Quality Assurance

All operations within EMCM are under the purview of an effective Quality Management System, the primary mandate of which, is to control and to assure that only high quality and safe products will leave EMCM and thus enter the market and that compliance with the applicable regulations is maintained.

To this effect, EMCM is an ISO 9001:2008, EN ISO 13485:2003 & CAN/CSA ISO 13485:2003 certified company which acknowledges the compliance maintained in business practices as well as manufacture of Medical Devices. EMCM possesses a Good Manufacturing License for the manufacture of Pharmaceuticals and also a Tissue License for the storage, processing and distribution of Human Tissue. For the above, we are subject to several national, European and US (FDA) inspections to be able to manufacture products for global markets. To read more on the licenses, please refer to the side bar. 

Training programs are established and maintained on all levels of the organisation and include basic GMP, pharmaceutical workmanship, pharmaceutical techniques and various function specific training depending on activities and position within the organisation.

According to standard procedures, EMCM performs validation and/or verification of processes, qualification of equipment, utilities and analytical methods. All critical processes for manufacturing Biomaterials and Pharmaceuticals are validated. A Master Validation Plan describes the requirements and structure, including responsibilities for the execution of validation and qualification. Equipment qualification follows the IQ/OQ/PQ qualifications, according to planning. Routine maintenance and calibration are structurally planned and executed.