We are a medical device manufacturer since the 70's. With people coming and going our drawings and BOM structure has evolved into two different groups. Group 1 drawings (traditional) for example would be of a molded component that would specify the material in the notes. Group 2 drawings (new)...
Thank you for the response. Sections 13.3 and 17 specifically are what led me to make my conclusion about verification testing. Are you saying that if they supplied us with process conditions, certificate of analysis perhaps, instead of verification testing, this would suffice?
I can tell you...
Our company outsources to two passivation companies, both are required to "Passivate per ASTM A967, Nitric 1" and supply certificates. One company has an internal requirement to always verify effectiveness of passivation with each lot and the other will only verify effectiveness of passivation...
