Part 1. The Quality Management System (QMS) Foundation
8.1 The Architecture of Compliance (ISO 9001 / 13485)
A Quality Management System (QMS) acts as the organization's engineered operating logic, not mere...
8.2 Documentation Control & Data Integrity
The validity of a manufacturing process relies entirely on the integrity of its documentation. If...
8.3 Lean Quality Foundations: 5S & Visual Factory
Quality cannot exist in chaos. 5S is not a housekeeping methodology; it is a foundational quality...