ISO 13485 - What requirements should I look for in my suppliers

[m_penaso]

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.

 

[wrodnigg]

Hello Maria,

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.

It depends:

How "critical" are these two components?
And: are we talking about products for the States or for Europe?

You should do a risk assessment for your product and its parts/components.
Then you know the criticality of these components.

What could happen to them and which consequences would a failure have for the product and a patient.

Then you should think how you can reduce the risk.

E.g. if you test each single part by incoming inspection there is no need for a quality system for your supplier. If you do not want to check each single item, you have to set actions to assure the quality...

You should tell us more to give us the opportunity to be more specific with an answer...