ISO Audit Planning & Preparation Flashcards

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?

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.

During opening meetings, what is the primary purpose of reviewing the audit plan with the auditee?

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.

Which type of audit is conducted by an organization on its own processes and systems?

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.

What should an auditor do when an auditee cannot provide requested documented information during the audit?

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.

In ISO 9001:2015, 'context of the organization' (Clause 4) is relevant to audit planning because it:

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.

An audit team leader is responsible for which of the following during audit preparation?

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.

Which of the following is the CORRECT sequence for planning an ISO 9001 audit?

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.