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Part 1. Multiple choice. Encircle the best answer among the given choices for each question.

1. What is the primary purpose of a Quality Management System?

A) To maximize profit
B) To ensure customer satisfaction and continual improvement
C) To comply with government regulations
D) To reduce operational costs
2. ISO 9001:2015 requires an organization a Quality Manual
A) True
B) False
3. Which clause of ISO 9001:2015 focuses on the "Context of the Organization"?
A) Clause 4
B) Clause 5
C) Clause 6
D) Clause 7
4. ISO 9001:2015 requires organizations to appoint a Management Representative.
A) True
B) False
5. Which of the following is an example of mandatory documented information required by ISO
9001:2015?
A) Marketing Strategy
B) Quality policy
C) Employee job descriptions
D) Organizational chart
6. What is the main goal of risk-based thinking in QMS?
A) To avoid all risks entirely
B) To identify, evaluate, and address risks and opportunities
C) To eliminate non-conformities
D) To create extensive risk documentation
7. What is the first step in conducting an internal QMS audit?
A) Correcting identified non-conformities
B) Preparing an audit checklist
C) Scheduling the audit and notifying relevant parties
D) Conducting the opening meeting
8. What should quality objectives be according to ISO 9001:2015?
A) Complex and resource-intensive
B) Specific, measurable, achievable, relevant, and time-bound (SMART)
C) General and flexible to allow interpretation
D) Based solely on customer satisfaction
9. Which of the following tools is commonly used for identifying root causes in a QMS?
A) Pareto Chart
B) Fishbone Diagram
C) Gantt Chart
D) PERT Diagram
10. Which metric is used to measure customer satisfaction in a QMS?
A) Overall Equipment Effectiveness (OEE)
B) Customer Complaint Rate
C) Supplier Performance Index
D) Process Capability Index
11. What is the most important step after identifying a non-conformity?
A) Punishing the responsible employee
B) Issuing a corrective action request
C) Closing the non-conformity immediately
D) Conducting a management review
12. The process approach in QMS emphasizes:
A) Viewing processes in isolation
B) Optimizing individual tasks
C) Managing interrelated processes as a system
D) Eliminating unnecessary steps
13. What is the key responsibility of top management in implementing ISO 9001?
A) Conducting all internal audits
B) Ensuring a sufficient budget for quality activities
C) Demonstrating leadership and commitment to the QMS
D) Approving all work instructions
14. What is the main purpose of supplier evaluation in a QMS?
A) To reduce supplier costs
B) To ensure suppliers meet quality requirements
C) To identify alternative suppliers
D) To ensure supplier profitability
15. What is the first step in the corrective action process?
A) Verify the effectiveness of the action
B) Identify and document the non-conformity
C) Assign responsibilities for corrective actions
D) Determine the root cause
16. In ISO 9001:2015, customer satisfaction is:
A) Measured through internal audits
B) Determined by comparing the company’s profits
C) A primary focus for achieving quality objectives
D) Not required for certification
17. Which tool is commonly used to monitor process performance?
A) Histogram
B) Fishbone Diagram
C) Process Flowchart
D) Control Chart
18. When changes are made to a QMS, what is the most important factor to consider?
A) Speed of implementation
B) Communication with stakeholders
C) Cost of the change
D) Avoiding documentation updates
19. Which tool is part of the DMAIC approach used for improvement projects?
A) Failure Mode and Effects Analysis (FMEA)
B) Gantt Chart
C) Root Cause Analysis
D) Six Sigma
20. A critical supplier has delivered materials that fail to meet the agreed-upon specifications. This has
caused delays in your production process. What should you do first?
A) Issue a formal complaint to the supplier and demand compensation.
B) Stop using the supplier immediately and find a replacement.
C) Isolate the non-conforming materials, document the issue, and initiate a root cause analysis.
D) Continue production with the defective materials to avoid further delays.
21. During an internal audit, you discover that one department is not following the documented
procedure for handling customer complaints. What is the best course of action?
A) Ignore it since no complaints have been missed.
B) Notify the department manager and require immediate corrective action.
C) Document the non-conformity, perform a root cause analysis, and assign corrective action
responsibilities.
D) Suspend all complaint-handling activities until the procedure is followed.
22. A major customer complains about consistent delays in delivering your products. Upon
investigation, you find that delays are due to inefficient scheduling. What should you do?
A) Apologize to the customer and assure them it won’t happen again.
B) Develop a detailed action plan to improve scheduling and communicate it to the customer.
C) Offer the customer a discount for future purchases.
D) Blame the delays on external factors beyond your control.
23. A production employee makes repeated errors on a new task, leading to non-conforming
products. What action should you take?
A) Replace the employee with someone more experienced.
B) Retrain the employee on the task and evaluate their competence after training.
C) Punish the employee for causing repeated errors.
D) Change the process to make it less prone to errors.
24. Your organization is planning to launch a new product. To ensure compliance with ISO 9001:2015,
what should you do to address risks and opportunities?
A) Wait until after the product launch to address risks.
B) Create a risk register, analyze potential risks, and implement mitigation plans.
C) Focus only on customer-related risks.
D) Assume the current processes will handle any risks.
25. During a management review, data shows that customer satisfaction scores have been declining
for the past three quarters. What should management prioritize?
A) Create a customer rewards program to regain loyalty.
B) Review and revise processes impacting customer satisfaction and set improvement targets.
 C) Focus on reducing operational costs to offset the impact.
D) Increase marketing efforts to attract new customers.

Part II. Essay

A. Explain the purpose and benefits of implementing a Quality Management System (QMS) in an
organization. Provide examples to support your answer.

B. Discuss the seven quality management principles outlined in ISO 9001:2015. How do these
principles contribute to achieving continual improvement and customer satisfaction?
C. What are the challenges of performing internal audits, and how can they be addressed to
ensure meaningful results?

D. Define non-conformity in the context of a QMS. How should organizations respond to non-
conformities, and what steps should be taken to prevent recurrence?