ISO 13485:2016
Medical device quality management
Certificate number: 117 24 Q0M 0193 R1S
Certificate cycle: 2024-12-21 to 2027-12-20
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QualityISO 13485 & ISO 9001
Quality and inspection.
A shared definition of acceptance connects engineering intent, manufacturing and inspection.
Quality management certifications
ISO 13485 and ISO 9001
Shanghai Jishan Jinjie Industrial Technology Co., Ltd.
Certified scope: production and sales of structural components for medical equipment (pure water filtration systems, biological analysis instruments and medical oxygen generators).
ISO 9001:2015
Quality management
Certificate number: 117 24 QU 0154-10 R3S
Certificate cycle: 2024-11-18 to 2027-11-17
View original certificate (PDF)Inspection facilities
Full inspection, clearly organized.
A dedicated area for checking production parts against agreed requirements.
Full-inspection area
Dedicated workstations for full inspection according to the agreed acceptance criteria.
Inspection facilities
A closer look at inspection.
People, instruments and components in the inspection process.
Dimensional inspection room
Coordinate and optical measurement workstations with inspection personnel.
CMM inspection in practice
An operator measures component geometry using a coordinate measuring machine.
Optical measurement in practice
Optical inspection of component features at a dedicated workstation.
Pneumatic dimensional measurement
A dedicated measuring fixture supports dimensional checks of production parts.
Inspection capabilitiesMeasure the features
Measure the features
that matter.
The equipment shown supports coordinate measurement, optical measurement and air gauging; final inspection is organized around the agreed part requirements.
| Inspection method | Equipment | Application |
|---|---|---|
| Coordinate measurement | 3D CMM | Dimensional and geometric inspection |
| Optical measurement | Video measuring system | Profiles and visible features |
| Air gauging | Pneumatic measuring instrument | Dimensional comparison with a suitable gauge and reference |
The inspection method and acceptance criteria should be specified for the part. Equipment specifications are not a blanket guarantee of achievable part tolerance.
Before productionAgree on what
Agree on what
acceptance means.
Identify critical dimensions, surface appearance and required records early. Contact our team for current quality-system documentation and a project-specific inspection discussion.
Discuss quality requirements- Critical dimensions and datums
- Surface appearance and finish criteria
- Material and documentation requirements
- Sampling and inspection expectations
- Packaging and handling requirements