Organizations entering the nuclear supply chain typically pursue one of several paths, depending on their products, target customers, and risk tolerance:

Full NQA-1 Program Implementation

For suppliers of safety-related components, a quality assurance program compliant with ASME NQA-1 and 10 CFR 50 Appendix B is the standard expectation. This means:

• A quality manual and procedures addressing all 18 NQA-1 requirements
• Qualified personnel with defined responsibilities and documented training
• Supplier qualification and procurement controls extending into your own supply chain
• Inspection, testing, and process controls appropriate to nuclear safety significance
• Nonconformance management and corrective action systems with root cause rigor
• A records system that maintains retrievable documentation for decades
• Internal audit programs and management review processes
• Part 21 evaluation procedures integrated into your nonconformance process

If you currently hold API Q1 certification, you’ll recognize the structure-NQA-1’s 18 requirements parallel the 18 criteria of Appendix B, much as API Q1 builds on ISO 9001. But the implementation expectations, documentation depth, and regulatory stakes are higher.

ISO 19443 Certification

For organizations targeting international nuclear markets or supplying items important to nuclear safety (ITNS) outside the U.S. safety-related classification, ISO 19443 offers an alternative framework. Built on ISO 9001, it adds nuclear-specific requirements including:

• Nuclear safety culture expectations embedded in leadership and organizational requirements
• Graded application of quality requirements based on safety significance
• Specific controls for counterfeit, fraudulent, and suspect items (CFSI)
• Enhanced traceability and configuration management

ISO 19443 is increasingly required for European nuclear projects and is gaining traction globally as the civil nuclear industry seeks supply chain standardization.

Commercial Grade Dedication

Not every item entering a nuclear plant requires a full NQA-1 pedigree. Commercial grade dedication (CGD) provides a pathway for items manufactured under commercial quality programs to be accepted for safety-related applications. The dedication process-performed by the purchaser or a qualified dedicating entity-involves technical evaluation, critical characteristic identification, and verification activities that provide reasonable assurance the item will perform its safety function.

For some suppliers, supporting customer CGD activities may be more practical than implementing a full nuclear QA program. Understanding where your products fit in this landscape is part of the strategic evaluation.