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 — Авиакосмическая промышленность и оборона
Стандарт
AS9100 Rev D / EN 9100:2018
Технически эквивалентен ISO 9001:2015 с более чем 100 дополнительными требованиями, специфичными для авиакосмической отрасли.
Область аудита
Прецизионная 5-осевая CNC-обработка, фрезерование и точение высокопроизводительных титановых сплавов для авиакосмических конструкционных и силовых применений.
Целевая отрасль
Авиация, космос и оборона
13485
ISO 13485:2016 — СМК для медицинских изделий
Стандарт
ISO 13485:2016
Глобальный стандарт для цепочек поставок медицинских изделий, согласованный с FDA QSR 21 CFR 820.
Область аудита
Субподрядное производство прецизионных титановых ортопедических имплантатов, костных винтов и компонентов специализированных хирургических инструментов со строгим контролем биосовместимости и загрязнений.
Целевая отрасль
Medical Devices & Bio-tech
9001
ISO 9001:2015 — Общая производственная СМК
Стандарт
ISO 9001:2015
Фундаментальная основа для международной коммерческой торговли и обеспечения качества.
Область аудита
Предоставление услуг по контрактному производству прецизионных металлических деталей и многоосевой обработке специальных сплавов, включая титан, никелевые суперсплавы и нержавеющие стали.
Целевая отрасль
Общая высокоточная промышленность
Certification Матрица валидации
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 | Авиация, космос и оборона | Multi-axis titanium machining for high-stress structural parts, propulsion components, and critical flight hardware. | Активен / Полностью проверен |
| ISO 13485:2016 | Medical Implants & Instruments | Очистка, прослеживаемость и изготовление биосовместимых титановых компонентов для ортопедических и хирургических применений. | Активен / Полностью проверен |
| ISO 9001:2015 | Общая высокоточная промышленность | Глобальное коммерческое контрактное производство деталей из специальных металлов для авиакосмической, медицинской, энергетической и промышленной отраслей. | Активен / Полностью проверен |
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.
Внутренние системные аудиты и анализ пробелов
Этап 1: Непрерывное отслеживаниеOur 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.
Ежегодные надзорные аудиты регистратора
Этап 2: Проверка третьей сторонойLeading 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.
Внедрение CAPA и снижение рисков
Этап 3: Постоянное улучшениеAny 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 Вопросы и ответы
Answers to the most frequently asked questions about our manufacturing certifications, audit scope, and quality documentation from procurement and supplier quality engineers.
Какие сертификаты качества имеет BOZE для титановой CNC-обработки?
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.
Можете ли вы предоставить копии текущих сертификатов для утверждения поставщика?
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.
Кто является вашим регистратором сертификации и как часто проводятся аудиты?
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.
Покрывает ли сертификация BOZE AS9100D как авиакосмические, так и оборонные программы?
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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