Risk Management Procedure
SKU: SOP 7-003
The ISO 14971 Risk Management Procedure governs the overall risk management process, including the identification and mitigation of risks identified during each phase of medical device design, production and post commercialization activities.
- ISO 14971:2012 Compliant
- FDA QSR Compliant
- ISO 13485:2016 Compliant
- MDR EU 2017/745 Compliant
- Includes Related Forms
- MS Word and Excel Format
- Digital Content - Instant Download
ISO 14971 Risk Management Procedure
The ISO 14971 Risk Management Procedure serves as the top level procedure that governs the overall risk management process including design risk management, rocess risk management, and analysis of post commercialization feedback.
ISO 14971 Risk Management Procedure Overview
Risk management is divided into two sections: (1) Design Risk Management and (2) Process Risk Management. Both sections are incorporated into the Risk Management Plan (Reference FORM 0033).
ISO 14971 Risk Analysis
Risk Analysis shall be performed for new products / processes, changes to existing products / processes, or as required through post market information.
Included in the Risk Management process are:
ISO 14971 Risk Management Plan
A Risk Management Plan (Reference FORM 0033) shall document the scope of the planned risk management activities, identification of roles and responsibilities, criteria for risk acceptability, method of verification and post-market activities.
ISO 14971 Risk Management Report
A Risk Management Report (Reference FORM 0034) shall document the results of the risk analysis so that a decision can be determined as to whether the residual risks associated with the identified hazards are acceptable, with regard to the intended application of the device or process.
ISO 14971 Risk Management File
A Risk Management File shall be established for each product being considered which will consist of the Risk Management Plan (FORM 0033); Design Risk Management (FORM 0031); Production Risk Management (FORM 0032); Risk Management Report (FORM 0034); and post-market surveillance documentation.
ISO 14971 Post Market Risk Review
A review of Post-Market / Post-Production risk shall be conducted based upon complaint reports, complaint trends. Based on information received from the field (e.g. compliant monitoring, feedback from sales representative, reports from regulatory authorities, service / repair information), it will be determined if current risk analyses remain complete and adequate. This review will include:
Risk Management Procedure Compliance
The ISO 14971 Risk Management Procedure complies with requirements of ISO 14971:2012, ISO 13485:2016, FDA QSR, and MDR EU 2017/745.
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