance.

A system for internal auditsshould be established by theassessment unit and agreed with the management of theorganization.

External audits of suppliersshould be managed by the assess-ment unit on behalf of manage-ment, who agree the schedule ofaudits to be performed. Thefrequency of audits should bedetermined by factors such as the importance of items and theperformance of the supplier.

Surveillance of work perform-ance is considered to be the besttechnique for assessing andreporting on a specific area, or anongoing activity. It is flexible andless formal than audits and canbe performed in a relatively shortperiod of time with limitedpreparation.

Peer evaluation is a criticalexamination of specific nuclearsafety related subjects by seniorstaff from one or more othernuclear power plants to seekimprovements and to promotegood practices. The evaluationteam should consist of experts in all areas of evaluation in orderto promote the sharing of

Self-explanatory.

Self-explanatory.

Self-explanatory.

Self-explanatory.


26

613(cont.)

617

experience and to developrelationships between the peersand the people at the nuclearpower plants.

Senior management may arrangefor a review of the technical con-tent of activities and processes,with a view to improving theeffectiveness of these activities orprocesses.

Self-explanatory.


Safety Guide 50-SG-Q6: Quality Assurance in Procurement of Items and Services

27

201

204

205

The responsible organizationshall ensure that procured itemsand services meet establishedrequirements and perform asspecified and that selected sup-pliers continue to provide accept-able items and services duringthe fulfilment of their procure-ment obligations. The responsibleorganization may delegateprocurement activities to otherorganizations, but shall retain theresponsibility for the overalleffectiveness of these activities.

Nuclear safety shall be the funda-mental consideration in the iden-tification of the items, servicesand processes to which the QAprogramme applies. A gradedapproach based on the relativeimportance to nuclear safety ofeach item, service or processshall be used. The gradedapproach shall reflect a plannedand recognized difference in theapplications of specific QArequirements.

This graded approach should beapplied throughout the supplychain.

The utility should ensure thatmanagement system and productrequirements are containedwithin procurement documents. This includes any additionalmanagement system require-ments necessary to meet IAEA50-C-Q requirements.

The graded approach is describedwithin the utility quality systemdocumentation as part of qualityplanning and procurement activi-ties. The utility should ensurethat any grading requirements areincluded within procurementdocuments. It may be necessaryto ensure that the supplier under-stands the safety significance ofthe procured items and services.

Self-explanatory.

201–206 Arrangements for procurement


28

501

502

603

801

Submitted quotations (bids ortenders) from prospectivesuppliers should be evaluated in a logical manner to ensure thatthey conform to the requirementsof the procurement documents.

The evaluation of quotations car-ried out by the responsible organ-ization should be a team effortinvolving the organizational unitsresponsible for the technical andprocurement activities. The sizeof the team undertaking the eval-uation should be determined bythe size and complexity of theitem or service to be purchased.

The extent and necessity of pre-and post-award communicationdepends on the uniqueness of theproduct, its complexity, the pro-curement frequency with thesame supplier and pastperformance in the supply ofsimilar items or services.

Certain items with a provenrecord may be available fromcommercial stock. Procurementdocuments should provide

Conformance to requirementscan include evaluating the totalityof specified management systemrequirements. ISO 9001:2000 nolonger contains a requirement forcontract review but emphasizescustomer satisfaction throughdetermining and meetingrequirements.

Self-explanatory.

Self-explanatory.

Self-explanatory.

501–503 Evaluation of quotations and award of contract


601–607 Evaluation of supplier performance

801–802 Commercial grade items

29

801(cont.)

802

901

sufficient information from cata-logues and suppliers’ specifica-tions to enable the correct item tobe supplied. All relevanttechnical data and trialinformation should be requested.These items may requireconfirmatory analysis or testingto demonstrate the adequacy ofthe item to perform its intendedfunction.

When a commercial grade item isproposed for any safety function,a thorough technical evaluationof the complexity of the item andits safety significance should becarried out. The criticalcharacteristics required for thatfunction should be included asacceptance criteria in theprocurement documents.

