M
Hello,
I am in charge of the design of medical equipment, and we are in the component selection process. After reading many posts in the forum, I would like to know what requirements should I look for in my suppliers in order to be able to certify ISO 13485 in the future. My problem is that two components are so specific that only 2 small companies make them. For this reason I am worried, I started thinking I will have to modify my design because my suppliers haven’t got a QMS implemented.
I read some posts regarding the possibility of auditing or sending a survey to the supplier.
What have you done to cope with this issue?
Thanks in advance,
Maria.
I am in charge of the design of medical equipment, and we are in the component selection process. After reading many posts in the forum, I would like to know what requirements should I look for in my suppliers in order to be able to certify ISO 13485 in the future. My problem is that two components are so specific that only 2 small companies make them. For this reason I am worried, I started thinking I will have to modify my design because my suppliers haven’t got a QMS implemented.
I read some posts regarding the possibility of auditing or sending a survey to the supplier.
What have you done to cope with this issue?
Thanks in advance,
Maria.