Quality Assurance Policy

SMAM provide the best quality in products and services for the satisfaction of our Customers worldwide, at every stage of the product life cycle, with the right expertise and commitment of all our employees.
The approach that the whole organization follows is to meet the communicated and implicit needs of the External Customer (the Market), the Internal Customer, the laws and regulatory standards that represent the state of the art in the medical device industry, always integrated with the concept of process and product risk management.
Due to the good relationship with all stakeholders, our focus has been on a management approach that is not limited to the timely resolution of events.

The main incorporated factors of the Basic Quality Assurance Policy involve:

  • Customer satisfaction and respect
  • Product Quality
  • Compliance with legal and regulatory requirements
  • Competence, reliability, courtesy
  • Fair pricing
  • Respect for the safety, health and rights of stakeholders 

Assumption of responsibility for the safety of medical devices

SMAM is fully aware of its social responsibility as a medical device manufacturer.
Therefore, we apply a policy of taking responsibility for the safety of all products we manufacture. 

Maintenance of the quality management system (QMS).

SMAM has been ISO 13485 certified for the quality management system (QMS) specifically for companies in the medical industry since November 12, 2004 along with ISO 9001 system certification since November 12, 2004.
All departments and processes involved in the design, manufacture and after-sales service of radiological medical devices and related services offered to our Customers are covered by the certified QMS.
QMS procedures are used in the controls and activities implemented to ensure product quality and safety based on the Basic Quality Assurance Policy stated above
The cycle of Planning, Execution, Control, Action for Improvement, together with the activities of internal audits and at any partners whose processes are deemed critical to the quality of medical devices, are repeatedly applied to assess the opportunity for continuous improvements.

Market feedback information

With a view to maintaining the usual safety and improving the usability and performance characteristics of our products we implement continuous evaluation of information gathered from the market and users of our devices.
This also enables us to plan future developments while maintaining the right ratio of efficacy, performance and price in compliance with the obligations imposed by medical device laws.


The President