AS9100D
Aerospace Quality Management
Scope:
Aerospace, defense, and aviation titanium components
Evidence:
QMS certificate, documented AS9100D scope statement, internal audit reports available under NDA.
Boze Titanium Manufacturing Center | Sub-page of Capabilities · D2 'Who can' dimension
Titanium Compliance & Certifications
Our titanium machining facility operates under 8 active compliance scopes — AS9100D aerospace QMS, ISO 13485 medical device QMS, ISO 9001:2015 general QMS, ASTM B348 / F136 material conformance, EN 10204 3.1 mill test certification, DFARS-compliant sourcing, REACH / RoHS 3 EU declarations, and ISO 5832-3 implant material standards.
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AS9100D Aerospace QMS Certified
ISO 13485 Medical Device QMS
EN 10204 3.1 Mill Test Certificates
8 Active Compliance Scopes
AS9100D ISO 9001:2015 ISO 13485:2016 ASTM B348 ASTM F136 EN 10204 3.1 DFARS REACH / RoHS 3
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
Active Compliance Scope
Eight Compliance Scopes We Operate Under Today
Compliance is not a single certificate — it is a stack. Each row below identifies the standard, the scope of products it covers, and the documented evidence available for customer audit under NDA.
ISO 13485:2016
Medical Device QMS
Scope:
Surgical implants, instruments, and Class I/II titanium medical components
Evidence:
QMS certificate, design-control file, process-validation records per ISO 13485 §7.5.6.
ISO 9001:2015
General Quality Management
Scope:
All titanium machining production regardless of end-market
Evidence:
QMS certificate, process FMEA library, corrective-action log available for customer audits.
ASTM B348 / F136
Material Standard Conformance
Scope:
Ti Grade 1–5 bar/billet; Ti-6Al-4V ELI implant-grade (F136)
Evidence:
MTR traceable to mill heat; chemistry verified by spectrometer; mechanicals per ASTM E8/E18.
EN 10204 3.1
Mill Test Certificate
Scope:
All production orders — chemistry and mechanical properties from upstream mill
Evidence:
3.1 certificate issued by mill, independent of Boze manufacturing, per EN 10204 §4.
DFARS
US Defense Material Sourcing
Scope:
Aerospace and defense programs subject to DFARS 252.225-7008 / 7009
Evidence:
CofC traces material to approved mill; specialty-metal compliance statement available.
REACH / RoHS 3
EU Chemical & Substance Compliance
Scope:
European-market components subject to REACH SVHC declaration or RoHS substance limits
Evidence:
SVHC declaration letter; substance-test report from SGS / TUV on request.
ISO 5832-3
Implants for Surgery — Wrought Ti-6Al-4V
Scope:
Wrought titanium alloy for surgical implants (international counterpart to ASTM F136)
Evidence:
MTR per ISO 5832-3 composition table; mechanicals per ISO 6892-1.
Document Deliverables
What Compliance Documents Ship with Your Order
For aerospace and medical procurement, documentation is part of the deliverable — not an optional add-on. The seven standard documents below ship with or accompany your shipment.
| Document | Standard / Format | Issued By | When It Ships |
|---|---|---|---|
| Mill Test Certificate (MTR) | EN 10204 3.1 | Upstream mill (independent) | With every heat-traced order |
| Certificate of Conformance (CoC) | AS9100D / ISO 9001 | Boze QC | With every shipment |
| First Article Inspection Report (FAIR) | AS9100D / AS9102 | Boze QC + CMM operator | Before production release |
| CMM Inspection Report | ISO 10360 / customer drawing | Boze metrology lab | With every shipment |
| DFARS Specialty-Metal Compliance Letter | DFARS 252.225-7008 | Boze procurement | On request for US defense orders |
| SVHC / REACH Declaration | REACH (EC) No 1907/2006 | Boze compliance | On request for EU orders |
| Heat-Treatment Chart Record | AMS 2774 / customer spec | Boze heat-treat supplier | When heat-treat is in scope |
Honest Scope
What Compliance We Don't Cover (And Why)
Procurement teams are best served by clear scope — including what is intentionally outside our coverage. The five items below are excluded from our current QMS scope. We work with accredited partners to deliver them when required.
NADCAP-accredited heat treatment
Heat treatment is subcontracted to NADCAP-accredited suppliers when in scope; we do not hold NADCAP accreditation in-house.
NADCAP-accredited NDT (penetrant, mag-particle, ultrasonic)
NDT is performed by independent NADCAP-accredited labs (e.g., SGS, Bureau Veritas). We coordinate the testing and include the lab report in the FAIR package.
In-house CMM calibration
CMM calibration is performed annually by accredited labs traceable to NIST / NPL standards. We do not issue CMM calibration certificates ourselves.
ITAR-restricted part manufacturing for US persons
We manufacture to drawing under commercial terms. For ITAR-controlled articles we work with US-domiciled distributors.
