ISO 9001:2015 requires audits to be planned and conducted to ensure the quality management system conforms to requirements and is effectively implemented. While ISO 9001 sets the requirement, it explicitly refers auditors to ISO 19011 for detailed guidance on audit planning and execution.
ISO 9001:2015, Clause 9.2.2 (NOTE) states that guidance for auditing management systems is provided in ISO 19011 .
Based on ISO 19011:2018 (Clause 6.3 – Initiating and preparing for the audit), the audit team leader is responsible for finalising key planning issues before documenting the audit plan, especially for multi-site and multi-country audits.
Explanation of the selected options:
A. Arrangement of translation of the audit report
ISO 19011 requires consideration of communication and language arrangements during audit preparation. Where sites are located in different countries, potential language difficulties must be addressed during planning, including translation needs for reports and communications.
C. Structuring the audit plan to account for audit trails
ISO 19011 requires audits to follow audit trails across processes, functions, and interfaces. The audit plan must be structured to allow logical progression through interrelated processes, which must be decided before the plan is documented.
D. Determining available IT infrastructure for remote participation
ISO 19011 allows the use of remote auditing techniques. When audit team members are located in different countries, the audit team leader must confirm the availability of IT infrastructure to support remote participation in opening and closing meetings as part of audit planning.
E. Considering processes not operating at the time of the audit
ISO 19011 requires the audit team leader to consider process availability. If some processes are not operating during the audit period, alternative audit methods (such as records review or rescheduling) must be planned in advance and reflected in the audit plan.
Explanation of why the other options are not selected:
B: ISO 19011 requires identification of roles and functions to be audited, not specific names, at the audit planning stage.
F: Moderation or grading of nonconformities is performed after audit findings are raised, not during audit planning.
G: Post-audit communication arrangements are addressed during reporting and follow-up activities, not before documenting the audit plan.
H: Follow-up audits are planned only if required after audit results are known, not during initial audit planning.
