03 ISO 19443 Structure and Requirements - Handout

ISO 19443
Structure and Requirements of the ISO 19443
www.tuv-sud.com/nucleartraining
nucleartraining@tuvsud.com
TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022

Motivation
In this part of the course we will:

▪ Walk through the ISO 19443 standard
▪ Familiarize ourselves with the structure of ISO 19443
▪ Talk about the requirements of ISO 19443
Our goals are:

▪ to understand the general idea of ISO 19443
▪ to explain why the ISO 19443 standard is inevitable in the nuclear industry
TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 2

Contents
1 Introduction
2 Benefits of ISO 19443
3 Structure of ISO 19443
4 ISO 19443 Requirements
5 Summary

Introduction
▪ All ISO 9001:2015 requirements are covered in ISO 19443:2018
ISO 19443:2018:
▪ Concretizes the ISO 9001:2015 requirements
▪ Broadens the ISO 9001:2015 requirements
The Guideline to ISO 19443:2018 (ISO/TR 4450:2020)

▪ Provides additional information
▪ Provides possible methods to fulfill ISO 19443:2018 requirements
▪ Supports the use of ISO 19443:2018
▪ Contains no additional requirements

Introduction
ISO 19443 basics
▪ Conform to ISO 9001:2015 requirements

▪ Prepared in close cooperation with IAEA
▪ Takes into account

• Responsibility of each state for nuclear safety
• Historically grown national culture

Contents
1 Introduction
5 Summary

Benefits of ISO 19443
▪ International standard for the supply chain of the nuclear industry

▪ Auditing and certifying with qualified audits for the nuclear industry
▪ Increased confidence in nuclear management systems
▪ International recognition
▪ Avoidance of recurring audits of different standards
▪ One international standard instead of several national regulations
▪ Based on ISO 9001:2015 (Supplier is supposed to be familiar with ISO 9001)

Benefits of ISO 19443
▪ Simplifies bidding on the international market

▪ Simplifies access to international suppliers
▪ Confidence in the nuclear management system of the certified supplier
▪ Reduction of management system audits
Benefits for Newcomers:

▪ Easier access to the requirements of the nuclear industry
Confidence in ISO 19443 certified “nuclear management systems” is gained through

▪ Quality of audits
▪ Continuing improvement

Contents
1 Introduction
5 Summary

Structure of ISO 19443 - How to read the ISO 19443
Title and high
7 Support level structure
7.1 Resources of ISO 9001
7.1.1 General
7 Support
7.1 Resources Requirement
7.1.1 General of ISO 9001
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance
and continual improvement of the quality management system.
The organization shall consider:

a) The capabilites of, and constraints on, existing internal resources
b) What needs to be obtained from external providers. Additional
Determination and provisions of resources shall ensure that nuclear safety is not compromised. requirement
of ISO 19443
Contents
1 Introduction
5 Summary

Structure of the ISO 9001/19443
General remarks
Quality management principles
High Level
Process approach Structure
0-3
Risk-based thinking
PDCA
Terms and Definitions
Plan 4 Why do I exist? 5 Come on boss 6 Plan precisely

Do 7 All what I need 8 Let‘s do it
Check 9 Measure it or forget it
Act 10 I need to improve

Chapter 0 - General
0 Introduction
0.2 Quality 0.4 Relationship with

0.1 General Management 0.3 Process Approach other management
Principles system standards
0.3.2 Plan-Do-Check- 0.3.3 Risk-based

0.3.1 General Act Cycle Thinking

Chapter 0 - General
0.1 General
▪ Strategic introduction to quality management systems
▪ Benefits for suppliers and customers
▪ Quality management system requirements as specified are complementary to requirements for products and services
▪ Introduction to the process approach, which incorporates Plan-Do-Check-Act (PDCA) cycle and risk-based thinking
▪ Introduction to verbal forms used in the standard
no additional 19443 requirements
Verbal Forms:
• “shall“ → requirement
• “should“ → recommendation
• “may“ → permission
• “can“ → possibility or a capability

Chapter 0 - General
0.2 Quality Management Principles
▪ based on the quality management principles described in ISO 9000
Quality Management Principles Additional ISO 19443 Principles

• Leadership • Nuclear Safety Culture
• engagement of people • Determination of ITNS items
• customer focus and activities
• process approach • Graded approach to the
• evidence-based decision application of quality
making requirements
• improvement
• relationship management ITNS: Important to Nuclear Safety

Chapter 0 - General
0.3 Process approach
▪ Process approach when developing, implementing and improving the effectiveness of a quality management system
▪ Purpose: enhance customer satisfaction by meeting customer requirements
▪ Understanding and managing interrelated processes as a system
▪ Involves the systematic definition and management of processes, and their interactions
Subchapters:
▪ 0.3.2 Plan-Do-Check-Act Cycle
▪ 0.3.3 Risk-based Thinking
No specific ISO 19443 requirements

