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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:
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?