EN ISO 19443:2022
(Main)Quality management systems - Specific requirements for the application of ISO 9001:2015 by organizations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety (ITNS) (ISO 19443:2018)
Quality management systems - Specific requirements for the application of ISO 9001:2015 by organizations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety (ITNS) (ISO 19443:2018)
This International Standard specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
This International Standard applies to organizations supplying ITNS products or services.
Application of this standard to organizations performing activities on a licensed nuclear site is subject to prior agreement by the Licensee.
Requirements specified in this International Standard are complementary (not alternative) to customer and applicable statutory and regulatory requirements.
Qualitätsmanagementsysteme - Spezifische Anforderungen für die Anwendung von ISO 9001:2015 für die Organisationen in der Lieferkette auf dem Sektor der Kernenergie, die für die nukleare Sicherheit wichtige Produkte und Dienstleistungen (ITNS) liefern (ISO 19443:2018)
Diese Internationale Norm ist anwendbar für Organisationen, die für die nukleare Sicherheit wichtige Produkte oder Dienstleistungen liefern.
Die Anwendung dieser Norm auf Organisationen, die Tätigkeiten an einer lizensierten kerntechnischen Anlage durchführen, bedarf der vorherigen Zustimmung des Lizenznehmers.
Die in dieser Internationalen Norm festgelegten Anforderungen sind eine Ergänzung (keine Alternative) zu Anforderungen der Kunden und zu zutreffenden gesetzlichen und behördlichen Anforderungen.
Systèmes de management de la qualité - Exigences spécifiques pour l'application de l'ISO 9001:2015 par les organisations de la chaîne d'approvisionnement du secteur de l'énergie nucléaire fournissant des produits ou services importants pour la sûreté nucléaire (IPSN) (ISO 19443:2018)
La présente Norme internationale spécifie les exigences relatives au système de management de la qualité lorsqu'un organisme:
a) doit démontrer son aptitude à fournir constamment des produits et des services conformes aux exigences des clients et aux exigences légales et réglementaires applicables; et
b) vise à accroître la satisfaction de ses clients par l'application efficace du système, y compris les processus pour l'amélioration du système et l'assurance de la conformité aux exigences des clients et aux exigences légales et réglementaires applicables.
Toutes les exigences de la présente Norme internationale sont génériques et prévues pour s'appliquer à tout organisme, quels que soient son type ou sa taille, ou les produits et services qu'il fournit.
NOTE 1 Dans la présente Norme internationale, les termes «produit» ou «service» s'appliquent uniquement aux produits et services destinés à, ou exigés par, un client.
NOTE 2 L'expression «legal requirement» recouvre en anglais le concept, utilisé dans la présente Norme internationale, d'exigence légale et réglementaire.
La présente Norme internationale s'applique aux organisations qui fournissent des produits ou services IPSN.
L'application de la présente norme à des organisations réalisant des activités sur un site nucléaire bénéficiant d'une licence est soumise à l'accord préalable du titulaire de la licence.
Les exigences spécifiées dans la présente Norme internationale sont complémentaires (et non des alternatives) aux exigences du client ainsi qu'aux exigences légales et réglementaires applicables.
Sistemi vodenja kakovosti - Posebne zahteve za uporabo standarda ISO 9001:2015 v organizacijah v dobavni verigi sektorja jedrske energije, ki dobavljajo izdelke in storitve, pomembne za jedrsko varnost (ITNS) (ISO 19443:2018)
Ta mednarodni standard določa zahteve za sistem vodenja kakovosti. Uporablja se, kadar organizacija:
a) dokazuje svojo sposobnost, da dosledno dobavlja izdelke in storitve, ki izpolnjujejo zahteve odjemalcev in ustrezne zakonodajne ter regulativne zahteve, in
b) namerava izboljšati zadovoljstvo odjemalcev z učinkovito uporabo sistema, vključno s procesi za nenehno izboljševanje sistema in zagotavljanje skladnosti z zahtevami odjemalcev ter ustreznimi zakonodajnimi in regulativnimi zahtevami.
