BSI Reviews & Capacity

The problem is that they seem to use contractors and who they send is random. When we got started with them originally the person they sent was amazing (5+/5) and they came for the first few times. After that apparently, he cost too much and they started sending random contractors who were more focused on minor gotchas than adding any real value (i.e. regulatory pragmatism as you put it earlier).

9 month of constant nagging to become a customer. In the end daily phone-calls. had to wait four months from 13485 certification to receiving the certificate.

Other departments in our company handle Techdoc reviews, so we only have QMS certification.

Compared to our company’s corporate audits, which try to mimic an FDA audit, the BSI audits are pretty meek. Back in 2019 we used to get more findings, but ever since revamping our QMS the BSI audits tend to be a cake walk. Last year we got such a junior auditor, that he had trouble getting through all the material, that he really had to skim documents, those are the “best”.