Chapter 0 - General
Sources of Activities Receivers of
Inputs Outputs
Inputs Outputs
Predecessor Matter, Matter, Subsequent

Processes Energy, Energy, Processes
Information Information
e.g. at providers e.g. at customers
(internal or external), e.g. in the form e.g. in the form (internal or external), at
at costumers, at of materials, of product, other relevant
other relevant resources, service, interested third parties
interested parties requirements decision
possible controls and check

points to monitor and
measure performance
Source: DIN EN ISO 9001:2015

Chapter 0 - General
Plan-Do-Check-Act Cycle
determine current performance implement the plan

establish a need to improve collect data
define the improvement objective
implement the change

set a new standard analyze the results
start another PDCA cycle check for deviation in implementation
Source: TÜV SÜD

Chapter 0 - General
Risk based
thinking
Preventive action to Analysing any
eliminate potential nonconformity that
nonconformities do occur
Plan and implement

Taking actions to actions to address
prevent recurrence risks and
opportunities
Source: TÜV SÜD ET

Chapter 1 - Scope
Requirements
for Organization,
that ISO 9001
demonstrates plans to enhance
provision of high customer
quality products satisfaction
performs activities
supplies ITNS
on licensed nuclear ISO 19443
items/activities
site
Source: TÜV SÜD

Chapter 1 - Scope
▪ In Addition to ISO 19443, the Guidance is a helpful tool for
organizations
Guidance on ISO 19443 / ISO TR 4450:

▪ provides guidance on the implementation of the ISO 19443
requirements
▪ provides examples of possible steps an organization can
take to meet the requirements of ISO 19443
▪ Has no additional requirements
▪ The suggestions in the guidance are not mandatory
Source: TÜV SÜD

Chapter 2, Chapter 3
▪ Chapter 2: Normative References: ISO 9001:2015 – ISO 9000:2015
▪ Chapter 3: Terms and Definitions : ISO 19443 adds the following Nuclear-specific Terms and Definitions:
Counterfeit /
Commercial grade
Activity Fraudulent / Graded Approach
item or activity
Suspect (CFS) item
Important to
Nuclear Safety Item Licensee Nuclear Safety
(ITNS)

Chapter 4 - Context of the Organization
4 – Context of the
Organization
4.2 Understanding
4.1 Understanding
the needs and 4.3 Determining the 4.4 QMS and its
the organization and
expectations of scope of the QMS Processes
its context
interested parties
4.4.3 The
4.4.1
organization shall
4.4.2
…. documentation

Chapter 4.1 Understanding the organization and its context
▪ Organization:
– Determination of external and internal issues
• relevant to organizations purpose and strategic direction
• That affect its ability to achieve intended result of organizations QMS
– Monitor and review information about issues
Additional ISO 19443 requirements

▪ issues shall consider the influence of nuclear safety
ISO TR 4450
▪ organization should consider any risks and the nuclear safety implications to its activities. → risk-based thinking (0.3.3)

Chapter 4.2 Understanding the needs and
expectations of interested parties
▪ determine the interested parties

▪ determine the requirements of these interested
parties
No additional ISO 19443 requirements

▪ Still especially relevant for the Nuclear Supply Chain,
as a lot of interested Parties are involved

Chapter 4.3 Determining the scope of the quality management system
▪ The Organization shall determine boundaries and applicability of the quality management system to establish scope with
following taken into consideration:
a) external and internal issues
b) requirements of relevant interested parties
c) products and services of organization
Further Information in
ISO 10005:2018 ‐ Quality management systems - Guidelines for quality plans
ISO 10006:2018 ‐ Quality management systems - Guidelines for quality management in projects

4.4 Quality management system and its processes
Responsibility Operation
and Authority and Control
Processes
needed for QMS
Inputs Outputs
Resources
Sequence and interaction
Risks and
Opportunities
Review

Chapter 5 - Leadership
5 – Leadership
5.3 Organizational
5.1 Leadership
roles,
and 5.2 Policy
responsibilities and
Commitment
authorities
5.2.1 5.2.2
5.1.1 5.1.2 Customer 5.1.3 Nuclear
Establishing the Communicating
General Focus Safety Culture the quality policy
quality policy

