ThesunIndustry's Quality Assurance

Raw Material Sourcing
We prioritize the exclusive procurement of materials from trusted suppliers who maintain certified quality management systems at their state-of-the-art facilities. Our suppliers boast a wide range of comprehensive certifications, including rohs, Reach, MSDS, FDA, LFGB, UL, EN549, BPA free, EN71, and more. By adhering to this rigorous sourcing approach, we guarantee full compliance with your industry's stringent requirements.

ISO Class 8 Cleanroom Injection
Our ISO Class 8 clean room injection molding is used to manufacture medical devices, medical devices, pharmaceutical packaging, biotechnology products and other products that require a high degree of hygiene and accuracy. By producing in a controlled environment, contamination and variation in the production process can be minimized, thereby improving the quality and reliability of the product.

IQ/OQ/PQ Validation
In the manufacture of medical supplies, IQ/OQ/PQ Validation stands as a pivotal quality assurance and compliance procedure. This comprehensive process ensures that production equipment and processes function within controlled and dependable parameters, guaranteeing the manageability and uniformity of the production cycle.

End-to-End Quality Control
We provide comprehensive quality documentation, including ISO 9001:2015 certification, IATF 16949 certification, First Article Inspection (FAI), Production Part Approval Process (PPAP) reports, Material Technical Data Sheets (TDS), Coordinate Measuring Machine (CMM) inspection reports, Statistical Process Control (SPC) reports, Material Certificates, Dimensional Inspection Reports (CMM), Design for Manufacturing (DFM) feedback, and more. The management of these documents ensures the traceability and control of product quality.

High-Precision Inspection Technology
Throughout the research and development process, we employ cutting-edge inspection equipment and techniques, such as the Hexagon 3D Coordinate Measuring Machine, tensile strength testing apparatus, as well as various precision optical and projector inspection devices. These tools ensure the high quality and precision of our products during the production process and prior to delivery to our customers.

Quality Documentation

  • ISO 9001:2015 Certification
  • IATF 16949 Certification
  • First Article Inspection (FAI)
  • PPAP Report (Production Part Approval Process)
  • Material Technical Data Sheets (TDS)
  • CMM Inspection Report
  • SPC Report (Statistical Process Control)
  • Material Certificates
  • Dimensional Inspection Report (CMM)
  • DFM feedback

High Precision:

  • Product size tolerance ±0.01mm
  • Tooling size tolerance ± 0.005mm(5μm)
  • Long service life of tooling: 1 million die times
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