Quality & Certifications
Third-party verified.
Not self-declared.
Our quality system is audited and certified by accredited bodies. Every certificate listed below is current and verifiable. Download the original or scan the QR code directly.
Active certifications
Quality Management System
ISO 9001:2015
GB/T 19001-2016
What this certification covers
Every process in your order
runs under a certified QMS
ISO 9001:2015 governs how we plan, execute, inspect, and document work across all manufacturing processes, not just the final output.
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Milling, turning, EDM. First-article inspection and in-process dimensional checks on every job.
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Tooling qualification, process parameter records, cavity-level traceability
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Material batch records, build parameter logs, post-processing inspection
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Incoming material verification, bend angle checks, weld inspection
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Coating thickness measurement, adhesion testing, appearance standards
Medical Devices QMS
ISO 13485:2016
GB/T 42061-2022
What this certification covers
Medical-grade controls
on certified components
ISO 13485:2016 is the international QMS standard for medical device manufacturing. For the hardware and plastic components we process for medical equipment, it layers regulatory-grade traceability, risk management, and documentation on top of our ISO 9001 system.
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Risk-based process controlRisk management applied across product realization, from material selection through final inspection.
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Full traceability & recordsMaterial batch, process parameter, and inspection records retained for each medical-component order.
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Process validationValidation of special processes whose output cannot be fully verified by later inspection.
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Cleanliness & handlingHandling, cleaning, and packaging controls appropriate to medical-equipment components.
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Document & change controlControlled documentation and change management aligned to regulatory record-keeping requirements.
Accreditation & recognition
Need a copy for your supplier audit?
We can provide the original certificate, scope documentation, and audit history on request.
