ISO 13485:2016 QMS: Outsourced Processes

[shimonv]

Hello guys,

Need some guidance here.
We are a Class I medical device start up firm. We have outsourced our industrial design (plastics) to a contract manufacturing vendor, which is ISO 9001 certified. They are fairly co-operative in sharing their manufacture control documents for the plastic and mechanical parts (final assembly and testing will still be done in our premises.
What additional type of controls and documentation should we put place in place (at our end and vendor end) so that we are able to satisfy quality requirements as per ISO13485 norms? Or do we absolutely have to manufacture from only ISO 13485 certified vendors?

Thanks

Hi Dtbal and welcome to the cove.
In a nutshell, you are the legal entity and as such you need to comply with all the applicable sections of ISO 13485, including manufacturing controls.

Your subcontractor does not have to follow ISO 13485; ISO 9001 will suffice.
Further to that you need to establish a quality agreement with the subcontractor will all the applicable elements.

Good-luck,
Shimon

 

[Dtbal]

Hi Dtbal and welcome to the cove.
In a nutshell, you are the legal entity and as such you need to comply with all the applicable sections of ISO 13485, including manufacturing controls.

Your subcontractor does not have to follow ISO 13485; ISO 9001 will suffice.
Further to that you need to establish a quality agreement with the subcontractor will all the applicable elements.

Good-luck,
Shimon

Hello Shimon,
Thank you so much for your guidance. We were uncertain of this requirement for our vendor.

Much appreciated.

Regards,
Dt