My question is specifically on how do organizations maintain the quality agreement requirements with their contract manufacturer - in my example, an organization who manufactures medical devices and consumer electronics have a contract manufacturer. The organization proposed two different quality agreements but the contract manufacturer is suggesting a single agreement with two sets of requirements.
I was leaning two different quality agreements but was also thinking of a single agreement based on the ISO 13485 standard, where they had the text from ISO 9001 in black and specific medical device requirements in blue text.
I would love to hear from you all if you have encountered this situation and what approach did you take?
Thanks!
I was leaning two different quality agreements but was also thinking of a single agreement based on the ISO 13485 standard, where they had the text from ISO 9001 in black and specific medical device requirements in blue text.
I would love to hear from you all if you have encountered this situation and what approach did you take?
Thanks!