Biomedical Auditor Risk Management & Control Flashcards
6 cards from real CBA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Biomedical Auditor Risk Management & Control flashcards as text
What is the primary goal of risk management in biomedical auditing?
Answer: Mitigate risks to quality and compliance
The goal is to identify and reduce potential risks that could impact product quality, patient safety, or regulatory compliance.
Which tool is commonly used to assess and prioritize risks?
Answer: Risk matrix
A risk matrix ranks risks based on their likelihood and severity, helping auditors focus on the most significant threats.
What is a control measure in the context of risk management?
Answer: A preventive action to reduce risk
Control measures are procedures or mechanisms put in place to reduce the impact or likelihood of identified risks.
Why is documentation of risk controls important?
Answer: To maintain traceability and accountability
Documenting risk controls ensures transparency, traceability, and accountability in managing risks across the quality system.
Which standard provides guidance on risk management for medical devices?
Answer: ISO 14971
ISO 14971 outlines processes for identifying, evaluating, and controlling risks associated with medical devices.
How can auditors verify that risk controls are effective?
Answer: Evaluate performance data and documentation
Auditors can assess the effectiveness of risk controls by reviewing performance data, conducting interviews, and inspecting documentation.