ISO AUDITOR ISO Audit Execution & Evidence Gathering 3 — Questions and Answers
Question 1: When auditing clause 8.4 of ISO 9001 (control of externally provided processes), which evidence is MOST relevant?
- Internal training records for shop-floor employees
- Approved supplier lists, purchase orders, and supplier evaluation records (Correct answer)
- Customer satisfaction survey results
- Management review meeting minutes
Correct answer: Approved supplier lists, purchase orders, and supplier evaluation records
Clause 8.4 focuses on external providers, so approved supplier lists and evaluation records are the primary evidence sources.
Question 2: An auditor uses a checklist but the auditee's answers reveal an unexpected risk area not on the checklist. What should the auditor do?
- Stay strictly on the checklist to maintain scope
- Note the area and explore it further with additional questions (Correct answer)
- Terminate the interview and revise the checklist before continuing
- Report it to management without gathering more evidence
Correct answer: Note the area and explore it further with additional questions
Checklists guide but do not limit auditors — unexpected risk areas should be explored to ensure complete evidence gathering.
Question 3: Which of the following best describes 'objective evidence' as used in ISO 9001 auditing?
- Any verbal statement made by an auditee during an interview
- Data or information that can be proven true based on facts obtained through observation, measurement, or testing (Correct answer)
- An auditor's professional judgment about process effectiveness
- A signed declaration from top management
Correct answer: Data or information that can be proven true based on facts obtained through observation, measurement, or testing
Objective evidence must be verifiable and fact-based, not opinion or unverified assertion.
Question 4: During a closing meeting, the lead auditor presents a finding the auditee strongly disputes. What is the correct approach?
- Withdraw the finding to maintain a positive relationship
- Record the auditee's disagreement and retain the finding if supported by evidence (Correct answer)
- Escalate the dispute to the certification body immediately
- Reopen the audit to gather more evidence before the meeting ends
Correct answer: Record the auditee's disagreement and retain the finding if supported by evidence
Disputed findings should be acknowledged and logged, but retained if the evidence is sound; resolution can occur post-audit.
Question 5: An auditor is evaluating conformity of the inspection and testing process. Which combination of evidence sources provides the most robust conclusion?
- One interview with the quality manager only
- Procedure review, calibration records, inspection logs, and observation of the inspection activity (Correct answer)
- Customer feedback forms and delivery records
- Management review minutes and strategic plans
Correct answer: Procedure review, calibration records, inspection logs, and observation of the inspection activity
Combining document review, records, and direct observation triangulates evidence and reduces the risk of missing nonconformities.
Question 6: What is the primary purpose of conducting an opening meeting at the start of an audit?
- To present preliminary findings to management
- To confirm the audit scope, objectives, and methods, and introduce the audit team to auditee management (Correct answer)
- To negotiate which processes will be excluded from the audit
- To distribute the audit checklist to all auditees
Correct answer: To confirm the audit scope, objectives, and methods, and introduce the audit team to auditee management
The opening meeting establishes mutual understanding of scope, objectives, methods, and logistics before evidence gathering begins.
Question 7: When auditing a calibration process, an auditor finds that one measuring instrument is past its calibration due date. The calibration procedure requires monthly calibration. This is best classified as:
- An opportunity for improvement because it is a single instance
- A nonconformity against the calibration procedure requirement (Correct answer)
- A major nonconformity that requires immediate halt of production
- Not a finding because the instrument may still be accurate
Correct answer: A nonconformity against the calibration procedure requirement
Failure to calibrate per the documented schedule is a clear nonconformity regardless of the instrument's likely accuracy.
ISO AUDITOR ISO Audit Execution & Evidence Gathering 3
When auditing clause 8.4 of ISO 9001 (control of externally provided processes), which evidence is MOST relevant?