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.

What's Inside

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.

DocumentWhat it verifiesAvailability
Company ProfileLegal entity, founding year, factory location, business scope and ownership structureOn request
Factory LayoutProduction areas — mold shop, compression, LSR, cleanroom, QC lab, packaging and warehouseOn request
Equipment ListActual machine brands, models and quantities at the stated locationOn request
ISO CertificatesISO 9001 / 14001 / 45001 / 13485 management systems, with certified entity, scope and validityOn request
Cleanroom ReportISO Class 7 classification of the designated medical LSR area (cert. CR-2026-0714)On request
CTI Material ReportsFDA, LFGB, RoHS, REACH and related compliance for solid silicone and LSROn request
FAI SampleFirst-article inspection report format with measured dimensions and gauge IDsRedacted sample
Cpk StudyProcess-capability studies (LSR-MED-007, FVMQ-SEAL-010) with control chartsUnder NDA
Calibration SummaryInstrument IDs, calibration dates and traceability to national metrology standardsUnder NDA
PPAP ChecklistProduction part approval documentation for automotive and higher-tier projectsUnder 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.

How It Works

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.

Transparency

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