Global Manufacturing Certifications & Compliance Framework
Our production infrastructure operates under a highly audited, internationally recognized quality management system. Validated by world-leading registrars, BOZE aerospace-grade and medical-grade manufacturing certifications guarantee that every machined titanium component adheres to uncompromising regulatory and safety parameters.
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Verified Quality Verified Quality Management Systems
Our production infrastructure operates under a highly audited, internationally recognized quality management system. Validated by world-leading registrars, every certification guarantees uncompromising regulatory and safety compliance.
9100
AS9100 Rev D — Aerospace & Defense
Standard
AS9100 Rev D / EN 9100:2018
Technically equivalent to ISO 9001:2015 with 100+ additional aerospace-specific requirements.
Audit Scope
Precision 5-axis CNC machining, milling, and turning of high-performance titanium alloy components for aerospace structural and propulsion applications.
Target Industry
Aviation, Space & Defense
13485
ISO 13485:2016 — Medical Devices QMS
Standard
ISO 13485:2016
Global standard for medical device supply chains, aligning with FDA QSR 21 CFR 820.
Audit Scope
Sub-contract manufacturing of precision titanium orthopedic implants, bone screws, and specialized surgical instrument components with strict bio-compatibility contamination control.
Target Industry
Medical Devices & Bio-tech
9001
ISO 9001:2015 — General Manufacturing QMS
Standard
ISO 9001:2015
The foundational baseline for international commercial trade and quality assurance.
Audit Scope
Provision of precision metal contract manufacturing and multi-axis machining services for specialty alloys including titanium, nickel-based superalloys, and stainless steels.
Target Industry
General High-Precision Industrial
Certification Validation Matrix
A complete overview of BOZE’s active quality management certifications — each verified by world-leading registrars through annual surveillance audits.
| Certification Standard | Primary Industry Focus | Audit Scope & Boundary | Verification Status |
|---|---|---|---|
| AS9100 Rev D | Aviation, Space & Defense | Multi-axis titanium machining for high-stress structural parts, propulsion components, and critical flight hardware. | Active / Fully Audited |
| ISO 13485:2016 | Medical Implants & Instruments | Bio-compatible titanium component cleaning, traceability, and fabrication for orthopedic and surgical applications. | Active / Fully Audited |
| ISO 9001:2015 | General High-Precision Industrial | Global commercial contract manufacturing of specialty metal parts across aerospace, medical, energy, and industrial sectors. | Active / Fully Audited |
The Annual Audit Compliance Sustainability
Certification is not a static badge — it is a dynamic, continuously verified system. Our compliance framework is tested quarterly internally and validated annually by independent third-party registrars.
Internal System Audits & Gap Analysis
Phase 1: Continuous TrackingOur certified internal quality auditors conduct scheduled cross-departmental reviews every quarter to ensure total adherence to AS9100D and ISO 13485 operational clauses. Any non-conformities are logged, tracked, and resolved through our CAPA system before they can impact production quality.
Annual Registrar Surveillance Audits
Phase 2: Third-Party VerificationLeading international registrars (SGS, TÜV SÜD, BSI) perform rigorous on-site surveillance audits annually. Auditors verify tool calibration logs, material traceability data, process control documentation, and employee competency records against the relevant standard’s clause requirements.
CAPA Implementation & Risk Mitigation
Phase 3: Continuous ImprovementAny process variance — whether identified internally or during registrar audits — triggers our formal Corrective and Preventive Action (CAPA) workflow. Root-cause analysis (5-Why, Fishbone, FMEA) is applied to determine systemic causes, and engineering protocols, toolpath strategies, or inspection plans are updated accordingly.
Certification Compliance Q&A
Answers to the most frequently asked questions about our manufacturing certifications, audit scope, and quality documentation from procurement and supplier quality engineers.
Which quality certifications does BOZE hold for titanium CNC machining?
BOZE CNC operates under three internationally recognized quality management certifications: AS9100 Rev D (aerospace and defense), ISO 13485:2016 (medical devices), and ISO 9001:2015 (general manufacturing). Each certification is maintained through annual surveillance audits conducted by accredited third-party registrars. Our AS9100D scope specifically covers precision 5-axis CNC machining of titanium alloys for aerospace structural and propulsion applications.
Can you provide copies of current certifications for supplier approval?
Yes. Certified copies of our current AS9100D, ISO 13485:2016, and ISO 9001:2015 certificates are available upon request. Each certificate includes the official scope statement, registrar accreditation details, issue and expiry dates, and the unique certificate number. We can provide these as part of your supplier qualification package or directly to your procurement portal. Contact our quality management team via our RFQ page to request current certificates.
Who is your certification registrar, and how often are you audited?
Our quality management system is audited by internationally recognized registrars including SGS, DNV GL, and BSI. We undergo annual surveillance audits for each certification, with full re-certification audits every three years. In addition, our internal audit team conducts comprehensive cross-departmental reviews on a quarterly basis, ensuring continuous compliance between registrar visits. All audit findings — including observations, non-conformities, and corrective actions — are documented and traceable.
Does BOZE's AS9100D certification cover both aerospace and defense programs?
Yes. AS9100 Rev D is the aerospace, space, and defense industry-specific quality management standard. Our certification scope explicitly covers the manufacture of precision machined components for aerospace structural assemblies, propulsion systems, and defense hardware. The standard incorporates all ISO 9001:2015 requirements plus additional aerospace-specific provisions including configuration management, counterfeit part prevention (AS6174/AS5553), first-article inspection (AS9102), and special process control. For defense contracts requiring DFARS compliance, we can additionally provide certified material sourcing from qualifying countries.
Request our current certification documents for your supplier qualification process.
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