▪ Chapter 5.1 Leadership and Commitment
Top management shall demonstrate leadership and commitment by:
▪ Chapter 5.1.1 General:

a) take accountability for the effectivness of the QMS
b) ensure that quality policy and quality objectives are established
c) ensure integration of the QMS requirements into business processes
d) promote the use of process approach and risk-based thinking
e) ensure that resources needed for the QMS are available
f) communicate the importance of effective QMS
g) ensure that the QMS achieves its intended results
h) engage persons to contribute to the effectiveness of the QMS
i) promote improvement
j) support other relevant management roles
Additional ISO 19443 requirements
▪ Nuclear safety is taken into account in decision making
▪ Chapter 5.1 Leadership and Commitment
Top management shall demonstrate leadership and commitment by
▪ Chapter 5.1.2 Customer Focus

a) Ensure requirements (customer, applicable statutory and regulatory) are determined, understood and consistenly met
b) Ensure risks and opportunities and the ability to enhance customer satisfaction are determined and addressed
c) the focus on enhancing customer satisfaction is maintained

5.1 Leadership and commitment
5.1.3 Nuclear safety culture
The organization shall ensure an appropriate nuclear safety culture by consideration of

a) Leadership and commitment of top and line management to nuclear safety,
ensuring awareness by all personnel of nuclear safety and encouraging a questioning attitude
b) Appropriate approach to decision making with respect to quality, cost and schedule without compromising nuclear safety
c) Transparency in communication
d) Use of documented information
e) Reporting of issues (human, technical and organizational)
f) Lessons learned
g) Challenging unsafe acts, behaviours and conditions

ISO 19443 Requirements
Definition “Nuclear Safety Culture“
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.
Nuclear Safety
#1 = behavioural #2 = structural
individuals organization
Technological factors Nuclear Safety Culture

Source: ISO/TR 4450
TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 Unternnnnnnnnnnnn32

Chapter 5- Leadership
5.2 – Policy
5.2.1 Establishing the Policy 5.2.2 Communicating the Policy

-appropriate to purpose and context of -available and maintained as documented
organization information
-supports its strategic direction -communicated, understood and applied within
-provides framework for quality objectives the organization
-includes commitment to satisfy requirements -available to relevant interested parties
-includes commitment to improvement of QMS
-considers nuclear safety

-includes commitment to ensure nuclear safety
is not compromised

5.3 Organizational roles, responsibilites and authorities
Assign the responsibility Appoint a member of the

and authority for: organizations management,
• ensuring that QMS conforms to the requirements of the standard

who has:
• ensuring that processes are delivering their intented outputs
• the organizational independence and
• reporting on the performance of the QMS and on opportunities
authority to manage nuclear safety and
for improvement to top management
quality issues
• ensuring promotion of customer focus throughout organization
• unrestricted access to top management.
• ensuring that integrity of the QMS is maintained when changes to
it are planned and implemented
ISO 19443

Chapter 6 - Planning
6 – Planning
6.2 Quality
6.1 Actions to
objectives and 6.3 Planning of
address risks and
planning to achieve changes
opportunities
them
6.2.1, 6.2.2
6.1.3 Determination 6.1.4 Graded approach

6.1.1, 6.1.2 of ITNS items and to the application of
activities quality requirements

6.1 Actions to address risks and opportunities
Issues (4.1) 6.1.1

Consider
Requirements (4.2)
When planning for the risks and opportunities
Quality Management 6.1.1
that need to be addressed to:
System, the • give assurance that the quality management system can
organization shall… Determine achieve its intended result(s);
• enhance desirable effects;
Maintain • prevent, or reduce, undesired effects;
and • achieve improvement.
Retain 6.1.2
• actions to address risks and opportunities
Plan
• how to: integrate and implement actions into its QMS
. related documented information.. processes evaluate the effectiveness of these actions.

6.1 – Actions to address risks and
opportunities
6.1.3 Determination of ITNS items and 6.1.4 Graded approach to the application of
activities quality requirements
-grade the application of requirements related
-break down ITNS products and services into to quality management documentation,
items and activities monitoring and measurement
-determine the items and activities, whose
failure or malfunction might influence the -take into account: customer requirements for
products and/or services safety function(s) ITNS products or services , complexity of
item/activity, organizational aspects
Maintain/retain documented information

6.2 Quality objectives and planning to achieve them
6.2.1 Establishing quality objectives at relevant functions, levels and processes needed for the QMS
Quality objectives:
• Consistent with quality policy
• Measurable
• Take applicable requirements into account
• Relevant to conformity of products and services
• Relevant to enhance customer satisfaction
• Monitored
• Communicated
• Updated as appropriate
• Documented (documented information)
. Address nuclear safety (ISO 19443)

6.2 Quality objectives and planning to achieve them
6.2.2 Planning how to achieve its quality objectives
What will be done?

What resources will be
required?
Who will be responsible?
When will it be completed?
How will the results be

evaluated?

