Mock exam 40 Questions. Answers & Explanations Included

Part A — Scenario-Based Questions
1. Unapproved Supplier

During an audit of purchasing, you find that one purchase order for a critical component was issued to a supplier not on the approved supplier list. The Purchasing Manager says the material was urgently needed and the supplier had been used successfully before.

What is the BEST auditor response?

A. Immediately raise a major nonconformity against Clause 8.4.
B. Accept the explanation because it was an emergency.
C. Investigate how suppliers are evaluated, selected, monitored and approved and whether defined controls were followed.
D. Raise an observation because the material was acceptable.

Answer: C

Explanation: The auditor should first gather sufficient objective evidence. Clause 8.4.1 requires the organization to establish criteria for evaluation, selection, monitoring and re-evaluation of external providers. An unapproved supplier may represent a nonconformity, but the auditor should understand the applicable controls and any authorized exception process before reaching that conclusion.

2. Obsolete Work Instruction

An operator is using Work Instruction WI-104 Revision 3. The document system identifies Revision 5 as current. The supervisor says the technical requirements are identical and Revision 5 only changed formatting.

What should the auditor do?

A. Accept Revision 3 because its technical content is unchanged.
B. Investigate controls ensuring appropriate versions of documented information are available where needed.
C. Immediately issue a major nonconformity.
D. Order the supervisor to destroy Revision 3.

Answer: B

Explanation: Clause 7.5.3 addresses control of documented information. The auditor should establish whether obsolete information is adequately controlled and whether the organization’s document-control requirements have been followed.

3. Quality Objective

The organization’s quality objective states:

“Improve customer satisfaction.”

Complaints are reviewed monthly, but there is no defined target or measurement criterion.

Which clause is MOST directly applicable?

A. 5.1.2
B. 6.2
C. 7.4
D. 9.3

Answer: B — Clause 6.2

Explanation: Quality objectives must be measurable, monitored, communicated and updated as appropriate. The organization must also determine what will be done, resources required, responsibilities, timing and how results will be evaluated.

4. Expired Calibration

One measuring device used for final product acceptance is found to be three months beyond its calibration date.

The Quality Manager immediately removes it from service.

What should the auditor investigate NEXT?

A. Who should be disciplined.
B. Whether previous measurement results may have been adversely affected and what actions were taken.
C. Whether the calibration laboratory should be replaced.
D. Whether every measuring device should be recalibrated.

Answer: B

Explanation: Clause 7.1.5.2 requires appropriate action when measuring equipment is found unfit for its intended purpose, including consideration of whether previous measurement results have been adversely affected.

5. Internal Audit Program

The organization’s procedure requires every department to be audited annually. Purchasing was not audited last year, despite significant supplier quality problems.

What is the BEST conclusion?

A. No issue because ISO 9001 does not specify annual auditing.
B. There is potential evidence of a nonconformity because the organization’s audit program was not implemented as planned.
C. Only an OFI can be issued.
D. Purchasing does not require auditing.

Answer: B

Explanation: Clause 9.2 requires internal audits at planned intervals and requires the audit program to consider process importance, organizational changes and previous audit results. Additionally, the organization did not follow its own established annual audit program.

6. Management Review

Management review records cover customer satisfaction, audit results, process performance and nonconformities. There is no evidence that the effectiveness of actions addressing risks and opportunities was reviewed.

Which requirement should be investigated?

A. 7.1.5
B. 8.5.1
C. 9.3.2
D. 10.3

Answer: C — Clause 9.3.2

Explanation: Management review inputs include the effectiveness of actions taken to address risks and opportunities.

7. Customer Complaint

A customer received the wrong product. The organization immediately shipped the correct product but performed no root-cause analysis because the problem had been corrected.

What should the auditor determine?

A. Whether correction alone was appropriate considering the nature of the nonconformity and potential recurrence.
B. Whether compensation was provided.
C. Whether the employee was disciplined.
D. Whether complaints are permitted under ISO 9001.

Answer: A

Explanation: Clause 10.2 distinguishes correction from corrective action. The organization must evaluate the need for action to eliminate the cause so that the nonconformity does not recur or occur elsewhere.

8. Quality Policy Awareness

An employee cannot recite the quality policy word-for-word but clearly explains how their work contributes to quality and customer satisfaction.

What is the BEST conclusion?

A. Nonconformity against 5.2.
B. Nonconformity against 7.3.
C. No nonconformity solely because the employee cannot recite the policy verbatim.
D. Major nonconformity.

Answer: C

Explanation: Clause 7.3 requires relevant persons to be aware of the quality policy, relevant objectives, their contribution to QMS effectiveness and implications of not conforming. Memorization is not required.

9. Supplier Performance

A supplier’s defect rate increased from 1% to 8% over six months. Purchasing continues ordering because the supplier offers the lowest price.

What should the auditor investigate?

A. Supplier ownership.
B. Monitoring of supplier performance and actions arising from that monitoring.
C. Supplier employee training.
D. Price negotiations.

Answer: B

Explanation: Clause 8.4.1 requires criteria for evaluation, selection, monitoring of performance and re-evaluation of external providers.

