Quality Management System of “ELECTROPULSE” company conforms to the requirements of ISO 9001:2000 – Quality Management System Certification, ISO 13485:2003 Medical Device Certification and Directive 93/42/EEC Annex II (excluding Section 4).

The quality policy objective is to provide necessary technical, economical and administrative conditions for establishment and maintenance of the quality level required for medical devices used in electrophysiology, pacing and surgery at all stages of their life cycle.

To achieve the said objective we have decided that the quality management system of our company must meet the requirements of the international standards ISO 13485:2003, ISO 9001:2000 and Directive 93/42/EEC Annex II (excluding Section 4).

ISO 9001:2000        |   ISO 13485:2003    |       CE Mark        

     

Our goals
The principal goal of our management is to create conditions providing deliberate involvement of all Electropulse team in the quality management process as well as conditions under which each member can demonstrate its creative ability.
The priority lines of manufacturing of user-friendly and easy-to-use medical devices are as follows:

• Improvement of production standards and continuous perfection of device designs by means of high technologies introduction and production computerization.
• Continuous training of the personnel in professional field as well as up-to-date methods of quality management.

Our principles
We advocate team spirit to establish good work environment promoting efficient problem identification and solving for continuous quality improvement.
We pay special attention to technical, administrative and human factors having an influence on product quality.
We carry out self-apprising activities and internal audits on a regular basis.
We have well-organized interaction with our suppliers and customers for continuous product quality improvement.
We settle all controversial points that can arise from a position of required quality maintenance.

Personnel responsibilities
Our management intends to follow the above stated policy rigorously and urges all Electropulse personnel to do so.
Each member of Electropulse team, from top management to junior service staff, is responsible for the quality of its work and strives for customer satisfaction.

Model of a process-based quality management system according to
ISO 13485:2003