6.3 Planning of changes of the Quality Management System
Determine
• Purpose of the changes
• Potential consequences
• Integrity of the QMS
• Availability of resources
• Allocation or reallocation of responsibilities and
authorities
• The communication of changes (ISO 19443)

Changes to the QMS shall be managed to ensure that
nuclear safety is not compromised

Chapter 7 - Support
7 – Support
7.4 7.5
7.1 7.2 7.3
Communicat Documented
Resources Competence Awareness
ion Information
7.1.2 7.1.4 7.1.5 7.5.2

7.1.1 7.5.1 7.5.3 Control
Environment Monitoring +
7.1.3 Creating + of documented
General for operation measuring General information
7.1.6 of processes resources Updating

Chapter 7 - Support
▪ Chapter 7.1 Resources
The organization shall determine and provide the resources needed for :
▪ Chapter 7.1.1 General:

a) Establishment,
b) Implementation,
c) Maintenance and continual improvement of the quality management system
The organization shall consider
Internal resources
Ensure that Nuclear Safety is
not compromised..
External resources

Chapter 7 - Support
7.1 - Resources
7.1.2 People 7.1.3 Infrastructure 7.1.6 Organizational

knowledge
- provides persons -
necessary for the - provides the infrastructure

necessary for the - determines the knowledge
effective implementation necessary for the operations
of its quality operation of its processes
of its processes
management system
- Maintains the knowledge
- Determines how to acquire
No additional ISO 19443 requirements additional knowledge when
change is needed
Chapter 7 - Support
7.1.4 Environment for the operation of processes
Determine, provide and maintain a suitable environment.
Suitable environment: combination of human and

physical factors, such as
• Social
• Psychological
• Physical
• psychological factors include non-blaming ISO 19443

• physical factors include cleanliness

Chapter 7 - Support
7.1.5 – Monitoring and
measuring resources
7.1.5.1 General 7.1.5.2 Measurement traceablitiy

-provides resources to obtain valid and reliable Measuring equipment shall be:
results when monitoring or measuring is used -calibrated or verified against measurement
-resources suitable for the specific type of standards
monitoring and measuring -identified in order to determine their status
-resources maintained to ensure their fitness -safeguarded from damage
-retain documented information as evidence
-the suitability of the resources takes into -retains as documented information the
account the measuring range and output of the determination and the actions
measurement accuracy taken

Accuracy and specification zone
Specification zone
Measurand
Measured value
Measurement Measurement Measurement

uncertainty uncertainty uncertainty
Source: ISO/TR 4450

Chapter 7 - Support
7.2 Competence
Organization:
• Determine necessary competence of persons
• Ensure that these persons are competent on the basis
of education
• Take actions to acquire the necessary competence
• Retain documented information as evidence of
competence
• address qualification of person(s) ISO 19443

• maintain competence and qualification

Example of a skills matrix
Design activties Manufacturing activities Inspection activities Language skills
(1) (1) (3) (1) (3) (1) (2)
Design Drawings Design Design Welding Heat Assembling Painting NDT Visual Visual Dim. Eng Ger Spa Chi
and risk issuance calculations on calculations on treatment inspection inspection inspection
analysis software #1 software #2 of welds on
coating
Indiv. A x x MM/YY
Indiv. B x MM/YY

Chapter 7 - Support
7.3 Awareness
Are the persons doing work under the organizatio‘s control

aware of:
• quality policy
• relevant quality objectives
• their contribution to the effectiveness of the qms
• the implications of not conforming with the
requirements?
• train persons involved in the realization of ITNS

products or services on the importance of their tasks
(incl. potential nuclear safety considerations of errors in
their activities ISO 19443

Teamwork: Importance of individual‘s role in achieving nuclear safety
Situation A:
An experienced welder is instructed by supervision to complete a complex

weld configuration that has not been welded before. It is needed urgently so
that it could be radiographed that night to push the job on. The welder is
uncertain if his own personal qualifications are up to date.
How should the welder behave? Should he proceed with the welding to
keep the job going? Or is it more appropriate to check with welding
supervision whether his personal qualifications are up to date?
Source: TÜV SÜD

Situation B:
The Manufacturing of high grade material bolts was contracted to a Tier 2 supplier. Drawings
and specification were supplied by the Tier 2 supplier giving details of the material
specification and certification to be providded by the manufacturer. The Tier 2 supplier
subcontracted the work to Tier 3/ Tier 4/ Tier 5 suppliers, who then subcontracted the work to
the final manufacturer. During the subcontracting stages, errors and assumptions were made
about the material to be used and the certification to be provided. This resulted in the bolts
inadvertently being manufactured from a lower grade material and without the required
certification.
What went wrong?
Source: TÜV SÜD

