Jul 3, 2023
Comprehend the ISO 13485 Quality Management System for Medical Devices’ Plan-Do-Check-Act Cycle
The ISO 13485 standard was created for regulatory compliance even though it is based on the “Plan, Do, Check, Act” concepts from the ISO 9001 process model. As a result, some of the inappropriate ISO 9001 criteria are not included in ISO 13485, which instead includes specific requirements for organizations involved in the life-cycle of medical devices. Because of this, it becomes more prescriptive and necessitates a QMS with more extensive documentation.
The ISO 13485 standard was created for regulatory compliance even though it is based on the “Plan, Do, Check, Act” concepts from the ISO 900