Biomedical Auditor Risk Management & Control

Question 1

What is the primary goal of risk management in biomedical auditing?

Accepted Answer

Mitigate risks to quality and compliance

Answer

The goal is to identify and reduce potential risks that could impact product quality, patient safety, or regulatory compliance.

Question 2

Which tool is commonly used to assess and prioritize risks?

Accepted Answer

Risk matrix

Answer

A risk matrix ranks risks based on their likelihood and severity, helping auditors focus on the most significant threats.

Question 3

What is a control measure in the context of risk management?

Accepted Answer

A preventive action to reduce risk

Answer

Control measures are procedures or mechanisms put in place to reduce the impact or likelihood of identified risks.

Question 4

Why is documentation of risk controls important?

Accepted Answer

To maintain traceability and accountability

Answer

Documenting risk controls ensures transparency, traceability, and accountability in managing risks across the quality system.

Question 5

Which standard provides guidance on risk management for medical devices?

Accepted Answer

ISO 14971

Answer

ISO 14971 outlines processes for identifying, evaluating, and controlling risks associated with medical devices.

(CBA) Certified Biomedical Auditor Practice Test