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

Increase sales through marketing

Answer

Improve staff scheduling

Answer

Speed up clinical trials

Question 2

Which tool is commonly used to assess and prioritize risks?

Accepted Answer

Risk matrix

Answer

Checklists

Answer

Flowcharts

Answer

Training logs

Question 3

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

Accepted Answer

A preventive action to reduce risk

Answer

A method to increase sales

Answer

A type of customer service feedback

Answer

A device for process automation

Question 4

Why is documentation of risk controls important?

Accepted Answer

To maintain traceability and accountability

Answer

To prepare marketing reports

Answer

To train sales personnel

Answer

To apply for tax benefits

Question 5

Which standard provides guidance on risk management for medical devices?

Accepted Answer

ISO 14971

Answer

ISO 9001

Answer

ISO 13485

Answer

ISO 14001

Question 6

How can auditors verify that risk controls are effective?

Accepted Answer

Evaluate performance data and documentation

Answer

Request marketing metrics

Answer

Count staff feedback forms

Answer

Measure social media engagement