ISO AUDITOR ISO Audit Planning & Preparation 3 — Questions and Answers
Question 1: An auditor is preparing to audit the 'Design and Development' clause (8.3) but the organization has excluded it. What should the auditor do first?
- Audit the clause anyway to ensure completeness
- Verify whether the exclusion is justified based on the organization's context and products (Correct answer)
- Accept the exclusion without question since only the organization can determine applicability
- Report the exclusion as a nonconformity immediately
Correct answer: Verify whether the exclusion is justified based on the organization's context and products
ISO 9001:2015 allows exclusions only when requirements cannot be applied and this does not affect conformity; the auditor must verify the justification.
Question 2: During opening meetings, what is the primary purpose of reviewing the audit plan with the auditee?
- To give the auditee time to prepare answers
- To confirm the scope, objectives, methods, and logistics, and address any concerns (Correct answer)
- To negotiate a reduction in the audit scope
- To introduce all auditors and exchange business cards
Correct answer: To confirm the scope, objectives, methods, and logistics, and address any concerns
The opening meeting's primary purpose is mutual confirmation of scope, objectives, and methods, ensuring all parties understand and can facilitate the audit.
Question 3: Which type of audit is conducted by an organization on its own processes and systems?
- Second-party audit
- Third-party audit
- First-party audit (Correct answer)
- Surveillance audit
Correct answer: First-party audit
First-party audits are internal audits conducted by or on behalf of the organization itself for management review and internal purposes.
Question 4: What should an auditor do when an auditee cannot provide requested documented information during the audit?
- Accept verbal assurances and move on
- Record the unavailability and consider its significance when forming findings (Correct answer)
- Immediately raise a major nonconformity
- Reschedule the audit for another day
Correct answer: Record the unavailability and consider its significance when forming findings
The auditor should note the lack of available evidence and assess its impact on audit findings, which may or may not result in a nonconformity depending on context.
Question 5: In ISO 9001:2015, 'context of the organization' (Clause 4) is relevant to audit planning because it:
- Dictates the exact number of auditors required
- Identifies internal and external issues that could affect the QMS and should inform audit scope and risk focus (Correct answer)
- Replaces the need to review quality objectives
- Determines the certification body to be used
Correct answer: Identifies internal and external issues that could affect the QMS and should inform audit scope and risk focus
Understanding organizational context helps auditors focus on relevant risks and issues that may affect the QMS, making the audit more targeted and effective.
Question 6: An audit team leader is responsible for which of the following during audit preparation?
- Writing all corrective action plans for the auditee
- Communicating with the auditee, preparing the audit plan, and assigning tasks to team members (Correct answer)
- Performing all audit interviews personally
- Signing off on the auditee's management review
Correct answer: Communicating with the auditee, preparing the audit plan, and assigning tasks to team members
The audit team leader coordinates planning, liaises with the auditee, prepares the audit plan, and delegates responsibilities among auditors.
Question 7: Which of the following is the CORRECT sequence for planning an ISO 9001 audit?
- Conduct interviews → Prepare checklists → Establish objectives → Review documents
- Establish objectives and scope → Review documented information → Develop audit plan and checklists → Conduct opening meeting (Correct answer)
- Conduct opening meeting → Establish objectives → Review documents → Prepare checklists
- Prepare report → Conduct interviews → Establish objectives → Review documents
Correct answer: Establish objectives and scope → Review documented information → Develop audit plan and checklists → Conduct opening meeting
ISO 19011 prescribes establishing objectives and scope first, then reviewing documentation, then developing the audit plan and tools before fieldwork begins.
ISO AUDITOR ISO Audit Planning & Preparation 3
An auditor is preparing to audit the 'Design and Development' clause (8.3) but the organization has excluded it.
What should the auditor do first?