Vse zahteve, specificirane v tem mednarodnem standardu, so splošne in namenjene za uporabo v vseh organizacijah, ne glede na vrsto in velikost ali izdelke in storitve, ki jih zagotavljajo.
OPOMBA 1: Izraza »izdelek« ali »storitev« se v tem mednarodnem standardu navezujeta samo na izdelke in storitve, ki so namenjene odjemalcu ali jih odjemalec zahteva.
OPOMBA 2: Zakonske in regulativne zahteve so lahko izražene kot pravne zahteve.
Ta mednarodni standard se uporablja za organizacije, ki dobavljajo izdelke in storitve, pomembne za jedrsko varnost (ITNS).
Za uporabo tega standarda za organizacije, ki dejavnosti izvajajo v jedrskih objektih, za katere je bilo izdano dovoljenje, je potrebno predhodno soglasje imetnika dovoljenja.
Zahteve, določene v tem mednarodnem standardu, dopolnjujejo (niso alternativna možnost za) zahteve odjemalcev ter ustrezne zakonske in regulativne zahteve.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2022
Sistemi vodenja kakovosti - Posebne zahteve za uporabo standarda ISO 9001:2015
v organizacijah v dobavni verigi sektorja jedrske energije, ki dobavljajo izdelke in
storitve, pomembne za jedrsko varnost (ITNS) (ISO 19443:2018)
Quality management systems - Specific requirements for the application of ISO
9001:2015 by organizations in the supply chain of the nuclear energy sector supplying
products and services important to nuclear safety (ITNS) (ISO 19443:2018)
Qualitätsmanagementsysteme - Spezifische Anforderungen für die Anwendung von ISO
9001 für die Organisationen in der Lieferkette auf dem Sektor der Kernenergie, die für
die nukleare Sicherheit wichtige Produkte und Dienstleistungen (ITNS) liefern (ISO
19443:2018)
Systèmes de management de la qualité - Exigences spécifiques pour l'application de
l'ISO 9001:2015 par les organisations de la chaîne d'approvisionnement du secteur de
l'énergie nucléaire fournissant des produits ou services importants pour la sûreté
nucléaire (IPSN) (ISO 19443:2018)
Ta slovenski standard je istoveten z: EN ISO 19443:2022
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
27.120.01 Jedrska energija na splošno Nuclear energy in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 19443
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2022
EUROPÄISCHE NORM
ICS 03.120.10; 27.120.01
English Version
Quality management systems - Specific requirements for
the application of ISO 9001:2015 by organizations in the
supply chain of the nuclear energy sector supplying
products and services important to nuclear safety (ITNS)
(ISO 19443:2018)
Systèmes de management de la qualité - Exigences Qualitätsmanagementsysteme - Spezifische
spécifiques pour l'application de l'ISO 9001:2015 par Anforderungen für die Anwendung von ISO 9001 für
les organisations de la chaîne d'approvisionnement du die Organisationen in der Lieferkette auf dem Sektor
secteur de l'énergie nucléaire fournissant des produits der Kernenergie, die für die nukleare Sicherheit
ou services importants pour la sûreté nucléaire (IPSN) wichtige Produkte und Dienstleistungen (ITNS) liefern
(ISO 19443:2018) (ISO 19443:2018)
This European Standard was approved by CEN on 24 July 2022.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19443:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex A (informative) A-deviations . 4
European foreword
The text of ISO 19443:2018 has been prepared by Technical Committee ISO/TC 85 "Nuclear energy,
nuclear technologies, and radiological protection” of the International Organization for Standardization
(ISO) and has been taken over as EN ISO 19443:2022 by Technical Committee CEN/TC 430 “Nuclear
energy, nuclear technologies, and radiological protection” the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2023, and conflicting national standards
shall be withdrawn at the latest by February 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 19443:2018 has been approved by CEN as EN ISO 19443:2022 without any modification.
