ISO-Certified Quality Management System | Custom Thermoformed Packaging


At Dordan Manufacturing, quality is engineered into every step of the custom thermoformed packaging process. From initial design and CNC tooling to production and ISO Class 8 cleanroom manufacturing, our Quality Management System (QMS) ensures the consistent delivery of high-performance thermoformed packaging that meets both regulatory requirements and customer expectations.

We are certified to:

  • ISO 9001:2015 – General Quality Management

  • ISO 13485:2016 – Medical Device Packaging Quality

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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 trays, dunnage trays, clamshells, blisters, and insert trays. Every project undergoes cross-departmental analysis between engineering, production, and quality control teams to:

  • Identify critical dimensions and tolerances

  • Minimize production variability

  • Ensure regulatory and functional compliance

Our system emphasizes:

  • Continuous process improvement

  • Document control and traceability

  • Statistical analysis and reporting

  • Internal audits and validation protocols

Thermoforming Quality Control Procedures


Dordan’s thermoforming Standard Operating Procedure (SOP) governs all aspects of custom packaging production, including:

 Pre-Production

  • Incoming material inspections for quality and traceability

  • First article inspections to verify form, fit, and function

  • Equipment readiness checks and calibration verification

  • Quality Control Drawings (QC DWGs) created with critical-to-quality dimensions

In-Process

  • Routine in-process inspections using calibrated measurement tools

  • Automated optical inspection systems for real-time defect detection

  • Documentation of all inspections and dimensional measurements

  • CPK analysis and reporting for process capability tracking

Post-Production

  • Finished parts sorted, inspected, counted, and packed according to client shipping specifications

  • Statistical performance reports generated and reviewed by engineering and QC for continuous improvement

Cleanroom Manufacturing Quality Procedures (ISO Class 8)


As an ISO Class 8 cleanroom thermoforming manufacturer, Dordan follows elevated quality procedures for the production of medical-grade packaging, including:

  • Enhanced gowning protocols and material staging room with controlled air pressure zones

  • FDA-certified cleaning agents for all tooling and material entry

  • Terminal sterilization and room sanitization protocols

Cleanroom Controls Include:

  • Particulate count monitoring and environmental data tracking

  • Quarterly environmental risk assessments

  • Custom cleanroom material handling systems

  • Continuous documentation of operator compliance and gowning procedures

All cleanroom production is performed in accordance with ISO standards and governed by our ISO 13485-certified cleanroom SOP, ensuring consistent, sterile, and regulation-compliant medical packaging.

DOWNLOAD CLEANROOM/QC FACT SHEET

Medical thermoforming company

Process Capability & Statistical Reporting


After each production run, Dordan uses internal statistical software to calculate job performance metrics. These reports are reviewed by our engineering, production, and quality management teams to:

  • Benchmark process capability (CPK)

  • Validate in-spec production

  • Identify opportunities for continuous process improvement

Other In-House Thermoforming Services: