ISO-9001-Lead-Auditor Exam Dumps : QMS ISO 9001:2015 Lead Auditor Exam

Comprehensive and Detailed In-Depth Explanation:

The audit schedule provides a structured timeline of activities to be conducted during the audit.

Clause References:

ISO 19011:2018, Clause 6.4.2 – Preparing the Audit Plan:

Requires the development of an audit schedule, including the sequence and timing of activities.

ISO/IEC 17021-1:2015, Clause 9.1.3 – Audit Program:

Certification bodies must establish a schedule for conducting audits.

Why is the Correct Answer C?

The audit schedule ensures systematic execution of the audit by defining activities, responsible auditors, and timeframes.

A well-planned schedule improves efficiency and helps auditors cover all necessary areas within the given time.

Why are the Other Options Incorrect?

A (Audit objectives) → Define why the audit is conducted, not the schedule.

B (Audit criteria) → Define the standards and requirements to be evaluated, not the timeline.

D (Audit offer) → Refers to the initial proposal sent to the auditee, not the activity timeline.

B. Control of externally provided processes, products, and services: This is relevant because the organization has outsourced the manufacture of its own brand products to a supplier. According to ISO 9001, the organization must ensure that externally provided processes remain within the control of its quality management system.

C. Design and development of products and services: Even though the organization no longer manufactures in-house, it still needs to control the design and development of its products, especially since they are now being produced by an external provider.

F. Organisation roles and responsibilities: The change in strategy has led to a significant reduction in staff, which would have an impact on the roles and responsibilities within the organization. It is important to audit how these changes have been managed and communicated within the organization to ensure continued effectiveness of the quality management system.

These audit trails are aligned with the requirements of ISO 9001:2015, which emphasizes the importance of controlling externally provided processes and products, managing design and development, and clearly defining roles and responsibilities within the quality management system.

According to ISO 9001:2015, clause 8.4, an organization is required to control the processes, products and services provided by external providers, including those that affect the quality of the organization’s own products and services. This includes determining the controls to be applied to the external provision of processes, products and services, as well as the information to be communicated to the external providers. The organization is also required to monitor, measure, and evaluate the performance of the external providers and retain documented information of these activities.

Therefore, in the scenario given, ABC Ltd is responsible for controlling the processes, products and services provided by Teak Ltd, as they affect the quality of ABC Ltd’s own products and services. This means that ABC Ltd should have established criteria and methods for evaluating the performance of Teak Ltd, as well as documented information of the results of such evaluation. ABC Ltd should also have defined the supply arrangements with Teak Ltd, including the specifications, requirements, and verification activities related to the products and services provided by Teak Ltd.

Hence, the best options to describe how to plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd are A and D, as they are aligned with the requirements of ISO 9001:2015, clause 8.4. The other options are either irrelevant or beyond the scope of the audit, as they do not pertain to the control of external provision by ABC Ltd.