The aim of the training is to inform the participants about EN ISO 13485: 2016 Medical Devices Quality Management Systems and to train competent auditors who can take an active role in the audit cycle which is required by the standard. The participants who can successfully complete this training will be the auditors (internal-external) who can contribute to the development of EN ISO 13485 standards and quality management system systematically and objectively.
Management systems provide a continuous improvement mechanism and discipline to your organization in addition to the market advantage. In addition, the quality consciousness of the employees and increase customer satisfaction, provides an important step towards institutionalization.
The Management System Standards are one of the most important internationally proven references to establish an effective management system. In the rapidly developing production and service sector; One of the most important criteria that ensures continuous growth and customer satisfaction on national and international grounds is the understanding of "Quality Competition". This is achieved through the "Management System" within the company.
EN ISO 13485: An international standard, which is based on the 2016 standard process approach model, with special requirements for medical devices.This standard sets out a quality management system that can be used by an organization for the development and improvement of processes related to the design and development, production, installation and service of medical devices.
ISO 13485: 2016 Medical Devices With QMS training, is aimed to refresh the knowledge of participants about EN ISO 13485: 2016, to provide an understanding of the standard from an auditor point of view, to review the accepted criteria related to auditing and to take the first steps of the auditors experience with practical applications.
ISO 13485:2016 is the medical device industry's quality management system (QMS) standard. The scheme specifies the requirements for a quality management system for medical devices.
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