Quality Control & Testing
Three-tier inspection system backed by ISO 9001, ISO 13485 and IATF 16949. In-house lab plus accredited third-party testing for full traceability.
Inspection
Three-Stage Quality Gate
Every batch passes incoming, in-process and outgoing inspection before release.
Incoming Quality Control
Raw silicone, plastic pellets, metal inserts and packaging materials are verified against specifications before entering production.
- Certificate of analysis review
- Batch sampling per AQL 1.0 / 2.5
- Moisture and contamination check
- Supplier scorecards and audits
In-Process Quality Control
Parametric monitoring during molding, extrusion and assembly to catch deviations in real time.
- First-article inspection (FAI)
- Cavity pressure / temperature logs
- Dimensional checks at set intervals
- Visual defect classification
Outgoing Quality Control
Final inspection, functional testing and documentation before shipment with full lot traceability.
- Final AQL sampling inspection
- Functional / leak / burst tests
- COA and inspection reports
- Carton labeling verification
Testing
Laboratory & Testing Capability
In-house instruments plus partner labs for specialized medical and automotive testing.
Dimensional
2.5D vision system, profile projectors, CMM and custom gauges for ID/OD, wall thickness and tolerances.
Mechanical
Tensile, tear, elongation, compression set, hardness (Shore A/D) and rebound resilience.
Environmental
High-temp aging, UV/ozone, salt spray and chemical resistance testing.
Biocompatibility
ISO 10993 / USP Class VI cytotoxicity, sensitization and irritation test coordination.
Inside the LAB
LAB. Room
Flame-retardant test, salt spray test, high & low temperature aging, constant temperature & humidity testing — all in-house.
LAB Room
Flame Retardant Test · Tooling Room
Aging & Humidity Tests
Inside the Lab
Quality Inspection Room
A dedicated inspection room with 2.0 / 2.5 profile projectors, CMM, microscope and surface roughness tester — every batch verified before packing.
Certificates
Certification Documents
Download high-resolution copies and audit reports under NDA.
Start Your Project
Need a Custom Inspection Plan?
We can build customer-specific control plans, PPAP packages and incoming inspection agreements.