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
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.
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