Tuvsud ISO 19443 Webinar Slides

ISO 19443
The future quality

management standard
for nuclear supply chain
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TÜV SÜD | ISO19443 THE FUTURE QUALITY MANAGEMENT STANDARD FOR NUCLEAR SUPPLY CHAIN 4/23/2021 2
Meet the speaker
Ms. Özlem Yilmaz
Nuclear Safety Expert and Project Manager
With a Master's Degree in Nuclear Technology and 6 years of research and work experience in severe
accident analysis and management, Özlem has a broad knowledge and understanding of both the
nuclear technology and nuclear safety culture. In her current position as project manager, she is part of
the team coordinating the accreditation process at TÜV SÜD in accordance with ISO 19443. Being part
of the working group developing sustainability criteria for the supply chain in nuclear industry rounds up
her portfolio.
Meet the panelists
Mr. Dominique Kugler
CEO – Equipment Inspection and Management Systems and Manufacturer Assessment, TÜV SÜD France
As TÜV SÜD France’s CEO and Head of Industry Service Department, Dominique has two decades of experience involving all aspects
of inspection of welded equipment's covering as well as pressure equipment and parts for nuclear sector. He also specializes in
assessment of management systems – including ISO 19443 – and manufacturer qualification.
Dr.-Ing. Marc Schlagenhaufer

Head of Department – Human Technology Organization, Regulation and Procedures, TÜV SÜD
As the Head of Department, Marc is involved in the topics of operational guidelines, Business organization, Technical qualification of
personnel, Quality management, Ergonomic, Human factors, Safety management and culture of German NPPs. He also has a
broad understanding of Quality management / assurance standards like ISO 9001, ISO 19443 and NQA-1.
Motivation
▪ The organizations providing products and services that are important to nuclear safety (ITNS), for nuclear facilities in
operation, construction or designing phase, are having many challenges while trying to comply with industry specific
quality and safety requirements, at the same time, competing in international market.
NEEDED: An international quality management standard, above and beyond ISO 9001, in order to compel suppliers to
consider quality related crucial points of nuclear facilities in a harmonized way around the world and help the nuclear supply
chain to overcome its challenges.
Agenda
1 Introducing the new standard: ISO 19443
2 Structure of the standard
3 Benefits to suppliers
4 Crucial requirement areas of ISO 19443
Integrating the requirements of ISO 19443 into the existing

5
management system
Safety culture
Introducing the New Standard / Development History Quality
Econo Security
mics
Safety
▪ GSR Part II
2016 Environ
Safety and Performance
Health
ment
▪ „Integrated Management“ – GS-R-3 IAEA 2006

Safety culture
2006
1996 ▪ „Quality Management“ - 50-C/SG-Q IAEA - 1996
1978 ▪ „Quality Assurance“ – IAEA – 50-C-QA
Introducing the New Standard / Development Idea
+ GS-R-3
IAEA
+ Experience with
+ Industrial Specific
international requirements ISO 9001 ISO 19443
Experience
authorities
ASME
+ NQA-1
The New Standard : ISO 19443
▪ May 2018 – ISO 19443 “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)“
▪ January 2020 – ISO/TC 23406 Nuclear sector – Requirements for bodies providing audit and certification of quality
management systems for organizations supplying products and services important to nuclear safety (ITNS)
▪ September 2020 – ISO/TR 4450– Guidance for the application of ISO 19443:2018 “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)"
Aim of ISO 19443
▪ Improve understanding of quality requirements for nuclear needs throughout the supply chain.
▪ Standardize the requirements, harmonize the quality and safety culture internationally.
▪ Facilitate acceptance by regulatory bodies.
▪ Long term sustainable relationship between licensee and supplier.
ISO 19443 Structure
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:
ISO 9001:2015 full text
— 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 activities; „Nuclear specific“ additional requirements
— graded approach to the application of quality requirements.
ISO 19443 Structure
Contents
8 Operation
8.1 Operational planning and control
8.1.1 Provisions for counterfeit, fraudulent or suspect (CFS) items
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determination of requirements related for products and services Basics of ISO 9001:2015
8.2.3 Review of the requirements for products and services Slight adaptation
8.2.4 Changes to requirements for products and services
In-depth revision
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.4.1 Design and development verification and validation testing
Benefits to Suppliers
Licensee Supply Chain
(contractor
Tier
customer)
Contractor #1 Contractor #2 Contractor #3 Contractor #n

(Licensee (Licensee (Licensee (Licensee Tier #1
supplier)
Common understanding
supplier) supplier) supplier)
Supplier #1 Supplier #2 Supplier #3 Supplier #n

(Contractor (Contractor (Contractor (Contractor
Tier #2
supplier) supplier) supplier) supplier)
Sub-Supplier #1 Sub-Supplier #2 Sub-Supplier #3 Sub-Supplier #n

(Sub-Supplier) (Sub-Supplier) (Sub-Supplier) (Sub-Supplier) Tier #3
Tier #n
Common understanding
Benefits to Suppliers
▪ Common understanding and acceptance between customer (licensee/operator) and supply chain to improve the effectiveness of supply
chain according to nuclear safety.
Improved safety culture
supports Consistent quality
Customer satisfaction
▪ Help suppliers through a basic international understanding
Access to international market
supports International recognition
Reduced risk
▪ Most suppliers have a management system implemented according to ISO 9001:2015.
Integration time is reduced
supports Cost of integration is reduced
▪ Due to the integration of IAEA requirements and other nuclear guidelines into the international accepted principles of ISO 9001:2015, the
standard facilitates the acceptance by regulatory bodies.
supports Reliable supply chain and long-lasting partnerships
Selection of Crucial Requirement Areas of ISO 19443
▪ Nuclear safety culture

