Woraphot
3rd October 2007, 01:17 AM
Hi,
Our product is IC package that may be a component in electronic equipment for medical product. At this moment, we don't have any medical product but we would like to consider ISO 13485 in the future business. In this case, Is it possible to certify ISO 13485 ?
Best regards,
Woraphot
Gert Sorensen
3rd October 2007, 01:54 AM
Hi, and welcome to the Cove.
Can you please explain, what an "IC package" is?
:bigwave:
Sidney Vianna
3rd October 2007, 02:34 AM
Can you please explain, what an "IC package" is?Probably Integrated Circuit, a.k.a chip, microchip, microcircuit, etc...
Woraphot
3rd October 2007, 02:45 AM
Hi,
IC package is Integrated Circuit product.
BR,
Woraphot
Gert Sorensen
3rd October 2007, 02:52 AM
Hi,
Our product is IC package that may be a component in electronic equipment for medical product. At this moment, we don't have any medical product but we would like to consider ISO 13485 in the future business. In this case, Is it possible to certify ISO 13485 ?
Best regards,
Woraphot
If you don't produce medical devices then I personally wouldn't consider certification to 13485. Basically you will just be adding to your cost of certification. What you might consider is to align your quality system to 13485 and the QSR and get your organization used to the added procedures and demands that would be implemented. If, and when, you need to be certified, then it shouldn't take very long to actually obtain the certificate.
:bigwave:
DannyK
3rd October 2007, 09:48 AM
You do not need to get certified to ISO 13485 if you are providing components for a medical device.
I do not see any benefit to incorporate any part of ISO 13485 in your system since you are not producing a medical device.
w_grunfeld
3rd October 2007, 11:51 AM
Woraphot,
It is possible but why should you want to?? As an IC packge manufacturer you are not even supplying a finished component, your product could be used by IC manufacturers for a variety of applications that you may not even know what they are.
The semiconductor industry is using TS16949 and its commodity specific Semiconductor Supplement. This is the standard that is appicable to your industry, not ISO13485. Yout customers are IC manufacturers not medical device manufacturers!
Willy
Woraphot
4th October 2007, 01:17 AM
Hi, ALL and Willy
I absolutely agree with all of you. Yes, our end product is variety of application but we do not exactly know such as automotive, appliance, computer, mobilephone, or medical etc. We are currently TS 16949 certified and we are feeling that ISO 13485 standard may be also required from medical customers in the near future like TS 16949. That's why we are starting to learn about it. Any way I would like to thank everyone in the forum to give me good comments.
BR,
Woraphot
