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

The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.

Table

Audit evidence

ISO 9001 Clause 8 extract

Four of the 10 pallets of stock sampled in the warehouse were not labelled.

“8.5.2 … shall use suitable means to identify outputs …”

A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor.

“8.7.1 … shall ensure that outputs that do not conform to their requirements are identified and controlled …”

One of the fork-lift truck drivers had no fork-lift truck driving licence.

“8.5.1 e … shall include, as applicable … the appointment of competent persons …”

There was no pest control provision in the warehouse.

“8.5.4 … shall preserve the outputs during production and service provision …”

Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full.

“8.1 … shall plan, implement and control the processes …”

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 promotes the process approach, which allows organizations to structure their activities into interrelated processes. This approach helps ensure that processes effectively achieve intended results.

Clause 0.3.1 (Process Approach) states that " The application of the process approach in a quality management system enables understanding and consistency in meeting requirements, considering processes in terms of added value, and achieving effective process performance. "

This aligns directly with option C, making it the correct answer. The other options are either partially correct or do not fully capture the purpose of the process approach:

Option A (Improvement based on interested parties) is a benefit but does not define the main goal.

Option B (Financial value) is not the primary focus of the process approach.

Option D (Reduction of resource consumption) may be an indirect benefit but is not a core objective.

In this scenario, the organization has set a quality objective of achieving a 90% minimum exam pass rate for all courses. The auditor’s task is to assess whether this objective is being monitored effectively and if appropriate actions are taken when the objective is not met.

B. You would determine how the exam pass rate figures were analysed: ISO 9001:2015, particularly Clause 9.1 (Monitoring, measurement, analysis, and evaluation), requires organizations to evaluate performance data. The auditor should verify how the organization analyses the pass rate data to ensure trends are identified, and corrective actions are planned based on this analysis.

D. You would determine what corrective action was being taken to address the low pass rates: When performance falls short of the objective, as seen with Course 4 (where the pass rate is below 90% in all months), Clause 10.2 (Nonconformity and corrective action) requires organizations to take corrective actions to address issues. The auditor would need to check if corrective actions have been initiated to address consistently low pass rates.

Statements A, C, E, and F do not directly address the monitoring and corrective action required under ISO 9001:2015 in this context​​.