Quality on this page is not a claim about good intentions. It is two certificates with numbers you can verify, a three-stage inspection routine, the measuring equipment that supports it, and an honest statement of the one report we cannot issue.
ISO 9001:2015 — Quality Management System
| Certificate number | 39124Q108024R0S |
|---|---|
| Certificate holder | Dongguan Tangxia Xingyu Hardware Products Factory (Haihan CNC is its export brand) |
| Scope | Manufacture of Metal Turning Parts |
| First issued / re-issued | 21 Aug 2024 / 21 Aug 2026 |
| Valid until | 20 Aug 2027 |
| Issued by | Shenzhen Onelink Certification Center Co., Ltd. (CNAS C277-M · IAF member) |
ISO 13485:2016 — Medical Device Quality Management System
| Certificate number | 39125M208006R0S |
|---|---|
| Scope | Manufacture of hardware turned parts for medical devices (subassemblies) |
| First issued / re-issued | 25 Aug 2025 / 21 Aug 2026 |
| Valid until | 24 Aug 2028 |
| Issued by | Shenzhen Onelink Certification Center Co., Ltd. (IAF member · IAS MSCB-375) |
What the medical certificate covers — and what it does not
The ISO 13485 scope is turned hardware for medical devices, supplied as subassemblies. We are not a finished-device manufacturer: we do not sterilise, we do not package for sterile presentation, we do not assemble finished instruments, and we hold no product registration. If your project needs any of those, we sit one tier below you in the supply chain — and saying so now is cheaper than discovering it later.
The ISO 13485 scope is turned hardware for medical devices, supplied as subassemblies. We are not a finished-device manufacturer: we do not sterilise, we do not package for sterile presentation, we do not assemble finished instruments, and we hold no product registration. If your project needs any of those, we sit one tier below you in the supply chain — and saying so now is cheaper than discovering it later.
Checked three times before it ships
- Incoming inspection (IQC)Bar stock and material certificates are verified against the order before anything is cut. A wrong grade caught here costs a phone call; caught after machining it costs a batch.
- In-process inspection (IPQC)First-article approval plus patrol checks through the run. Dimensions are measured at the machine, where the result can still change the process rather than merely reject the output.
- Outgoing inspection (OQC)Final inspection by full or AQL sampling, with a dimension report issued on request.
What we measure with
Inspection Equipment
Automatic CNC vision measuring machine (DH 3020)The machine behind most outgoing dimension reports — automatic, non-contact measurement of profiles and features.
Manual vision & 2D measuring systemsFor first-article checks and features that need a human eye on them.
Digital height gaugeSteps, heights and reference dimensions.
Micrometers & callipersMitutoyo and shop-grade instruments for everyday in-process checks.
Salt-spray test chamberCoating adhesion and corrosion testing on plated and passivated parts.
Which reports we can and cannot issue
Reports
| Dimensional / inspection report | Available — issued from our optical measuring systems, against the drawing callouts you specify |
|---|---|
| First article inspection (FAI) report | Available on request, before production is released |
| Material certificate | Available — mill certificates for the bar stock we run |
| Salt-spray / corrosion test | Available for plated and passivated parts |
| Hardness report | Available where the part is heat-treated, through our specialist partners |
| Touch-probe CMM report | Not available — see the note below |
One report we cannot issue — and why we say it first
We cannot issue a coordinate measuring machine (CMM) report. Our automatic measuring machine is a vision, or optical, measuring system: it measures by image, with no contacting probe. That is a different instrument from a touch-probe CMM, and for some tolerances and geometries it is not an equivalent substitute.
We cannot issue a coordinate measuring machine (CMM) report. Our automatic measuring machine is a vision, or optical, measuring system: it measures by image, with no contacting probe. That is a different instrument from a touch-probe CMM, and for some tolerances and geometries it is not an equivalent substitute.
There are three-dimensional features an optical system measures well, and deep bores or internal features it cannot reach at all. Tell us which callouts you need certified and we will tell you — before quoting — whether our equipment can do it with confidence. That is a more useful answer than a promise we cannot keep at inspection.
Quality — Common Questions
Are you ISO certified?
Yes — ISO 9001:2015 for the quality management system and ISO 13485:2016 for hardware turned parts supplied as medical-device subassemblies. Both certificates are shown on our home page with their numbers and validity dates.
Can you supply a full inspection report with the parts?
Yes — dimensional reports are issued from our optical measuring systems, and FAI reports can be provided before production starts. Tell us which dimensions matter and they are the ones that will be reported.
Do you have a CMM?
Not a touch-probe CMM. Our automatic measuring machine works by vision. For some drawings that is fully sufficient; for others it is not, and we will tell you which case yours is before you order rather than after delivery.
What happens if parts are out of tolerance?
They do not ship. Non-conforming parts are quarantined and either reworked or scrapped, and you are told before your delivery date is affected — not afterwards.
Need a report with your parts?Tell us which callouts have to be certified and we will confirm before quoting what our equipment can measure and report.Get a Quote →