▪ Risk-based thinking
▪ Determination of ITNS items or activities
▪ Traceability and verification
▪ Counterfeit / Fraudulent / Suspect Items
▪ Documented information
▪ Interested parties
Important additional definitions
▪ Commercial grade items (CGI),
▪ Graded approach
Nuclear Safety Culture
Nuclear safety 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 Technological factors Nuclear safety culture
radiation risks.
#1 Behavioral #2 Structural
individuals organization
Nuclear safety culture contributes to nuclear safety

Safety culture is characterized by two components and an optimal interaction between individuals and organisation to ensure nuclear
safety.
Sources: IAEA safety series No. 57-INSAG-4, 1991 „Safety Culture-A report by the international nuclear
safety advisory group“
INPO „Principles for a Strong Nuclear Safety Culture“
Nuclear Safety Culture
Impacts for supplier
All activities involved in the supply of ITNS products or services can and do influence nuclear safety
▪ Management: leadership, decision-making and creating a respectful work environment

▪ Expected behavior: questioning attitude, adherence to procedures, transparency in reporting issues and events
Any supplier involved in the supply of ITNS products or services is a key partner in ensuring that appropriate level of nuclear
safety is achieved.
Determination of ITNS items or activities
Products or services, whose failure could result in undue radiation

exposure of people or the environment are important to nuclear
safety (ITNS)
ITNS product/service as
specified by the customer
Critical Point: identification of all the items/

services important to nuclear safety Item(s) Activity(ies)
Non-ITNS ITNS Non-ITNS ITNS

Item(s) Item(s) Activity(ies) Activity(ies)
This determination builds the basis for the graded approach to the application of quality requirements.
Interested Parties
Challenges
Other relevant Licensee Bi- and multilateral

interested parties contracting
between
states to improve State
Operator
trade and trust 
Constructor/ Authority/Regulator
Manufacturer of
Nuclear convention 
NPP TSO of Regulator
Neighboring states, IAEA requirements
environmental
groups, European union
residents of the Supply Chain
location
Integrating the requirements of ISO 19443 into the existing management
system
QUALITY
Design and Organization Training,

Management Delivery
manufacturing and experience and
system reliability
quality communication culture
Integrating the requirements of ISO 19443 into the existing management
system
Actions needed Management system ready TÜV SÜD services

for nuclear market
Certification
Implementation of get an independent third party
improvements assessment by an accredited body
Determination of the
gaps and required action Pre-Assessment
points get a first overview of your system:
observations, recommendations and
Data collection and identification of action points and gaps
analysis of the existing
system
Training
standardized and customized trainings
Decision to get part of the
from our nuclear training center
nuclear market
Vision of ISO 19443:2018
Nuclear industry is an international industry faced with the main challenge of maintaining consistent high quality in the
international supply chain.
ISO 19443 builds the bridge between nuclear industry safety demands and modern international management to ensure
consistent high quality and safety.
ISO 19443 is an important strategic step to build a sustainable bridge
Nuclear safety
standards/
Requirements
ASME NQA-1
KTA 1401/02
KEPIC QAP
IAEA GRS Part 2
…
Regulator ISO 19443 is an important strategic step to build a sustainable bridge
Nuclear Licencee
world Operator
Nuclear safety
standards/
Requirements
ISO 9001:2015
ASME NQA-1
Modern
KTA 1401/02
Management
KEPIC QAP
IAEA GRS Part 2
…
Nuclear Licencee Supplier Supplier
world Operator world
Nuclear safety
standards/
Requirements
ISO 9001:2015
ASME NQA-1
Modern
KTA 1401/02
Management
KEPIC QAP
IAEA GRS Part 2
…
Nuclear Licensee Supplier Supplier
world Operator world
Transform your business
today with TÜV SÜD
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4/23/2021
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ISO 19443

The future quality

▪ Everyone will automatically be placed on “mute

Dr.-Ing. Marc Schlagenhaufer

1 Introducing the new standard: ISO 19443

2 Structure of the standard

4 Crucial requirement areas of ISO 19443

Integrating the requirements of ISO 19443 into the existing

▪ „Integrated Management“ – GS-R-3 IAEA 2006

1996 ▪ „Quality Management“ - 50-C/SG-Q IAEA - 1996

1978 ▪ „Quality Assurance“ – IAEA – 50-C-QA

▪ Facilitate acceptance by regulatory bodies.

▪ Long term sustainable relationship between licensee and supplier.

The following also apply:

Contractor #1 Contractor #2 Contractor #3 Contractor #n

supplier) supplier) supplier)

Supplier #1 Supplier #2 Supplier #3 Supplier #n

Sub-Supplier #1 Sub-Supplier #2 Sub-Supplier #3 Sub-Supplier #n

▪ Nuclear safety culture

Nuclear safety Nuclear safety

Nuclear safety culture contributes to nuclear safety

▪ Management: leadership, decision-making and creating a respectful work environment

Products or services, whose failure could result in undue radiation

Critical Point: identification of all the items/

Non-ITNS ITNS Non-ITNS ITNS

Other relevant Licensee Bi- and multilateral

Design and Organization Training,

Actions needed Management system ready TÜV SÜD services

ISO 19443 is an important strategic step to build a sustainable bridge

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