Our company is a multi-industry special process provider of laser and electron beam welding services and we do some supply-chain management and build to print. Specifically for these questions, we perform subcontract welding and some supply-chain management of both hardware and implantable devices for medical manufacturers.

Our company has a design-excluded AS9100 QMS and we hold Nadcap certifications for welding. I have been asked to explore ISO 13485 registration in addition to the AS9100. I have two questions:


Does having both AS9100 and ISO 13485 make sense for a special process provider?
What would be the advantages and/or drawbacks of having and trying to maintain both registrations?

Jim,

I have worked for an AS9100 Registered organization that also supplied medical device manufactures. These customers usually only required us to be ISO 9001 Registered and they would then flow down specific requirements related to the product they where procuring.

Duel ICOP quality management systems can become a very large headache for an organizations because of the differing requirements of individual standards but it can be done.

My recommendation would be to first determine if the market really requires your organization to hold an ISO 13485 registration. You may find that it is not required and the potential customer may find your AS9100 system to their liking because you are part of a regulation driven industry already.