LostLouie
Starting to get Involved
Let me say that this site has been a wonderful source of information over many years, for a great many within the regulated industries and I'd be glad to thank those responsible for starting and maintaining it.
Now for my question....
I'm working with a medical device manufacturing site that was taken over by a much larger corporation (c. 2010). However this site has never been geared up for anything more than ISO 9001 and now, belatedly, is planning for ISO 13485:2016 accreditation. They have never been involved with product design or changes which have been imported to them from customers (other corporation sites).
My query is that they are blind to external Design development processes and have no visibility nor input to product design, will this be a justification for any non conformances in the product during an audit?
Thanks for your attention.
Now for my question....
I'm working with a medical device manufacturing site that was taken over by a much larger corporation (c. 2010). However this site has never been geared up for anything more than ISO 9001 and now, belatedly, is planning for ISO 13485:2016 accreditation. They have never been involved with product design or changes which have been imported to them from customers (other corporation sites).
My query is that they are blind to external Design development processes and have no visibility nor input to product design, will this be a justification for any non conformances in the product during an audit?
Thanks for your attention.