A PRACTICAL ANALYSIS OF THE ROLE OF ISO 13485 IN ENSURING QUALITY MANAGEMENT IN HEALTHCARE ORGANIZATIONS

Abstract

The ISO 13485 standard is a globally recognized standard for medical device quality management systems. This standard is particularly important for hospitals that manufacture or distribute medical devices, as it helps to ensure the safety and effectiveness of these devices. This article discusses the importance of ISO 13485 for hospitals, including the benefits of certification and the steps involved in the certification process.