ISO 13485: Medical devices

NEN-EN-ISO 13485

is an international standard for the Quality Management System of an organization focused on the design and manufacture of medical devices. This quality management system, which is in harmony with ISO 9001, focuses on meeting customer’s and legal requirements and the organization’s own policy, to improve customer’s satisfaction. With respect to ISO 9001, ISO 13485 focuses extra attention to specific medical requirements like cleanliness, care, effective traceability and a warning/ recall system. Customized production and distribution of medical devices and the patient’s well-being are also focus points.

The criteria for this standard are designed to facilitate:
– Developing structural plans (documentation) and defining & coordinating the organization’s processes and activities in accordance with design, development, production and distribution of medical devices
– Determination of specific medical & health concerns, prioritizing these concerns, and taking preventive and corrective actions
– Deciding on and acquiring the support goods and services like machines, materials, people and space, to conform to high quality production and distribution within legal & customer requirements
– Continuously monitoring/ measuring and examining production & distribution processes
– Taking appropriate actions by adjusting and implementing plans, processes and activities to improve quality performance

ISO 13485 is intended to be applicable to any size organization within the medical device industry, including manufacturers and suppliers of medical devices and its related services, as well as distributers. The QMS for medical devices is often required and implemented by organizations offering medical devices on the European and international market, and thereby must comply with applicable legal requirements for those markets.

Using this standard helps you improve the design, production and distribution quality of medical devices that you offer. This is achieved by continual structural management and improvement of the QMS. A certificate of this standard helps your organization access the market that recognizes or requires such certification. It proves your commitment to quality, it reduces operational costs by highlighting process deficiencies, improves efficiency, and it increases customer’s satisfaction. This all will increase your profitability.