# Audit checklist for ISO 14971 Medical devices - Application of risk management to medical devices
# Based on version 2007-10-01
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# This checklist is not a substitute for reading, understanding, and implementing the associated standard.
# The descriptive phrase following each keyword reference is intended only as a helpful mnemonic for locating
# and recalling the referenced section of the standard.
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14971:3.1 Risk management process
14971:3.2 Management responsibilities
14971:3.3 Qualification of personnel
14971:3.4.a Risk management plan: scope
14971:3.4.b Risk management plan: asignments
14971:3.4.c Risk management plan: requirements
14971:3.4.d Risk management plan: criteria
14971:3.4.e Risk management plan: verification
14971:3.4.f Risk management plan: collection and review
14971:3.5 Risk management file
14971:4.1.a Risk analysis process: what device was analyzed
14971:4.1.b Risk analysis process: who did analysis
14971:4.1.c Risk analysis process: scope and date
14971:4.2 Intended use and identification of characteristics related to the safety of the medical device
14971:4.3 Identification of hazards
14971:4.4 Estimation of the risk(s) for each hazardous situation
14971:5 Risk evaluation
14971:6.1 Risk reduction
14971:6.2 Risk control option analysis (choose one or more option a or b or c)
14971:6.3 Implementation of risk control measure(s)
14971:6.4 Residual risk evaluation
14971:6.5 Risk/benefit analysis
14971:6.6.a Risks arising from risk control measures: new hazards
14971:6.6.b Risks arising from risk control measures: effect on other risks
14971:6.7 Completeness of risk control
14971:7 Evaluation of overall residual risk acceptability
14971:8 Risk management report
14971:9.a Production and post-production information: information about device
14971:9.b Production and post-production information: new or revised standards
