Risk Management File
Template & Procedure

These procedures and templates include all necessary requirements of ISO 14971. By buying these templates you can have ready to use files and save your time from searching and editing , with help of these files you can submit your report efficiently.

These templates consist of a basic framework as per the requirements of ISO 14971 where the user can use it as a comprehensive repository of identified risks, their potential impacts, the control measures and mitigation strategies.

• Procedure and record template included, made specific to every activity as per ISO 14971:2019 including Risk Management Plans, Risk Management Policy , Risk Management Report , Risk Management Team , FMEA Table are covered in these templates.
• Risk Management Policy establishes a structured framework for how risk management will be approached within the organization. It outlines the roles, responsibilities, and processes involved in identifying and addressing risks.
• The Risk Management Plan establishes a process for identifying and documenting potential risks that could impact the performance and safety of the medical device. This includes identifying both known and unknown risks. The plan defines strategies and actions for mitigating or reducing the impact and likelihood of identified risks. It outlines preventive measures that can be taken to address risks before they materialize. The plan assigns responsibilities for managing and monitoring specific risks to individuals or teams within the organization. It clarifies who is accountable for each aspect of risk management. The plan establishes processes for ongoing risk monitoring and reporting. It defines how risks will be tracked, how changes in risk status will be communicated, and how risk data will be reported to stakeholders.
• FMEA (Failure Mode and Effects Analysis) Table is a template which consists of the parameters that shall be considered while analyzing and estimating the Hazards. FMEA is used to identify and document all possible failure modes that could occur within a process, product, or system. FMEA assesses the severity, likelihood, and detectability of each identified failure mode. This assessment helps prioritize which failure modes pose the highest risks and require immediate attention. FMEA helps prioritize which failure modes to address first based on the calculated risk priority numbers (RPNs). FMEA prompts organizations to analyze the underlying causes of failure modes. By understanding the root causes, corrective and preventive actions can be developed to eliminate or reduce the likelihood of those failures. FMEA allows organizations to take proactive measures to prevent or reduce the occurrence of failures. This might involve design changes, process improvements, quality control measures, and other actions.
• Risk Management Report presents the results of risk assessments, including severity and likelihood for each identified risk. This information helps prioritize risks based on their potential impact. The report outlines the strategies and actions taken to mitigate or manage identified risks. It details preventive measures, controls, and corrective actions implemented to reduce the likelihood and impact of potential failures.