The products of the Medplast plant are high-quality and safe medical products manufactured using modern equipment in accordance with the requirements of world quality standards.
The products of Medplast LLC comply with the requirements of the national technical regulations of Ukraine, have been awarded the Mark of Compliance with technical regulations and are registered by the Ministry of Health of Ukraine.
The enterprise widely uses control statistical charts, advanced methods of calibration of measuring instruments, confirming and guaranteeing the accuracy of measurements, quality standards are functioning and continuously improving: Quality Management System ISO 9001: 2009 and Quality Management System EN ISO 13485: 2018
The validity of certificates of conformity of management systems is annually confirmed during inspection control during supervision and certification audits.
The introduction of a quality management system that meets several international standards at once, as well as the study and use of advanced international experience, forced a new approach to the improvement of technological processes and organization of enterprise management.
Each batch of finished products, without fail, undergoes control at the testing center. The manufactured products are accompanied by a protocol of the batch production history, where the materials used, the route of movement of the products through the sections during the manufacturing process, the results of control, etc.
The Quality Control Service is responsible for the quality at the plant, which includes:
- Department of technical control;
- Quality department.
The technical control department conducts control of input products (raw materials, materials, components) and finished products for compliance with the requirements of standards, the sanitary condition of premises, equipment, production personnel for compliance with the requirements of DSTU EN ISO 13485: 2018.
The TC department is equipped with modern equipment and instruments that undergo strict periodic metrological certification and verification, and also has qualified personnel, which allows us to carry out sanitary-chemical, medico-biological, toxic-hygienic, mechanical, functional tests according to the most advanced methods.
The technical control department conducts inspection control of production processes, technological operations and products (parts, assemblies), organizes and ensures the traceability of the results of monitoring the parameters of processes and products.
The quality department constantly evaluates the effectiveness of the quality management system at all levels and develops proposals for its improvement, carries out internal periodic audits of the quality management system, organizes personnel training in the field of quality, carries out work on registration and certification of products in Ukraine and abroad.
All quality control specialists have specialized education, the necessary technical knowledge, qualifications and experience. The most important responsibility of the Quality Control Department is to ensure that each batch of finished products released for sale meets the requirements established during their state registration.
The quality control department of Medplast LLC includes the following control stages:
- for incoming inspection of raw materials and materials,
- on interoperational control,
- for the control of the production of medical devices and printing products.
The purpose of quality control is to prevent the use or sale of materials or products that do not meet quality requirements. Quality control is aimed at preventing the release of medical devices that do not meet the requirements of regulatory documents, delivery conditions and contracts, or incomplete products, as well as strengthening production discipline and increasing the responsibility of all production links for the quality of products.
The quality control and technical control services are equipped with the necessary measuring and auxiliary, as well as testing equipment to ensure reliability in obtaining results, as well as in the required amount of consumables.
We guarantee full provision of external and internal regulatory documentation for quality control work, as well as documents for registering quality control results (logs, analytical sheets, passports, sampling protocols, etc.)