10. Competence

A welder has performed a critical welding operation for seven years. No training certificate exists. The manager says the employee is the company’s best welder.

What should the auditor do?

A. Immediately issue a nonconformity.
B. Determine how competence was established and what evidence of competence is retained.
C. Require training.
D. Automatically accept seven years’ experience.

Answer: B

Explanation: Clause 7.2 requires the organization to determine necessary competence and ensure people are competent based on appropriate education, training or experience. A training certificate is not necessarily the only acceptable evidence.

11. Auditee Refuses Evidence

A manager refuses to provide a record, claiming it has nothing to do with the audit.

What should the lead auditor do?

A. Argue with the manager.
B. Immediately terminate the audit.
C. Explain its relevance to the audit scope and seek appropriate access through the audit contact if necessary.
D. Automatically issue a major NC.

Answer: C

Explanation: The auditor should remain professional, explain the audit purpose and attempt to resolve access issues through established audit channels. Restrictions affecting achievement of audit objectives should be documented and communicated.

12. Nonconforming Product

Twelve defective products are correctly identified and quarantined. The supervisor says their disposition will be decided later.

What should the auditor investigate?

A. Available floor space.
B. Controls governing review, disposition and authorization of nonconforming outputs.
C. Whether they can be discounted.
D. Which employee caused them.

Answer: B

Explanation: Clause 8.7 requires nonconforming outputs to be identified and controlled to prevent unintended use or delivery and requires appropriate action and retained documented information.

13. Outsourced Process

A safety-critical heat-treatment process is outsourced. Purchasing says:

“Because it is outsourced, it is outside our QMS.”

What is correct?

A. Purchasing is correct.
B. Correct if the supplier is ISO 9001 certified.
C. The organization remains responsible for ensuring externally provided processes conform to requirements.
D. Control is only necessary when required by the customer.

Answer: C

Explanation: Outsourcing does not transfer the organization’s responsibility for conformity. Clause 8.4 requires control of externally provided processes, products and services.

14. Altered Inspection Record

An inspection record contains several entries changed using correction fluid, making the original results unreadable.

What should the auditor investigate FIRST?

A. Whether ISO 9001 explicitly prohibits correction fluid.
B. Controls over integrity, protection and changes to documented information.
C. Whether the inspector should be dismissed.
D. Whether electronic records should replace paper.

Answer: B

Explanation: Clause 7.5.3 requires documented information to be appropriately controlled, including protection against loss of integrity and control of changes.

15. Declining KPI

On-time delivery has a target of 95%. Results are:

94% → 91% → 89% → 86% → 84% → 82%

Management review states only: “Continue monitoring.”

What should concern the auditor?

A. The target isn’t 100%.
B. Whether performance is being adequately evaluated and appropriate actions determined.
C. Six months is insufficient data.
D. Delivery performance isn’t relevant to ISO 9001.

Answer: B

Explanation: Clauses 9.1 and 9.3 require evaluation of QMS/process performance. A sustained negative trend provides a logical audit trail into management review, quality objectives, corrective action and improvement.

16. Auditor Consultancy

A Production Director asks the certification auditor:

“Tell us exactly how we should redesign our corrective-action system.”

What is the BEST response?

A. Design the system.
B. Recommend another client’s system.
C. Explain requirements/findings without providing consultancy that compromises impartiality.
D. Refuse to discuss corrective action.

Answer: C

Explanation: An auditor can explain requirements and findings but should preserve independence and impartiality rather than designing the auditee’s management system.

17. Design Change

A design specification was changed following a customer request. Production implemented it immediately, but there is no evidence that the design change was reviewed or authorized.

Which clause is MOST relevant?

A. 7.4
B. 8.3.6
C. 8.5.4
D. 9.1.2

Answer: B — Clause 8.3.6

Explanation: Design and development changes must be identified, reviewed and controlled as necessary to ensure there is no adverse impact on conformity.

18. Customer Satisfaction

Customer satisfaction has exceeded targets for 18 months, so management stopped analyzing customer feedback six months ago.

Is this acceptable?

A. Yes.
B. Yes, if complaints are zero.
C. No; customer perceptions still need to be monitored.
D. Yes, until the KPI drops.

Answer: C

Explanation: Clause 9.1.2 requires the organization to monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled.

19. Auditor Independence

An internal auditor audits a process they personally manage.

What is the primary concern?

A. Competence.
B. Objectivity and impartiality.
C. Confidentiality.
D. Customer focus.

Answer: B

Explanation: Clause 9.2.2 requires auditors to be selected and audits conducted so as to ensure objectivity and impartiality of the audit process.

20. Disagreement at Closing Meeting

A manager strongly disagrees with a nonconformity and demands its deletion.

What should the lead auditor do?

A. Delete it.
B. End the discussion.
C. Review the requirement and objective evidence, explain the basis and record unresolved differences as appropriate.
D. Upgrade it to a major NC.

Answer: C

Explanation: Findings must be evidence-based. Differences concerning audit findings should be discussed and, where possible, resolved. Unresolved differences should be appropriately recorded.

