What is the General Purpose of ISO 13485 Standard

The general purpose of the ISO 13485 Medical Devices Quality Management System standard is to ensure that companies producing medical devices and providing technical support in this area operate in line with the quality standards. Producers applying ISO 13485 standard in their enterprises have competitive advantage in this way and gain prestige and prestige in the market. Within the framework of the general principles of quality systems, continuous improvement activities are widespread in the company, production errors are prevented, costs are reduced and progress is made in the profitability and efficiency of the company. In this way, while the reliability of the products of the company increases, the company gains a more systematic way of working compared to its competitors and the success rate increases.

ISO 13485. Medical Devices Quality Management System is a standard developed for this purpose. Companies that establish and apply ISO 13485 standard in their enterprises can apply for a ISO 13485 Certificate by applying to a certification body. To be valid, the certification body must be authorized by one of the national or international accreditation bodies.

A few of these accreditation bodies are: TURKAK (Turkish Accreditation Agency) in our country, FDA (Food and Drug Administration) in America, American Food and Drug Administration in Canada, CMDCAS (Canadian Medical Devices Conformity Assessment System in Canada) JPAL (Japanese Pharmaceutical Affairs Law) in Japan, ZLG in Germany (Zentralstelle der Lander für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten) and ZLS (Zentralstelle der Lander für Sicherheitsteehnik) and MDCO (Medical Device Control Office in Hong Kong), Medical Instruments Control Center.

One objective of the ISO 13845 standard is to lay the groundwork for medical device manufacturers who wish to mark their products with the CE mark. The CE marking system is a safety and health mark used by the European Union within the framework of the New Approach prepared by the European Union in 1985 to ensure free movement of goods. Products bearing the CE mark are considered healthy and safe for human, animal and environmental conditions.

The CE marking is not related to Quality Management Systems. The CE mark symbolizes that any product is designed and manufactured in accordance with European standards. In the modular structure, quality standards are required for some product groups.

In practice, it is sought to establish ISO 13485 Medical Devices Quality Management System in the company for CE marking system. Medical device manufacturers that have established ISO 13845 standard can easily put CE marking on their products. Within the scope of the European Union New Approach directives, medical devices are also included in the product groups that require CE marking for today.

All medical device manufacturers who want to establish ISO 13485 Medical Devices Quality Management System and have ISO 13485 Certificate, TÜRCERT Technical Control and Certification company, they will receive a fast, quality and reliable consulting service. As in all matters, you can immediately contact our company managers and employees to exchange opinions on the general purpose of ISO 13485 Medical Devices Quality Management System.