Medical device manufacturers have ISO 13485 Certificate and have the opportunity to reach markets all over the world. Because these companies, which established ISO 13485 Medical Devices Quality Management System in their enterprises, have proved that they produce more effective and safe medical devices. This is also an application that increases the profitability and efficiency of the company and gives superiority to its competitors. In the meantime, it is an effective application that meets the requirements of the relevant legal regulations and creates customer satisfaction by understanding customer needs and expectations.

Taking into account these benefits, medical device manufacturers are now more willing to establish and manage the ISO 13485 Medical Devices Quality Management System in their business and to obtain the ISO 13485 Certificate. ISO 13485 standardIs a quality standard for the medical sector built on the foundations of ISO 9001 Quality Management System. That's why it covers all kinds of medical devices.

In practice, production in accordance with ISO 13485 standard is the basis for the CE marking of the company. Medical device manufacturers wishing to obtain CE Certificate for their products must first establish and manage ISO 13485 Medical Devices Quality Management System.

The steps for setting up the ISO 13485 standard in the enterprise are not different from the ISO 9001 standard. As a result, this system is also a quality system. The most important feature is the completion of the documentation work. The company's quality policies and objectives should be defined, business processes and work flow charts should be prepared, implementation instructions should be prepared showing how the work will be done, job descriptions and powers and responsibilities of the employees should be determined, how the processes will be audited and corrective and preventive actions should be defined.

After the preparation stages are completed and the system is put into practice, the company must apply for a certificate by applying to a certification body. At this point, it is important that the certification body to be selected is accredited by a national or international accreditation body.

Certification bodyfirst performs a preliminary inspection of the documentation. If no discrepancies are detected during this period or after the discrepancies are resolved, field inspection starts in the firm's office and production facilities. When this audit is completed, if the company is convinced that the company is producing in accordance with ISO 13485 standard, ISO 13485 Medical Devices Quality Management System Certificate is issued and delivered.

The ISO 13485 Medical Devices Quality Management System was published by the International Standards Organization and was recently revised in 2012. The change is not significant. Only a number of changes have been made in the preamble of the standard and in Appendix Z.

 

our company TÜRCERT Technical Control and Certification provides fast, high quality and reliable consultancy services to all medical device manufacturers who want to establish ISO 13485 Medical Devices Quality Management System and have ISO 13485 Certificate. If you have any doubts about ISO 13485 Medical Devices Quality Management System certification process, we are always with you as a company.