Quality Management Systems
Quality management systems and risk management activities are integral principles to ensuring the design and manufacture of safe and effective medical devices. ISO 13485 outlines the quality management system requirements that can be used by an organization involved in one or more stages of the life-cycle of a medical device. ISO 14971 specifies terminology, principles and a process for risk management of medical devices, that are intended to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. GHTF Study Group 3 developed several documents to support ISO 13485 and ISO 14971 including documents covering Risk Management, Process Validation, Corrective and Preventive Action, and Control of Products and Services Obtained from Suppliers. These existing GHTF documents were developed between 2004 – 2010 and contain outdated QMS and risk management principles. The QMS Working Group intends to update these documents to ensure they are aligned with the current versions of ISO 13485 and ISO 14971.