The plant management mayarrange to obtain spares of plantitems at the time of procurementof the original items. The sparesshould meet the same QArequirements as the originals,with additional requirements toassure protection during longterm storage.

Self-explanatory.

Self-explanatory.


901 Procurement of spares

Safety Guide 50-SG-Q7: Quality Assurance in Manufacturing

30

202

303

The responsibility for theeffectiveness of the overall QAprogramme of the nuclear powerplant remains with theresponsible organization withoutprejudice to the manufacturer’sobligations and the legalrequirements imposed on themanufacturer.

The manufacturer shall be madeaware of the requirements of theresponsible organization andregulatory body (see the Code50-C-G (Rev. 1)) for samplingpoints, hold points and witnesspoints.

Self-explanatory.

The utility should ensure that thesupplier has incorporated utilityand regulatory sampling points,hold points and witness pointswithin documents such as qualityplans.

201–205 General


301–311 The manufacturing process

Safety Guide 50-SG-Q10: Quality Assurance in Design

31

207

208

213

The responsible organizationshall identify the principaldesigner who has responsibilityfor specifying the design require-ments and for approving thedesign output on its behalf.

The responsibilities of the princi-pal designer should include:

— Defining the baserequirement/specification

— Involvement in designreviews

— Involvement in designverification

— Approval of detail design— Review and approval of

design changes during allstages

— Control of interfaces— Review of relevant non-

conformance applications— Review and approval of the

QA programme.

Training and development fortechnical personnel shouldsupplement previous training,education and experience toprepare individuals to performtheir work.

Self-explanatory.

Self-explanatory.

IAEA 50-C-Q is more specific.It should be ensured that therequirement is specified andapplied where necessary.

201–223 Management


32

329 Design validation shall be carriedout to confirm by examinationand provision of objectiveevidence that the particularrequirements for a specificintended use are fulfilled, andthat the item conforms to defined requirements.

IAEA 50-C-Q is more specific.It should be ensured that therequirement is specified andapplied where necessary.

301–336 Performance


5.3. ISO 9001:2000 CLAUSES WITH NO CORRESPONDINGREQUIREMENTS AND GUIDANCE IN THE IAEA DOCUMENTS

The following table identifies the clauses of the ISO standards which do nothave corresponding requirements and guidance in the IAEA 50-C/SG-Q Code andSafety Guides. The utility should be aware of these differences to help understandwhat additional activities a supplier using ISO 9001:2000 would be implementing.

33

4.1

4.2

5.1

General requirements Control of outsourced processes is defined.

Documentation requirementsThe ISO intends to reduce the‘documentation load’ toorganizations.

Management commitment Top management shall provideevidence of its commitment tothe development and implemen-tation of the quality managementsystem and continual improve-ment of its effectiveness by:(a) Communicating to the organ-

ization the importance of

There are no requirements onoutsourcing of processes in theCode and Safety Guides. Utilitiesshould ensure that they arenotified of any outsourcingactivities. The utility may requireprior approval of these processes.

In the Code and Safety Guidesthere are defined requirements ondocumentation control. SafetyGuide Q3 gives detailed guid-ance on documentation controland all the stage related SafetyGuides (Q10–Q14) define therequirements specific to thevarious stages.

The Code, the Safety Guide 50-SG-Q1 and all stage relatedSafety Guides carefully definethe responsibilities and commit-ment of the management.

The IAEA documents do notseparate top management andmanagement in general. In every

5. Management responsibility

4. Quality management system

ClauseISO 9001:2000

additional requirementsComments

34

5.1(cont.)

5.2

5.5.2

meeting customer as well asstatutory and regulatoryrequirements,

(b) Establishing the qualitypolicy,

(c) Ensuring that qualityobjectives are established,

(d) Conducting managementreviews, and

(e) Ensuring the availability ofresources.

Customer focusTop management shall ensure thatcustomer requirements are deter-mined and are met with the aim ofenhancing customer satisfaction.

