ISO AUDITOR Audit Scheduling & Checklist Design 2 — Questions and Answers
Question 1: When developing an audit schedule for a multi-site organization, which factor should be weighted most heavily when allocating audit time?
- Geographic proximity of sites
- Risk level and operational complexity of each site (Correct answer)
- Alphabetical order of site names
- Date of last external certification audit
Correct answer: Risk level and operational complexity of each site
ISO 19011 requires that audit time allocation reflect the risk and complexity of the area being audited, ensuring higher-risk sites receive proportionally more attention.
Question 2: An auditor is designing a checklist for the purchasing process. Which element is LEAST appropriate to include?
- Criteria for supplier evaluation and selection
- Evidence of approved supplier list maintenance
- The personal opinions of purchasing staff about suppliers (Correct answer)
- Records of supplier performance monitoring
Correct answer: The personal opinions of purchasing staff about suppliers
Checklists must be objective and evidence-based; personal opinions are not auditable evidence and have no place in a conformance checklist.
Question 3: Under ISO 9001:2015, when must the internal audit program be reviewed and updated?
- Only when a nonconformity is found during a customer audit
- Annually on a fixed calendar date regardless of changes
- When significant organizational changes or audit results indicate a need (Correct answer)
- Solely at the discretion of the Quality Manager
Correct answer: When significant organizational changes or audit results indicate a need
ISO 9001 clause 9.2.2 requires the audit program to consider importance, changes, and results of previous audits, implying dynamic updating based on these factors.
Question 4: Which scheduling approach best supports the detection of systemic quality management issues across departments?
- Auditing one department completely before moving to the next
- Process-based auditing that follows a process across multiple departments (Correct answer)
- Random sampling of employees without prior notice
- Auditing only the departments with prior nonconformities
Correct answer: Process-based auditing that follows a process across multiple departments
A process-based approach traces a process horizontally through the organization, revealing interface failures and systemic weaknesses that departmental audits may miss.
Question 5: A checklist question reads: 'Is the calibration records file up to date?' What is the primary weakness of this question?
- It is too technical for general auditors
- It is closed-ended and limits the depth of evidence gathered (Correct answer)
- It focuses on an unimportant ISO 9001 requirement
- It should reference a specific form number
Correct answer: It is closed-ended and limits the depth of evidence gathered
Closed-ended yes/no checklist questions restrict auditor inquiry; open-ended or evidence-referenced questions elicit richer, more objective audit evidence.
Question 6: When scheduling follow-up audits after corrective actions, what is the primary criterion for determining timing?
- A fixed 30-day period required by ISO 9001
- The auditee's preferred date to minimize disruption
- The nature and risk of the nonconformity and the agreed corrective action deadline (Correct answer)
- The next scheduled external surveillance audit date
Correct answer: The nature and risk of the nonconformity and the agreed corrective action deadline
Follow-up audit timing should be proportional to the risk of the nonconformity and tied to the corrective action completion date agreed upon in the corrective action plan.
Question 7: An audit checklist for design and development should include verification that:
- Designers have engineering degrees from accredited universities
- Design outputs are reviewed against design inputs before release (Correct answer)
- All design changes are approved by senior management regardless of scope
- Design software is updated to the latest commercial version
Correct answer: Design outputs are reviewed against design inputs before release
ISO 9001 clause 8.3 requires that design outputs meet design input requirements; checklists must prompt auditors to verify this linkage with documented evidence.
ISO AUDITOR Audit Scheduling & Checklist Design 2
When developing an audit schedule for a multi-site organization, which factor should be weighted most heavily when allocating audit time?