SIST-TP CEN ISO/TR 4450:2023

SLOVENSKI STANDARD
01-januar-2023
Sistemi vodenja kakovosti - Navodila za uporabo standarda ISO 19443:2018
(ISO/TR 4450:2020)
Quality management systems - Guidance for the application of ISO 19443:2018 (ISO/TR
4450:2020)
Systèmes de management de la qualité - Lignes directrices pour l'application de l'ISO
19443:2018 (ISO/TR 4450:2020)
Ta slovenski standard je istoveten z: CEN ISO/TR 4450:2022
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.

CEN ISO/TR 4450
TECHNICAL REPORT
RAPPORT TECHNIQUE
October 2022
TECHNISCHER REPORT
ICS 03.120.10; 27.120.01; 03.100.70
English Version
Quality management systems - Guidance for the
application of ISO 19443:2018 (ISO/TR 4450:2020)
Systèmes de management de la qualité - Lignes
directrices pour l'application de l'ISO 19443:2018
(ISO/TR 4450:2020)
This Technical Report was approved by CEN on 23 October 2022. It has been drawn up by the Technical Committee CEN/TC 430.

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United Kingdom.
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COMITÉ EUROPÉEN DE NORMALISATION

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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. CEN ISO/TR 4450:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO/TR 4450:2020 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 CEN ISO/TR 4450:2022 by Technical Committee CEN/TC 430 “Nuclear
energy, nuclear technologies, and radiological protection” the secretariat of which is held by AFNOR.
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.
Endorsement notice
The text of ISO/TR 4450:2020 has been approved by CEN as CEN ISO/TR 4450:2022 without any
modification.
TECHNICAL ISO/TR
REPORT 4450
First edition
2020-09
Quality management systems —
Guidance for the application of ISO
19443:2018
Systèmes de management de la qualité — Lignes directrices pour
l'application de l'ISO 19443:2018
Reference number
ISO/TR 4450:2020(E)
©
ISO 2020
ISO/TR 4450:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO/TR 4450:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization . 1
4.1 Understanding the organization and its context . 1
4.2 Understanding the needs and expectations of interested parties . 1
4.3 Determining the scope of the quality management system . 1
4.4 Quality management system and its processes . 1
5 Leadership . 2
5.1 Leadership and commitment . 2
5.1.1 General. 2
5.1.2 Customer focus . 2
5.1.3 Nuclear safety culture . 2
5.2 Policy . 3
5.2.1 Establishing the quality policy . 3
5.2.2 Communicating the quality policy . 3
5.3 Organizational roles, responsibilities and authorities. 3
6 Planning . 3
6.1 Actions to address risks and opportunities . 3
6.2 Quality objectives and planning to achieve them . 6
6.3 Planning of changes . 6
7 Support . 6
7.1 Resources . 6
7.1.1 General. 6
7.1.2 People . 7
7.1.3 Infrastructure . 7
7.1.4 Environment for the operation of processes . 7
7.1.5 Monitoring and measuring resources . 7
7.1.6 Organizational knowledge . 8
7.2 Competence . 8
7.3 Awareness . 8
7.4 Communication . 8
7.5 Documented information . 8
7.5.1 General. 9
7.5.2 Creating and updating . 9
7.5.3 Control of documented information . 9
8 Operation .10
8.1 Operational planning and control .10
8.1.1 Provisions for Counterfeit, Fraudulent or Suspect (CFS) items .10
8.2 Requirements for products and services .10
8.2.1 Customer communication .10
8.2.2 Determination of requirements related for products and services .10
8.2.3 Review of requirements related for products and services .10
8.2.4 Changes to requirements for products and services .10
8.3 Design and development of products and services .10
8.4 Control of externally provided processes, products and services .10
8.4.1 General.10
8.4.2 Type and extent of control .11
8.4.3 Information for external providers .12
ISO/TR 4450:2020(E)
8.5 Production and service provision .12
8.5.1 Control of production and service provision .12
8.5.2 Identification and traceability .12
8.5.3 Property belonging to customers or external providers .12
8.5.4 Preservation .12