Management representativeTop management shall appoint amember of management who,irrespective of other responsibili-ties, shall have responsibility andauthority that includes:(a) Ensuring that processes

needed for the qualitymanagement system areestablished, implementedand maintained;

(b) Reporting to top manage-ment on the performance ofthe quality managementsystem and any need forimprovement; and

(c) Ensuring the promotion ofawareness of customerrequirements throughout theorganization.

place where IAEA documentsmention ‘management’, it should be interpreted as topmanagement.

The Code and Safety Guides give delegated responsibilities todifferent levels of management,e.g. senior management, line man-agement and supervisory manage-ment (BR3, Q5, Q13, etc.).

The IAEA documents do notspecifically identify the customer.

In the IAEA documents,‘management representative’ isnot defined, as the responsibilityfor this activity is placed withmanagement in general.

ClauseISO 9001:2000


35

5.5.2(cont.)

5.5.3

5.6

7.2.3

NOTE: The responsibility of amanagement representative caninclude liaison with externalparties on matters relating to thequality management system.

Internal communicationTop management shall ensurethat appropriate communicationchannels are established withinthe organization and thatcommunication takes placeregarding the effectiveness of the quality management system.

Management reviewTop management shall review the organization’s qualitymanagement system at plannedintervals to ensure its continuingsuitability, adequacy andeffectiveness. This review shallinclude assessing opportunitiesfor improvement and the need for changes to the qualitymanagement system, includingthe quality policy and qualityobjectives.

Records from managementreviews shall be maintained.

Customer communicationThe organization shall determineand implement effective

In the IAEA documents, internalcommunication is described butnot as explicitly as in the ISOstandard.

This requirement is included inthe ‘management self-assessment’requirement throughout the IAEAdocuments. The self-assessmentin this case is a combination ofmanagement review andmonitoring and measurement ofprocesses. No economic aspect inthe Code and SG-Q5 as an inputfor self-assessment is considered.

The ISO standard gives moredetails on the review (self-assessment) of outputs.ISO 9004:2000 gives examplesof management self-assessment.

Customer communication is notdefined within the IAEAdocuments. This requirement

7. Product realization

ClauseISO 9001:2000


36

7.2.3(cont.)

7.3.1

arrangements for communicatingwith customers in relation to:(a) Product information;(b) Enquiries, contracts or order

handling, including amend-ments; and

(c) Customer feedback, includ-ing customer complaints.

Design and developmentplanningThe organization shall plan andcontrol the design and develop-ment of the product. During thedesign and developmentplanning, the organization shalldetermine:(a) The design and development

stages;(b) The review, verification and

validation that are appropri-ate to each design anddevelopment stage; and

(c) The responsibilities andauthorities for design anddevelopment.

The organization shall managethe interfaces between differentgroups involved in design anddevelopment to ensure effectivecommunication and clearassignment of responsibility.

Planning output shall be updated,as appropriate, as the design anddevelopment progresses.

should enhance customer (utility)and supplier relationships.

‘Principal designer’ is a termused in 50-SG-Q10. Utilities mayrequire a principal designer to benominated within a supplierorganization.

ClauseISO 9001:2000


37

7.5.2

8.2.1

Validation of processes for pro-duction and service provisionThe organization shall validateany processes for production andservice provision where theresulting output cannot beverified by subsequentmonitoring or measurement. This includes any processeswhere deficiencies becomeapparent only after the product is in use or the service has beendelivered.

Validation shall demonstrate theability of these processes toachieve the planned results.

The organization shall establisharrangements for these processesincluding, as applicable:(a) Defined criteria for review

and approval of theprocesses,

(b) Approval of equipment andqualification of personnel,

(c) Use of specific methods andprocedures,

(d) Requirements for records(see 4.2.4), and

(e) Revalidation.

Customer satisfactionAs one of the measurements ofthe performance of the qualitymanagement system, the

The validation of processes is not a requirement in the IAEAdocuments. Validation is used as a method of ensuring theaccuracy of working leveldocuments.

The issue of customer focus doesnot need further explanation.

