Establishment of a policy for risk acceptability criteria.Specific requirements of ISO 14971 include: To maximize effectiveness of your risk management system, ISO 14971 can and should be an integral part of your quality management system (QMS) as required by ISO 13485. This includes ongoing monitoring of field experience, thereby embracing the concepts of continuous improvement and state of the art device performance. ISO 14971 helps your company establish, document, and maintain a systematic process to manage the risks associated with the use of a medical device. ISO 14971 improves your organization's ability to reduce uncertainty, and your ability to achieve the critical objective of ensuring device safety and effectiveness. ISO 14971 is formally recognized as the de facto risk management standard by regulatory authorities in the US, Europe, Canada, Australia, and more. Medical device regulators in almost all major markets recognize that risk management principles should be used to identify and address safety issues of devices throughout their life cycle.
