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  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.

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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. 

 
 
 
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Explore how NQA-1 Software can Benefit your Organization

Strengthen safety-related item traceability
Maintain complete identification and control of safety-related items and materials, with full genealogy from receipt through production and shipment.
Simplify NQA-1 certification and audits
Prepare for ASME NQA-1 Certification audits more efficiently by centralizing quality records, procedures and evidence in one auditable system.
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
Catch and control nonconforming items faster with automated corrective action workflows, lowering the cost and risk of rework or safety-related failures. 
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. 

nuclear plant

See how QT9 QMS and QT9 ERP Stack up Against the AS9100 Standard

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    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.

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    Skip the Validation Project. It's Already Done.

    Pass FDA and ISO audits faster. IQ/OQ/PQ documentation is already built in.
    Why choose validated software?

    • 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

    What compliance standards can QT9 support?

    • ISO 13485
    • ISO 9001
    • ISO 14001
    • ISO 15189
    • ISO/IEC 17025
    • AS9100 

    • FDA 21 CFR Part 11
    • QMSR (FDA 21 CFR Part 820)
    • FDA 21 CFR Part 210/211
    • EU MDR
    • EU GMP
    • GxP Compliance 

    Is IQ, OQ, and PQ documentation available?

    QT9 QMS and QT9 ERP validation supports Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for organizations operating in regulated environments. 

    How can validated software reduce compliance costs?

    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. 

    Explore QT9 Validation

    FAQ: NAQ-1

    What is NQA-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. 

    Who needs to comply with NQA-1?

    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. 

    What is NQA-1 certification?

    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. 

     

    How long does it take to become NQA-1 compliant?

    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. 

    How can QT9 QMS help meet my NQA-1 requirements?

    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. 

    Explore QT9 Quality Management Resources

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