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ISO 19443 Quality management
system for supply chain of the
nuclear energy sector
Hanna Kuivalainen
Hanna Kuivalainen
• Status of standard ISO
• YVL A.3 renewal and scope
• ISO 19443 requirements
• ISO guidance and conformity
assessment progress
The status of standard
• The formal publication of ISO 19443 was in June 2018.
• The document was prepared by Technical Committee ISO/TC 85,
Nuclear energy, nuclear technologies, and radiological
protection.The International Standard ISO 19443:2018 has the
status of a Finnish national standard
• WG (members from nine countries) has performed review of the
draft of the ISO 19443 guidance material.
• Guidance will be issued by the WG as an ISO Technical Report
• Conformity assessment - ISO/Casco conformity assessment
committee knowledge ja ISO/TC 85 Nuclear Activities => ISO/TS
(Technical specification) 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) - Under development
Hanna Kuivalainen
YVL A.3 Background Standards IAEA and
ISO 9000
• Renewal of YVL A.3 was supposed to be minor
updating for Management System for a nuclear
facility (2014)
• Many changes in backgroud standars:
– GS-R-3 Management Systems for Facilities and
Activities, IAEA 2006 => GS-R Part 2 (2016)
• The vocabulary was taken mainly from
ISO9000:2005 Quality management systems.
Fundamentals and vocabulary =>ISO 9001:2015 .
• New version will be published in March.
• Most changes in wording and clarification of
• Some requirements moved from YVL A.5
YVL A.3 Management and Leadership for
• YVL A.3 guide presents the general requirements of safety and
quality management that affect the contents, implementation,
maintenance, assessment, and improvement of the management
system of an organisation applying for a construction or operating
licence for a nuclear facility or one constructing or operating a
nuclear facility.
• The requirements of guide YVL A.3 apply, to the appropriate extent,
to the plant supplier, suppliers contributing to nuclear fuel fabrication,
safety-significant design and expert organisations, testing and
inspection organisations, component and material manufacturers,
and other safety-significant suppliers. If a requirement only concerns
the licensee or the nuclear facility, it is specifically mentioned.
• Other YVL-guides (YVL A.4, YVL A.5, YVL A.6, YVL A.7, YVL A.11,
YVL A.12, YVL B.1, and several YVL guides in E-series) give more
detailed ’how-to’ guidance
Hanna Kuivalainen
YVL A.3 Supply chain management
system reguirements
• 629. Suppliers of safety-significant products and related services
shall have in place a management system that is appropriate
certified (for example, ISO 9001 or ISO 19443) or independently
evaluated by an expert third party. Requirements for the
management system of manufacturers of serially manufactured
products are presented in the E series Guides.
• 629a. With regard to deliveries of products in safety class 1 and 2
and related services, the management system of the supplier
shall comply with the management system requirements set forth
in this guide and be compatible with the other standards used in
the operation. The management system can be supplemented in
the quality plan for justified reasons by applying the procedure
presented in paragraph 630.
Hanna Kuivalainen
Appropriate certification in YVL -guides
Hyväksytty sertifiointi (appropriate certification)
• Hyväksytyllä sertifioinnilla tarkoitetaan laatujärjestelmän
sertifiointia, jossa sertifiointielimen akkreditointi on tehty
standardin EN ISO/IEC 17021 vaatimuksia vasten ja
akkreditointi kuuluu FINASin solmimien monenkeskisten
tunnustamissopimusten (MLA) piiriin.
Appropriate certification
• Appropriate certification shall refer to a certification of quality
management system in which the certification body is accredited
against the requirements of standard EN ISO/IEC 17021 and
accreditation is covered by the multilateral recognition
arrangements (MLA) signed by Finnish FINAS.
Hanna Kuivalainen
ISO 19443 Quality management systems
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)
• Laadunhallintajärjestelmät. Erikoisvaatimukset ISO 9001:2015:n
soveltamiseen ydinenergiateollisuutta palvelevissa
toimitusketjuissa toimiville organisaatioille ydinenergiaturvallisuuden kannalta tärkeiden tuotteiden ja
• ISO collaborated with the International Atomic Energy Agency
(IAEA). IAEA has it’s own standards for Nuclear Safety. ISO
standards are complementary technical documents.
• The text reproduced from ISO 9001:2015 is placed in boxes
Hanna Kuivalainen
Principles and scope
Principles also apply the following :
– nuclear safety culture;
– determination of ITNS items and activites;
– graded approach to the application of quality requirements.
• Requirements specific to security management, and nuclear
material accounting and control don’t belong to this standard
• applies to organizations supplying ITNS products or services
• activities on a licensed nuclear site prior agreement by the
• complementary (not alternative) to customer and applicable
statutory and regulatory requirements
Hanna Kuivalainen
Terms, definitions, policy –
Quality Manager
• Some new terms and definitios: Activity, commercial grade item or
activity, Counterfeit/fraudulent/suspect (CFS) item (refer IAEA NPT-3.21), graded approach, important to nuclear safety ITNS, item
and nuclear safety (IAEA).
• Organisation and its context -External and internal issues shall
include nuclear safety considerations.
• Policy (5.2) and quality objectives (6.2.1) – include nuclear safety
and commitment to nuclear safety
• Quality Manager – member of the organization's management
– a) the organizational independence and authority to manage nuclear
safety and quality issues, and
– b) unrestricted access to top management.
