OncoTherm Kft. - Quality Policy
OncoTherm Kft. is entirely committed to the development and manufacture of safe and reliable “complementary therapy medical devices” and aims at providing a therapy, that increases the quality of life of patients.
Accordingly, it fulfils the requirements of the 93/42/EEC European Medical Device Directive and ISO 13485:2016 standard and additionally Canada legislations from the Medical Device Single Audit Program have also been incorporated.
Our overall objective is to consistently provide customer and regulatory compliance in products and services through special expertise, continual improvement in our process approach and employee development.
Our quality management system provides a framework for process management and measurement and improvement of our overall business performance by supporting continuous development and strategy building. It ensures the fulfilment of our customers’ and regulatory requirements.
We maintain the effectiveness of our quality system by periodically reviewing the determined measurable objectives related to:
• Product development and improvement.
• Regulatory compliance; internal and external audits.
• Customer focus and process effectiveness and efficiency.
• The planning and improvement of the quality system.
• Supplier quality assurance.
• Personnel training and competence improvement.