Quality

Product quality and safety, as well as customer satisfaction, are among Comecer’s priority goals. To this end, the company has realised major investments and trained its human resources to achieve a documented approach within a GMP context (product qualification).

Comecer certifies its products , therefore all systems are inspected and subject to an extensive system series of validation tests in compliance with current regulatory standards, within a national, European and international context. The current reference standard for the Quality System is UNI EN ISO 9001: 2000, certified by the prestigious international body TÜV. In addition to this, Comecer has obtained certifications for its Quality System according to the the ISO 13485:2003 requirements for the production of medical devices , as well as the certification of some products from TÜV and from FDA (Food and Drug Administration).

Validation protocols comply with the main reference standards and guidelines (ISO 14644, ISO 10648, EEC-GMP, PDA-TR Nr 34). Comecer considers implementation of its Quality System to be essential for a strategic control of the achieved success level and for a development planning towards higher quality standards in the future.