Annex A
(informative)
A-deviations
A-deviation: National deviation due to regulations, the alteration of which is for the time being
outside the competence of the CEN-CENELEC national member.
This European Standard does not fall under any Directive/Regulation of the EU.
In the relevant CEN-CENELEC countries, these A-deviations are valid instead of the respective
provisions of the European Standard until the national situation causing the A-deviation has
changed.
Clause Deviation
all Germany
In Germany, the development and establishment of safety regulations in the fields of
nuclear technology is reserved for the Nuclear Safety Standards Commission (KTA).
Furthermore the Federal Institute for Materials Research and Testing (BAM) sets
standards for safety for the transport of radioactive materials. The latest edition of the
referenced document (including any amendments) applies.
In Germany,
- KTA 1401 "General requirements regarding quality assurance" (Federal Gazette),
- KTA 1404 “Documentation During the Construction and Operation of Nuclear Power
Plants” (Federal Gazette),
- BAM GGR-011 “Quality Assurance Measures of Packagings for Competent Authority
Approved Package Designs for the Transport of Radioactive Material”
- and BAM GGR-016 “Quality Assurance Measures of Packagings for Non-Competent
Authority Approved Package Designs for the Transport of Radioactive Material”
apply to the aspects dealt with in this European standard.
The requirements of KTA 1401, KTA 1404, BAM GGR-011 and BAM GGR-016 take
precedence over the requirements of this standard.
For explanation:
The cited KTA safety standards are mandatory due to publication in Federal Gazette (german:
Bundesanzeiger – BAnz), which is the central platform for official (legal) announcements and notices
on the federal level. BAM is a senior scientific and technical Federal institute with responsibility to
the Federal Ministry for Economic Affairs and Energy (BMWi). BAM-GGR 011 and 016 are published
in the Official Bulletin of the Federal Institute BAM (volume 48, 3/2018 and volume 44, 04/2014).
According to the administrative regulation RSEB (Official Bulletin of the Federal Ministry of
Transport and Digital Infrastructure - VkBl. 2019, p. 306), BAM as competent authority may publish -
via its official bulletin in its BAM-GGR rules - mandatory requirements for its field of competence.
INTERNATIONAL ISO
STANDARD 19443
First edition
2018-05
Quality management systems —
Specific requirements for the
application of ISO 9001:2015 by
organizations in the supply chain of
the nuclear energy sector supplying
products and services important to
nuclear safety (ITNS)
Systèmes de management de la qualité — Exigences spécifiques pour
l'application de l'ISO 9001:2015 par les organisations de la chaîne
d'approvisionnement du secteur de l'énergie nucléaire fournissant des
produits ou services importants pour la sûreté nucléaire (IPNS)
Reference number
ISO 19443:2018(E)
©
ISO 2018
ISO 19443:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
ISO 19443:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Context of the organization . 4
4.1 Understanding the organization and its context . 4
4.2 Understanding the needs and expectations of interested parties . 4
4.3 Determining the scope of the quality management system . 5
4.4 Quality management system and its processes . 5
5 Leadership . 6
5.1 Leadership and commitment . 6
5.1.1 General. 6
5.1.2 Customer focus . 7
5.1.3 Nuclear safety culture . 7
5.2 Policy . 8
5.2.1 Establishing the quality policy . 8
5.2.2 Communicating the quality policy . 8
5.3 Organizational roles, responsibilities and authorities. 9
6 Planning .10
6.1 Actions to address risks and opportunities .10
6.2 Quality objectives and planning to achieve them .11
6.3 Planning of changes .12
7 Support .13
7.1 Resources .13
7.1.1 General.13
7.1.2 People .13
7.1.3 Infrastructure .13
7.1.4 Environment for the operation of processes .14
7.1.5 Monitoring and measuring resources .14
7.1.6 Organizational knowledge .15
7.2 Competence .16
7.3 Awareness .17
7.4 Communication .17
7.5 Documented information .18
7.5.1 General.18
7.5.2 Creating and updating .18
7.5.3 Control of documented information .19
8 Operation .20
8.1 Operational planning and control .20
8.1.1 Provisions for counterfeit, fraudulent or suspect (CFS) items .20
8.2 Requirements for products and services .21
8.2.1 Customer communication .21
8.2.2 Determination of requirements related for products and services .21
8.2.3 Review of the requirements for products and services .22
