We manage quality at every stage: from design and procurement, through injection molding production, to assembly and shipment

Suppliers are evaluated on a monthly basis for the quality of components delivered, timely order fulfillment, lead time, and so on. The supplier receives reports on a weekly / monthly basis with qualitative results (component deficiencies versus the amount consumed by Biazet), on the basis of which corrective, preventive, and improving actions are taken

We conduct periodic FMEA (Failure Mode and Effects Analysis) to identify and prevent potential defects and errors in processes and products. Risks are minimized through the use of Poka-Yoke solutions (error-proofing) on assembly lines, such as special tool holders that physically prevent incorrect assembly. Additionally, all manufactured products undergo electrical functional testing to verify proper device operation.

Injection-molded components are inspected based on dedicated quality documentation. Depending on client agreements, components undergo visual inspection performed directly at the machine by the operator. Additionally, one sample from each machine operating on a given shift is taken daily for dimensional inspection in our laboratory.

Simply put, these are standards that ensure that each product meets certain customer requirements, is safe and reliable.

Partnering with us for the entire production process offers:
• No risk of responsibility being shifted between suppliers – one partner, one accountability.
• Faster response times – a quality issue in a molded part can be corrected immediately in the injection process, without waiting for decisions or actions from an external partner.
• Optimization of logistics and inventory costs – we produce on a “just-in-time” basis.
• A single partner fully responsible for the final component or product.

The assembly process is monitored at each production shift where the line is used. Inspection is carried out by a foreman (a person who manages the line in a given shift) before the start of production and after a break. Control system m.in. correctness of the data on all printed labels, confirmation of components available on the line from the specification, settings in testers available on the line, protective ESD (if required), installation instructions (availability and compliance with the linear model), confirmation of checking the torques of screwdrivers, etc.

We have ISO 9001 (Quality Management Systems) and ISO 14001 (Environmental Management) certifications, and we also strive to implement and certify in accordance with ISO 13485, which is the international standard for a quality management system for medical devices.