Hello Covers,
Just wanted to pass along some good news. We had our 13485 assessment audit last week and have been recommended for certification. What's interesting (I think) about it is that we are an R&D company; i.e., we don't sell or manufacture a medical device. Fortunately, we had an auditor that could think on his feet. We had to get a little creative in areas such as record management and advisory notices.
A few months ago, we had a pre-assessment against a system that did not really reflect our business practices. The auditor was quite concerned that we were heading down the wrong path. As a result, we completely overhauled our Quality System and passed the audit with only 3 minor NCs (2 were corrected before he left).
So for all those wondering if you can get certification despite selling or manufacturing: an emphatic yes!
Just wanted to pass along some good news. We had our 13485 assessment audit last week and have been recommended for certification. What's interesting (I think) about it is that we are an R&D company; i.e., we don't sell or manufacture a medical device. Fortunately, we had an auditor that could think on his feet. We had to get a little creative in areas such as record management and advisory notices.
A few months ago, we had a pre-assessment against a system that did not really reflect our business practices. The auditor was quite concerned that we were heading down the wrong path. As a result, we completely overhauled our Quality System and passed the audit with only 3 minor NCs (2 were corrected before he left).
So for all those wondering if you can get certification despite selling or manufacturing: an emphatic yes!