8.5.5 Post-delivery activities .12
8.5.6 Control of changes .13
8.6 Release of products and services .13
8.7 Control of nonconforming outputs .13
9 Performance evaluation .13
9.1 Monitoring, measurement, analysis and evaluation .13
9.1.1 General.13
9.1.2 Customer satisfaction .13
9.1.3 Analysis and evaluation .13
9.2 Internal audit .13
9.3 Management review .13
9.3.1 General.13
9.3.2 Management review inputs .13
9.3.3 Management review outputs .13
10 Improvement .14
10.1 General .14
10.2 Nonconformity and corrective action .14
10.3 Continual improvement .14
Annex A (informative) Additional requirements of ISO 19443:2018 versus ISO 9001:2015.15
Annex B (informative) How to perform a risk analysis for the project? .18
Annex C (informative) Determination of ITNS items and activities .22
Annex D (informative) Practical example of determination of ITNS items and activities .24
Annex E (informative) Typical (general) example for graded approach .27
Annex F (informative) Practical example of graded approach .29
Annex G (informative) Metrological guidelines .32
Annex H (informative) Competence and qualification .35
Annex I (informative) Awareness training for personnel .38
Annex J (informative) List of ISO 19443 additional requirements related to documented
information .42
Annex K (informative) Good practices for 8.3 .45
Annex L (informative) Demonstration of the evidence of provisions for monitoring activities .50
Annex M (informative) Example of scheme for non-conformance information and request
for approval along supply chain .53
Bibliography .54
iv © ISO 2020 – All rights reserved

ISO/TR 4450:2020(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 relationship of ISO standards to the IAEA safety standards (http:// www -ns .iaea .org/ standards/ )
needs to be understood to avoid confusions.
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 of 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 www .iso .org/
iso/ foreword .html.
This document was prepared by the Technical Committee ISO/TC 85, Nuclear energy, nuclear
technologies, and radiological protection WG 4, Management systems and conformity assessment.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
ISO/TR 4450:2020(E)
Introduction
As general consideration, this guideline document:
— has been developed to assist users to apply the quality management system requirements of
ISO 19443:2018 by organizations in the supply chain of the nuclear energy sector supplying products
[1]
and services important to nuclear safety (ITNS) ,
— does not add to, subtract from, or in any way modify those requirements,
— does not prescribe mandatory approaches to implementation, or provide any preferred method of
[2]
interpretation of ISO 19443:2018 requirements supplementing those of ISO 9001:2015 , but only
provide examples of possible solutions an organization can implement to meet the requirements,
— proposes also good practices for some clauses of ISO 9001 when applied to ISO 19443.
[2]
Where there is no supplementary text to ISO 9001 (refer also to Annex A which gives a global picture
of additional requirements of ISO 19443:2018 versus ISO 9001:2015), the sentence “No ISO 19443
additional requirement to ISO 9001” has been included. In this case, for guidance on the initial text of
ISO 9001, refer to:
[2]
• ISO 9001:2015 , Annex A,
[3]
• ISO/TS 9002 , and
[4]
• ISO/IAF Auditing Practices Group .
Where it is considered that the added text is self-explanatory and thus no guidance has been added, the
sentence “No supplementary guidance provided “ has been included.
This guidance follows the layout of ISO 19443 and thus, users need to clearly understand the vocabulary
of ISO 9000 and ISO 9001, which underlie it, before addressing the added text in ISO 19443.
The delivery of all products or services will involve tiers (See Figure 1) to which the Licensee
requirements will be cascaded through Contractor(s) using technical specifications, procedures,
management system (including Quality Assurance and Quality Control) requirements, and other
contractual documents.
