24/05/2025

ISO 19443 requirements

ISO 19443 is a specialized standard that builds upon and supplements ISO 9001:2015 for organizations operating in the nuclear energy sector supply chain, specifically those providing products and services "Important to Nuclear Safety" (ITNS). It incorporates all of ISO 9001's requirements and then adds specific, more stringent criteria to address the unique demands and critical safety aspects of the nuclear industry.

The requirements of ISO 19443:2018 are structured according to the same 10-clause High-Level Structure (HLS) as ISO 9001, but within these clauses, there are significant additions and amplifications. Here's a summary of the key requirements, highlighting where they typically go beyond ISO 9001:

• Nuclear Safety Culture: This is a fundamental and pervasive requirement. Organizations must establish, implement, and maintain a robust nuclear safety culture that influences all activities, behaviors, and decision-making processes. This goes beyond general quality commitment to embed safety as the paramount value.
• Graded Approach: While not a standalone clause, the standard implicitly supports applying QMS requirements with a rigor proportional to the safety significance (ITNS classification) of the product or service.
• Prevention of Counterfeit, Fraudulent, and Suspect Items (CFSI): A crucial and explicit requirement unique to ISO 19443 is the need for processes to prevent, detect, and control CFSI throughout the supply chain.
• Traceability: Enhanced requirements for traceability of products, materials, processes, and personnel qualifications are critical.

The ISO 19443 standard is divided into 10 clauses (chapters). The 444 requirements are in clauses 4 to 10. The clauses cover the following areas:

1. Scope:  

Specifies the application for organizations supplying ITNS products and services to the nuclear energy sector.

2. Normative References:  

Refers to ISO 9001:2015 as the foundational standard.

3. Terms and Definitions:

Includes additional terms specific to the nuclear industry (e.g., "Important to Nuclear Safety," "Nuclear Safety Culture").

4. Context of the Organization:  

Understanding the organization and its context:

• Requires a deeper consideration of the unique internal and external issues relevant to nuclear safety, including regulatory landscape, societal expectations, and the long-term nature of nuclear operations.  
• Understanding the needs and expectations of interested parties: Emphasizes regulators, nuclear operators, and other key stakeholders with specific nuclear safety requirements.  
• Determining the scope of the quality management system: Clearly defines which products/services are ITNS and therefore fall under the heightened requirements.

5. Leadership:

Leadership and commitment:

• Top management must explicitly demonstrate commitment to nuclear safety culture and ensure resources are provided to prevent compromising nuclear safety.  
• Policy: The quality policy must explicitly include a commitment to nuclear safety and continual improvement of the QMS and its effectiveness in ensuring nuclear safety.  
• Organizational roles, responsibilities and authorities: Clear assignment of roles and responsibilities related to nuclear safety.

6. Planning:  

Actions to address risks and opportunities:

• Risk-based thinking must be applied with a strong emphasis on nuclear safety risks, considering potential severe consequences of failures.  
• Quality objectives and planning to achieve them: Objectives must directly contribute to nuclear safety and be clearly linked to the organization's role in the supply chain.

7. Support:  

Resources:

• Requires adequate resources (personnel, infrastructure, environment) to ensure nuclear safety is not compromised.  
• Competence: More stringent requirements for the competence and qualification of personnel performing ITNS activities, including specific nuclear sector knowledge and experience. Requires maintenance of qualifications.  
• Awareness: Enhanced awareness training for all personnel on the importance of nuclear safety, their contribution to the QMS, and the implications of non-conformance, particularly concerning ITNS. Promotes nuclear safety culture awareness.  
• Communication: Specific requirements for internal and external communication related to nuclear safety.  
• Documentation: Stricter controls over documentation for ITNS items, including enhanced requirements for authenticity, integrity, and long-term retention. A quality manual is often explicitly required, unlike in ISO 9001:2015.

8. Operation:  

Operational planning and control:

• More rigorous planning and control for ITNS processes, including interfaces.  
• Requirements for products and services: Detailed processes for reviewing customer requirements and statutory/regulatory requirements related to nuclear safety.  
• Design and development:  Specific requirements for nuclear design: Enhanced requirements for design control, verification, and validation, often requiring independent verification/validation by personnel not involved in the original design.  Commercial Grade Dedication (CGD): Explicit requirements for the process of "dedicating" commercial grade items (CGI) for use as ITNS items, ensuring they meet nuclear safety requirements.  Design tools: Demonstration that design tools are fit for purpose.  
• Control of externally provided processes, products and services (Procurement):  Supplier evaluation and qualification: Extremely rigorous processes for evaluating, selecting, and qualifying suppliers of ITNS, including extensive audits.  Flow-down of requirements: Ensures that all applicable ITNS and QMS requirements are effectively flowed down to all levels of the supply chain, including sub-tier suppliers.  CFSI control: Explicit measures to prevent, detect, and control counterfeit, fraudulent, and suspect items.  
• Production and service provision: Requires evidence that all production, installation, and monitoring/measuring activities for ITNS have been completed as planned and that products/services conform to requirements.  
• Release of products and services: Statement of delivery and other documents present at delivery.
• Control of nonconforming outputs: Stricter requirements for managing nonconforming ITNS outputs, including prompt reporting to relevant management levels, customers, and potentially regulatory bodies, along with containment actions.

