Quality Matters: ISO 13485 Internal Auditor Training for Industry Leaders
I. Introduction to ISO 13485 Internal Auditor Training A. Definition of ISO 13485 ISO 13485 is an international standard for quality management systems specific to the medical device industry. It sets requirements for a comprehensive quality management system, ensuring that medical devices and related services consistently meet regulatory and customer requirements. The standard focuses on maintaining effective quality management practices throughout the product lifecycle, from design to post-market surveillance. B. … Read more