What are the differences between ISO 13485 vs. AS9100C

[QualityCNC]

Hello everyone and thank you in advance for your help.

We are a Swiss CNC machining contract manufacturer who have been AS9100C certified for the last 2-3 years. We believe our next step is to pursue an ISO 13485 certification.

My question is- what are the differences between the two standards? Are the drastic differences between the two? How challenging would it be to get qualified for both standards?

Again, thank you in advance for any help.

 

[AndyN]

Hi: I'm guessing you haven't bought a copy of ISO 13485...

In so far as they are both based on ISO 9001, there's not much difference in most respects. So, in implementation terms, they aren't so different, when it comes to your specific management system - customer requirements are going to be perhaps the single most variable aspect to consider. Also, the finite requirements on control of non-conforming product, for example, which is really taken care of in the procedural aspects.

As far as certification goes, it will mean another audit - so timing of the addition of ISO 13485 to your AS 9100 cert is important, as is whether your CB has a dual-qualified auditor.

 

[Ronen E]

Hello and welcome to the Cove

If you refer to ISO 9001 as the baseline for both ISO 13485 and AS 9001 -

The differences between ISO 9001 and ISO 13485 are described in detail in ISO 13485 Annex B. ISO 13485 has requirements that are specific to medical devices, related to sterility/cleanliness and other topics.

I'm no expert on AS 9001, but I think that if you search the Cove you will find a lot of information on the differences between ISO 9001 and AS 9001.

Please note that ISO 13485 is about to be reissued (revised) sometime in 2015, or 2016 latest (you can read about it in the Cove).

Cheers,
Ronen.

 

[somashekar]

Hello everyone and thank you in advance for your help.

We are a Swiss CNC machining contract manufacturer who have been AS9100C certified for the last 2-3 years. We believe our next step is to pursue an ISO 13485 certification.

My question is- what are the differences between the two standards? Are the drastic differences between the two? How challenging would it be to get qualified for both standards?

Again, thank you in advance for any help.

Hi and Welcome to the COVE ~~~
13485 is about medical devices QMS and directs to meet the applicable regulatory requirements. So you have much to do in identifying the applicable regulatory requirements, and then blend that into your QMS.
What are your medical devices and where do you have your market for them ~~~~~