Hudson, WI — Phillips Plastics Corporation announced successful certification to ISO 13485:2003 standards, including design control. This certification will allow Phillips to participate to a greater extent with current and future customers in their design efforts. This accomplishment also makes Phillips Plastics’ Design Development Center a full service medical device product development facility. ISO 13485:2003 specifies requirements for quality management systems in which an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet regulatory requirements and customer requirements applicable to medical devices and related services. Holding to this standard will allow medical customers to advance their devices to market with only regulatory acceptance left to be completed.
According to Martin Lueders, Design Development Center Quality Systems Program
Manager, “The activities over the last few months have been successful, but the work does not stop. The Design Development Center will continue to improve on the quality system working to make it as robust as possible in so it instills the confidence from our customers’ perspective and is observed through the deliverables they are receiving from us.” The process for certification looked at four main areas of Phillips Plastics — management review, the corrective action process, customer complaint processes, and design control.
Phillips Plastics Corporation