Althena - Quality System Service
Our quality system is ISO 13485:2016 certified. However, our internal controls go far beyond the obligations of our system.
The quality control of our devices is carried out by specialised and specifically trained personnel. Various measurements of different parameters are carried out periodically in order to verify and prevent defects. The devices are analysed under a microscope utilising 4K technology. This allows us to eliminate any problems at the source..
All defects are catalogued and counted and the data are reported in special tables. This allows us to monitor their progress over time so as to predict the their causes.
Spot checks are performed on the incoming materials and only the suitable ones move on to the assembly stage.
We are subject to periodic on-site audits by all our customers. Our production standards are pharmaceutical-grade. Our manufacturing standards are pharmaceutical grade.
The quality of our products is a priority for us. Each device we produce represents us and tells our story.
Quality assurance
The QA department personnel is constantly updated on new regulations. They attend courses and participate in seminars and webinars. They work closely with all other departments. A characteristic of this department, like the others, is that it is integrated into all company processes. In fact, its interaction with all company functions is crucial for the success of each individual project.
QA drafts all documents for the CE marking of the devices, drafts the operating instructions, prepares for both internal audits and those at external suppliers. It also trains the internal personnel for quality checks.