8.2.4 Changes to requirements for products and services .23
8.3 Design and development of products and services .23
8.3.1 General.23
8.3.2 Design and development planning .23
8.3.3 Design and development inputs .24
8.3.4 Design and development controls .24
ISO 19443:2018(E)
8.3.5 Design and development outputs .26
8.3.6 Design and development changes . .26
8.4 Control of externally provided processes, products and services .27
8.4.1 General.27
8.4.2 Type and extent of control .28
8.4.3 Information for external providers .29
8.5 Production and service provision .31
8.5.1 Control of production and service provision .31
8.5.2 Identification and traceability .32
8.5.3 Property belonging to customers or external providers .33
8.5.4 Preservation .33
8.5.5 Post-delivery activities .34
8.5.6 Control of changes .34
8.6 Release of products and services .35
8.7 Control of nonconforming outputs .35
9 Performance evaluation .36
9.1 Monitoring, measurement, analysis and evaluation .36
9.1.1 General.36
9.1.2 Customer satisfaction .37
9.1.3 Analysis and evaluation .37
9.2 Internal audit .38
9.3 Management review .39
9.3.1 General.39
9.3.2 Management review inputs .39
10 Improvement .40
10.1 General .40
10.2 Nonconformity and corrective action .41
10.3 Continual improvement .42
Bibliography .43
iv © ISO 2018 – All rights reserved
ISO 19443:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies,
and radiological protection.
ISO 19443:2018(E)
Introduction
ISO collaborates closely with the International Atomic Energy Agency (IAEA). The IAEA establishes
standards for safety for use by its member states in the framework of national regulations. ISO
standards in the field of nuclear safety are complementary technical documents.
In this document, the text reproduced from ISO 9001:2015 is placed in boxes, in order to distinguish it
from the sector-specific requirements for nuclear safety given for each clause. It is understood that the
requirements of each clause include requirements for nuclear safety. Whenever the ISO 9001:2015 text
refers to “this International Standard”, this applies to this document, including the text outside the boxes.
Informative annexes referenced in ISO 9001:2015 are not included in this document.
0.1 General
ISO 9001:2015, Quality management systems — Requirements
0.1 General
The adoption of a quality management system is a strategic decision for an organization that can
help to improve its overall performance and provide a sound basis for sustainable development
initiatives.
The potential benefits to an organization of implementing a quality management system based on
this International Standard are:
a) the ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements.
This International Standard can be used by internal and external parties.
It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are
complementary to requirements for products and services.
This International Standard employs the process approach, which incorporates the Plan-Do-Check-
Act (PDCA) cycle and risk-based thinking.
The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and
managed, and that opportunities for improvement are identified and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes
and its quality management system to deviate from the planned results, to put in place preventive
controls to minimize negative effects and to make maximum use of opportunities as they arise
(see Clause A.4).
vi © ISO 2018 – All rights reserved
ISO 19443:2018(E)
Consistently meeting requirements and addressing future needs and expectations poses a challenge
for organizations in an increasingly dynamic and complex environment. To achieve this objective, the
organization might find it necessary to adopt various forms of improvement in addition to correction
and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated
requirement.
0.2 Quality management principles
ISO 9001:2015, Quality management systems — Requirements
0.2 Quality management principles
This International Standard is based on the quality management principles described in ISO 9000.
The descriptions include a statement of each principle, a rationale of why the principle is important
for the organization, some examples of benefits associated with the principle and examples of typical
actions to improve the organization’s performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
The following also apply:
— nuclear safety culture;
— determination of ITNS items and activites;
— graded approach to the application of quality requirements.
