Overview of ISO 13485 Certification: Who Needs It and Why
ISO 13485 is the designated standard for quality management of medical devices. A Quality Management System (QMS) is the most indispensable management system needed in every business to help meet their customers’ needs continuously. In other words, it helps in maintaining a business’s position or competitiveness in the market. Since the medical device industry must focus specifically on maintaining the quality and reliability of products for patients’ safety, the ISO 13485 certification is instrumental for their QMS. Here is why businesses in the medical device industry should be conscious of the certification and why it is important. What is the ISO 13485 Certification? ISO 13485 was clearly designed to assist manufacturers or businesses in the medical device industry with a powerful QMS. To achieve this certification, they need to standardize their processes and adopt effective quality management practices. It ensures that there is consistency in all the phases of producti...