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Quality Management · ISO 9001:2015 Certified
Certs

Certifications & quality system —
what every lot ships with.

Ceramitell operates a ISO 9001:2015 certified quality management system, with additional sector-specific certifications for automotive (IATF 16949), CE (EU markets), UL (US/Canada), and RoHS/REACH (EU chemical compliance). Every production lot ships with a lot-specific certificate of conformity — dimensional inspection, material properties, and electrical/thermal characterization where applicable.

ISO 9001
QMS Certified
IATF 16949
Automotive
CE / UL
EU + N. America
100%
Lot Cert Coverage
Certifications & Standards
ISO 9001IATF 16949CERoHS · REACHUL Recognized
01 · Certification Matrix

What each certification covers.

Below is the scope of each active certification — what it covers, where it's required, and when customers should ask for it. Most customers need ISO 9001 + one sector-specific cert; very few need all five.

CertificationUnitScopeRequired For
ISO 9001:2015QMSFull factory QMSMost B2B customers
IATF 16949AutomotiveTier 1/2 automotive supplyGlow plugs · auto igniters
CE MarkingEUHot surface igniters, heatersEU appliance OEMs
UL Recognition (E327654)N. AmericaComponent recognition for ignitersUS/Canada HVAC/BBQ
RoHSEU SubstanceLead, cadmium, mercury limitsEU electronics customers
REACHEU ChemicalSubstance registrationEU chemical customers
ISO 13356 (on request)MedicalY-TZP-A dental/orthopedicMedical device OEMs
FDA CompatibilityFoodY-TZP for food contactFood processing customers
Certification scans (PDF) are available on request before any sample shipment. Sector-specific certifications (medical ISO 13356, FDA) are available for relevant material grades with appropriate documentation.
02 · What Every Lot Ships With

Lot certification contents.

Every production lot ships with a Certificate of Conformity (CoC) — the specifics depend on product type. Below are the standard CoC contents we ship for each major product family.

🔥
Hot Surface Igniters (BLK)

UL Recognition E327654 + CE marking + electrical resistance per unit (cold resistance, insulation resistance) + dimensional inspection + cycle life qualification report for the lot.

Certificate → Electrical + dimensional + UL/CE
Precision Balls (G3–G60)

ABMA grade verification + roundness per ball + dimensional inspection (diameter, sphericity) + density verification + surface finish Ra measurement. Statistical sampling per ABMA protocol.

Certificate → ABMA grade + dimensional + finish
📐
Structural & Custom Parts

Dimensional inspection per drawing + material grade verification + surface finish + tolerance compliance. Statistical sampling for production lots; 100% inspection for prototype lots.

Certificate → Drawing + tolerance compliance
💎
Ceramic Powders

Particle size distribution (laser diffraction D10/D50/D90) + BET surface area + chemical purity (XRF) + phase analysis (XRD) + bulk and tap density + lot traceability.

Certificate → PSD + BET + XRF + XRD
💻
Semiconductor Components

Purity certification + particle count (per cm² at 0.3 μm) + dimensional + surface finish + electrical/thermal characterization where applicable. Optional third-party SGS/TÜV/Intertek certification.

Certificate → Purity + particle + 3rd-party
⚗️
Medical / Biomedical (Y-TZP-A)

ISO 13356 biocompatibility + Y-TZP-A grade verification + dimensional + chemical purity + dental block density. Biocompatibility test reports (cytotoxicity, sensitization) available on request.

Certificate → ISO 13356 + biocompatibility
03 · Quality Process

The quality work behind each lot.

ISO 9001 is the framework — but what actually matters is how we operate it day-to-day. Below is the inspection and quality work that happens between when raw material enters the factory and when the finished lot ships.

In-Process Quality Steps

★ Every Lot
  • Raw material incoming inspection — Powder lot traceability, particle size verification, purity check
  • Forming dimensional check — Green-state shrinkage allowance verification before sintering
  • Sintering temperature monitoring — Each furnace cycle logged, anomalies flagged
  • Post-sintering dimensional sampling — Statistical sampling per lot
  • Diamond grinding tolerance verification — CMM measurement of critical dimensions
  • Surface finish measurement — Profilometer for Ra verification on lapped surfaces
  • Final inspection and packaging — Visual inspection + photo documentation per lot

Optional Extra-Cost Certifications

Available on request
  • SGS / TÜV / Intertek lab tests — 3rd-party verification of material properties
  • UL Recognition test reports — For applications requiring UL component recognition
  • CE marking documentation — EU Declaration of Conformity
  • Material lineage certificates — Raw material origin documentation
  • ISO 13356 biocompatibility — For medical/dental applications
  • FDA-compatibility documentation — For food/pharma applications
  • ITAR awareness — For US aerospace customer compliance (we sign customer-supplied declarations)
★ Quality Outcome · Italian Pellet Stove OEM

7 years of supply — zero recall events, lot tracing intact.

Our Italian pellet stove OEM partner has received 7 years of BLK igniter supply (180,000 units/year) with zero recall events and complete lot traceability for every shipment. Field failure rate stays below 0.3% per year — meeting their UL Recognition spec. Quality complaints, when they occur, are investigated with full root-cause analysis returned within 5 business days. This is the operational expression of the ISO 9001 + IATF 16949 + UL Recognition certification stack — not the paper, but the everyday work behind it.

7-Year Quality Record
Italian OEM partnership
  • Zero Recall events
  • <0.3% Annual field failure rate
  • 5 days Root cause analysis SLA
  • 100% Lot traceability
04 · Certification FAQ

The questions quality buyers ask.

Can you share your ISO 9001 certification scan?
Yes — PDF scan of our current ISO 9001:2015 certification available on request before sample shipment. We also provide our QMS overview document (5-page summary) and welcome customer factory audits with advance scheduling. Some customers conduct annual quality audits of our facility.
Is your UL Recognition (E327654) verifiable?
Yes — UL File E327654 is verifiable directly at the UL Online Certification Directory. We supply the file number on quote sheets and welcome customer verification before purchase decisions. UL Recognition covers our hot surface igniter products for US/Canadian markets.
Can you handle factory audits from customer quality teams?
Yes — we welcome customer factory audits with 2–3 weeks advance scheduling. About 20% of our OEM customers conduct annual quality audits of our Hangzhou facility. Audit support team is bilingual (Mandarin + English). Some customers also request supplier audits by third-party assessors.
What's your typical response time on quality complaints?
For standard quality complaints: 5 business days for root cause analysis return. For urgent field-failure incidents: 48-hour initial response, 5-day full analysis. SEM analysis, dimensional check, electrical resistance trend, and full failure mode root cause documented in a written report for the customer.
Do you provide 3rd-party verified test reports?
Yes — SGS, TÜV, Intertek lab tests available for an additional fee on production orders. Particularly common for semiconductor, medical, and aerospace customers. Reports become customer property and can be cited in their downstream documentation.
How do you handle traceability across the supply chain?
Every production lot has a unique lot number tracing back through: raw material lot → sintering furnace cycle → grinding operation → final inspection. We retain lot records for 7 years (10 years for medical/aerospace). Customer-side traceability requirements can be accommodated with custom lot-stamp formats.