Embarking on the adventure of ISO 13485 compliance requires meticulous documentation, and at the heart of this documentation lies the ISO 13485 manual. This article unravels the intricacies of crafting an effective ISO 13485 manual, presenting insights into quality practices that cross beyond mere compliance.
Understanding ISO 13485
ISO 13485 is a globally recognized standard that sets the framework for a quality management system specific to the medical device industry. A fundamental part of accomplishing compliance is the introduction of a well-structured ISO 13485 manual, which serves as a guide for organization to navigate the complex landscape of quality management.
