News on the ISO 19443 standard version 2018 - Nuclear safety management systems (NSMS) - requirements

22/05/2025

1. SPECIFIC NUCLEAR SAFETY REQUIREMENTS

• emphasis on nuclear safety culture:
  • the establishment, implementation, and maintenance of a strong nuclear safety culture throughout the organization. This goes beyond general leadership commitment to quality and requires a deep-seated organizational value system where safety is paramount
  • behavioral aspects: the standard addresses not just processes, but also the behaviors and attitudes of individuals that contribute to safety
• determination of ITNS (Important to Nuclear Safety) items and activities:
  • the organization must clearly identify which of its products, services, processes, and activities are considered ITNS. This is a critical step as these items will be subject to heightened controls
  • graded approach: while not explicitly a "requirement" in itself, the standard implicitly supports a "graded approach" to quality management, where the rigor of controls is proportional to the safety significance of the item or activity
• enhanced risk approach:
  • nuclear-specific risks: while ISO 9001 requires risk-approach, ISO 19443 demands a more stringent and comprehensive analysis of risks specifically related to nuclear safety, including potential consequences of failure of ITNS items
  • worst-case scenarios: risk analysis often needs to consider worst-case scenarios and their impact on nuclear safety
• stricter control of documentation:
  • enhanced traceability: there are more stringent requirements for traceability of products, materials, processes, and personnel qualifications throughout the entire lifecycle, from design to decommissioning. This includes detailed record-keeping
  • authenticity and integrity: emphasizes the need to ensure the authenticity and integrity of documentation, given the long operational life of nuclear facilities
• competence and qualification:
  • specific nuclear competencies: ISO 19443 requires that personnel performing ITNS activities possess specific competencies and qualifications relevant to nuclear safety
  • maintenance of qualification: there is a strong emphasis on maintaining the qualification of personnel over time through ongoing training and evaluation
• control of externally provided processes, products, and services:
  • rigorous supplier evaluation and qualification: the standard places a much higher emphasis on the rigorous evaluation, selection, and ongoing monitoring of suppliers of ITNS products and services. This includes comprehensive audits and assessments
  • flow-down of requirements: specific requirements must be effectively flowed down to all levels of the supply chain to ensure that even sub-tier suppliers comply with nuclear safety standards
  • counterfeit, fraudulent, and suspect Items (CFSI) control: a critical and unique requirement in ISO 19443 is the explicit provision for preventing, detecting, and controlling counterfeit, fraudulent, and suspect items in the supply chain. This is vital to prevent the use of substandard components that could compromise safety
• operational control:
  • specific process controls: requires more detailed and robust controls for operational processes, especially those related to ITNS, to ensure consistent and safe execution
  • configuration management: implicitly or explicitly, a strong emphasis on configuration management to ensure that the physical configuration of the plant and its components matches the documented design
• nonconformity and corrective actions:
  • prompt reporting: nonconformities related to nuclear safety must be reported without undue delay to relevant management levels and, as appropriate, to the customer and regulatory bodies
  • root cause analysis: a more in-depth and systematic approach to root cause analysis for nonconformities is expected to prevent recurrence
  • containment of effects: emphasis on taking immediate action to contain the effect of a nonconformity on other processes or products
• design and development:
  • verification and validation by independent personnel: requires that design and development verification and validation testing be performed by competent personnel different from those who performed the original design
  • use of commercial grade items (CGI) as ITNS: provides requirements for how commercial grade items can be dedicated for use as ITNS items, a specific practice in the nuclear industry 

2. ARTICLES ARE 10 ACCORDING TO HIGH LEVEL STRUCTURE:

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement

3. PROCEDURES

• procedures (documented):  
  • scope (§ 4.3)
  • quality manual (§ 4.4.3)
  • quality policy (§ 5.2)
  • risk management (§ 6.1)
  • ITNS items and activities (§ 6.1.3)
  • graded approach (§ 6.1.4)
  • quality objectives (§ 6.2.1)
  • processes (§ 8.1)
  • design and development controls (§ 8.3.4)
  • external providers (§ 8.4.1)
  • nonconforming outputs (§ 8.7)

4.  RECORDS

• recordings: 
  • issues (§ 4.1)
  • stakeholders (§ 4.2)
  • processes (§ 4.4.2)
  • job descriptions (§ 5.3)
  • risks (§ 6.1)
  • ITNS items and activities (§ 6.1.3)
  • graded approach (§ 6.1.4)
  • monitoring and measuring resources (§ 7.1.5.1)
  • action plans (§ 7.1.5.2)
  • competence (§ 7.2)
  • communication (§ 7.4)
  • list of documents (§ 7.5.1)
  • documents of external origin (§ 7.5.3.2)
  • protection (§ 7.5.3.2)
  • processes (§ 8.1)
  • conformity of products and services (§ 8.1)
  • customer requirements (§ 8.2.3.1)
  • design and development activities (§ 8.3.1)
  • design and development requirements (§ 8.3.2)
  • design and development inputs (§ 8.3.3)
  • design and development controls (§ 8.3.4)
  • design and development testing (§ 8.3.4.1)
  • design and development outputs (§ 8.3.5)
  • design and development changes (§ 8.3.6)
  • external providers' documents (§ 8.4.1)
  • monitoring and measuring activities (§ 8.5.1.2)
  • identification and traceability (§ 8.5.2)
  • property belongong to customers or external providers (§ 8.5.3)
  • control of changes (§ 8.5.6)
  • release of products and services (§ 8.6)
  • inspection results (§ 9.1.1)
  • audit program (§ 9.2)
  • audit results (§ 9.2)
  • management review results (§ 9.3.3)
  • nature of nonconformities (§ 10.2.2)
  • results of corrective actions (§ 10.2.2)

5. PROCESSES

• process: 
  • design and develop (§ 8.3.1)
  • realize products and services by external provider (§ 8.4.1)
  • produce (§ 8.5.1)
  • audit internally (§ 9.2)

6. POLICY

• policy: 
  • quality policy (§ 5.2)

7. THE VERB SHALL IS USED 217 TIMES

8. DETAILS OF ARTICLES AND PARAGRAPHS