DitaiPlastic operates under documented quality systems aligned with global manufacturing standards. This page lists our active certifications across quality, environmental, automotive and medical device standards, material compliance documentation, and the audit/verification processes that back them up.
Active Certifications
| Certification | Status | Coverage | Verified By |
|---|---|---|---|
| ISO 9001:2015 | ✅ Certified | All operations | Bureau Veritas |
| ISO 13485:2016 | ✅ Certified | Medical device housings | SGS |
| IATF 16949 | ✅ Certified | Automotive Tier-1/2 | SGS |
| ISO 14001 | ✅ Certified | Environmental management | SGS |
| ISO 45001 | ✅ Certified | Occupational H&S | SGS |
| UL recognition | ✅ For specific materials | UL94 V-0 fire-rated parts | Underwriters Laboratories |
| FAR 25.853 capability | ✅ Material qualification | Aerospace cabin trim | FST testing per ASTM |
What Each Certification Means
ISO 9001:2015 — Quality Management System
The foundation of our quality system. ISO 9001 certification means we operate documented processes for:
- Customer requirement capture and review
- Design and development control
- Production and service provision
- Inspection and testing
- Calibration and measurement
- Non-conforming product handling
- Continuous improvement (CAPA, internal audits)
Certificate available on request. Annual surveillance audits + 3-year recertification cycle.
ISO 13485 — Medical Devices QMS
Required by medical device manufacturers for housing supplier qualification. Our ISO 13485:2016 certified system includes:
- Documented procedures aligned with ISO 13485:2016
- Cleanroom-capable production area (ISO Class 8)
- Material traceability from source lot to finished device
- Device History Record retained 7+ years per FDA 21 CFR 820
- Customer-specific quality agreements honored
Certified to ISO 13485:2016 by SGS. Certificate available on request.
IATF 16949 — Automotive QMS
Required by Tier-1 automotive customers. Our IATF 16949 certified system includes:
- PPAP (Production Part Approval Process) submission capability
- APQP (Advanced Product Quality Planning) for new programs
- Statistical Process Control (SPC) on critical characteristics
- FMEA documentation
- Cpk capability studies
- Embedded software / customer-specific requirements support
UL Recognition (Materials)
Specific material grades carry UL recognition for fire safety. Common applicable to our work:
- UL94 V-0 (vertical flammability)
- UL Yellow Card materials in our active inventory
- UL Standard 508A (industrial control panel enclosures)
UL Yellow Cards available for materials used in qualified programs.
FAR 25.853 (FST) — Aviation Materials
Federal Aviation Regulation 25.853 governs flammability, smoke density, and toxicity for aircraft cabin materials. Our capabilities:
- FST-rated material grades qualified (specific suppliers and lot certifications)
- Vertical Bunsen burner testing per Boeing BSS 7230
- Ohio State University smoke density testing
- NBS gas analysis for toxicity
- Material certificates from approved supplier list
For aerospace customers, we provide complete material traceability and Certificate of Conformance to FAR 25.853 for each shipment.
Material Compliance & Declarations
| Compliance | Coverage | Documentation Provided |
|---|---|---|
| RoHS (EU 2011/65/EU) | All materials | RoHS declaration per shipment |
| REACH (EC 1907/2006) | All materials | SVHC declaration per shipment |
| Conflict Minerals (Dodd-Frank Section 1502) | All materials | CMRT (Conflict Minerals Reporting Template) |
| FDA 21 CFR 177 (food contact) | Specific PETG, ABS, PP grades | FDA-compliant material certs |
| USP Class VI (medical biocompatibility) | Specific medical-grade materials | USP Class VI test reports |
| Prop 65 (California) | All materials | Warning labels where applicable |
| NSF 51 (food equipment) | Specific food equipment materials | NSF test reports |
| EU Toy Safety EN 71 | Specific toys-and-displays materials | EN 71 test reports |
Process & Capability Certifications (Customer-Specific)
Many customers require us to qualify for their specific quality programs. Examples we have completed:
- GM PPAP Level 3 — qualified for one Tier-1 GM supplier program
- Ford Q1 — process audit completed for Ford supplier
- Toyota TPS — kanban / pull system implementation for Toyota Tier-1
- Boeing D6-51991 — quality requirements for aerospace program
- Medical OEM QMS — multiple Class I and Class II medical device housings
Inspection & Test Equipment Calibration
All measurement and test equipment calibrated to traceable standards:
- Coordinate Measuring Machine (CMM): ISO 17025 calibration
- Calipers and micrometers: monthly internal calibration vs gauge blocks
- Color spectrophotometer: NIST-traceable
- Force gauges (for snap-fit testing): annual external calibration
- Ultrasonic thickness gauges: monthly internal
- Profilometers (for surface roughness): annual external
Calibration records retained 7 years; available for customer audit.
Customer Audit Performance
| Audit Type | Frequency | Results (Recent) |
|---|---|---|
| Customer site audits | Monthly | 0 critical NCRs in last 8 audits; 1.3 major NCRs avg |
| ISO 9001 surveillance | Annual | 0 NCRs in 2025 audit; 2 OFI |
| Internal audits | Quarterly | 4-7 minor findings per audit, all closed |
| BSCI (social audit) | Biennial | “B” rating in 2024 audit |
| EcoVadis (ESG) | Annual | Initial assessment underway |
How to Verify Our Certifications
- Direct verification: ISO 9001 (Bureau Veritas) and ISO 13485 / IATF 16949 / ISO 14001 / ISO 45001 (SGS) certificates via the issuer verification portals
- Certificate copies: Provided on RFQ submission or qualification request
- Audit invitation: Customers welcome to audit our facility (1-3 day format)
- Third-party verification: SGS, BV, TÜV inspections accepted at customer expense
Ongoing Certification Program
Our forward certification roadmap:
- 2027: AS9100 aerospace QMS (target)
- 2027: ASME pressure vessel certification (for specific products)
Need Specific Certificates for Your Program?
Submit your compliance requirements list with the RFQ. We’ll provide all applicable certificates, test reports, and material declarations within the quote response.
Certifications FAQ
Can you provide certificates before I commit to an order?
Yes — ISO 9001, ISO 13485, IATF 16949, ISO 14001 and ISO 45001 certificates, sample material declarations, and capability documentation provided with quote response (no NDA required for these standard documents).
Can we provide our own QMS instead of using yours?
Yes for customer-specific programs. We can operate under your QMS for designated programs, with our QC team trained on your procedures. Common practice for medical, automotive, and aerospace Tier-1 programs.
Do you have export control / ITAR registration?
For ITAR-restricted programs, we work under customer’s ITAR registration with appropriate access controls. Direct ITAR registration is not currently held due to non-US ownership; consult on a project-by-project basis.