In order to provide this type of medical device, we had to become ISO certified. We recently received our certifications for ISO13485, the medical standard, ISO9001, and ISO14001, the environmental standard. When we started this process, we realized we needed a good digital system to control all our documents and manage approval of document updates through version control. That's how we found BizzMine.
BizzMine is easy to use and very flexible, as we can customize many parameters to fit our organization. We also appreciate the templates that come with the product. This is how we set up our processes for document control, calibration, CAPA, and customer complaints. Thanks to the templates, we were able to start using the software in the field right away. Our machines and measuring devices need to be serviced daily, weekly, monthly, or annually, and all of this can be easily managed in our calibration process.
One of the main benefits of BizzMine is that it really helped us get through our process of becoming ISO certified in a short time and with less work. For our audit, we had our documents in good order and we could rely on the traceability of the approvals for the documentation. It only took us about 7 months to get certified, which is a record time since it usually takes 1 to 2 years.
We had friendly and prompt support during the implementation of the system, so it was a very pleasant experience working with the BizzMine team. On the business side, we found BizzMine very attentive and responsive to our needs and requirements.
Bo Jonsson, IT Infrastructure and System Integration
Mikael Klockseth, CEO