ontheopenroad said:
Similar issue here. My current company is a contract manufacturer. We do not make finished devices, and do not market/brand any finished products. We have a major customer for whom we are a major component manufacturer. They are "encouraging" us to pursue registration to 13485 because they are registered to 13485. I keep telling them that there is really no use in doing so.
If you are a medical device manufacturer, compliant with 9001 and the QSR, you probably have MOST of the necessary controls in place to be compliant with 13485.
I'm thinking about reviewing my QMS and making it "compliant" with 13485 without seeking "certification" to 13485, to appease the customer, but to prevent having to pay for the certification.
If you are a medical device manufacturer, compliant with 9001 and the QSR, you probably have MOST of the necessary controls in place to be compliant with 13485.
I'm thinking about reviewing my QMS and making it "compliant" with 13485 without seeking "certification" to 13485, to appease the customer, but to prevent having to pay for the certification.