8. Measurement, analysis and improvement

ClauseISO 9001:2000


38

8.2.1(cont.)

organization shall monitorinformation relating to customerperception as to whether theorganization has met customerrequirements. The methods forobtaining and using thisinformation shall be determined.

ClauseISO 9001:2000


Appendix I

COVERAGE OF IAEA CODE 50-C-Q BASIC REQUIREMENTSIN IAEA SAFETY GUIDES 50-SG-Q1 TO Q14

39

BR 1 BR 2 BR 3 BR 4 BR 5 BR 6 BR 7 BR 8 BR 9 BR 10

Management Performance Assessment

Stag

e re

late

d Sa

fety

Gui

des

Bas

ic re

quire

men

t rel

ated

Saf

ety

Gui

des

Qua

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assu

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e

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and

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Non

-con

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s

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rac

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Man

agem

ent s

elf-

asse

ssm

ent

Inde

pend

ent a

sses

smen

t

Q1 Establishing and Implementing a Quality Assurance Programme

Q2 Non-conformance Control and Corrective Actions

Q3 Document Control and Records

Q4 Inspection and Testing for Acceptance

Q5 Assessment of the Implementation ofthe Quality Assurance Programme

Q6 Quality Assurance in Procurement ofItems and Services

Q7 Quality Assurance in Manufacturing

Q8 Quality Assurance in Research and Development

Q9 Quality Assurance in Siting

Q10 Quality Assurance in Design

Q11 Quality Assurance in Construction

Q12 Quality Assurance in Commissioning

Q13 Quality Assurance in Operation

Q14 Quality Assurance in Decommissioning

++ + + +

+ +

+ + + + + +

+ + + + + + +

+ + + + +

+ + + + + + +

+ + + + + + +

+ + + + + + + + +

+ + + + + + +

+ + + + + + + + + +

+ + + + + + + + + +

+ + + + + + + + + +

+ + + + + + + + + +

40

Appendix II

CORRELATION BETWEEN THE BASIC REQUIREMENTS OF IAEA CODE 50-C-Q AND THE REQUIREMENTS IN ISO 9001:2000



Qua

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Clause in ISO 9001:2000

4. Quality management system (title only)

4.1 General requirements +4.2 Documentation requirements (title only)

4.2.1 General + +4.2.2 Quality manual +4.2.3 Control of documents +4.2.4 Control of quality records +5. Management responsibility (title only)

5.1 Management commitment + + +5.2 Customer focus

5.3 Quality policy +5.4 Planning (title only)

5.4.1 Quality objectives + + +5.4.2 Quality management system planning +5.5 Responsibility, authority and

communication (title only)

5.5.1 Responsibility and authority + + +5.5.2 Management representative

5.5.3 Internal communication + +5.6 Management review (title only)

5.6.1 General + + +5.6.2 Review input + + +

41



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5.6.3 Review output + + +6. Resource management (title only)

6.1 Provision of resources + + + +6.2 Human resources (title only)

6.2.1 General + +6.2.2 Competence, awareness and training +6.3 Infrastructure + +6.4 Work environment +7. Product realization (title only)

7.1 Planning of product realization + + +7.2 Customer related processes (title only)

7.2.1 Determination of requirements related to the product

+ + + +

7.2.2 Review of requirements related to the product

+ + + + + + +

7.2.3 Customer communication

7.3 Design and development (title only)

7.3.1 Design and development planning +7.3.2 Design and development inputs +7.3.3 Design and development outputs +7.3.4 Design and development review +7.3.5 Design and development verification +7.3.6 Design and development validation +7.3.7 Control of design and development changes +7.4 Purchasing (title only)

42



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Man

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asse

ssm

ent

Inde

pend

ent a

sses

smen

t


7.4.1 Purchasing process +7.4.2 Purchasing information +7.4.3 Verification of purchased product + +7.5 Production and service provision (title only)

