Mark Cooksey, DME Quality Engineer, Norton Healthcare
ISO 13485 is an often-misunderstood set of standards for a certified Quality Management System (QMS). ISO 13485 was created primarily for medical device manufacturers and has significant applicability to medical device servicers like Norton Healthcare Corporation’s Clinical Engineering (NHC CE). NHC CE chose full implementation and ISO certification, but your company can reap significant benefits by creating an “ISO-ready” QMS today by leveraging existing systems and developing new processes to address common gaps such as vendor management and quality improvement. Come learn shortcuts to lead your organization to become an ISO-ready organization. It’s closer than you think.
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