ISO 19443 – The what, when, where, and how?

Customers often require us to work in accordance with a variety of standards to ensure conformance with their specific requirements. These standards may apply to products, materials, inspection procedures, or testing protocols. In many cases, customers also mandate compliance with a recognized quality management system standard to ensure that the processes used to develop and deliver products or services are reliable and consistent. ISO 9001 has become a widely adopted quality management system standard internationally. Additionally, several industry-specific adaptations have been created to address unique sector requirements — such as SAE AS9100 for aerospace, ISO 13485 for medical devices, and IATF 16949 for automotive manufacturing. ISO 19443 is the nuclear industry-specific standard, designed specifically for suppliers providing products and services important to nuclear safety within the nuclear energy sector.

What is ISO 19443?

ISO 19443 introduces nuclear-specific requirements such as increased focus on safety culture, traceability, and configuration management. This is done by starting with the baseline requirements of ISO 9001:2015 and adding specific requirements to achieve the safety and reliability requirements of the nuclear industry. This international standard provides one common standard that customers can reference to their suppliers, regardless of geographic location or jurisdictional authority. ISO 19443 aims to meet the General Safety Requirements for Leadership and Management for Safety issued by the International Atomic Energy Agency in 2016 (IAEA GSR Part 2), which are the foundation for many countries’ regulations on nuclear safety.

Who are good candidates for accreditation?

ISO 19443 may be used as a means to meet regulatory requirements in various countries. ISO 19443 is designed for organizations that provide products or services with an impact on nuclear safety, known as “items important to nuclear safety” (ITNS). This includes manufacturers of nuclear components, engineering service providers, maintenance contractors, software developers for safety-critical systems, and other entities working directly or indirectly within the nuclear sector. Companies already operating under ISO 9001 and serving nuclear clients are particularly well-positioned to pursue ISO 19443 certification, as it builds on existing quality frameworks with added nuclear-specific controls.

How to achieve accreditation

Achieving ISO 19443 accreditation starts with understanding ISO 19443 and building a quality management system that addresses all the requirements in the standard. If desired, a pre-audit can be performed to test the newly implemented program. Once ready, the organization selects an accredited third-party certification body to perform the formal audit process. The length of the audit is determined by factors such as number of personnel, locations, functions, activities, and processes to be audited. If successful, the organization receives ISO 19443 certification, which must be maintained through annual surveillance audits and continuous improvement efforts.

If you believe ISO 19443 may be a strong fit for your organization, HSB is fully qualified to provide ISO 19443 certification services. Our team is available to guide you through the next steps, provide a customized quote, and help you schedule your certification audit. We welcome the opportunity to support your journey toward meeting nuclear industry quality requirements and look forward to speaking with you soon.