9. Performance Evaluation:  

Monitoring, measurement, analysis and evaluation:

• Focus on monitoring key performance indicators related to nuclear safety.  
• Internal audit: Internal auditors must be competent in nuclear safety requirements and concepts.  
• Management review: Top management reviews must specifically assess the effectiveness of the QMS in ensuring nuclear safety and the status of the nuclear safety culture. Review lessons learned from nuclear experience.

10. Improvement:  

Nonconformity and corrective action:

• Requires thorough root cause analysis for nonconformities affecting nuclear safety, with emphasis on preventing recurrence. Prompt reporting is key.  
• Continual improvement: continual improvement of the QMS effectiveness in ensuring nuclear safety.

In essence, ISO 19443 takes the robustness of ISO 9001 and elevates it to the extreme diligence and risk aversion required for the nuclear sector, embedding nuclear safety culture and stringent controls throughout every aspect of the quality management system.

Benefits of ISO 19443 certification

Certification to ISO 19443 offers significant benefits for organizations operating within the nuclear energy sector supply chain, especially those providing products and services "Important to Nuclear Safety" (ITNS). These benefits extend beyond general quality management to address the critical and unique demands of the nuclear industry.

Here are the key advantages:

1. Enhanced Nuclear Safety and Reliability:

   • This is the paramount benefit. ISO 19443 ensures that suppliers rigorously understand and meet the elevated demands of the nuclear industry, applying stringent quality controls that minimize the risk of defects, failures, and ultimately, enhance overall nuclear safety.
   • It helps ensure the reliability and long-term performance of ITNS products and services, which is crucial for the safe operation of nuclear facilities.

2. Stronger Safety Culture:

   • The standard explicitly requires and fosters the development of a robust nuclear safety culture throughout the organization. This cultivates a shared understanding of risks, encourages proactive behavior, and promotes a continual questioning attitude towards safety.
   • It increases employee awareness and engagement regarding their critical role in maintaining nuclear safety.

3. Improved Regulatory Compliance:

   • The nuclear industry is heavily regulated. ISO 19443 provides a structured framework that helps organizations identify, meet, and demonstrate compliance with national and international nuclear safety regulations and standards.
   • This reduces the risk of non-conformities, costly delays, and potential penalties.

4. Enhanced Risk Management:

   • ISO 19443 mandates a proactive and comprehensive approach to risk management, specifically for risks related to nuclear safety. This includes identifying, assessing, and mitigating risks throughout the entire supply chain.
   • It helps prevent issues before they arise, leading to a more resilient and secure supply chain.
   • Crucially, it includes specific requirements for the prevention and control of Counterfeit, Fraudulent, and Suspect Items (CFSI), which is vital in the nuclear sector.

5. Increased Credibility and Trust with Stakeholders:

   • Achieving ISO 19443 certification demonstrates a high level of commitment to quality, safety, and operational excellence.
   • This builds significant trust with key stakeholders, including nuclear operators (customers), regulatory bodies, and the public. It signals reliability and a genuine dedication to the highest standards.

6. Competitive Advantage and Market Access:

   • ISO 19443 is becoming an increasingly recognized and, in some cases, a de facto required standard for suppliers in the nuclear sector globally.
   • Certification can serve as a strong differentiator, making it easier to meet customer qualification requirements, win contracts, and access new domestic and international markets within the nuclear industry.
   • It simplifies the evaluation and qualification process for nuclear operators seeking reliable suppliers.

7. Streamlined and Harmonized Operations:

   • By providing a consistent and internationally harmonized framework, ISO 19443 helps standardize quality management processes across the nuclear supply chain.
   • This can lead to more efficient operations, reduced redundant audits, and clearer communication of requirements between organizations.

8. Continual Improvement:

   • Like ISO 9001, ISO 19443 promotes a culture of continual improvement, ensuring that the organization regularly reviews its processes, learns from experience, and seeks opportunities to enhance its QMS and, consequently, its nuclear safety performance.

In summary, ISO 19443 certification is not just about having a quality management system; it's about embedding nuclear safety at the core of an organization's operations, thereby building confidence, mitigating risks, ensuring compliance, and providing a strong competitive edge in a highly demanding and critical industry.