Situation C:
A supply chain organisation was suspicious of some electric
components they had just received; the surface texture did not
feel right.
How should the organisation react?
Source: TÜV SÜD

Teamwork
▪ Situation A:
• Let’s pretend that the welder has accomplished the task and completed the weld configuration. During the final check of the
documentation, just before delivering the product to the customer, it was found out that the welder was out of qualification.
The nonconforming output has been managed and the customer has been informed. The organisation has included the event
in its lessons learned process in order to prevent a recurrence. Please fill in the attached lessons learned report.
▪ Situation B:
• The order for the manufacturing of high grade material bolts was given to the end manufacturer via 5 subcontractors. During
the subcontracting stages, errors were made about the material to be used and the certification to be provided. As a result,
the bolts were manufactured from a lower grade material without the required certification. During the receipt inspection it was
found out that the bolts had been manufactured from the wrong grade of material and without the required certification. The
nonconforming output has been managed and the customer has been informed. The organisation has included the event in
its lessons learned process in order to prevent a recurrence. Please fill in the attached lessons learned report.
▪ Situation C:
• During the visual inspection of the components the inspector was suspicious of their surface texture. The components were
investigated, and it was found out that the products was counterfeit or fraudulent. The top surface has been sanded down and
re-marked. The nonconforming output has been managed and the customer has been informed. The organisation has
included the event in its lessons learned process. Please fill in the attached lessons learned report.

Lessons learned / Key questions
▪ Event
▪ How was the event recognized?
▪ Are other items affected as a result of those directly affected?
▪ Can other items be affected?
▪ Which investigations have been carried out to clarify the cause?
▪ What corrective actions have been taken?
▪ Was there human error?

Chapter 7 - Support
7.4 Communication
The Organization determines internal and external

communication relevant to the QMS:
• What to communicate?
• When to communicate?
• With whom to communicate?
• How to communicate?
• Who communicates?
• External parties can be licensee/operator, regulatory

bodies, national authorities etc.
ISO 19443

Chapter 7 - Support
7.5 – Documented information
7.5.1 General 7.5.2 Creating and updating
The QMS shall include: Creating and updating documented

-documented information required by the information:
ISO 9001:2015 -identification and description
-documented information determined by the -format and media
organization as being necessary -review and approval for suitability
-ensure the completeness and accuracy of

the translation
-Person performing the review shall be
different from the author(s)
Chapter 7 - Support
7.5.3 – Control of documented
information
7.5.3.1 7.5.3.2
Address following activities:
Control documented information, if it is: -distribution, access, retrieval and use
-available and suitable for use -storage and preservation
-adequately protected. -control of changes
-retention and disposition
-make the personal aware of changes to the

documented information
-adequately traceable and authenticated
-prevent the unintended use of obsolete
documented information
Chapter 8 - Operation 8 - Operation
8.1 8.2 8.4

8.3 8.5 8.7
Operational Requirements Control of 8.6
D&D of Production Control of
planning and for products and externally Release of
products and and service nonconforming
control services provided products and
services provision outputs
products etc. services
8.2.1 8.2.2
8.1.1 8.5.1 8.5.3
8.2.3 8.3.1 8.3.3 8.3.4 8.4.1
Provisions 8.5.2 8.5.6 8.7.1
for CFS 8.2.4 8.3.2 8.4.2
items 8.5.4 8.7.2
8.3.5 8.3.4.1 8.4.3
8.5.5
8.3.6 Verification
and
validating 8.5.1.1 8.5.1.2
testing
Control of Monitoring and
production measurement
equipment activities

Chapter 8 - Operation
8.1 Operational planning and control
plan and control the processes by:

• determining requirements
• establishing criteria
• determining resources
• implementing control of processes
• maintaining documented information
• Schedule and interface management shall be taken

into account.
ISO 19443

8.1.1 Provisions for counterfreit, fraudulent or suspect (CFS) items
prevent CFS items at all levels of operations including

• selecting of external providers
• specific information to external providers
• control of externally provided processes, products and
services
• monitoring and measurement activities
When CFS items are detected, they shall be managed as

nonconformities (see 10.2) and relevant parties, including the
customer shall be informed without delay.