7.5.1 Control of production and service provision

+

7.5.2 Validation of processes for production and service provision

+

7.5.3 Identification and traceability + + +7.5.4 Customer property

7.5.5 Preservation of product +7.6 Control of monitoring and

measuring devices+ +

8. Measurement, analysis and improvement (title only)

8.1 General + + + +8.2 Monitoring and measurement (title only)

8.2.1 Customer satisfaction

8.2.2 Internal audit + +8.2.3 Monitoring and measurement of processes + + + +8.2.4 Monitoring and measurement of product + +8.3 Control of non-conforming product +8.4 Analysis of data +8.5 Improvement (title only)

8.5.1 Continual improvement + + + +8.5.2 Corrective action +8.5.3 Preventive action +

Appendix III

CORRELATION BETWEEN IAEA SAFETY GUIDES 50-SG-Q1 TO Q14AND THE REQUIREMENTS IN ISO 9001:2000

43

1 2 3 4 5 6 7 8 9 10 11 12 13 14

Basic requirement related Safety Guides Stage related Safety Guides

Qua

lity

Ass

uran

ce in

Dec

omm

issi

onin

g

Qua

lity

Ass

uran

ce in

Ope

ratio

n

Qua

lity

Ass

uran

ce in

Com

mis

sion

ing

Qua

lity

Ass

uran

ce in

Con

stru

ctio

n

Qua

lity

Ass

uran

ce in

Des

ign

Qua

lity

Ass

uran

ce in

Siti

ng

Qua

lity

Ass

uran

ce in

Res

earc

h an

dD

evel

opm

ent

Qua

lity

Ass

uran

ce in

Man

ufac

turin

g

Qua

lity

Ass

uran

ce in

Pro

cure

men

t of

Item

s an

d Se

rvic

es

Ass

essm

ent o

f the

Impl

emen

tatio

n of

the

Qua

lity

Ass

uran

ce P

rogr

amm

e

Insp

ectio

n an

d Te

stin

g fo

r Acc

epta

nce

Doc

umen

t Con

trol a

nd R

ecor

ds

Non

-con

form

ance

Con

trol a

ndC

orre

ctiv

e A

ctio

ns

Esta

blis

hing

and

Impl

emen

ting

aQ

ualit

y A

ssur

ance

Pro

gram

me


4. Quality management system (title only)

4.1 General requirements + + + + + + + + + + + + + +4.2 Documentation requirements

(title only)

4.2.1 General + + + + + + + + +4.2.2 Quality manual + + + + + + + + +4.2.3 Control of documents + + + + + + + + + + +4.2.4 Control of quality records + + + + + + + + + + +5. Management responsibility

(title only)

