Certifications & Compliance
A clear, honest account of what we are certified for — management systems and material compliance — and exactly how you can verify each one before you commit.
Two Different Things: Certification vs. Compliance
International buyers often see "certifications" as one list. They are not. Understanding the difference protects your project.
Management-System Certifications
ISO 9001, ISO 14001, ISO 45001 and ISO 13485 are issued by an accredited certification body. They verify that our management processes — quality, environment, safety, medical-device quality — meet an international standard.
- ISO 9001 — Quality Management System
- ISO 14001 — Environmental Management System
- ISO 45001 — Occupational Health & Safety
- ISO 13485 — Medical Devices Quality Management
- SEDEX SMETA / BSCI — Social Responsibility Audit
Material & Product Compliance Tests
FDA, LFGB, RoHS, REACH and similar are test reports, not management certifications. A third-party laboratory tests a specific material or product against a regulation and issues a report. They are material-specific and expire or require re-testing per material batch.
- FDA 21 CFR 177.2600 — food contact (USA)
- LFGB — food contact (Germany / EU)
- RoHS / REACH — restricted substances (EU)
- PFAS non-detect — EPA 537.1 / ISO 21675
- EN 71-3 — toy safety migration
Why this matters: a factory can hold a valid ISO 9001 certificate and still need a fresh, material-specific LFGB report for your food-contact part. Always ask for the exact document that covers your product and market — not a general logo.
ISO Certifications & Social Audit
Each certificate is issued to a specific legal entity and site, with a defined scope. On every certificate you can verify these fields with the issuing body.
| Certificate | What it verifies | Scope covers |
|---|---|---|
| ISO 9001 | Quality management system | Design and manufacture of silicone rubber products |
| ISO 14001 | Environmental management system | Silicone rubber manufacturing operations |
| ISO 45001 | Occupational health & safety management | Manufacturing and associated activities |
| ISO 13485 | Medical-device quality management system | Medical-grade silicone components manufacturing |
| SEDEX SMETA / BSCI | Independent social responsibility audit | Labor, health & safety, environment and business ethics |
Five Fields to Verify on Any Certificate
| Field | What to check |
|---|---|
| Legal entity name | The certified company's full registered legal name matches who you are buying from. |
| Site address | The certified address is the actual production site, not a sales office. |
| Scope | The scope explicitly includes silicone product manufacturing. |
| Certificate number & validity | The number is present and the certificate is within its validity period. |
| Issuing body | The certification body is accredited and can independently confirm the certificate. |
We provide all five fields in full during customer qualification, and each is verifiable directly with the issuing certification body. Public display shows name, scope and status; identifiable values move under NDA.
Third-Party Test Reports
Independent laboratory testing covers both solid silicone and liquid silicone rubber (LSR) materials. Below is the standard panel maintained for our material families.
| Test Standard | Scope | Solid Silicone | LSR (Gas-Cured) |
|---|---|---|---|
| FDA 21 CFR 177.2600 | Rubber articles for repeated food use (USA) | PASS | PASS |
| LFGB | Food-contact compliance (Germany / EU) | PASS | PASS |
| EN 71-3 | Migration of certain elements — toys safety | PASS | PASS |
| REACH (SVHC) | Restricted substances (EU) | PASS | PASS |
| RoHS | Restriction of hazardous substances | PASS | PASS |
| California Prop 65 | California Proposition 65 settlements | PASS | PASS |
| TSCA | Toxic Substances Control Act (USA) | PASS | PASS |
| PAHS | Polycyclic aromatic hydrocarbons | PASS | PASS |
| Phthalates | Plasticizer / phthalate content | PASS | PASS |
| PFOS & PFOA | Perfluorinated compounds | PASS | PASS |
| Halogen | Halogen content | PASS | PASS |
| Siloxane | Volatile siloxane content | PASS | PASS |
Tested by CTI — Centre Testing International Group Co., Ltd. (Shenzhen, China). Reports are material-specific and issued per batch/material family; full reports are available on request.
For food-contact projects, see our dedicated FDA & LFGB manufacturer page, and the FDA vs LFGB comparison for the regulatory differences between US and EU markets.
See the Documents Before You Commit
You should be able to verify what we claim. Here is how we make that straightforward.
- Redacted sample first — a copy with sensitive internal references masked, so you can confirm the format and issuer.
- Full originals under NDA — legal entity, site, scope, number and validity, verifiable with the issuing body.
- Batch-level traceability — material test reports tied to the specific batch of your order.
Document Availability
| Document | Availability |
|---|---|
| ISO 9001 / 14001 / 45001 certificates | On request |
| ISO 13485 certificate | On request |
| SEDEX SMETA / BSCI report | On request |
| FDA / LFGB / RoHS / REACH test reports | On request |
| PFAS screening report | On request |
| Cleanroom test report (CR-2026-0714) | On request |
| Calibration certificates | Under NDA |
| SPC / Cpk study data | Under NDA |
Verify Us Before You Order
Tell us your product and target market — we'll send the specific certificates and test reports that apply to your project.
Request Your Compliance Pack See Quality Document Samples