ISO 13485 – Medical devices – Quality management systems
ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. Borrowing the structure of ISO 9001, ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices, and medical components.
Created by the International Organization for Standardization, ISO 13485 is based on eight quality management principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact based decision-making and mutually beneficial supplier relationships. When fully adopted, these principles have been proven to enhance organizational performance.