At each level, the external provider (called hereby “contractor”, “supplier” or “sub-supplier”) will be
potentially in position to be “the organization” considered by ISO 19443.
vi © ISO 2020 – All rights reserved

ISO/TR 4450:2020(E)
Figure 1 — Schematic breakdown of tiers.
0.1 General
No ISO 19443 additional requirement to ISO 9001.
0.2 Quality management principles
No supplementary guidance provided.
0/3 Process approach
No ISO 19443 additional requirement to ISO 9001.
0.4 Relationship with other management system standards
No supplementary guidance provided.
TECHNICAL REPORT ISO/TR 4450:2020(E)
Quality management systems — Guidance for the
application of ISO 19443:2018
1 Scope
This document provides guidance on the implementation of the ISO 19443 requirements, with examples
of possible steps an organization can take to meet the requirements.
It does not add to, subtract from, or in any way modify those requirements.
This document does not prescribe mandatory approaches to implementation, or provide any preferred
method of interpretation.
2 Normative references
There are no normative references in this document.
No ISO 19443 additional requirement to ISO 9001.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Context of the organization
4.1 Understanding the organization and its context
As part of risk-based thinking of ISO 19443:2018, 0.3.3, the organization should consider any risks and
the nuclear safety implications to its activities.
Refer also to Annex B.
4.2 Understanding the needs and expectations of interested parties
No ISO 19443 additional requirement to ISO 9001.
4.3 Determining the scope of the quality management system
No ISO 19443 additional requirement to ISO 9001.
4.4 Quality management system and its processes
4.4.1 No ISO 19443 additional requirement to ISO 9001.
4.4.2 No ISO 19443 additional requirement to ISO 9001.
ISO/TR 4450:2020(E)
[5]
4.4.3 Refer to ISO 9000:2015 for definition of quality manual or quality plan and to following
standards referenced in ISO 9001:2015, Annex B:
[6]
— ISO 10005, Quality management systems — Guidelines for quality plans . This document provides
guidance on establishing and using quality plans as a means of relating requirements of the process,
product, project or contract, to work methods and practices that support product realization.
Benefits of establishing a quality plan are increased confidence that requirements will be met, that
processes are in control and the motivation that this can give to those involved.
[7]
— ISO 10006, Quality management systems — Guidelines for quality management in projects . This
document is applicable to projects from the small to large, from simple to complex, from an individual
project to being part of a portfolio of projects. ISO 10006 is to be used by personnel managing
projects and who need to ensure that their organization is applying the practices contained in the
ISO quality management
The intent of this subclause is for the organization to demonstrate compliance with ISO 19443
requirements, whatever the form, format or media. Quality manual and/or quality plan are examples
of typical ways to comply with this clause, but any other means (e.g. matrix, correspondence table, etc.)
can be used.
5 Leadership
Material can be found as guidelines for whole chapter 5 in the following documents.
[21]
— IAEA, Safety Series No.75-INSAG-4, 1991 – Safety Culture
[22]
— INPO – “Principles for a Strong Nuclear Safety Culture”
[23]
— WANO – Principles PL | 2013-1 - Traits of a Healthy Nuclear Safety Culture
[24]
— IAEA, No.INSAG-10, 1996 – Defence in Depth in Nuclear Safety
[25]
— AIEA, No.INSAG-13, 1999 – Management of Operational Safety in Nuclear Power Plants
[26]
— IAEA, No.INSAG-15, 2002 – Key Practical Issues in Strengthening Safety Culture
[27]
— IAEA Bulletin 50-1 – September 2008 – The mind-set of nuclear safety
[28]
— IAEA General Safety Requirements - GSR Part 2:2016 - Leadership and Management for Safety
— IAEA Safety Guide No. GS-G-3.1:2006 - Application of the Management System for Facilities and
[29]
Activities
[30]
— IAEA Safety Reports Series No 83:2016 - Performing Safety Culture Self-assessments
5.1 Leadership and commitment
5.1.1 General
No supplementary guidance provided.
