Uncovering the Importance of ISO 19443 for Nuclear Safety

Although ISO created the ISO 9001 quality management system standard that laid out the requirements to ensure that the processes enable consistent quality of the materials, products and services, there became a need for more specialized standards being introduced for particular industries. One such industry was the nuclear sector, who was in need of enhanced requirements for global standardization of the nuclear supply chain.

While there are many stakeholders who continue to encourage companies to become ISO 19443 certified, it still has some ways to go before it will be fully adopted across the industry. Now, with the commercial deployment of small modular reactors (SMRs) paired with growing concerns around the growing number of counterfeit, fraudulent, and suspect items (CFSIs), more and more suppliers are moving towards certification.

TÜV SÜD recently interviewed Paula Auer-Saupe, Quality Management Expert and Lead Auditor, regarding how the industry has taken steps towards this new certification process in recent years. 

What is ISO 19443’s purpose?
ISO 19443, a nuclear-specific quality management standard to optimize safety and quality throughout the nuclear supply chain, was introduced to the market in order to build upon the principles stated in ISO 9001. While ISO 9001 specifies requirements for a quality management system (QMS) across a variety of industries, ISO 19443 was created to specifically address organizations within the nuclear energy sector supplying products and services important to nuclear safety (ITNS). Its purpose is to increase the safety culture within the sector and harmonize supplier assessments, such as auditing processes.

The motivation behind requiring ISO 19443 as a nuclear management quality standard is to create long-term, sustainable relationships between the licensee and supplier. This in turn will improve the suppliers’ understanding of quality requirements for nuclear needs, standardize these requirements across the world, and facilitate acceptance by regulatory bodies.

What exact benefits will compliance have for suppliers?
Thanks to the general acceptance of ISO 19443 throughout the supply chain, this will support industry regulation standardization, improve the effectiveness of the supply chain according to nuclear safety culture, and reduce the time and cost associated with integration, as well as reduce uncertainty across the supply chain. This in turn will create a reliable supply chain with long-lasting partnerships.

When was ISO 19443 officially published?
Although released in 2018, ISO 19443 is quickly moving towards becoming a certified requirement for organizations supplying products and services ITNS. Soon accredited third parties will be authorized to certify these organizations who have successfully implemented and can demonstrate compliance to ISO 19443, in addition to ISO 9001.

What was required before ISO 19443?
Prior to ISO 19443:2018, there was no earlier version in existence, only the IAEA Safety Standard Series No. GS-R-3 dealing with quality requirements for facilities and activities. Suppliers were required to adhere to ISO 9001. There were other national standards in existence as well. For example, within the United States, suppliers were required to adhere to Nuclear Quality Assurance-1 (NQA-1) and in Germany, those were adhering to the Nuclear Safety Standards Commission (KTA).

NQA-1 is an industry consensus standard that was created by the American Society of Mechanical Engineers and overseen by the Nuclear Regulatory Committee (NRC) with the latest edition of the standard being issued in January 2018. But while a standard like NQA-1 offers specific, concrete examples on how operations should be conducted, ISO 19443 provides a process-oriented management system.

Will this international standard override previously accepted national standards or the ISO 9001?
It is the goal for all suppliers who do business with other countries to abide by ISO 19443 in the coming years. The move towards global harmonization of standards would help to regulate international supply chains and offer new opportunities for the world economy.

In light of the global pandemic, the resiliency of supply chains is more important than ever before. Suppliers, operators, and licensees across the world will need to develop strong, long-lasting partnerships to weather future issues together, and ISO 19443 is one major step in that direction. Obtaining ISO 19443 certification, which builds upon ISO 9001, is expected to make double auditing obsolete and thus save money.

Who exactly is required to comply with ISO 19443 within the supply chain?
Now ISO 19443 will require both the raw material suppliers and OEM manufacturers — essentially everyone touching the supply chain within the industry — to comply. Some will not be as concerned about the norm as others, but many component suppliers will be affected. This will also help to identify any counterfeit, fraudulent and suspect items that may be uncovered within the supply chain and will allow companies to quickly eliminate them.

Are there any notified bodies available for certification as of March 2021?
Due to the delays caused by COVID-19, there are no organizations who have been accredited to certify the ISO 19443 standard yet. However, many are in the process of obtaining this accreditation and should have it by the end of 2021. Importantly there are pre-certification options for organizations who want to undergo an audit in preparation for the future process.

How does a supplier demonstrate compliance without certification?
One possibility would be to conduct a pre-audit process with an external company that would help the supplier to understand whether or not they are currently fulfilling the requirements. Another option would be to conduct an internal audit that would also identify any gaps in current processes for complete compliance.

What does the certification process for ISO 19443 look like?
The process to become certified according to ISO 19443 includes a three-year audit cycle over the span of 36 months. After the initial audit and certificate issuance, there will be regular surveillance audits every year for the following two years. A recertification audit must occur at the end of the third year for reissued certification.

How qualified are the auditing authorities?
In the end, it’s important to understand that the ISO 19443 accreditation process is highly detailed and extremely strenuous. Auditors tasked with verifying the quality management systems for nuclear suppliers are highly trained, qualified experts. TÜV SÜD is proud to have our own dedicated team of skilled ISO 19443 audit professionals across the globe.

More About Paula Auer-Saupe, Quality Management Expert and Lead Auditor, TÜV SÜD

With over 12 years of audit experience in various quality management standards related to process industry, machinery and power generation, Paula is a member in the DIN Working Group 62- Quality Management in Nuclear Technology. She is also a technical reviewer for several other quality management standards and the in-charge of accreditation in accordance to ISO 19443 in TÜV SÜD.