Part B — Objective Questions
21. Which ISO 9001 clause addresses organizational context?

A. Clause 4
B. Clause 5
C. Clause 7
D. Clause 10

Answer: A — Clause 4

22. Which clause addresses risks and opportunities?

A. 4.4
B. 5.2
C. 6.1
D. 8.1

Answer: C — Clause 6.1

23. Who is accountable for QMS effectiveness?

A. Quality Manager
B. Internal Auditor
C. Top Management
D. Certification Body

Answer: C — Top Management

Reference: Clause 5.1.1.

24. Which clause addresses competence?

A. 7.1
B. 7.2
C. 7.3
D. 7.5

Answer: B — Clause 7.2

25. Which clause specifically addresses customer satisfaction?

A. 8.2.1
B. 8.6
C. 9.1.2
D. 10.2

Answer: C — Clause 9.1.2

26. Audit findings should primarily be based on:

A. Auditor experience.
B. Management opinion.
C. Objective evidence evaluated against audit criteria.
D. Industry best practices.

Answer: C

Explanation: Audit conclusions must be supported by verifiable evidence rather than personal opinion.

27. Which is an ISO 19011 auditing principle?

A. Profitability
B. Evidence-based approach
C. Production efficiency
D. Customer retention

Answer: B — Evidence-based approach

Other important auditing principles include integrity, fair presentation, due professional care, confidentiality, independence and risk-based approach.

28. What BEST describes a correction?

A. Action eliminating the cause of a nonconformity.
B. Action eliminating a detected nonconformity.
C. Action preventing every possible nonconformity.
D. Action improving profitability.

Answer: B

Key distinction:
Correction → fixes the detected problem.
Corrective action → addresses its cause to prevent recurrence.

29. Corrective action means:

A. Reworking defective material.
B. Replacing a defective product.
C. Action to eliminate the cause of a nonconformity and prevent recurrence.
D. Identifying a defect.

Answer: C

Reference: Clause 10.2.

30. ISO 9001:2015 requires organizations to:

A. Appoint someone titled “Management Representative.”
B. Maintain a Quality Manual in all circumstances.
C. Determine documented information necessary for QMS effectiveness in addition to specifically required documented information.
D. Maintain six mandatory documented procedures.

Answer: C

Explanation: ISO 9001:2015 gives organizations greater flexibility regarding documented information than earlier versions of the standard.

Part C — Matching Questions

Match each scenario with:

A — 7.1.5 Monitoring and measuring resources
B — 7.2 Competence
C — 8.4 Externally provided processes/products/services
D — 8.7 Control of nonconforming outputs
E — 10.2 Nonconformity and corrective action

31. The organization cannot demonstrate the competence of an employee performing specialized inspection.

Answer: B — Clause 7.2

32. Defective product is accidentally released without appropriate authorization.

Answer: D — Clause 8.7

33. Measuring equipment used for acceptance is outside its calibration interval.

Answer: A — Clause 7.1.5

34. Supplier defects repeatedly increase, but supplier performance isn’t reviewed.

Answer: C — Clause 8.4

35. The same customer complaint occurs four times, but each incident is only corrected.

Answer: E — Clause 10.2

Exam tip: Repetition is a strong audit trail toward the effectiveness of corrective action.

Part D — Auditor Judgment

Use:

A — Clear evidence supporting a nonconformity
B — Further investigation/evidence required
C — Not necessarily a nonconformity

36. The organization does not have a Quality Manual.

Answer: C — Not necessarily a nonconformity

Explanation: ISO 9001:2015 does not explicitly require organizations to maintain a document titled Quality Manual.

37. An employee cannot quote the Quality Policy word-for-word but understands its relevance to their work.

Answer: C — Not necessarily a nonconformity

Explanation: Awareness is required; memorization is not.

38. The organization’s documented procedure requires every unit to be inspected. For one completed lot, records show 15 of 100 units were not inspected.

Answer: A — Clear evidence supporting a nonconformity

Explanation: There is a defined requirement and objective evidence that the requirement was not fulfilled. The auditor should still understand the scope and consequences when determining the precise finding/classification.

39. One customer complained about late delivery during the previous year.

Answer: C — Not necessarily a nonconformity

Explanation: A complaint is evidence of customer dissatisfaction, but a complaint by itself does not automatically demonstrate failure to meet an ISO 9001 requirement. Audit how the complaint was handled and how customer perception is monitored.

40. An operator uses a document marked “UNCONTROLLED COPY.” The operator says it contains the current manufacturing parameters, but you haven’t compared it with the approved version.

Answer: B — Further investigation required

Explanation: The words “UNCONTROLLED COPY” alone do not prove a nonconformity. Compare it with the approved version, determine its intended use and examine document-control requirements before making a finding.

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Quick Answer Key

1–10: C, B, B, B, B, C, A, C, B, B
11–20: C, B, C, B, B, C, B, C, B, C
21–30: A, C, C, B, C, C, B, B, C, C
31–40: B, D, A, C, E, C, C, A, C, B