5.1.2 Customer focus
No ISO 19443 additional requirement to ISO 9001.
5.1.3 Nuclear safety culture
[8]
Definition of IAEA Safety glossary :
2 © ISO 2020 – All rights reserved

ISO/TR 4450:2020(E)
The assembly of characteristics and attitudes in organizations and individuals which establishes that, as an
overriding priority, protection and safety issues receive the attention warranted by their significance.
Section 5.1.3 of the standard addresses the principles of nuclear safety culture as a contribution to
nuclear safety, see Figure 2:
Figure 2 — Nuclear safety and nuclear safety culture
5.2 Policy
5.2.1 Establishing the quality policy
Appropriate nuclear safety considerations of 5.2.1 e) should take into account nuclear safety culture
aspects.
It’s up to the organization to develop separated policies for quality and safety or an integrated one.
5.2.2 Communicating the quality policy
No ISO 19443 additional requirement to ISO 9001.
5.3 Organizational roles, responsibilities and authorities
No supplementary guidance provided.
6 Planning
6.1 Actions to address risks and opportunities
No supplementary guidance provided.
ISO/TR 4450:2020(E)
6.1.1 The only ISO 19443 additional requirement to ISO 9001 is the requirement to maintain and retain
documented information issued to identify actions to address risks and opportunities. As reminder of
the state of the art, the following can be considered as a good practice for both 6.1.1 and 6.1.2.
The organization should develop a documented risk management method, related to the achievement of
applicable requirements. This includes, as appropriate to the organization and the product:
a) assignment of responsibilities for risk management;
b) definition of risk criteria (e.g., likelihood, consequences, risk acceptance), which could require use
of probabilistic model;
c) identification, assessment and communication of risks throughout product realization including
supply chain;
d) identification, implementation and management of actions to mitigate risks that exceed the defined
risk acceptance criteria;
e) tolerability of risks remaining after implementation of mitigating actions.
See Annex B for proposed practical solution.
6.1.2 See above 6.1.1.
6.1.3 Determination of ITNS items and activities
Depending on the context of the product or service, the determination of ITNS items and activities
can generally be performed by the following technical analysis performed in two consecutive steps as
shown in Figure 3.
Figure 3 — Determination of ITNS items and activities (see practical example In Annex D)
4 © ISO 2020 – All rights reserved

ISO/TR 4450:2020(E)
Annex D - Step #3 is performed in two steps.
— Step #3-1: The product or service would normally be broken down in different items or activities
[see ISO 19443:2018, 6.1.3 a)]. When relevant and depending on the complexity of product and
service, following analysis methods can be used: F.A.S.T. (Functional Analysis System Technique),
Value engineering, etc.
— Step #3-2: Identification of the impact of the potential failure or malfunction of each item or activity
on the product or service function(s) specified by the customer as related to nuclear safety [see
ISO 19443:2018, 6.1.3 b)]:
— a risk analysis, performed for each item or activity, would support this identification, considering
that the conclusion should be formulated in a binary sense (ITNS or non-ITNS);
— it is recommended to refer to one of the different type of risk analysis methods as listed in
[9]
IEC/ISO 31010 , e.g. Failure modes and effects analysis (FMEA).
NOTE When appropriate, design/construction codes or standards can be used for identification
of the impact of the potential failure or malfunction of each item or activity on the above function(s)
related to nuclear safety.
For a practical example (electromechanical pump) of ITNS determination, refer to Annex D.
