Quality Policy

Sclavo Diagnostics International S.r.l. has the primary objective of marketing QUALITY products in order to guarantee CUSTOMER SATISFACTION in the context of the mission identified and defined in the Manual, respecting the HEALTH and SAFETY of the staff and the PROTECTION of the HEALTH OF THE PATIENTS. Customer’s satisfaction must be pursued and realized in respect with the safety of the people involved in the realization of the product and the service provided to the Customer, as well as all the binding regulations connected to them.

Therefore, it believes that all staff must be involved, each within their own responsibilities, and commit themselves with determination in the short and long term to the achievement of the following objectives:

1. pursue the assigned objectives oriented to the continuous improvement of the products;
2. focusing on continuous improvement of the quality of the products, with particular reference to the satisfaction of the requirements expressed by our customers, to our internal standards and to the legal requirements applicable to the products / services we offer;
3. operate in compliance with legislations and regulations in force and other signed requirements regarding safety management and personnel management
4. Reduce residual risks for the safety and security of staff at the workplace through the implementation of appropriate training and information programs, the adoption of appropriate work procedures and instructions and through an appropriate work organization
5. Pursue continuous improvement of the process performance;
6. Promote and guarantee the information, education and training process to ensure a proper application of the integrated management system.

In line with the strategies just described, Sclavo Diagnostics International S.r.l. is committed to pursue and achieve the following priority objectives:

• Aim to the complete satisfaction of the Customer's needs, through compliance with the contractual terms, prevention and the management of non-conformities and complaints.
• Maintain and progressively improve its standards of efficacy.
• Promote studies and research in order to achieve continuous improvement of products and processes
• Adopt the best available technologies to ensure the efficiency of the production process, using system solutions that optimize the quality levels of the products.
• Optimize the level of control and influence on suppliers, through the systematic use of auditing and the proper management of successive follow-up.
• Promote sensitivity to company policy and the professional growth of its employees and the intent with which it operates, through training and information.
• Commit to the respect of applicable legal requirements and other prescriptions that concern its aspects, as well as the satisfaction of mandatory requirements relating to the activities carried out.
• Act to prevent and minimize the environmental impacts of its activities.
• Improve the management of hazardous substances in the company in the knowledge of impacts that these chemical agents have and could have on the environment and on the health of the workers who use them.
• Promote the culture of Quality, the Environmental protection and the respect for Health and Safety of the workers in the company.
• Develop, keep active and periodically check emergency procedures, in order to reduce possible environmental impacts related to such situations.
• Promote consultation, as appropriate, of Workers, of Contractors and of relevant interested External parts.
• Prevent injuries and occupational illness through appropriate protective measures, monitoring actions, control and surveillance and systematic analysis of events that have occurred.
• Keep active and constantly improve the Integrated Management System (ISO 9001- ISO 13485) of the company by continuous updating and systematic application of processes, in order to maintain the document management system always efficient, effective and coherent with the business reality.
• Allocate adequate human resources and materials to achieving the aforementioned objectives

The table below highlights in detail an identifier prospect of interested stakeholders and related needs/expectations.