In ISO 14971 risk management, which artifact is maintained to document risk activities?

In ISO 14971 risk management, which artifact is maintained to document risk activities?

• A. A documented risk management file.
• B. A marketing risk brief.
• C. A financial risk register.
• D. A product liability waiver.

Answer: (A)

In ISO 14971, all risk management activities are captured in a single, auditable artifact: the documented risk management file. This file records the entire lifecycle of risk management for a medical device—how risks were identified, analyzed, evaluated, and controlled; the criteria used to judge risk acceptability; the actions taken to reduce risk (including residual risk and any benefit-risk judgments); and decisions around production and post-production activities. It also logs reviews, approvals, and changes over time, providing traceability and evidence that the risk management process was applied consistently and in compliance with the standard. That makes it the best choice because it directly documents the process and decisions around risk, which ISO 14971 requires, whereas the other items don’t serve this purpose within the standard’s framework: a marketing risk brief focuses on market considerations, a financial risk register tracks financial risks, and a product liability waiver is a legal document, not a record of the risk management activities for the device.

In ISO 14971, all risk management activities are captured in a single, auditable artifact: the documented risk management file. This file records the entire lifecycle of risk management for a medical device—how risks were identified, analyzed, evaluated, and controlled; the criteria used to judge risk acceptability; the actions taken to reduce risk (including residual risk and any benefit-risk judgments); and decisions around production and post-production activities. It also logs reviews, approvals, and changes over time, providing traceability and evidence that the risk management process was applied consistently and in compliance with the standard.

That makes it the best choice because it directly documents the process and decisions around risk, which ISO 14971 requires, whereas the other items don’t serve this purpose within the standard’s framework: a marketing risk brief focuses on market considerations, a financial risk register tracks financial risks, and a product liability waiver is a legal document, not a record of the risk management activities for the device.