5.1 Management commitment + + + + + + + + + + + + + +5.2 Customer focus

5.3 Quality policy + + + + + + + +5.4 Planning (title only)

5.4.1 Quality objectives + + + + + + + +5.4.2 Quality management system

planning+ + + + + + +

5.5 Responsibility, authority and communication (title only)

5.5.1 Responsibility and authority + + + + + + + + + + + + + +5.5.2 Management representative

5.5.3 Internal communication + + + + + + + +

44

1 2 3 4 5 6 7 8 9 10 11 12 13 14


Qua

lity

Ass

uran

ce in

Dec

omm

issi

onin

g

Qua

lity

Ass

uran

ce in

Ope

ratio

n

Qua

lity

Ass

uran

ce in

Com

mis

sion

ing

Qua

lity

Ass

uran

ce in

Con

stru

ctio

n

Qua

lity

Ass

uran

ce in

Des

ign

Qua

lity

Ass

uran

ce in

Siti

ng

Qua

lity

Ass

uran

ce in

Res

earc

h an

dD

evel

opm

ent

Qua

lity

Ass

uran

ce in

Man

ufac

turin

g

Qua

lity

Ass

uran

ce in

Pro

cure

men

t of

Item

s an

d Se

rvic

es

Ass

essm

ent o

f the

Impl

emen

tatio

n of

the

Qua

lity

Ass

uran

ce P

rogr

amm

e

Insp

ectio

n an

d Te

stin

g fo

r Acc

epta

nce

Doc

umen

t Con

trol a

nd R

ecor

ds

Non

-con

form

ance

Con

trol a

ndC

orre

ctiv

e A

ctio

ns

Esta

blis

hing

and

Impl

emen

ting

aQ

ualit

y A

ssur

ance

Pro

gram

me


5.6 Management review (title only)

5.6.1 General + + + + + + + +

5.6.2 Review input + + + + + + + +

5.6.3 Review output + + + + + + + +

6. Resource management (title only)

6.1 Provision of resources + + + + + + + +

6.2 Human resources (title only)

6.2.1 General + + + + + + + +

6.2.2 Competence, awareness and training

+ + + + + + + + + + + + + +

6.3 Infrastructure + + + + + + + + +

6.4 Work environment + + + + + + + + +

7. Product realization (title only)

7.1. Planning of product realization + + + + + + + + + +

7.2 Customer related processes (title only)

7.2.1 Determination of requirements related to the product

+ + + + + + + + +

7.2.2 Review of requirements related to the product

+ + + + + + + + +

7.2.3 Customer communication

7.3 Design and development (title only)

7.3.1 Design and development planning

+ + + + + + +

45

1 2 3 4 5 6 7 8 9 10 11 12 13 14


Qua

lity

Ass

uran

ce in

Dec

omm

issi

onin

g

Qua

lity

Ass

uran

ce in

Ope

ratio

n

Qua

lity

Ass

uran

ce in

Com

mis

sion

ing

Qua

lity

Ass

uran

ce in

Con

stru

ctio

n

Qua

lity

Ass

uran

ce in

Des

ign

Qua

lity

Ass

uran

ce in

Siti

ng

Qua

lity

Ass

uran

ce in

Res

earc

h an

dD

evel

opm

ent

Qua

lity

Ass

uran

ce in

Man

ufac

turin

g

Qua

lity

Ass

uran

ce in

Pro

cure

men

t of

Item

s an

d Se

rvic

es

Ass

essm

ent o

f the

Impl

emen

tatio

n of

the

Qua

lity

Ass

uran

ce P

rogr

amm

e

Insp

ectio

n an

d Te

stin

g fo

r Acc

epta

nce

Doc

umen

t Con

trol a

nd R

ecor

ds

Non

-con

form

ance

Con

trol a

ndC

orre

ctiv

e A

ctio

ns

Esta

blis

hing

and

Impl

emen

ting

aQ

ualit

y A

ssur

ance

Pro

gram

me


7.3.2 Design and development inputs

+ + + + + + +

7.3.3 Design and development outputs

+ + + + + + +

7.3.4 Design and development review

+ + + + + + +

7.3.5 Design and development verification

+ + + + + + +

7.3.6 Design and development validation

+ + + + + + +

7.3.7 Control of design and development changes

+ + + + + + +

7.4 Purchasing (title only)

7.4.1 Purchasing process + + + + + + + +

7.4.2 Purchasing information + + + + + + + +

7.4.3 Verification of purchased product

+ + + + + + + + +

7.5 Production and service provision (title only)

7.5.1 Control of production and service provision

+ + + + + + + +

7.5.2 Validation of processes for pro-duction and service provision

+ +

7.5.3 Identification and traceability + + + + + + + + + + +

7.5.4 Customer property

7.5.5 Preservation of product + + + + + + + +

7.6 Control of monitoring and measuring devices

+ + + + + + + + +

46

1 2 3 4 5 6 7 8 9 10 11 12 13 14


