Quality Compliance NQA-1
NQA-1 Compliance Made Simple
QT9™ QMS is purpose-built to help nuclear facility suppliers and manufacturers meet NQA-1 requirements accurately and efficiently, with QT9 ERP supporting connected production, supply chain, and operational data to strengthen compliance and traceability.
Safety-Related Item Control
QT9 QMS enforces the identification, control and documentation of safety-related items required under NQA-1, while QT9 ERP maintains lot, serial and item-level traceability across production and procurement.
Supplier & Procurement Qualification
QT9 QMS manages supplier evaluations, approved vendor lists and procurement document control central to NQA-1, while QT9 ERP tracks purchase orders, receiving and supplier performance history.
NQA-1 Audit & Certification Readiness
QT9 QMS centralizes the documentation, records and audit trails required to support NQA-1 Quality Program Certification, backed by QT9 ERP transaction history for complete audit evidence.
Nonconformance & Corrective Action Control
QT9 QMS drives root-cause investigation and corrective action tracking required by NQA-1, while QT9 ERP supplies production, inventory and supplier data to support faster resolution.
NQA-1 Compliance for Modern Nuclear Facility Suppliers and Manufacturers
Manage nuclear facility compliance items and synchronize documentation with anyone, anywhere. Stay NQA-1 compliant.
Explore how NQA-1 Software can Benefit your Organization
Strengthen safety-related item traceability
Simplify NQA-1 certification and audits
Tighten supplier and procurement control
Qualify and evaluate suppliers, control procurement documentation, and track receiving inspections to ensure purchased items and services meet NQA-1 requirements.
Reduce nonconformance risk and rework
Improve cross-functional accountability
Connect quality, engineering and production teams around shared documentation and records, ensuring accountability across every phase of the facility life cycle.
See how QT9 QMS and QT9 ERP Stack up Against the AS9100 Standard
QT9 is Available in the Cloud or On-Premise
Flexible deployment to match your IT strategy without compromising security or speed.
Work smarter with intelligent automation in quality and compliance
QT9 Software’s built-in automation streamlines compliance workflows, quality checks, and alerts, reducing human errors, accelerating decision-making and freeing your team to focus on higher-value work.
Speed up implementation with pre-validated software
QT9 Software offers a fully pre-validated environment, with every module and feature tested and documented for compliance. Save time, avoid costly internal validation processes and go live faster with confidence.
Ensure audit-ready traceability across all processes
Track every action, change and event in real time with QT9 Software. Timeline-based traceability supports inspections, audits and product recalls by providing complete visibility into your processes and product history.
Empower teams with secure, self-service portals
QT9 Software provides dedicated web portals for employees, suppliers and customers, enabling secure self-service access to documentation and data while streamlining collaboration across your organization.
Catch and resolve issues instantly with real-time monitoring
Monitor operations live with real-time dashboards and automated alerts using QT9 Software. Enable proactive responses to nonconformances, minimize downtime and improve compliance outcomes across your organization.
Onboard faster with an intuitive, user-friendly platform
Whether you’re a startup or an enterprise, QT9 Software’s clean, intuitive interface minimizes the learning curve, empowering users to work confidently, complete tasks accurately and stay audit-ready from day one.
Skip the Validation Project. It's Already Done.
Pass FDA and ISO audits faster. IQ/OQ/PQ documentation is already built in.
• Support compliance initiatives with proven software platforms
• Accelerate implementation with cloud-based deployment options
• Maintain audit-ready records with complete traceability
• Utilize electronic approvals and role-based access controls
• Benefit from ongoing software updates and system improvements
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• ISO 13485 |
• FDA 21 CFR Part 11 |
QT9 QMS and QT9 ERP validation supports Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for organizations operating in regulated environments.
Validated software can reduce the time and resources required to establish compliant processes, maintain audit-ready records and support regulatory requirements. By centralizing quality and operational data, organizations can improve efficiency while reducing manual administrative effort.
FAQ: NAQ-1
NQA-1 is ASME's Nuclear Quality Assurance standard, defining 18 basic requirements derived from NRC 10 CFR 50 Appendix B that quality assurance programs must meet. It provides quality assurance requirements and guidance applicable to all phases of a nuclear facility's life cycle, covering structures, systems, components, activities, or organizations essential to a facility's safe, reliable, and efficient performance.
NQA-1 applies to any organization designing, supplying, or servicing safety-related items or services for nuclear facilities. This includes nuclear power plant operators, DOE national laboratories, small modular reactor developers, and nuclear engineering and construction firms, as well as suppliers of safety-related components, materials, and services where compliance with NRC 10 CFR 50 Appendix B is mandatory.
The ASME NQA-1 Certification Program provides centralized, independent, third-party certification for quality assurance programs that conform to the NQA-1 standard. It involves a full audit of the organization's Quality Assurance Program by trained ASME auditors, and a successful audit results in an NQA-1 Quality Program Certificate. Certification runs on a three-year cycle, with one triennial program audit and two interim audits within that period.
Timelines vary based on an organization's starting point. Manufacturers with an existing ISO 9001 system typically achieve compliance in nine to twelve months, since the documentation framework and process discipline carry over directly, while manufacturers starting from scratch should plan for twelve to eighteen months.
QT9 QMS can help simplify your path toward NQA-1 compliance and certification. We offer more than 25 modules that come standard, including Document Control, Supplier Management, Nonconforming Products, Corrective Actions, Employee Training and Inspections — directly aligned to NQA-1's 18 basic requirements.
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