.We Are Certified To:
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ISO 9001:2015 – General Quality Management
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ISO 13485:2016 – Medical Device Packaging Quality
Above: Dordan QC technicians inspect medical trays in Dordan's cleanroom
Thermoforming Quality Control Features
Thermoforming quality control encompasses a comprehensive set of procedures and standards designed to ensure that each product meets specified requirements. Quality Control measures include:
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Pre-Production
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Incoming material inspections for quality and traceability
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First article inspections to verify form, fit, and function
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Equipment readiness checks and calibration verification
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Quality Control Drawings (QC DWGs) created with critical-to-quality dimensions
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In-Process
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Routine in-process inspections using calibrated measurement tools
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Automated optical inspection systems for real-time defect detection
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Documentation of all inspections and dimensional measurements
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CPK analysis and reporting for process capability tracking
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Post-Production
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Finished parts sorted, inspected, counted, and packed according to client shipping specifications
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Statistical performance reports generated and reviewed by engineering and QC for continuous improvement
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Risk-Based Quality Management for Thermoforming
Dordan’s QMS supports a risk-based, data-driven approach to the design and manufacture of thermoformed medical, automotive, electronic, industrial, and retail packaging. Every project undergoes cross-departmental analysis between engineering, production, and quality control teams to:
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Identify critical dimensions and tolerances
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Minimize production variability
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Ensure regulatory and functional compliance
Our System Emphasizes:
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Continuous process improvement
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Document control and traceability
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Statistical analysis and reporting
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Internal audits and validation protocols
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Defect detection
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Documentation of all inspections and dimensional measurements
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CPK analysis and reporting for process capability tracking
Cleanroom Manufacturing Quality Procedures
As an ISO Class 8 cleanroom thermoforming manufacturer, Dordan follows elevated quality procedures for the production of medical-grade packaging, including:
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Enhanced gowning protocols and material staging room with controlled air pressure zones
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FDA-certified cleaning agents for all tooling and material entry
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Terminal sterilization and room sanitization protocols
Cleanroom Controls Include:
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Particulate count monitoring and environmental data tracking
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Quarterly environmental risk assessments
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Custom cleanroom material handling systems
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Continuous documentation of operator compliance and gowning procedures
What Sets Us Apart?
63 Years of Thermoforming Experience
Full Validation Support
Fully Integrated Supplier
Risk-Based Engineering
4th-Generation Family-Owned Since 1962, Made in USA
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