Factory Audit & Quality Documentation Package
You should be able to verify what we claim, not just read it. This single documentation package lets you audit our factory, equipment, certificates, test reports and process capability before you commit to a project.
Documents That Support Every Claim
Each document below maps to a specific manufacturing claim on this site. Together they form the evidence base an engineering buyer needs to qualify a supplier.
| Document | What it verifies | Availability |
|---|---|---|
| Company Profile | Legal entity, founding year, factory location, business scope and ownership structure | On request |
| Factory Layout | Production areas — mold shop, compression, LSR, cleanroom, QC lab, packaging and warehouse | On request |
| Equipment List | Actual machine brands, models and quantities at the stated location | On request |
| ISO Certificates | ISO 9001 / 14001 / 45001 / 13485 management systems, with certified entity, scope and validity | On request |
| Cleanroom Report | ISO Class 7 classification of the designated medical LSR area (cert. CR-2026-0714) | On request |
| CTI Material Reports | FDA, LFGB, RoHS, REACH and related compliance for solid silicone and LSR | On request |
| FAI Sample | First-article inspection report format with measured dimensions and gauge IDs | Redacted sample |
| Cpk Study | Process-capability studies (LSR-MED-007, FVMQ-SEAL-010) with control charts | Under NDA |
| Calibration Summary | Instrument IDs, calibration dates and traceability to national metrology standards | Under NDA |
| PPAP Checklist | Production part approval documentation for automotive and higher-tier projects | Under NDA |
Public pages show document names, scope and status. Identifiable values — exact certificate numbers, raw measurement data and proprietary process detail — are released in full during qualification, under NDA where required.
From Request to Approved Supplier
A straightforward qualification flow — no hidden steps, no vague promises.
1. Request the Package
Tell us your product type and compliance needs. We send the standard documentation package for review.
2. Review the Evidence
Check the equipment list, certificates, test reports and capability data against your requirements.
3. Audit On-Site or Remotely
Visit the factory in Dongguan, or take a live virtual walkthrough of the production lines and QC lab.
4. Qualify & Start
Sign an NDA where needed and move into DFM, tooling and sampling for your project.
What We Disclose, and What Stays Confidential
We publish what can be verified, and we are clear about what requires an NDA — so there are no surprises during your audit.
Published Openly
- Document names, scope and status
- Equipment brands and models (YIZUMI, ENGEL, BOY, MAKINO, Mitsubishi, HEXAGON)
- Cleanroom classification and scope (cert. CR-2026-0714)
- Process-capability results (Cpk 1.24 / Cp 1.39 / Cpk 1.32)
Released Under NDA
- Exact certificate numbers and certified legal entity
- Raw measurement data and control charts
- Calibration certificates and instrument serial numbers
- Client-specific drawings and proprietary process detail
The split above mirrors our certifications and engineering evidence pages, so the audit package lines up with what you read elsewhere on the site.
Request the Factory Audit Package
Tell us your product type and compliance needs, and we will send the relevant documents — or arrange a virtual walkthrough.
Request the Audit Package Or Request a Quote