6.1.4 Graded approach to the application of quality requirements
The intent of the ISO 19443 is to define the graded approach as it should be applied by the organization
to the items constituting and/or activities resulting in the ITNS product or service ordered by the
customer. A practical understanding of the requirement would be:
Items and/or activities supplied by the organization itself:
— Quality management. Set of requirements are those of ISO 19443 since the product or service
supplied by the organization to its customer is ITNS. However, the organization can grade, for
each item or activity, the conditions in which the implementation of all ISO 19443 requirements is
performed, to the extent authorized by ISO 19443 provisions, with a particular focus on:
— Documentation requirements. As an example, grading provisions could address number and
extent (complexity, level of detail, …) of documented information (from a single certificate
of compliance to a full set of lifetime records, procedures, plans, specifications, drawings,
reports, …) the organization maintains and retains for the item or activity, having regard to the
appropriate level of assurance to be established, based on the level of risk (i.e. ITNS or not),
— Monitoring and measurement requirements. Grading examples could be, but not limited to:
— Conditions for review and/or approval of documented information.
— Internal assessment and oversight of processes (internal audit, inspection, document review
…). It’s recommended that the oversight particularly takes into consideration the processes
“the result of which the specified quality cannot be readily determined by inspection of test
of the product”.
— Design and development : number and type of reviews (e.g. peer reviews), methods of
verification, means of validation (e.g. testing, alternative calculations, mock-ups, …).
— Production control: sampling procedures, witness/hold points on ITP, resources, gate
reviews …
ISO/TR 4450:2020(E)
Items and/or activities supplied by an external provider:
— Quality management. The set of requirements determined as applicable for the external provider
could be, but not limited to:
— for externally provided “ITNS items and activities”: ISO 19443,
— for externally provided “non ITNS items and activities”, one of the following given as
examples: ISO 9001, specific quality management requirements, industrial good practices,
no particular ones.
— Documentation requirements. As an example, grading provisions could address number and
extent (complexity, level of detail, …) of documented information, defined having regard to the
appropriate level of assurance to be established, based on the level of risk (i.e. ITNS or not):
— the organization should issue for control of externally provided item and activities,
— the external provider should maintain and retain for the item or activity (from a single
certificate of compliance to a full set of lifetime records, procedures, plans, specifications,
drawings, reports, …),
— Monitoring and measurement requirements. Grading examples could be, but not limited to:
— Conditions for review and/or approval by the organization of documented information issued
by the external provider,
— External provider assessment and processes oversight (audit, inspection, document review,
design and development reviews, …) through sampling rules, witness/hold points, gate reviews
… It’s recommended that the oversight particularly takes into consideration the processes “the
result of which the specified quality cannot be readily determined by inspection of test of the
product”.
Refer to Annex E for typical general example of grading and to Annex F for a practical simplified example
(electromechanical pump) of grading.
For more general information, refer to:
[10]
— IAEA-TECDOC-1740 ;
[11]
— IAEA-Technical Report-328 .
6.2 Quality objectives and planning to achieve them
6.2.1 No supplementary guidance provided.
6.2.2 No ISO 19443 additional requirement to ISO 9001.
6.3 Planning of changes
No supplementary guidance provided.
7 Support
7.1 Resources
7.1.1 General
No supplementary guidance provided.
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ISO/TR 4450:2020(E)
7.1.2 People
No ISO 19443 additional requirement to ISO 9001.
7.1.3 Infrastructure
No ISO 19443 additional requirement to ISO 9001.
7.1.4 Environment for the operation of processes
b) Psychological
Nuclear safety culture studies have identified that it is important that the workforce can be
open with reporting when they have made mistakes. Experience has shown that this requires
management to have a non-blaming approach, though still considering the root-causes of mistakes
may require changes in activities, retraining or ultimately removal from ITNS work.
c) Physical
Cleanliness is a significant matter in the manufacture, assembly and construction of Structures
Systems and Components (SSCs) that will be subject to ionising radiation.
7.1.5 Monitoring and measuring resources
7.1.5.1 General
Nuclear SSCs frequently require fine tolerances and thus, it is necessary to put the emphasis on
measuring resources requirements within nuclear context compared to current industrial practices.
