Welcome back to another insightful episode of Tales from the Audit Crypt. Professor Rallis-Daw here. In observance of All Hallows Day, we bring forth the following tale from deep with the audit crypt.   The corridors of MedTech Manor were silent… too silent. Only the faint hum of servers and the ghostly flicker of fluorescent lights kept vigil as the date crept closer — February 2, 2026. That was the night the QMSR  would awaken. At first, no one heeded the warnings. “We’ll u

Today’s tale is one of inadvertent mishandling of internal audit findings —a grim reminder of what befalls those who ignore the warnings etched into the very bones of Clause 8.2.4 of ISO / EN ISO 13485:2016 which states that, "The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.

🎙 Welcome back to another insightful episode of Tales from the Audit Crypt ! Today, we unravel a critical but often undermanaged aspect...