Hanna Kuivalainen
Nuclear Safety Management
Nuclear Safety
Management System
Quality Management
control and
Occupational Health and
Safety Management
(ISO 45001:2018)
Environmental Management
(ISO 14001:2015)
Leadership for Safety,
Nuclear Safety Culture,
ITNS, CFSI, Safety
Graded Approach,
Project Control
Supply Chain
Management, Product
and services,
Independet review
Hanna Kuivalainen
Leadership and nuclear safety culture
• Requirements for top management not to compromise nuclear safety
in decision making (5.1.1) and Nuclear Safety Culture (5.1.3)
• Commitment to nuclear safety,
• Encouraging a questioning attitude
• Open communication
• Use of needed documented information
• Reporting HOF issues
• Lesson learned
• Challenging unsafe acts, behaviours and conditions
• Analyze and evaluate nuclear safety culture aspects (9.1)
Environment (7.1.4) Psychological factors include non-blaming
ITNS - persons shall understand the importance of their work and
consequences of errors in their activities
Hanna Kuivalainen
ITSN and Graded Approach
• Quality manual or quality plan (4.4.3), risk management (planning
6.1.1, 6.1.2)
• ITNS (6.1.3) – break down products and activities to items and
• Safety Classification specified by customer in line with Licensee’s
• Graded Approach (6.1.4) – grade the application of requirement
taking into account:
– ITNS specified by customer
– Complexity of items
– Organizational aspects
• Measuremnet traceability ( outputs and actions taken
Hanna Kuivalainen
Nuclear safety is not compromise
• Changes – communication of changes
• Changes to quality management system so that safety is not
• Not include – organizational changes directly like YL A.3
• Determination and provisions of resources (7.1.1)
• Management review – receive the attention by its significance
Hanna Kuivalainen
Resources so that safety in not compromised (7.1.1)
Suitability of the monitoring and measurement resources (
Competence and qualification of persons – shall maintained
Persons shall be trained to understand the importance of their
tasks (7.3)
• Translations needs to be correct (7.5.2)
• Documentation: Independent review, traceable, authenticated
• Documented information: change communication, prevent misuse
of old documentation
Hanna Kuivalainen
Operation – products and services
Project and configuration management (8.1)
Schedule and interface management
Managing the interfaces with exernal parts (8.2.1)
Managing the changes of requirements
Design and development has many new requirements (8.3)
Verification and validation test shall be planned, performed,
controlled, reviewd and documented
• Organisation shall spesify when commersial grade items can be
• Documented information from design and development changes
• Many requirements for control of externally provided processes,
products and services (8.4)
Hanna Kuivalainen
CFS – counterfit, fraudulent or suspect
Prevention has to go through the whole organisation
- Selection of suppliers
- Specific information from CFS and requirements for control sub
tier provides
- Control of externally provided processes
- Monitoring and measurement activities
- Handling detected CFS
- Customer information
IAEA documentation
Hanna Kuivalainen
Production and service provision
• Control of production and service provision - addings
– Customer and statuory and regulatory requirements related to
monitoring and measurement
• Control of production equipment - new chapter
• Monitoring and measurement activities – new chapter
– Independent inspections
• Identification and traceavility – addings
• Preservation
– Prevention of ITNS product deterioration
• Control of nonconforming outputs – addings
Hanna Kuivalainen
Performance evaluation
• Conformity to products needs to consider when thinking
performance and effeciveness of the quality management. (9.1)
• Customer requirements in internal audits (9.2)
• Auditors independence – not audit own work
• Management review – nuclear safety (9.3)
• Lessons learned from nuclear field
• Not exist: regular self-assessment
• YVL A.3: The management and all organisational levels shall
carry out regular self-assessment of their own work performances
against pre-defined criteria. Experts in the topic shall be utilised in
self-assessment of safety culture and leadership.
Hanna Kuivalainen
• Lessons learned from experience
• Risk evaluation
• Can apply:
– Technical R&D
– Identify good practices
• Resources for improvements plans, share to its supply chain
relevant OE
• Nonconformaties and corrective actions are managed and
reported without undue delay to management and customer.
• Impact analysis and root cause analysis for nonconformity.
• Safety culture continual improvement
Hanna Kuivalainen
The ISO guidance planned activities
The ISO guidance activities have been agreed to meet the
following sequence (see N061):
1. Early February 2019 (and for 2 months duration): review/ballot of
the ISO Technical Report outside of the Working Group;
2. Early April 2019 (and for 2 months duration):
a. compilation and distribution of comments by the ISO Secretariat;
b. subsequent National Committee assessment of the reported
3. July 2019: Working Group meeting to upgrade the Technical
Report as appropriate;
4. September 2019: review and approval of the Technical Report by
the ISO TC 85 Chairman;
5. October 2019: release of the Technical Report.
Hanna Kuivalainen
Planning the conformity assessment
The review of ISO TS WD 23406 has being performed during the
meeting with a particular focus on discussions addressing the:
• knowledge and skills of the certification functions;
• definition of the technological sectors.
As a fast track project, ISO TS 23406 roadmap is confirmed as
2019 – Q1: working draft completion
2019 – Q2: CD ballot
2019 – Q4: ballot analysis and standard update as needed
2020 – Q1: publication of ISO TS 23406
Next meeting is planned April 9th 2019 to review the Working
Draft with a particular focus on the:
competence section; ISO 19443 knowledge.
Hanna Kuivalainen