The trap: Companies document everything but fail to link QMS processes. Practical fix: Create a process map showing interactions between Document Control (4.2.4), CAPA (8.5), and Design Control (7.3). Use a simple RACI matrix.
Risk tip: Clause 4.1.2 requires risk management for all QMS processes. Example: If your supplier approval process has a failure mode (delayed approval), document that risk. iso 13485 2016 a practical guide pdf full
Practical steps to satisfy 7.4.1 (Evaluation of suppliers): The trap: Companies document everything but fail to