case Study

Hi this is Yong Jiang from American Diagnosis, and we had ISO 9001 enforced in 2015 with help by Nate from icomply [Compliancehelp].

I really appreciated his help because at that time we knew nothing about the ISO quality system and he taught me how to comply with that, also gave us example protocols so we can follow that. I really appreciate that.

Q: What do you actually do here?
We do medical device research and development. Most of the time we focus on R&D, but we are also marketing our product to the European market so we do small scale production.

Q: Why did you choose Compliancehelp?

I called several companies, and then finally I talked to Nate and I find I had a very good feeling, so that’s why I chose, kind of randomly, but it happened. Maybe just chemical.

Q: How are the audits going?

The audits are going very well each year because we have a good user manual–good, quality manual we can follow. We get an internal auditor every year just to follow the instructions, and It went very well.

Q: Have you noticed benefits with having undergone the ISO 9001 internal audit?

We have Nate’s quality system enforced so we can always trace it back once something goes wrong, so we believe we have a better product compared to other companies without this system. This is one thing we are proud of. This year we got a lot of contracts for service because people say, “Oh, you’ve got a quality system, we trust you!”