Therefore, particular attention is drawn to situations (See Figure G.1) where:
— the measuring interval of the measuring equipment is much higher than the measurand (e.g. when
use of a ruler of 0,3 m rather than a micrometer 0 mm to 25 mm for the acceptance of a measurand
of 0,5 mm),
— the measured value is close to the specified limits (boundaries of specification zone) and therefore,
due to measurement uncertainty, the real value may be outside the specification zone,
— the measurement uncertainty is much lower than the tolerance given in the specification.
To avoid or minimize incorrect judgement of conformity to requirements, it is suggested, as a good
practice, to select measuring equipment which has:
— a measuring interval close to the measurand (e.g. manometer range 0 bar to 100 bar for a measured
value of 80 bar),
— a measurement accuracy with a minimum coverage factor of 8 compared with the value of the
th
tolerance (e.g. use of a calliper with a measurement accuracy of 1/100 mm when the tolerance is
th
1/10 mm).
As a good practice, the organization should also:
— maintain a monitoring and measuring equipment register, and define the process employed for
their calibration/verification including details of equipment type, unique identification, location,
frequency of checks, check method and acceptance criteria,
— ensure that environmental conditions are suitable for the calibration, inspection, measurement and
testing being carried out.
ISO/TR 4450:2020(E)
7.1.5.2 Measurement traceability
The monitoring and measuring equipment (e.g. measuring instrument, software, measurement
standard or auxiliary apparatus or combination thereof) necessary to perform a measurement process
needs a metrological confirmation by verification and/or calibration when it is used to certify the
conformity of the product.
This metrological confirmation ensures that measuring equipment conforms to the requirements for
its intended use, taking into account calibration or verification, as referred to in Annex G.
7.1.6 Organizational knowledge
No ISO 19443 additional requirement to ISO 9001.
7.2 Competence
For definition of Competence refer to ISO 9000 and, for Qualification, interpretation is provided in
ISO 9000 and examples given in Annex H.
Examples for knowledge and skills which can be taken into account for competence are given in
Annex H.
Examples for demonstration of ability to pronounce qualification are given in Annex H.
7.3 Awareness
This awareness training for persons involved (including workers and managers) in ITNS products and
services realization should consider nuclear safety culture topics [see ISO 19443:2018, 5.1.3 a)] such as:
— What nuclear safety is;
— What an ITNS product, service, item or activity is;
— Importance and impact of individual’s role in achieving nuclear safety;
— How individuals know they are working on ITNS;
— What my role is in preventing CFS Items being brought into the organization;
— Management: leadership, decision-making and creating a respectful work environment;
— Expected behavior : questioning attitude, adherence to procedures, transparency in reporting
issues, events and NCR; …
Refer to Annex I for more detailed material.
7.4 Communication
No supplementary guidance provided.
7.5 Documented information
To confirm that the specified requirements have been met, the documentation is of great importance in
the nuclear industry (“culture of the proof”) by demonstrating
— effective performance of an action (traceability), and
— conformance with applicable requirements.
This is why ISO 19443 as added to ISO 9001 additional requirements for documented information.
Those additional requirements are identified in the table of Annex J.
8 © ISO 2020 – All rights reserved

ISO/TR 4450:2020(E)
7.5.1 General
No ISO 19443 additional requirements to ISO 9001.
For supplementary guidance, see good practices proposed by ISO 9001:2015, A.6 and ISO/TS 9002.
7.5.2 Creating and updating
Comprehensive identification of documented information is necessary especially for products and
services that will need to be replicated during the life of a nuclear facility.
Translation of documented information is not just a question of languages (Refer also to Annex H for
competence) but could also include measurement systems considerations and information (e.g. metric/
imperial, US/British liquid volumes) and date conventions (e.g. DD/MM/YYYY vs MM/DD/YYYY). It is
useful to indicate where translations have been made, when and by whom.
Consideration should be given to making a clear statement at the outset as to the systems to be applied
[12]
and abbreviations used, e.g. SI units as defined in ISO 80000 series .
The degree of review and approval of documented information will generally depend on the safety
determination of the product and services
...