Benefits for OPODIS PHARMA company applying ISO 13485:2016 that certified by CGLOBAL: Meeting the mandatory requirements of Decree 36/2016/ND-CP on management of medical equipment; Create more trust with customers; Labor productivity increased...
Benefits for OPODIS PHARMA company applying ISO 13485:2016 that certified by CGLOBAL: Meeting the mandatory requirements of Decree 36/2016/ND-CP on management of medical equipment; Create more trust with customers; Labor productivity increased...
SO 13485 is a safety management system standard for medical products published by ISO organization. ISO 13485 standard is based on the foundation of ISO 9001 standard. This standard purpose to meet statutory and customer-specific requirements, manage risk and maintain efficient production processes, requirements for contamination control, product hygiene, special needs with sterile medical devices and product traceability requirements.
According to the provisions of Decree 36/2016/ND-CP on the management of medical equipment, the application of ISO 13485 is one of the mandatory conditions for the quality management system that medical device manufacturers must comply with. In fact, medical supplies need to be completed before the product go to the market from January 1st, 2020.
OPODIS PHARMA Company was established in 2007. The factory of OPODIS PHARMA company is designed and built according to the standard for the production of good medicine of the World Health Organization GMP-WHO in Tay Ninh province. After more than 12 years of development, the company has developed many quality product lines with natural herbal origin.
During the assessment process, the auditors of CGLOBAL Center for Quality Certification and Testing raised many problems that OPODIS still in existence so that the company could improve their quality management system in the manufactures supplies of medical equipment.
Through the assessment of the production area, the warehouse of raw materials, the warehouse of finished products, the overall review of the management system, production operating procedures, production monitoring forms, instructions for maintaining hygienic conditions, clean room conditions. Auditors consider that OPODIS basically meets the requirements of ISO 13485:2016 and is eligible for certification.
Benefits of OPODIS PHARMA company in particular and medical device manufacturing companies in particular when applying ISO 13485:2016: Meeting the mandatory requirements of Decree 36/2016/ND-CP on equipment management medical condition; Create more trust with customers; Labor productivity increased; Having a competitive advantage over similar products; Improve product quality; Control hygiene hazards and have specific plans in time; Easier access to foreign markets; Convenient in integration with other management systems (ISO 9001, ISO 14000, ...).
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