ISO 19443:2018(E)
0.3 Process approach
0.3.1 General
ISO 9001:2015, Quality management systems — Requirements
0.3 Process approach
0.3.1 General
This International Standard promotes the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality management system, to enhance customer
satisfaction by meeting customer requirements. Specific requirements considered essential to the
adoption of a process approach are included in 4.4.
Understanding and managing interrelated processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its intended results. This approach enables the organization
to control the interrelationships and interdependencies among the processes of the system, so that
the overall performance of the organization can be enhanced.
The process approach involves the systematic definition and management of processes, and their
interactions, so as to achieve the intended results in accordance with the quality policy and strategic
direction of the organization. Management of the processes and the system as a whole can be
achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3)
aimed at taking advantage of opportunities and preventing undesirable results.
The application of the process approach in a quality management system enables:
a) understanding and consistency in meeting requirements;
b) the consideration of processes in terms of added value;
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and information.
Figure 1 gives a schematic representation of any process and shows the interaction of its elements.
The monitoring and measuring checkpoints, which are necessary for control, are specific to each
process and will vary depending on the related risks.
viii © ISO 2018 – All rights reserved
ISO 19443:2018(E)
Figure 1 — Schematic representation of the elements of a single process
ISO 19443:2018(E)
0.3.2 Plan-Do-Check-Act cycle
ISO 9001:2015, Quality management systems — Requirements
0.3.2 Plan-Do-Check-Act cycle
The PDCA cycle can be applied to all processes and to the quality management system as a whole. Fig-
ure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.
NOTE Numbers in brackets refer to the clauses in this International Standard.
Figure 2 — Representation of the structure of this International Standard in the PDCA cycle
The PDCA cycle can be briefly described as follows:
— Plan: establish the objectives of the system and its processes, and the resources needed to deliver
results in accordance with customers’ requirements and the organization’s policies, and identify
and address risks and opportunities;
— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and
services against policies, objectives, requirements and planned activities, and report the results;
— Act: take actions to improve performance, as necessary.
x © ISO 2018 – All rights reserved
ISO 19443:2018(E)
0.3.3 Risk-based thinking
ISO 9001:2015, Quality management systems — Requirements
0.3.3 Risk-based thinking
Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management
system. The concept of risk-based thinking has been implicit in previous editions of this
International Standard including, for example, carrying out preventive action to eliminate potential
nonconformities, analysing any nonconformity that do occur, and taking action to prevent recurrence
that is appropriate for the effects of the nonconformity.
To conform to the requirements of this International Standard, an organization needs to plan and
implement actions to address risks and opportunities. Addressing both risks and opportunities
establishes a basis for increasing the effectiveness of the quality management system, achieving
improved results and preventing negative effects.
Opportunities can arise as a result of a situation favourable to achieving an intended result, for
example, a set of circumstances that allow the organization to attract customers, develop new
products and services, reduce waste or improve productivity. Actions to address opportunities
can also include consideration of associated risks. Risk is the effect of uncertainty and any such
uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide
an opportunity, but not all positive effects of risk result in opportunities.
ISO 19443:2018(E)
0.4 Relationship with other management system standards
ISO 9001:2015, Quality management systems — Requirements
0.4 Relationship with other management system standards
This International Standard applies the framework developed by ISO to improve alignment among
its International Standards for management systems (see Clause A.1).
This International Standard enables an organization to use the process approach, coupled with the
PDCA cycle and risk-based thinking, to align or integrate its quality management system with the
requirements of other management system standards.
This International Standard relates to ISO 9000 and ISO 9004 as follows:
— ISO 9000, Quality management systems — Fundamentals and vocabulary provides essential
background for the proper understanding and implementation of this International Standard;
— ISO 9004, Managing for the sustained success of an organization — A quality management approach
provides guidance for organizations that choose to progress beyond the requirements of this
International Standard.
Annex B provides details of other International Standards on quality management and quality
management systems that have been developed by ISO/TC 176.
This International Standard does not include requirements specific to other management systems,
such as those for environmental management, occupational health and safety management, security
management, nuclear accounting and control or financial management.
