ISO 19443 Quality management system in the nuclear energy supply chain

The ISO 19443 standard defines the requirements for a quality management system for organizations supplying products and services to the nuclear energy sector. It is a specialized version of the ISO 9001 standard, tailored to the unique needs of the nuclear sector, aiming to ensure the highest level of safety, quality, and reliability. Its implementation and certification help organizations build customer trust and meet the stringent regulatory requirements in this sector.

What is ISO 19443 About?

ISO 19443 pertains to the quality management system in the context of the supply chain for the nuclear energy sector. It is aimed at organizations that design, manufacture, assemble, and service products and services related to nuclear energy. Its primary goal is to ensure that the delivered products and services meet rigorous quality and safety requirements, minimizing risks associated with their use in the critical nuclear sector.

Main Requirements of ISO 19443

ISO 19443 imposes several requirements on organizations to ensure an adequate level of quality and safety.

The key requirements include:

• Quality Management System (QMS): Organizations must implement and maintain an effective quality management system compliant with ISO 9001 requirements, with additional requirements specific to the nuclear sector.
• Risk Management: Identifying, analyzing, and controlling risks related to the quality and safety of products and services. Organizations must implement risk management processes that encompass both technical and organizational risks.
• Nuclear Safety: Organizations must consider nuclear safety requirements at every stage of the product lifecycle, from design through production to delivery and servicing.
• Personnel Competence: High requirements regarding the qualifications, training, and competencies of personnel involved in processes related to nuclear energy.
• Supplier Supervision: Strict requirements for the qualification and supervision of suppliers to ensure that all products and services delivered by subcontractors meet quality and safety standards.
• Documentation and Traceability: Precise requirements for documentation, traceability, and quality control at every stage of production and delivery.

ISO 19443 Certification

Organizations that meet the requirements of the ISO 19443 standard can apply for a certificate of compliance issued by accredited certification bodies. It is worth noting that the certification of this standard is handled by a limited number of certification bodies that possess the appropriate competencies and experience in the nuclear energy sector. A common issue with certification bodies is the lack of local auditors; therefore, we will help you reach the appropriate bodies that meet your expectations and requirements.

ISO Certification Bodies

We will gather offers and prepare a comparison of offers to simplify the entire process.