ISO 19443 Training

Motivation & Development History

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

Motivation

▪ Get to know ISO 19443

▪ Understand the purpose and
benefits of ISO 19443
▪ Learn more about the history and
development of ISO 19443
▪ Get to know similar standards and
their relation to ISO 19443

Source: TÜV SÜD

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 Motivation and Development

1 Introduction to ISO 19443

2 History & Development

3 Benefits

4 Comparison

5 Summary

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

Introduction to 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)”

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

Introduction to 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)”

ISO 19443
ISO 9001

ITNS

Source: TÜV SÜD

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

1 Introduction to ISO 19443

2 History & Development

3 Benefits

4 Comparison

5 Summary

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

History 03/14 First Meeting
11/13 Proposal Stage (NP)
06/16 Preparatory Stage (CD)
03/17 Committee Stage (DIS)
03/18 Enquiry Stage (FDIS)
ASME NQA-1 05/18 Approval Stage
05/18 Publication
IAEA Safety
Standards
Start 01/20 ISO TS 23406
NQS 100:2011
Bureau Veritas
ISO 19443
AREVA 09/20 ISO TR 4450

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

Source: TÜV SÜD

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

Development

▪ Conform to ISO 9001/2015 requirements

▪ Prepared in close cooperation with IAEA
IAEA Safety
▪ Influenced by (national) standards: ISO 9001
Standards
• ISO 9001/2015
• IAEA Safety Standards
• KTA 1401/2017
ISO 19443

Source: TÜV SÜD

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

 Motivation and Development

1 Introduction to ISO 19443

2 History & Development

3 Benefits

4 Comparison

5 Summary

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

Benefits

▪ One International standard for the supply chain of the nuclear

sector
▪ International recognition
▪ Confidence in nuclear management systems
▪ Confidence in certified suppliers

▪ Auditing and certifying with qualified audits for the nuclear field
▪ Avoid recurring audits for different standards
▪ Based on widely known and implemented ISO 9001: no need
to establish a completely new QMS

▪ Easier bidding on the international market Source: TÜV SÜD

▪ Easier access to nuclear industry requirements
TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 10
 Motivation and Development

1 Introduction to ISO 19443

2 History & Development

3 Benefits

4 Comparison

5 Summary

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

Comparison

▪ between ISO 19443 and similar standards:

• ISO 9001/2015
• IAEA Safety Standards
• KTA 1401/2017
• ASME NQA-1

Source: TÜV SÜD

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ISO 19443 – ISO 9001/2015
▪ All ISO 9001/2015 requirements are covered by ISO 19443

▪ ISO 19443 concretizes and complements the aspects of ISO 9001

▪ The Guideline to ISO 19443
• Provides additional information but has no additional requirements
• Provides possible methods to fulfill ISO 19443 requirements
• Supports the use of ISO 19443
ISO 9001
▪ Additional ISO 19443 quality management principles:
• Nuclear Safety Culture
• Determination of ITNS items and activities ISO 19443
• Graded Approach to the application of quality requirements
Source: ISO 19443

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

ISO 19443 – IAEA Safety Standards

Source: IAEA
Source: IAEA

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

ISO 19443 – IAEA Safety Standards

Fundamental Safety Principles

• fundamental safety objective and ten associated safety principles
• fundamental safety objective: to protect people and the environment
from harmful effects of ionizing radiation

Leadership and Management for Safety

• establishes requirements that support Principle 3 of the FSP
• establishing, sustaining and continuously improving leadership and
management for safety and an integrated management system

Application of the Management System for Facilities and Activities

• provides guidance for following the requirements for management
Source: IAEA systems that integrate safety, health, security, quality assurance and
environmental objectives.

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

ISO 19443 – KTA 1401/2017

▪ KTA 1401: National German Regulation

ISO 19443 KTA 1401
• Describes Quality Management System • Describes Quality Management System
Requirements Requirements
• Applicable processes and standards need to • Describes Quality Assurance Requirements
be selected and documented

▪ KTA 1401 is completely covered by ISO 19443

▪ ISO 19443 is not covered completely by KTA 1401

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

ISO 19443 – ASME NQA-1

▪ ASME NQA-1: US Standard (based on 10CFR50 – Code of Federal Regulations)

▪ “Quality Assurance Requirements for Nuclear Facility Applications”
▪ Provides a means for an organization supplying items or services, which provide a
safety function.
▪ In contrast to the ISO 19443, the NQA-1 provides requirements that prescribe the
extent of controls needed in specific areas of a nuclear quality program.

The general idea of the standards is different, therefore

→Certain aspects of ISO 19443 are covered with NQA-1
→Certain aspects of ISO 19443 are not covered by NQA-1

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

 Motivation and Development

1 Introduction to ISO 19443

2 Benefits

3 History & Development

4 Comparison

5 Summary

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

Summary

▪ Developed starting 2013 and published in 2018,

joined by the guidance in 2020

▪ For organizations in the supply chain of the nuclear sector

▪ Based on ISO 9001 and the IAEA Safety Regulations

Source: TÜV SÜD
▪ Benefits & Goals:
– One International standard for the supply chain of the nuclear sector
– International recognition
– Confidence in nuclear management systems & certified suppliers
– Qualified audits establish trust
– Easier bidding and access to the market
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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.

’’
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