INTEGRATED QUALITY AND ENVIRONMENTAL POLICY
Akzenta International SA recognizes the responsibility for ensuring quality, protecting health and preventing incidents, as well as protecting the environment as an integral part of its business activities. The General Management constantly strives to convey to all staff its commitment to operate within a Management System compliant with the requirements of EN ISO 13485:2021/A11, UNI EN ISO 9001:2015, and UNI EN ISO 14001, confirming its cultural values identifiable in:
- Supply of quality, safe, and reliable medical devices and dental products.
- Meeting customer requirements while also supporting the intended applications of the devices.
- Research and innovation to expand the range of products.
- Constant attention to maintaining the effectiveness of processes and organization.
- Encouragement of staff on environmental and safety issues.
In line with these guiding values, our General Management believes that the followings are fundamental factors for developing its level of competitiveness in the market:
- Compliance with all applicable laws and regulations.
- Pursuit of a concept of continuous improvement and optimal use of management resources in terms of quality and environmental management.
- Spreading of its quality and environmental management objectives and its performance regarding these objectives, both within the company and to customers and all interested parties.
- Ensuring that its activities are safe for employees, affiliates, suppliers, subcontractors, or others with whom it comes into contact in the course of its services.
- Close collaboration with customers and suppliers with the aim of achieving the highest quality standards.
- Adopting a forward-looking approach to future business decisions that may affect quality and environmental management.
- Thoroughly training employees on the requirements and areas of responsibility of quality and environmental management.
Our goal is to meet and exceed the expectations of customers and employees by involving and motivating all employees and implementing a properly documented management system in accordance with ISO 9001, ISO 13485, and ISO 14001.
The General Management of Akzenta International SA also commits to:
- Establishing measurable objectives and indicators during the periodic review by management; in order to adequately monitor its organization.
- Complying with Regulation (EU) 2017/745, the Medical Device Directive, Regulation 2016/425 and responding to the requirements of ISO 9001 and ISO 13485.
- Serving as a Manufacturer of medical devices under Regulation (EU) 2017/745 and the Medical Device Directive; acting as a mandate and importer under the Medical Device Directive and Regulation (EU) 2017/745.
- Communicating and sharing objectives with all staff.
- Maintaining and continually improving the effectiveness of the company’s management system, a tool used to monitor the progress of processes and therefore the company.
- Promoting and supporting, with the most suitable resources and means, this Policy, constantly verifying its application.
- Encouraging every individual in the company to promote initiatives and ideas aimed at achieving business objectives to support company improvement.
- Involving and consulting workers, creating an open communication type that encourages dialogue with stakeholders, employees, and the community, to better understand the effects on the environment and safety of its activities.
- Providing training and education to its personnel.
Date: March 1, 2024
General Management