Qua

lity

Ass

uran

ce in

Dec

omm

issi

onin

g

Qua

lity

Ass

uran

ce in

Ope

ratio

n

Qua

lity

Ass

uran

ce in

Com

mis

sion

ing

Qua

lity

Ass

uran

ce in

Con

stru

ctio

n

Qua

lity

Ass

uran

ce in

Des

ign

Qua

lity

Ass

uran

ce in

Siti

ng

Qua

lity

Ass

uran

ce in

Res

earc

h an

dD

evel

opm

ent

Qua

lity

Ass

uran

ce in

Man

ufac

turin

g

Qua

lity

Ass

uran

ce in

Pro

cure

men

t of

Item

s an

d Se

rvic

es

Ass

essm

ent o

f the

Impl

emen

tatio

n of

the

Qua

lity

Ass

uran

ce P

rogr

amm

e

Insp

ectio

n an

d Te

stin

g fo

r Acc

epta

nce

Doc

umen

t Con

trol a

nd R

ecor

ds

Non

-con

form

ance

Con

trol a

ndC

orre

ctiv

e A

ctio

ns

Esta

blis

hing

and

Impl

emen

ting

aQ

ualit

y A

ssur

ance

Pro

gram

me


8. Measurement, analysis and improvement (title only)

8.1 General + + + + + + + + +8.2 Monitoring and measurement

(title only)

8.2.1 Customer satisfaction

8.2.2 Internal audit + + + + + + + + +8.2.3 Monitoring and measurement

of processes+ + + + + + + + + +

8.2.4 Monitoring and measurement of product + + + + + + + +

8.3 Control of non-conforming product

+ + + + + + + + + +

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

8.5.1 Continual improvement + + + + + + + + + + + + + +8.5.2 Corrective action + + + + + + + +8.5.3 Preventive action + + + + + + + +

REFERENCES

[1] INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Assurance for Safety inNuclear Power Plants and other Nuclear Installations, Code and Safety Guides Q1–Q14,Safety Series No. 50-C/SG-Q, IAEA, Vienna (1996).

[2] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, QualityManagement Systems — Requirements, ISO Standard 9001:2000, Geneva (2000).

[3] INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Assurance Standards:Comparison between IAEA 50-C/SG-Q and ISO 9001:1994, IAEA-TECDOC-1182,Vienna (2000).

[4] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, QualityManagement Systems — Guidelines for Performance Improvements, ISO Standard9004:2000, Geneva (2000).

[5] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, QualityManagement Systems — Fundamentals and Vocabulary, ISO Standard 9000:2000,Geneva (2000).

47

CONTRIBUTORS TO DRAFTING AND REVIEW

Berthon, P. European Atomic Forum (FORATOM)

Cerzosimo, R. Webcraft Inc., United States of America

Clark, C.R. International Atomic Energy Agency

Danielson, G., Jr. Department of Energy, United States of America

Dua, S. Atomic Energy of Canada Limited, Canada

Florescu, N. Cernavoda Nuclear Power Plant, Romania

Glauser, E.C. Swiss Federal Nuclear Safety Inspectorate, Switzerland

Hille, M. Siemens AG, Germany

Karbassioun, A. International Atomic Energy Agency

Kleinert, K.-P. Siemens AG, Germany

Lehman, J.P. European Atomic Forum (FORATOM)

Lyne, D. International Organization for Standardization

Mazzini, M. Comisión Nacional de Energía Atómica, Argentina

Perrin, R. Framatome, France

Pieroni, N. International Atomic Energy Agency

Redman, N. Amethyst Management Ltd, United Kingdom

Rim, Y. KEPCO, Republic of Korea

Rondinell, V. Eletronuclear, Brazil

Sandberg, B. Forsmarks Kraftgrupp AB, Sweden

Steinberg, N. Atomaudit Ltd, Ukraine

Szabo, T. International Organization for Standardization

Van der Geld, F. Stork Nucon BV, Netherlands

Vassileva, E. Kozloduy Nuclear Power Plant, Bulgaria

Vincze, P. Paks Nuclear Power Plant, Hungary

Watson, G. International Organization for Standardization

Consultants Meetings

Vienna, Austria: 19–21 January 1999, 10–13 September 2001

Advisory Group Meeting

Vienna, Austria: 11–13 January 2000

48

Safety Reports Series No · quality standards: comparison between iaea 50-c/sg-q and iso 9001:2000...

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Transcript of Safety Reports Series No · quality standards: comparison between iaea 50-c/sg-q and iso 9001:2000...