ISO 19443 - the future of quality management for the nuclear supply chain

7 October 2021

David Goodfellow explains how ISO 19443 delivers an holistic approach on a worldwide scale, ensuring that materials, products, processes and services are fit for purpose

Few countries can build a nuclear power plant using only regional suppliers, but a global supply chain brings inherent risk and the nuclear sector has tight safety regulations throughout its supply chain. As a nuclear new-build project typically has an expected life span of 60 years, operators need the assurance of long-term and reliable supplier relationships. 

In the absence of a harmonised international standard that precisely addressed the specific needs of the nuclear industry, suppliers were required to adhere to ISO 9001 while taking the over arching principles of IAEA GSR Part 2 into account, alongside other relevant national standards. However, without an appropriate dedicated international standard, it was becoming increasingly difficult for the nuclear industry to work on a regulated basis across national boundaries. 

The complexity caused by the range of different approaches made it impossible to ensure every organisation within the supply chain was fulfilling the same criteria. There was clearly a need for a unified, international standard applicable across the global nuclear industry.

Global harmonisation

ISO 19443 was released in 2018 and builds upon the quality management system (QMS) requirements of ISO 9001, with a specific focus on nuclear safety.

The standard enables organisations, regardless of size or location, to demonstrate that their QMS meets best practice for the specific requirements of the nuclear industry. It confirms the quality and reliability of processes, with additional focus on development and continuous improvement. 

While national standards offer specific examples of how operations should be conducted, ISO 19443 provides a process-oriented management system. It aims to bridge the safety demands of the nuclear industry and the supply chain’s international management approaches. Suppliers, operators and licensees across the global nuclear supply chain need to develop strong long-lasting partnerships and ISO 19443 is a major step in that direction. 

ISO 19443 is increasingly becoming a certified requirement for organisations that supply products and services important to nuclear safety. The potential for commercial deployment of small modular reactors (SMRs) and concerns around a growing number of counterfeit, fraudulent and suspect items within the supply chain, is seeing many stakeholders encouraging companies to become ISO 19443 certified. 

ISO 19443 is not a legal requirement for nuclear suppliers, but it is increasingly likely that certification will become mandatory. Meeting ISO 19443 now will therefore future-proof an organisation and help it to gain a competitive advantage, as the standard shows the quality and reliability of processes, preparation, leadership and strategic planning.

If ISO 19443 becomes increasingly accepted throughout the supply chain, it will support industry regulation standardisation and improve the nuclear safety culture. It will also minimise the time and cost associated with integration and reduce uncertainty across the supply chain.

A nuclear safety culture

It is vital that the entire supply chain demonstrates a sound safety culture. The Institute of Nuclear Power Operations states that: “Nuclear safety is a collective responsibility. No one in the organisation is exempt from the obligation to ensure safety first.” It defines a safety culture as: “An organisation’s values and behaviours — modelled by its leaders and internalised by its members — that serve to make nuclear safety the overriding priority.”

ISO 19443’s primary purposes are to increase the safety culture within the nuclear industry and harmonise supplier assessments, such as auditing processes. The standard will improve suppliers’ understanding of quality requirements needed by nuclear, standardise these requirements across the world and facilitate their acceptance by regulatory bodies. This will help to create long-term, sustainable relationships between licensees and their suppliers.

The certification process for ISO 19443 includes a three-year audit cycle. After the initial audit and certificate issuance, there are surveillance audits every year for the following two years. A recertification audit must occur at the end of the third year for reissued certification. 

From a safety perspective it would be best to classify all nuclear power plant components in the highest safety class to ensure they are of the highest quality. However, this approach is not very realistic from an economic perspective. Therefore, ISO 19443 follows the ‘application of graded quality requirements’ approach, which is based on the ‘defence in depth’ principles of the IAEA’s Safety Fundamentals. Applying this approach helps to balance quality with economic aspects to enable safe and commercially attractive nuclear projects. 

About the author

David Goodfellow is UK Business Assurance Manager at TÜV SÜD

David Goodfellow, UK Business Assurance Manager at TÜV SÜD

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