8.2 - Requirements for
products and services
8.2.1 - Customer communication 8.2.2 Determining the requirements

Communication with customer: Define the requirements for products and
-providing information relating to products and services, including:
services -any statutory and regulatory requirements
-handling contracts or orders -those considered necessary by the
-obtaining customer feedback organization
-handling customer property
ISO 19443
-managing the interfaces with external parties

8.2.3 –
Review of the requirements
for products and services
8.2.3.1 8.2.3.2
Conduct a review before supplying the
product: retain documented information:
-requirements specified by the customer -on the results of the review
-requirements specified by the organization -on any new requirements for the products
-statutory and regulatory requirements and services
-contract or order requirements
-on the actions taken as the results of the

-involve all relevant groups associated with review
the supply of the products or services

8.2.4 Changes to requirements for products and services
ensure that:
• relevant documented information is amended
• relevant persons are made aware of the changed
requirements
• Changes to requirements for products and services

shall be properly managed.
ISO 19443

8.3 – Design and development
of products and services
8.3.1 General 8.3.2 Design and development

planning
-establish and maintain a design and Determine stages and controls for d&d :
development process -nature and complexity of the activities
-ensure the subsequent provision of products -required process stages
and services -required verification and validation activities
-internal and external resource needs
-the level of control expected
-internal and external design interfaces
-document design and development activities
-design tools fit for purpose -identify those process stages requiring
authorization before progression to the next
stage
8.3 Design and development of products and services
8.3.3 Design and development inputs
Determine the requirements for the specific type of

products and services and consider
• functional and performance requirements
• information derived from previous similar designs
• statutory and regulatory requirements
• standards or codes of practice
• potential consequences of failure

8.3.4 - Design and
development controls
Control that:
-the results to be achieved are defined
-reviews are conducted -authorization required prior progress
-verification and validation is conducted to the next stage
-any necessary actions are taken on problems -verification and validation to be
performed by competent person(s)
8.3.4.1 different from those having performed
the design
Design and development
verification and validation Ensure that test plans and/or specifications:
testing -identify the products and/or services
-define test objectives and conditions,
parameters to be recorded and relevant
acceptance criteria

8.3 – Design and development
of products and services
8.3.5 Design and development 8.3.6 Design and development

outputs changes
-identify, review and control changes
The outputs shall: retain documented information on:
-meet input requirements -design and development changes
-reference acceptance criteria -results of reviews
-specify the characteristics of the products -authorization of the changes
and services -actions taken to prevent adverse impacts
-substantiate design and development
-specify conditions under which commercial
changes
grade items or activities can be used as ITNS
-personnel involved shall be competent and
items or activities
have knowledge of the requirements
Good practices for design and development of products and services
Planning of design and development
Identification of design inputs & Design and development changes (6)

Design validation (5)
confirmation of feasibility (1)
Determination of type of
Design verification (4)
design outputs (2)
Issuing of the draft design

outputs (3)
Design and development reviews (7)

8.4 – Control of externally
provided processes, products
and services
8.4.1 General 8.4.2 Type and extent of control

determine the controls when: -
-incorporating products and services from externally provided processes remain
external providers into own products and within the control of the own QMS
services -potential impact of externally provided
-providing products and services directly to the processes, products and services?
customer by external providers -determine verification or other activities
-a process is provided by an external provider
-consider any level of the supply chain and -define responsibilities and authorities
take into account the graded approach -appropriate control of the supply chain
-demonstrate equivalence of provisions taken -responsibility for the conformity of all
externally provided processes and products
Demonstration of the evidence of provisions for monitoring activities
Typical inspection and test plan
Organization
(Title of) Inspection and Test Plan / Project Name / … Reference Revision
Name/Logo
Equipment Technical specification Rev. Code & Standard Safety classification
Production Procedure(s) Organization performer Organization Customer monitoring Owner monitoring Authorities monitoring
activity monitoring
No Descr. Ref. Rev. Name Date Record Interv. Name Date Interv. Name Date Interv. Name Date Interv. Name Date &
& Visa No. & Visa & Visa & Visa Visa
1
Additional comments Results Remarks

8.4.3 Information for external providers
requirements shall include: ISO 19443

Communicate to external providers the requirements for: • associated QMS requirements
-the processes, products and services • technical specifications
-the approval of products and services, methods and • drawings, codes, standards, regulations
equipment • identification of the documentation
-competence External provider shall:
-control and monitoring of the provider‘s performance • notify the organization of nonconforming products and
-verification or validation activities services
• obtain the organization’s approval for nonconforming
products and services disposition
• notify the organization of changes
• provide access to all relevant parties

8.5 Production and service provision
8.5.1 Control of production and service provision

ISO 19443
Implement production and service provision under
controlled conditions:
• customer and statutory and regulatory requirements
-availability of documented information
related to monitoring and measurement activities
-availability and use of suitable monitoring resources
• evidence that all activities have been completed
-the use of suitable infrastructure and environment
• top management involvement; measure product
-the appointment of competent persons
conformity and on-time delivery performance
-the validation of the ability to achieve planned results
• take action if planned results are not, or will not be
-the implementation of actions to prevent human error
achieved
-the implementation of release, delivery and post-delivery
• ensure that nuclear safety is not compromised
activities
.

