Quality Assurance & Testing

Quality Integrated from Design Through Production

At Paragon, quality assurance is not a final checkpoint, it is built into how products are designed, sourced, and manufactured. From incoming materials through final inspection and shipment, our systems ensure every step meets defined specifications and compliance requirements.

Operating under ISO 9001, ISO 13485, and FDA-aligned systems, we maintain structured, documented processes that support consistent outcomes in regulated and high-reliability environments.

Controlled Processes That Ensure Repeatable Outcomes

Quality at Paragon is driven by structured systems—not individual interpretation. We define, document, and control how assemblies are built, inspected, and released to ensure consistency across every program.

Approved documentation is used at all times

All changes are formally reviewed and tracked

Processes remain repeatable and auditable

Corrective actions are documented and resolved

This approach reduces variability and ensures consistent performance across builds.

Incoming Inspection and Material Verification

Quality begins before production. Paragon verifies all incoming materials against specifications, documentation requirements, and customer expectations prior to release to the manufacturing floor. This includes:

Material compliance (RoHS, REACH, UL where required)

Full traceability documentation

Alignment with program-specific and regulatory requirements

By validating materials at receipt, we reduce downstream risk and prevent issues from entering production.

Testing and Verification Aligned with Program Requirements

Paragon performs structured testing to confirm assemblies meet functional, electrical, and mechanical requirements prior to release. Testing requirements are defined early in the engineering process and executed under controlled procedures. Capabilities include:

Continuity testing

Functional testing

Electrical verification

First Article Inspection (AS9102 where applicable)

Final inspection prior to shipment

All testing is documented to support traceability, compliance, and audit readiness.

Documentation and Full Traceability

Traceability is central to Paragon’s quality system. Material certifications, inspection records, and production documentation are maintained to support audits, compliance requirements, and program validation. This ensures build history, inspection results, and material records are always accessible, providing confidence in regulated and mission-critical applications.

Supporting Regulated and High-Reliability Industries

Paragon’s quality assurance processes support medical, aerospace, defense, and industrial programs where compliance and reliability are non-negotiable. Our systems align with:

ISO 9001:2015

ISO 13485:2016

FDA-certified manufacturing environments

ITAR-registered programs

These controls ensure our quality practices meet both regulatory expectations and real-world performance demands.

Continuous Improvement and Corrective Action

We document, review, and resolve non-conformances, corrective actions, and process improvements. Quality assurance at Paragon includes ongoing evaluation and improvement. Nonconformances, corrective actions, and process improvements are documented, reviewed, and resolved through structured systems. This disciplined approach ensures that issues are not only corrected, but prevented from recurring.

Quality You Can Build On

Paragon’s quality assurance capabilities provide the structure, documentation, and oversight required to support reliable manufacturing outcomes. From inspection and testing to traceability and audit readiness, our quality systems are designed to protect your program at every stage.

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