Internal Audit Essentials for Students

What is the primary purpose of an internal audit? A) To punish employees B) To ensure compliance C) To increase sales D) To reduce costs

• C) To increase sales

• D) To reduce costs

• A) To punish employees

• B) To ensure compliance

Which of the following is a key principle of ISO 19011? A) Confidentiality B) Independence C) Profitability D) Flexibility

• B) Independence

• C) Sustainability

• D) Complexity

• A) Transparency

In a cGMP environment, what is the main focus of an audit? A) Employee satisfaction B) Product quality C) Marketing strategies D) Financial performance

• C) Marketing strategies

• D) Financial performance

• B) Product quality

• A) Employee satisfaction

What does GDPMD stand for? A) Good Distribution Practice for Medical Devices B) General Distribution Process for Medical Devices C) Good Development Practice for Medical Devices D) General Development Process for Medical Devices

• Good Distribution Protocol for Medical Devices

• General Distribution Practice for Medical Devices

• Good Device Practice for Medical Distribution

• A) Good Distribution Practice for Medical Devices

Which method is commonly used in audits to gather evidence? A) Observation B) Guessing C) Assumption D) Intuition

• Hunches

• Speculation

• Random Selection

• A) Observation

When conducting an audit, what is the importance of planning? A) To waste time B) To ensure efficiency C) To confuse the team D) To avoid responsibility

• A) To waste resources

• B) To ensure efficiency

• D) To create unnecessary work

• C) To delay the process

In ISO 13485, what is a critical aspect of the quality management system? A) Employee training B) Customer feedback C) Document control D) Marketing plans

• D) Sales strategies

• C) Document control

• A) Supplier audits

• B) Product design

What should an auditor do if they find a non-conformance during an audit? A) Ignore it B) Report it C) Celebrate it D) Blame others

• A) Ignore it

• B) Report it

• D) Blame others

• C) Celebrate it

Which of the following is NOT a benefit of conducting internal audits? A) Improved processes B) Increased costs C) Enhanced compliance D) Better risk management

• B) Increased costs

• D) Greater market share

• C) Increased employee satisfaction

• A) Streamlined communication

In a scenario where a medical gas manufacturer fails to document a critical process, which standard is primarily violated? A) cGMP B) ISO 9001 C) GDPMD D) ISO 13485

• A) ISO 14001

• A) cGMP

• C) ISO 45001

• B) cGMP for Food