I have taken on a big challenge with my new job...establishing ISO 13485 and AS9100 in an ISO 9001 compliant contract manufacturing company. We make precision products for a multitude of industries, including medical device OEM. Customers are desiring and in one case demanding our certification to relevant standards in their industry in order to remain a preferred approved supplier. Top management has weighed the benefits and elected to pursue the aerospace and medical device related standards. I was recruited for this enormous job :mg:. Not complaining (I like a challenge and being employed!). Anyway, I NEED A BRAVE EXPERT in the field to proof read the draft QMS manual that incorporates all these standards into one. Any takers????
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