Have any of you come across this, and how do we prevent it? I work for a medical device manufacturer that buys custom components that are manufactured by an ISO 13485 certified component manufacturer. I just audited this supplier. The components they make for us are considered to be in the R&D phase of development. Meanwhile, we as a medical device manufacturer are starting to do design verification and "froze" our medical device design many months ago. The supplier on the other hand has not put our specifications into their quality system. They have no work instructions for manufacturing our component. They can't show training records showing their people were trained to our specific process. They can't show that the specifications we provided to them have been reviewed. They don't have controls for the drawings we have provided to them.
This miscommunication seems to be pretty common. Are there some things that I can suggest to this component manufacturer so they prevent this from happening in the future? Also, are there any suggestions for the medical device manufacturer to prevent this from happening? Audit of course, but anything else? Thanks for reading my rant.
This miscommunication seems to be pretty common. Are there some things that I can suggest to this component manufacturer so they prevent this from happening in the future? Also, are there any suggestions for the medical device manufacturer to prevent this from happening? Audit of course, but anything else? Thanks for reading my rant.