Class III implantable device design responsibility
We manufacture Class I/II titanium implants to validated processes. We are not a Class III design house and do not hold 510(k) / CE MDR Class III submission authority.
Quality
Uncompromising Quality Control
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.
CMM Inspection
Coordinate Measuring Machines verify every critical dimension against GD&T to ±0.005 mm before any part ships.
FAIR Reports
Project-specific First Article Inspection Reports delivered for every new part number — engineered for fast PPAP / FAIR approval.
Material Traceability
Material Test Reports (mill certificates) accompany every shipment for full source-to-component traceability.
Frequently Asked Questions
Compliance FAQ for Aerospace, Medical & Defense Buyers
1 What certifications does Boze Titanium Manufacturing Center hold?
Our titanium machining facility operates under AS9100D (aerospace QMS), ISO 9001:2015 (general QMS), and ISO 13485:2016 (medical device QMS). Certifications are issued by an accredited third-party certification body and are available for customer audit under NDA.
2 Are you AS9100D-certified for aerospace titanium CNC machining?
Yes. Our AS9100D scope covers CNC machining, milling, turning, 5-axis machining, and inspection of titanium components for aerospace and aviation. We maintain a documented AS9100D scope statement, internal audit program, and management review per AS9100D §9.3.
3 Do you hold ISO 13485 certification for medical titanium implants?
Yes. We manufacture titanium surgical implants and instruments under ISO 13485:2016, with documented design-control records, process validation per ISO 13485 §7.5.6, and full traceability per ISO 13485 §7.5.8.
4 What material standards do you comply with for titanium?
We routinely work to ASTM B348 (wrought titanium bar and billet, Grades 1–5), ASTM B265 (titanium plate and strip), ASTM F136 (Ti-6Al-4V ELI for surgical implants), AMS 4928 (aerospace material spec), and ISO 5832-3 (implants for surgery).
5 Can you provide EN 10204 3.1 mill test certificates?
Yes. Every heat-traced order ships with an EN 10204 Type 3.1 certificate issued by the upstream mill (independent of our manufacturing). The 3.1 certificate includes chemical composition, mechanical properties, and heat-treatment condition traceable to the original mill heat number.
6 Are you DFARS-compliant for US defense procurement?
We source titanium to DFARS 252.225-7008 / 252.225-7009 for US defense and aerospace programs. We provide a specialty-metal compliance letter on request confirming the mill source for each heat. Direct ITAR-restricted part manufacture is not our current scope — we work with US-domiciled distributors for ITAR articles.
7 How do you prevent counterfeit parts in aerospace titanium supply?
Our AS9100D scope includes AS9100D §8.1.4 counterfeit-parts prevention: documented procurement controls, approved-supplier list, material verification at receipt (independent spectrometer check), quarantine of suspect material, and traceability of every heat from receipt through delivery.
8 Do you provide First Article Inspection Reports (FAIR)?
Yes. We issue FAIRs per AS9102 (or customer-specific format) before production release. The FAIR includes dimensional report from CMM inspection, material certification, and process records. For AS9100D programs the FAIR is part of the documented first-article verification per AS9100D §8.5.1.1.
9 Are you compliant with REACH and RoHS for European markets?
We provide SVHC (Substances of Very High Concern) declaration letters per REACH (EC) No 1907/2006 and RoHS 3 substance-compliance statements on request. For medical devices the REACH and RoHS requirements interact with MDR biocompatibility — we follow the customer-supplied regulatory matrix.
10 What NDT methods do you support on titanium parts?
We coordinate NDT through NADCAP-accredited independent labs: liquid penetrant (ASTM E1417), magnetic particle (ASTM E709 — limited on titanium), ultrasonic (ASTM E213 / E2375), and visual (ASTM E468). NDT is not performed in-house; we manage the lab interface and include the lab report in the FAIR package.
Applications
Titanium Parts That Perform Where It Matters
From aircraft structures to surgical implants, precision titanium machining delivers the strength, bio-compatibility, and corrosion resistance that demanding industries rely on.
[Aerospace Structural Element] AERO
Aerospace Structural Elements
Brackets, fittings & frames machined from Grade 5 Ti-6Al-4V under AS9100D-controlled processes.
[Orthopedic Bone Screw] MED
Orthopedic Bone Screws
Implant-grade Grade 23 ELI (Ti-6Al-4V ELI) parts machined in cleanroom-controlled environments.
[Marine Valve Components] MAR
Marine Valve Components
Corrosion-resistant titanium valves, shafts & housings engineered for extreme offshore service.
[Motorsport Fasteners] MTR
Motorsport Fasteners
High-strength titanium bolts, studs & hardware for racing and high-performance vehicles.
Other Capabilities
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Request a Formal Compliance Review
Submit your drawings and program requirements. We will respond within 48 hours with a written compliance matrix identifying the applicable standards and the documentation package that will ship with your order.
About Boze Titanium Manufacturing Center
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.
AS9100D ISO 13485 ISO 9001 500+ Clients 15+ Years OEM/ODM