ISO 13485

[gms1]

Anyone had to deal with this standard? My quality manager is asking if there is some kind of certification for mastercam and my reseller is saying mastercam can't really provide that. Is there some kind of solution to be certified to this iso standard?

[JoshC]

From what i read about that standard is its a standard related to medical devices, which doesn't seem to apply here since mastercam is a software not a medical device. 

[GoetzInd]

Yes, this is the quality system standard for medical devises. He is probably wondering what Mastercam can do to adhere to the file rev control area of the standard which is a legit concern. This would be handled by a PLM/version control software that would cover everything you do. Not mastercam. Most people don't version control the CAM file but the .NC code since that might see changes outside of CAM anyway.

 

Mike 

[gms1]

My quality manager is asking because part of the standard is to certify all software that aids in the manufacture of the devices. My reseller is telling me mastercam cant really provide that and it makes sense so I am left wondering how do i certify nc code

[Jobnt]

"certify all software"

Define certify. 

Is it just quality control that has to keep finding new and idiotic ways to justify their existence? 

[GoetzInd]

To certify our code here we have a robust verification (vericut) and version control process that works very well. Serial numbers and ver numbers of programs even get passed down as macro variables in the programs for tracking and recording of probing data etc. This is all part of our AS9100 quality system. However, in another division of our company, the verification process is defined as "checked by machinist", and guess what, both pass our AS9100 audits and most of the time the auditors have no idea of what actually adds control and value and are just checking boxes that you process is being followed. 

Mike

[Jobnt]

5 minutes ago, GoetzInd said:

However, in another division of our company, the verification process is defined as "checked by machinist", and guess what, both pass our AS9100 audits and most of the time the auditors have no idea of what actually adds control and value and are just checking boxes that you process is being followed. 

I'm not familiar with ISO 13485, but in AS9100 you define what your process is and as long as you adhere to it you should pass any audit. Therefore the auditors really don't have any idea of what adds quality and value.