Our Certifications
Certified Quality Systems You Can Rely On
Paragon Manufacturing Corp operates under comprehensive quality and regulatory systems designed to support highly regulated, performance-critical manufacturing environments. Our certifications, registrations, and compliance standards are not marketing claims — they define how we build, document, inspect, and deliver every assembly.
From medical and aerospace programs to defense and industrial applications, Paragon provides manufacturing systems that meet the expectations of engineers, quality teams, auditors, and procurement professionals alike.
Why Our Certifications Matter to Your Program
In regulated manufacturing, quality systems directly affect product reliability, compliance, and program risk. Certifications are not standalone credentials, they are the framework that governs process control, documentation, traceability, and accountability. Paragon’s certified systems ensure:
Repeatable, documented manufacturing processes
Controlled change management and revision control
Full material and build traceability
Audit readiness for customer and regulatory reviews
Consistent execution from prototype through production
ISO 9001:2015 – Quality Management Systems
Paragon is ISO 9001:2015 certified, confirming that our organization operates under a structured quality management system focused on consistency, risk mitigation, and continuous improvement.
ISO 9001 governs how we:
- Control and document manufacturing processes
- Manage corrective and preventive actions
- Train and qualify personnel
- Evaluate suppliers and materials
- Maintain accountability across production programs
For our customers, ISO 9001 certification ensures that every assembly is produced under defined, repeatable procedures.
ISO 13485:2016 & FDA Certification – Medical Manufacturing
Paragon is ISO 13485:2016 certified and FDA certified, enabling us to support medical device manufacturing programs requiring stringent regulatory oversight.
Our medical quality system supports:
- FDA-regulated manufacturing environments
- Risk-based process controls
- Documented traceability and record retention
- Controlled change management
- Validation and inspection requirements
These systems allow Paragon to manufacture components and assemblies used in regulated medical applications while meeting FDA and ISO expectations for quality, consistency, and compliance.
UL Recognition & Material Compliance
Paragon maintains UL recognition and supports manufacturing programs requiring electrical safety and material compliance.
Our material and safety compliance standards include:
- UL 94 V-0 rated insulation materials where required
- UL-recognized components and assemblies
- RoHS-compliant metals and materials
- REACH compliance documentation available upon request
- FDA-grade overmolding compounds for applicable programs
These standards ensure that products meet safety, environmental, and regulatory requirements across a wide range of applications.
ITAR Registration & Defense Manufacturing Support
Paragon is ITAR registered, allowing us to support defense-related manufacturing programs requiring controlled handling of technical data, materials, and assemblies.
ITAR registration ensures:
- Secure management of controlled technical information
- Compliance with U.S. export regulations
- Controlled access to production processes
- Alignment with defense and aerospace procurement requirements
This registration supports customers operating within defense, aerospace, and government supply chains.
IPC Standards & Electrical Assembly Quality
Paragon adheres to recognized IPC standards for cable and wire harness manufacturing, ensuring workmanship consistency and electrical reliability.
Our quality infrastructure includes:
- IPC-620 standards for cable and wire harness assemblies
- J-STD standards governing soldering processes and acceptance criteria
- In-house IPC-620 and J-STD certified instructor capabilities
These standards guide material handling, assembly execution, inspection criteria, and technician training — reinforcing consistent quality across electrical and electro-mechanical assemblies.
Government & Supply Chain Identifiers
Paragon Manufacturing Corp is registered within commercial and government procurement systems to support regulated sourcing and supplier verification requirements.
CAGE Code: 1AFC0
DUNS Number: 156880358
Primary NAICS: 334419 – Other Electronic Component Manufacturing
Secondary NAICS: 332618 – Other Fabricated Wire Product Manufacturing
These identifiers enable participation in government, aerospace, defense, and regulated commercial supply chains.
Build With Confidence
Whether your program requires FDA-certified manufacturing, ISO-controlled processes, IPC-guided assembly standards, or ITAR-compliant production environments, Paragon Manufacturing Corp provides the systems, discipline, and accountability required for long-term success.
