Motto

“Electropulse” – high technologies at the service of health care

Mission

Development and introduction of breakthrough technologies, medical equipment and devices for high-performance surgeons’ work and patients’ safety.

Policy goal

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

To achieve this 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).

Objectives

Major leadership objectives:

·                     To lead the process of establishment and maintenance of quality management system meeting the requirements of ISO 13485, ISO 9001 and Directive 93/42/EEC;

·                     To meet legal and standard requirements of medical equipment output on Russian and EU markets;

·                     To define and meet market requirements;

·                     To inform certification body about meaningful changes in product’s project or in quality management system;

·                     To inform competent authorities about adverse events;

·                     To create conditions providing competent work of personnel dealing with production quality;

·                     To raise awareness of personnel about the importance and urgency of their work and their contribution to the achievement of quality objectives;

·                     To educate personnel in the sphere of quality management systems confirming to ISO 13485, ISO 9001 and Directive 93/42/EEC.

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 in the policy realization

·                     Our management intends to follow the above stated policy rigorously and urges all Electropulse personnel to do so.

·                     Each member of the team, from top management to junior service staff, is responsible for the quality of his work and strives for our customers’ acknowledgement and satisfaction.

President of ELECTROPULSE Ltd.

A.A. Kostrikin

Model of a process-based quality management system in “Electropulse” company