Quality
As part of our commitment to manufacture and offer products and services of the highest quality and guarantee, and to meet the expectations of our customers, the Gennova Group has implemented a quality management system certified according to the ISO 13485:2018 standard, which guarantees compliance with the legal requirements of Regulation 2017/746 on in vitro diagnostic medical devices.
At Gennova, we consider quality management as the fundamental way to ensure safety and reliability in the design, development, production and marketing of in vitro diagnostic (IVD) medical devices.
Our quality policy is based on the following key principles:
Commitment to the customer and product safety
We strive to exceed our customers' expectations by complying with legal and technical regulations to ensure safe and reliable products.
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Leadership
We value our human team, promoting a culture of cohesion and clear communication that enables decision-making with a forward-looking vision.
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Internal collaboration
We promote individual responsibility, the prevention of non-conformities, and the reduction of risks, both in products and in the work environment.
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Process management
We identify, manage, and continuously improve our processes, evaluating their interdependence and allocating the necessary resources to achieve the objectives.
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Focus on risk management
We assess and manage the risks associated with our processes and products, ensuring that any changes are evaluated in advance to maintain safety.
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Market surveillance
We constantly evaluate and adapt our strategies to improve the quality of our products and services, responding to market needs.
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Continuous improvement
We constantly evaluate and adapt our strategies to improve the quality of our products and services, responding to market needs.
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Follow-up and post-marketing
We analyze market and competitor data to continuously improve, making decisions based on risk management.
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Collaboration with suppliers
We work closely with our suppliers, fostering mutual trust to achieve shared benefits.
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