Class III implantable device design responsibility
We manufacture to drawing under ISO 13485, but we are not a Class III design house and do not hold 510(k) / CE MDR Class III submission authority.
Evaluate titanium CNC machining suppliers against a 7-dimension framework (QMS / Material / Capacity / Inspection / Documentation / Financial / Regulatory) with a 25-point scorecard and red/yellow/green triage signals — plus self-disclosure Q&A.
AS9100D
Aerospace Quality Management System
ISO 9001:2015
Certified Quality Management System
ISO 13485
Medical Device Quality Standard
MTR Traceability
Material Test Reports with Every Shipment
Evaluation Framework
Use the same template against any titanium supplier.
| Dim | Dimension | Weight |
|---|---|---|
| D1 | Quality Management System | 20% |
| D2 | Material Traceability & Standards | 15% |
| D3 | Manufacturing Capacity & Capability | 15% |
| D4 | Inspection & Metrology | 15% |
| D5 | Documentation & Reporting | 10% |
| D6 | Financial Stability & Supply-Chain Security | 15% |
| D7 | Regulatory & Defense Compliance | 10% |
25-Point Scorecard
| Dim | Criterion | Pts |
|---|---|---|
| D1 | Active AS9100D certificate issued by accredited CB? | 5 |
| D1 | Documented QMS scope statement & internal audit program? | 4 |
| D1 | Active ISO 13485:2016 certificate for medical programs? | 4 |
| D2 | Mill Test Certificate per heat (EN 10204 3.1)? | 4 |
| D3 | ≥100 CNC machining centers with titanium-specific experience? | 3 |
| D3 | Tolerances to ±0.005 mm (aerospace-grade)? | 3 |
| D4 | In-house CMM (Zeiss / Hexagon / equivalent)? | 4 |
| D5 | Certificate of Conformance with every shipment? | 2 |
| D6 | Audited financial statements available under NDA? | 4 |
| D7 | DFARS-compliant material sourcing for US defense? | 3 |
Triage Signals
🟢QMS certificate scope statement lists "titanium machining" specifically
Strong — scope-specific certificates indicate real QMS coverage
🟢MTR issued by upstream mill (not by the machine shop itself)
Strong — independent mill certification per EN 10204 §4
🟡MTR issued by the machine shop only (no separate mill 3.1)
Caution — should be mill-side 3.1, shop-issued CoC is supplementary
🟡"NADCAP-certified" claim without naming the special process
Caution — NADCAP is per-process (HT, NDT, etc.)
🔴No certificate available for customer audit, even under NDA
Walk away — indicates fabricated credentials
🔴"We can do anything" without specifying capability limits
Walk away — usually unmeasured capability or hidden outsourcing
Honest Scope
We manufacture to drawing under ISO 13485, but we are not a Class III design house and do not hold 510(k) / CE MDR Class III submission authority.
Heat treatment and NDT are subcontracted to NADCAP-accredited partner labs; we coordinate the testing and include their reports in the FAIR package.
For ITAR-controlled articles we work with US-domiciled distributors; direct ITAR part manufacture is not our current scope.
We are aligning with NIST 800-171 controls for CUI handling. Full CMMC L2 certification is in progress (target 2026 Q4).
Quality
Every titanium part is verified, documented, and traceable before it leaves our Baoji facility — because in aerospace and medical manufacturing, documentation is just as critical as the cut itself.
Coordinate Measuring Machines verify every critical dimension against GD&T to ±0.005 mm before any part ships.
Project-specific First Article Inspection Reports delivered for every new part number — engineered for fast PPAP / FAIR approval.
Material Test Reports (mill certificates) accompany every shipment for full source-to-component traceability.
Frequently Asked Questions
Use a 7-dimension framework: D1 Quality Management, D2 Material Traceability, D3 Capacity & Capability, D4 Inspection & Metrology, D5 Documentation, D6 Financial Stability & Supply-Chain Security, D7 Regulatory & Defense Compliance. Weight D1 highest (20%), score on 100-point scale across 20-25 criteria.
The certificate scope must explicitly include "titanium" or "titanium alloys" — not just "CNC machining" or "aerospace machining". Generic scope indicates generic certification, not titanium-specific QMS coverage.
Ask for a sample 3.1. Verify the issuing party (must be the upstream mill, not the machine shop), the mill heat number matches your lot number, chemical composition is within ASTM B348/F136 limits, and mechanicals match ASTM E8/E18.
±0.005 mm (0.0002 in) on critical features is aerospace-grade. ±0.01 mm is typical for general aerospace. Beyond ±0.005 mm expect process review and additional cost. Ask for CMM uncertainty budgets per ISO 10360-2 to verify the claim.
3.1 is issued by the mill independent of manufacturing — standard for titanium aerospace. 3.2 is co-signed by mill and independent third-party — higher-criticality applications. Shop-issued CoC is NOT a 3.1 substitute.
Ask for OFAC / EU sanctions screening procedure, annual supplier audit log, sample compliance letter. Verify they screen both mill and sub-tiers. For US defense, also request DFARS specialty-metal compliance letter confirming mill source for each heat number.
Tour CNC floor + metrology lab, QMS scope statement + recent audit summary, sample MTR, sample FAIR package, financial summary under NDA, qualified mill sources list, customer references in your industry, known exclusions (Class III, NADCAP, ITAR — anything they cannot do).
For aerospace and medical titanium work, ≥100 CNC machining centers is the typical threshold. Below 50 centers you risk capacity issues during peak demand. Above 200 indicates a tier-1 supplier with diversified program mix.
Applications
From aircraft structures to surgical implants, precision titanium machining delivers the strength, bio-compatibility, and corrosion resistance that demanding industries rely on.
Brackets, fittings & frames machined from Grade 5 Ti-6Al-4V under AS9100D-controlled processes.
Implant-grade Grade 23 ELI (Ti-6Al-4V ELI) parts machined in cleanroom-controlled environments.
Corrosion-resistant titanium valves, shafts & housings engineered for extreme offshore service.
High-strength titanium bolts, studs & hardware for racing and high-performance vehicles.
Other Capabilities
Submit your drawings and program requirements. We will respond within 48 hours with our completed scorecard, evidence documentation, and an open invitation for a site visit or virtual audit.
One Metal. One Focus. Infinite Precision.
Founded in 2011 in Baoji's Titanium Valley, BOZE Metal is dedicated exclusively to titanium — from raw material to precision engineering. AS9100D, ISO 13485 & ISO 9001 certified with 500+ clients across Aerospace, Medical & Motorsport industries, we deliver end-to-end precision titanium CNC machining with full material traceability from source to component.
Boze Titanium Manufacturing Center is operated by Baoji Boze Metal Products Co., Ltd.
Certifications verified by NADCAP and compliant with ASTM International titanium standards (B265, B348, B381, F136, F2924) and ISO 13485 medical-device QMS.