ISO 13485 Certification
ISO 13485 is a stand-alone QMS standard derived from the ISO 9000 quality management standard series with an emphasis on medical devices. The ISO 13485 standard is an efficient way to meet the extensive requirements of a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address regulations and responsibilities while demonstrating a commitment to medical device safety and quality. The value of ISO 13485 lies not only in its implementation but also in providing a tool for a thorough audit to test the system's effectiveness. It gives the manufacturer more confidence in its ability to consistently achieve and maintain regulatory compliance.