I have been consulting the site since the end of june 2009, I realy like it, I found a lot of ansers to my questions. I have just got my first job in this field, I have a certificate in quality assurance. It was very simple for the Iso 9001 certification that i studied, but last week one of our major customers asked to be certified ISO 13485.
Could you plase tell me what do I have to do in our case, we are already certified Iso 9001. What ae the steps. Do I have to make an other manual, other procedures and other forms or just add things to the ISo 9001 documentation. It will be very apreciated if you give me some examples.
We are producting Titanium powders that are used for chirurgical implants by our customer. What is th class and regulation for our product