We Don't Have ISO 13485. Here's How We Still Machine Medical Parts.

A North American veterinary device company found us on LinkedIn and needed a supplier holding ISO 13485. We don't. They came to China, walked our floor, and liked what they saw — which left us with a capability they wanted and a certificate we couldn't produce. This is the arrangement we worked out, and it's still running.

Discuss a Certified Supply Chain Arrangement

The Conversation That Usually Ends Here

Let me start with the part most suppliers leave out. FSCPRECISION does not hold ISO 13485. We also don't hold ISO 9001. We are a machining shop in Shenzhen that has been cutting metal since 2005. We are not a certified medical device manufacturer, and we don't describe ourselves as one.

So when a veterinary medical equipment company in North America contacted us through LinkedIn, the first real conversation was short. They needed ISO 13485 from their supplier. We didn't have it. Normally that's where the thread dies — and honestly, for a lot of medical buyers it should. If you need the certificate to sit on the invoice with your supplier's name on it, we are not your shop, and you should know that in the first email rather than the fourth.

But this one didn't die, and the reason is worth explaining, because it's the same reason a lot of medical machining actually gets done.

They Came and Looked

The customer was already planning a trip to China. They asked to visit, and they came to our floor and looked at the machines.

What they were checking isn't complicated, and it isn't something a certificate tells you. They wanted to see whether the equipment was real, whether it was maintained, whether the shop was organised, and whether the people running it understood what they were doing. That's a twenty-minute conversation in front of a machine with a machinist, and it tells you more than a framed document on a wall.

Their conclusion, as they put it to us: you can make these parts. Which was good news and bad news at the same time — the capability was there, the paperwork wasn't, and for a regulated device the paperwork isn't optional.

The Arrangement We Actually Landed On

The solution came from the customer, not from us, which I think is worth saying plainly. They went and found an ISO 13485 certified supplier of their own.

Here's how the work flows now:

We machine the components — the parts where the machining itself is what matters: tolerances, surface finish, material integrity.
We deliver them to their certified partner, who receives them under their own quality system and performs incoming inspection against the agreed criteria.
That partner completes final packaging and shipping, and carries the device-level quality system responsibility that comes with the certificate.

Everyone is doing the thing they're actually set up to do. The certified partner isn't pretending to have machining capacity they don't have, and we aren't pretending to hold a quality system certification we've never been audited for. The customer gets parts that meet drawing and a supply chain that satisfies their regulatory obligation.

It's still running. We've been supplying components into that arrangement continuously since we set it up.

Why this is not a loophole

I want to be careful here, because "how to machine medical parts without the certificate" can read like advice on dodging a requirement. It isn't, and the distinction matters.

The certificate covers a quality system — how a company controls its processes, documents its decisions, traces its materials and manages its records. It attaches to an organisation, not to a spindle. In regulated markets the obligation for the finished device sits with whoever puts their name on it. Machining operations very commonly sit underneath that, subcontracted, with traceability and documented inspection running in both directions.

What makes the arrangement legitimate is that nobody is pretending. The certified partner knows exactly who machined what and inspects it under their own system. We know exactly what we're responsible for and what we aren't. If either side blurred that line, the whole thing would be worthless — and would deserve to be.

Straight Talk

When We're the Right Shop and When We're Not

Your situation	Are we a fit?	Why
You need the supplier's ISO 13485 cert on the invoice	No	We don't hold it. Find a certified shop — genuinely.
You have a certified partner and need real machining capacity	Yes, strongly	This is exactly the arrangement described above.
You're a device OEM building a tiered supply chain in Asia	Yes	We fit under your QMS rather than replacing it.
Prototype or pre-production parts before you lock the supply chain	Yes	No certificate needed to prove a design machines well.
Non-medical industrial, robotics, automation, aerospace	Yes	Certification is usually not the gate in these industries.
You need someone to own full device-level regulatory responsibility	No	That's not what a machining shop does, certified or not.

We'd rather lose a lead in the first email than waste three weeks of a buyer's time discovering this later. If you're reading this page and you need the certificate itself, we've saved you a conversation.

What We Can Document Instead

Being honest about what we don't have only works if what we do have is real. Here's the list, and it's short on purpose:

Dimensional inspection reports from our own CMM — measured, not estimated.
First-article inspection data on new jobs, so the first part is proven before the rest are cut.
Material traceability on request — we can tell you what stock a part came from.
Documented process settings for repeat orders, so batch five matches batch one.
ISO 2768-mH as the default general tolerance, tighter where the drawing calls for it.
NDA available — which is why this customer's name isn't on this page.

What we cannot do is issue a certificate we don't hold, or claim compliance we've never been audited for. Every shop can print a logo on a PDF. That's precisely why the customer came and looked at the machines instead.

FAQ

Medical Machining Without Certification

Do you hold ISO 13485 certification?

No. FSCPRECISION does not hold ISO 13485 or ISO 9001. We are a machining shop, not a certified medical device manufacturer. What we do instead is machine components that feed into a customer's own certified supply chain — the certified partner retains device-level quality system responsibility. We say this upfront because a medical buyer who needs the certificate on the invoice should disqualify us early rather than late.

Can an uncertified shop legally machine parts for medical devices?

In most regulated markets the device manufacturer — or the supplier whose name goes on the device labelling — carries the quality system obligation for the finished device. Individual machining operations are commonly subcontracted. The practical requirement is traceability, documented inspection and a clear agreement about who owns which step, which is exactly what the certified partner manages in the arrangement described here.

How can a medical device company use a shop without ISO 13485?

The usual working model is a tiered arrangement: the device company's certified supplier holds the quality system and device-level responsibility, while the machining partner produces defined components against agreed drawings and inspection criteria. The certified partner receives the parts, performs incoming inspection under their own system, and completes final assembly, packaging and release.

What documentation can you provide without certification?

Dimensional inspection reports from our own CMM, first-article inspection data, material traceability on request, and documented process settings for repeat orders. We work to ISO 2768-mH as the default general tolerance and can hold tighter where the drawing requires it. We cannot issue certificates we do not hold, and we do not claim compliance we have not been audited for.

Do you plan to get ISO 13485 certified?

We get asked this regularly and the honest answer is that we evaluate it against what our customers actually need. Most of the medical work we do arrives inside a customer's own certified supply chain, where the certificate already sits with the partner who owns device release. If that changes, we'll change with it — but we'd rather be accurate about today than promise a future audit.

Talk Straight

Tell Us What You Actually Need

If you're sourcing machined components for a regulated device and the certification question is where every conversation stalls, tell us how your supply chain is structured. We'll say plainly whether we fit, and if we don't, we'll tell you that too.

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