Quality System

Our Vision

Safety, reliability, quality, innovation and customer satisfaction are the directions that we follow every day to design and manufacture products in order to improve the quality of people’s lives. This is the reason why, from the very beginning, we have worked in order to obtain and maintain a quality management system that would allow us to achieve these goals.

In 2013 we have been certified for CE marking of our first Medical Device EasyVein according to Medical Device Directive MDD 93/42 / EEC which has permitted to enter the market. Moreover we have also obtained the certification of Quality Management System according to UNI EN ISO 9001: 2008 regarding the design and manufacture of devices Electromedical diagnostic imaging.

Right after, in continuous improvement perspective, we have implemented a Quality Management System according to UNI CEI EN ISO 13485: 2012 and according to the Quality System Regulation 21 CFR Part 820 FDA and in 2014. Consequently, we obtained the certification of System Quality Management also according to UNI CEI EN ISO 13485: 2012 regarding the design

UNI EN ISO 9001:2008 Certificate»

CEI UNI EN ISO 13485:2012 Certificate»

The importance of the Quality System

The client satisfaction is our main interest. We would like to hear your suggestions, your instructions and your desires.

If you had problems or you have not been satisfied with our product or service, please contact us. We will be happy to help you. Continuous improvement is a main interest for us.

For any issue, please contact the Quality Assurance dept of InSono to qlt@insono.it.

Quality System Strategy of InSono

Since its foundation, InSono has been involved to be in strict touch with the player of its markets trying to achieve the maximum satisfaction and loyalty of the customer. Fos such reason it is committed to:

  • Developing products and processes designed and manufactured in order to satisfy the requirements of the customers and all the regulations they are subjected to, especially those which are applicable to medical devices;
  • Developing products and processes designed and manufactured to meet the needs of the customer, to anticipate their expectations and to deliver solutions that create value for them;
  • Speed ​​up the distribution of products and services through the adoption of the most innovative and reliable technical instruments as well as making the organization more efficient.

To fulfill its mission, InSono wants to:

  • Develop and maintain a management quality system as a tool to achieve the goals, to fulfill their commitments, to promote the continuous improvement of business processes, to ensure compliance with the statutory and regulatory requirements for products and related services;
  • Adopt a system of risk management, in order to ensure the minimization of the the residual risk for all the prodcts by adopting a proper policy of risk management which is commensurate to the different hazard of products;
  • Commit all energies and capabilities available in listening indications, suggestions and desires of the customer;
  • Focus every activity on the needs of the customer to satisfy at best and as soon as possible;
  • Constantly consolidate its activities in order to ensure to the customers safer, more reliable and higher value products;
  • Provide products and services belonging to all the requirements imposed by the laws in force in order to ensure the safety and health of patients and of all users of its products, with particular regard to the provisions pertaining to the basic safety and essential performance of medical devices placed on the market;
  • Organize culture and disseminate appropriate methodologies so that everyone who works with its technology will always be able to provide the best service expected by the customer.

Carrying out its mission InSono is involved:

  • with customers to provide products and services that meet the statutory and regulatory requirements, high-quality, demonstrating transparency and reliability, ensuring product quality at competitive prices, through the analysis and cost containment;
  • with suppliers, to foster a fruitful “alliance” in order they could play a important role in the tuning of the performances and of the characteristics of the product;
  • with commercial partners to promote the spirit of initiative, to encourage their professional growth, to ensure fruitful and serene professional relationships and to ensure a safe working environment in which everyone can be satisfied;
  • with the investors to foster the growth of the Company, ensuring adequate profitability and financial stability which are essential elements for the success of the Quality Policy.