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ISO 9001:2015 QUALITY MANAGEMENT SYSTEM
ISO 9001 Quality Management System ensures the monitoring and management of all processes of companies. All processes performed during system integration are documented and aimed to continuously improve these processes. ISO 9001 Quality Management System is a system applicable to all companies and serves as a door to development for all companies.
ISO 22716:2007 GMP SYSTEM
ISO 22716 GMP System is of great importance for cosmetics, medical device, biocidal and pharmaceutical companies that will continue to operate within the Ministry of Health. GMP (Good Manufacturing Practices) is defined as good manufacturing practices. Physical and documentation preparations for the operation of the company must be made. These preparations ensure customer satisfaction and preparation for customer inspections, as examined in the inspections carried out by the Ministry of Health. Hygiene, production follow-up, employee performances and general process management are the basic elements.
ISO 13485 MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM
ISO 13485 Medical Device Quality Management System is a document obtained by ensuring that medical device production processes carried out within the Ministry of Health comply with the necessary standards. The document content examines the company's physical and document adequacy. Control of all processes is important in the production of medical devices made with precision. Hygiene, production monitoring, employee performances and general process management are the basic elements.
COSMETIC PRODUCT REGISTRATION PROCEDURES
Obtaining production permits for cosmetic products begins with the company's ÜTS registration process. The company's ÜTS registration is completed with the official documents of the company and the online application made with the company representative. Then, the responsible technical staff must be registered and in this process, chemistry or chemical engineering department graduates or pharmacy graduates who have completed 2 years in the field of cosmetics are qualified. Finally, the products are recorded in the system with their label and content information, and this process is completed with the control of ministry officials. Products whose ÜTS registration process is completed are ready for sale, and their production and sales operations can be continued in the enterprise that has GMP standards and has a product safety file.
MEDICAL DEVICE REGISTRATION PROCEDURES
In order to obtain a medical device production permit, the company must undergo physical and documentary inspection. First of all, the production area is organized according to the company's GMP standards. The company must have a responsible manager and sales technical staff. Application is made to the Ministry of Health with application files and company official documents. After the application, the ministry audit takes place and the company's ÜTS record is created. Product registration procedures vary depending on product class. Relevant medical device documents and labels are prepared and recorded in the system, and after the control of ministry officials, the products are ready for production and sale.
DETERGENT AND BIOCIDAL REGISTRATION PROCEDURES
Production permits for detergent and biocidal products follow different paths. First of all, the product content and intended use are examined. Product dossiers and labels are prepared for products defined as detergents, and their production continues under the Ministry of Trade and Customs. For biocidal products, an application must be made to the Ministry of Health. Physical, microbiological and chemical analyzes of the products should be performed. Product information forms, labels and application documents should be prepared. Products approved by the Ministry of Health can be put into production.
BARCODE PROCESSING
While the use of barcodes speeds up product shipments of companies, it is also mandatory information required for cosmetics, medical device, biocidal and pharmaceutical products during the registration phase to the ministry system. In order to obtain a barcode, official documents of the company and notary approval of the official are required. There is an application fee and annual payments thereafter to complete the application. After company registration, the name, quantity, target market and class of the products are determined and registered.
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