Hi there,
I recently took a job in a small medical company that produce class I & II devices per contract requirement. We are the manufacturing who make the product per customer design and requirement. I was asked to implement & get the ISO13485:2016 certified. I understand the company quality manual and company procedure are two different document. I know every company has their own functional and operation, but I like to see if anyone could help provide some leads.
I recently took a job in a small medical company that produce class I & II devices per contract requirement. We are the manufacturing who make the product per customer design and requirement. I was asked to implement & get the ISO13485:2016 certified. I understand the company quality manual and company procedure are two different document. I know every company has their own functional and operation, but I like to see if anyone could help provide some leads.
- Showing some procedure samples (not the quality manual) that meet ISO13485:2016 requirement.
- The company is currently using QuickBooks & other MS words for document and records. Does these require software validation?
- Is the company allowed to get the ISO certified again if they get a “NC” and how often is it?