8.5.1 – Control of
production and service
provision
ISO 19443
8.5.1.1 Control of 8.5.1.2 Monitoring and
production equipment measurement activities
-take into account the graded approach
-validate and maintain computer -monitoring and measurement for
controlled aided production equipment product acceptance
-define storage requirements including
periodic preservation/condition Documented information:
monitoring -item inspected
-monitoring or measurement performed
-data of performance
-identification of personnel who
performed
-acceptance criteria

8.5.2 Identification and traceability
Identify:
• outputs to ensure the conformity of products and
services
• the status of outputs with respect to monitoring and
measurement
control:
• unique identification of the outputs
ISO 19443
• ensure that marks or labels do not prejudice product
conformity
• stamps, electronic signatures: control their usage

8.5.3 Property belonging to customers or external providers
How to handle property belonging to customers or

external providers?
• be careful with the property
• identify, protect and safeguard the property
When the property is lost or damaged?
• report this to the customer or external provider
• retain information on what has occurred

8.5 - Production and service
provision
8.5.4 Preservation 8.5.5 Post-delivery activities

-preserve the outputs during production and determine the extent of post-delivery activities
service provision consider:
Preservation can include: -statutory and regulatory requirements
-identification -potential undesired consequence
-handling -nature, use and lifetime of products and
-contamination control services
-packaging -customer requirements
-transport -customer feedback
-access limitation
-cleaning actions to be taken, incl.
-detection and removal of foreign objects -investigation and reporting, when problems
-special handling for sensitive products are detected after delivery
-identification and labelling, incl. safety warnings
8.5.6 Control of changes
How to deal with changes for production and service

provision?
• review and control changes for production or service
provision
• retain documented information
• describe the results of the review and assessment of
changes
• persons authorizing the change

8.6 Release of products and services
-implement planned arrangements

• verify that the arrangements have been satisfactorily
completed
-retain documented information, incl.
• evidence of conformity with the acceptance criteria
• traceability to the person(s) authorizing the release
ISO 19443
• statement of conformity
• all required documented information must be present
at delivery

8.7 Control of nonconforming outputs
• timely identified 8.7.1
Ensure
• controlled to prevent unintended use or delivery
outputs that do not
confirm to their
8.7.1
requirements with the conforming outputs:
• correction
deal • segregation, containment, return or suspension
8.7.1 • informing the customer
-contain the effect of nonconformity on • obtaining authorization for acceptance
other products
-scrap 8.7.2
documented information that describes
-“use-as-is” or repair justification
retain • the nonconformity
approved by the customer
• the actions taken
8.7.2
.
• any concessions obtained
-incl. justification
Control of nonconforming outputs
Example of scheme for non-conformance information and requst for approval along supply chain
External provider Organization Customer
Product can be
made conform
to requirements
by repair
according to
Non Requrest for approval is
procedures Sending of non-conformance
conformance already report to the next level of the Approval made to the next level if the
corresponding manufacturing
Approval
approved by supply chain for approval of
procedure has initially been
repair procedure before any
in relation with the next level of of repair procedure approved by the next level of of repair procedure
intervention on the product
the supply chain the supply chain
the
contractural
requirements Product cannot
Request for authorization is
be repaired
and supplier‘s
Sending of non-conformance Authorization made to the next level if the Authorization
report to the next level of the requirement not satisfied is
intention is to supply chain for authorization defined in a document approved
propose „use as as „use-as-is“ for „use-as-is“ by the next level of the supply for „use-as-is“
is“ chain

Chapter 9 - Performance evaluation
9 - Performance evaluation
9.1
Monitoring, 9.3
9.2
measurement, Management
analysis, Internal audit review
evaluation
9.1.1 9.1.2 9.1.3 9.2.1 9.2.2 9.3.1 9.3.2 9.3.3

9.1 – Monitoring, measurement,
analysis and evaluation
9.1.1 General 9.1.2 Customer satisfaction

monitor customers’ perceptions
determine: -Have their needs and expectations been
-what to monitor and measure fulfilled?
-the methods for monitoring, analysis etc.
-when to monitor and measure Examples:
-when to analyse and evaluate the results -customer surveys
-customer feedback …
Demonstrate:
-conformity to products and services requirements
-ability of the processes to achieve planned results
9.1.3 Analysis and evaluation
evaluate:
• conformity of products and services
• the degree of customer satisfaction
• the performance and effectiveness of the qms
• the effectiveness of actions taken
• the performance of external providers
• the need for improvements to the qms
ISO 19443
• Nuclear safety culture aspects