Sector-specific quality management system standards based on the requirements of this
International Standard have been developed for a number of sectors. Some of these standards specify
additional quality management system requirements, while others are limited to providing guidance
to the application of this International Standard within the particular sector.
A matrix showing the correlation between the clauses of this edition of this International Standard
and the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site
at: www .iso .org/tc176/sc02/public.
Management system requirements specific to security management, and nuclear material accounting
and control are not addressed in this International Standard.
xii © ISO 2018 – All rights reserved
INTERNATIONAL STANDARD ISO 19443:2018(E)
Quality management systems — Specific requirements
for the application of ISO 9001:2015 by organizations in
the supply chain of the nuclear energy sector supplying
products and services important to nuclear safety (ITNS)
1 Scope
ISO 9001:2015, Quality management systems — Requirements
1 Scope
This International Standard specifies requirements for a quality management system when an
organization:
a) needs to demonstrate its ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to
any organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services
intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
This International Standard applies to organizations supplying ITNS products or services.
Application of this standard to organizations performing activities on a licensed nuclear site is subject
to prior agreement by the Licensee.
Requirements specified in this International Standard are complementary (not alternative) to customer
and applicable statutory and regulatory requirements.
ISO 19443:2018(E)
2 Normative references
ISO 9001:2015, Quality management systems — Requirements
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
ISO 9001:2015, Quality management systems — Requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the
following apply.
3.1
activity
task which contributes to the realization of the products or services
3.2
commercial grade item or activity
item (see 3.6) or activity (see 3.1) that affects nuclear safety and that was not designed, manufactured
or performed in accordance with specific nuclear requirements
Note 1 to entry: Commercial-grade items do not include items where the design and manufacturing process
require in-process inspection and verification to ensure that defects or failures to comply are identified and
corrected (i.e. where one or more critical characteristics of the item cannot be verified). Critical characteristics
are important design, material, and performance characteristics of a commercial grade item that, once verified,
will provide reasonable assurance that the item will perform its intended safety function.
Note 2 to entry: The determination of the critical characteristics, the means for verification and acceptance for
intended safety functions are the responsibility of the customer.
3.3 Counterfeit/fraudulent/suspect (CFS) item
3.3.1
counterfeit items
items that are intentionally manufactured, refurbished or altered to imitate original products without
authorization in order to pass themselves off as genuine
[SOURCE: IAEA NP-T-3.21]
3.3.2
fraudulent items
items that are intentionally misrepresented with intent to deceive
Note 1 to entry: Fraudulent items include items provided with incorrect identification, falsified or inaccurate
certification. They may also include items sold by entities that have acquired the legal right to manufacture a
specified quantity of an item but produce a larger quantity than authorized and sell the excess as legitimate
inventory.
2 © ISO 2018 – All rights reserved
ISO 19443:2018(E)
[SOURCE: IAEA NP-T-3.21]
3.3.3
suspect items
items where there is an indication or suspicion that it may not be genuine
[SOURCE: IAEA NP-T-3.21]
3.4
graded approach
process or method employed to ensure that the application of the requirements related to quality
management, documentation, monitoring and measurement is commensurate, with nuclear safety
significance
3.5
important to nuclear safety
ITNS
characteristic of a product, service, item or activity, whose failure could result in undue radiation
exposure of people or the environment
3.6
item
all-inclusive term used in place of any of the following: assembly, component, equipment, material,
module, part, software, structure, sub-assembly, sub-system, system or unit
Note 1 to entry: This definition replaces the ISO 9000 definition.
3.7
licensee
holder of a current authorization granted by the nuclear regulator to an organization that has the
responsibility for the siting, design, construction, commissioning, operation or decommissioning of a
nuclear installation
3.8
nuclear safety
achievement of proper operating conditions, prevention of accidents and mitigation of accident
consequences, resulting in protection of workers, the public and the environment from undue
radiation risks
[SOURCE: IAEA Safety glossary]
Note 1 to entry: The implementation of a quality management system is essential to ensure nuclear safety.
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