9.2 Internal audit
Does the QMS conform to the own requirements? 9.2.1
provide Does the QMS conform to the requirements of the ISO 9001?
information Is the QMS effectively implemented and maintained?
conduct internal audits
at planned intervals
-define audit criteria and scope for each audit 9.2.2
-select auditors and conduct audits
Implement audit
-report results of the audits
9.2.1 programme
-take corrective actions without undue delay
-Does the QMS conform to customer -retain documented information as evidence of the results
requirements?
9.2.2
-qualified auditors
-do not audit the work you have
.
undertaken or have been responsible for

9.3 – Management
review
9.3.1 General 9.3.2 Management 9.3.3 Management

-review the QMS at planned intervals review inputs review outputs
ensure:
-suitability -status of actions from previous reviews
-adequacy -changes in internal and external issues
-effectiveness -performance of the QMS
-alignment -adequacy of the resources
-opportunities for improvement
-nuclear safety is considered
-lessons learned from nuclear
experience

Chapter 10 - Improvement
10 - Improvement
10.1 10.2 10.3

General Nonconformity and corrective actions Continual improvement
10.2.1 10.2.2

10.1 General
determine opportunities for improvement:
• improve products and services to meet requirements
• correct, prevent or reduce undesired effects
• improve the performance and effectiveness of the
QMS
ISO 19443
• lessons learned from nuclear experience
• risk mitigation
• technical advances and research and development
• methods for identifying good practices
share with customers learning from experience

10.2 Nonconformity and corrective actions
-control and correct the nonconformity 10.2.1
-deal with the consequences
react to the -eliminate the cause(s) of the nonconformity
take action
nonconformity -review the effectiveness of any corrective action taken
-update risks and opportunities
-make changes to QMS, if necessary
10.2.1
retain
-Manage and report nonconformities

without undue delay
-analyse impact assessment of the
documented information as evidence of: 10.2.2 nonconformity
-the nature of the nonconformities -undertake root cause analysis
-the results of any corrective action
.
No additional ISO 19443 requirement
10.3 Continual improvement
continually improve:
• the suitability
• the adequacy
• the effectiveness of the qms
consider the results of analysis and evaluation
• Are there needs or opportunities for improvement?
ISO 19443
• encompass nuclear safety culture

Contents
1 Introduction
5 Summary

Summary
In this part of the course we:

▪ have made ourselves familiar with the additional requirements of ISO 19443:2018 related to ISO
9001:2015
▪ were introduced to the guidance for the application of ISO 19443:2018
▪ have deepened our understanding of the specific requirements of ISO 19443:2018 through practical
examples

Copyright
‘‘ The contents of the training materials are protected by copyright.

TÜV SÜD Energietechnik GmbH Baden-Württemberg reserves all rights resulting
thereof, especially with regard to reprinting, publication by photomechanical
reproduction or other means, and storage in data processing systems (in whole
or in part).
This document and any information it contains shall not be used for any other
purpose than the one for which they were provided.
’’
Stock photos and ClipArt's: Licensed by TÜV SÜD.com Image Database.

03 ISO 19443 Structure and Requirements - Handout

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ISO 19443

Structure and Requirements of the ISO 19443

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022

In this part of the course we will:

Our goals are:

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 2

2 Benefits of ISO 19443

3 Structure of ISO 19443

4 ISO 19443 Requirements

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 3

▪ All ISO 9001:2015 requirements are covered in ISO 19443:2018

The Guideline to ISO 19443:2018 (ISO/TR 4450:2020)

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 4

ISO 19443 basics

▪ Conform to ISO 9001:2015 requirements

▪ Takes into account

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 5

2 Benefits of ISO 19443

3 Structure of ISO 19443

4 ISO 19443 Requirements

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 6

▪ International standard for the supply chain of the nuclear industry

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 7

▪ Simplifies bidding on the international market

Benefits for Newcomers:

Confidence in ISO 19443 certified “nuclear management systems” is gained through

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 8

2 Benefits of ISO 19443

3 Structure of ISO 19443

4 ISO 19443 Requirements

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 9

The organization shall consider:

2 Benefits of ISO 19443

3 Structure of ISO 19443

4 ISO 19443 Requirements

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 11

Plan 4 Why do I exist? 5 Come on boss 6 Plan precisely

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 12

0.2 Quality 0.4 Relationship with

0.3.2 Plan-Do-Check- 0.3.3 Risk-based

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 13

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 14

Quality Management Principles Additional ISO 19443 Principles

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 15

No specific ISO 19443 requirements

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 16

Predecessor Matter, Matter, Subsequent

possible controls and check

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 17

determine current performance implement the plan

implement the change

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 18

Plan and implement

Source: TÜV SÜD ET

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 19

Source: TÜV SÜD

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 20

Guidance on ISO 19443 / ISO TR 4450:

Source: TÜV SÜD

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 21

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 22

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 23

Additional ISO 19443 requirements