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

According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:

Understand the requirements of ISO 9001 and how they relate to the audit

Understand the organization’s quality management system and its processes

Understand the applicable legal, regulatory, contractual and other requirements that affect the audit

Understand the needs and expectations of interested parties other than customers

Plan and conduct audits in accordance with ISO 19011

Evaluate audit evidence and draw appropriate conclusions

Communicate audit findings effectively1

Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.

The nonconformity was raised against ISO 9001:2015 Clause 8.5.1 – Control of production and service provision. This clause requires organisations to carry out production and service provision under controlled conditions, including:

the use of suitable infrastructure and equipment,

the availability and use of appropriate monitoring and control, and

the prevention of nonconforming outputs being delivered to customers.

In this scenario, the evidence shows a systemic failure in operational control, not isolated human error.

Explanation of the selected evidence:

E. The organisation failed to control the laundry operations in 5 shops adequately.

Clause 8.5.1 requires consistent control of service provision. The fact that 80% of complaints come from five specific shops demonstrates a lack of effective operational control in those locations.

G. The organisation failed to maintain all of its equipment to an adequate standard.

Clause 8.5.1 requires suitable infrastructure for service provision. Management acknowledged that equipment in these shops is old and cannot currently be replaced, meaning it is not being maintained at a level necessary to ensure conformity of service.

H. Some equipment used was not suitable for the laundry process.

The poor cleaning outcomes and high complaint levels directly indicate that the equipment is not fit for purpose, which is a clear breach of the requirement to provide suitable resources for controlled service provision under Clause 8.5.1.

Explanation of why the other options are not appropriate evidence for Clause 8.5.1:

A relates to strategic planning and investment decisions, not directly to operational control.

B and C relate to inspection activities, which were not evidenced in the scenario.

D and F relate to complaint handling behaviour, which would align more closely with Clause 9.1.2 (customer satisfaction) or Clause 10.2 (nonconformity and corrective action), not Clause 8.5.1.

ISO-aligned conclusion:

The nonconformity is justified because the organisation is continuing to provide services using unsuitable and inadequately maintained equipment, resulting in repeated service failures in multiple locations. This demonstrates a clear failure to control service provision as required by ISO 9001:2015 Clause 8.5.1, supported by evidence E, G and H.

ISO 9001:2015 requires organisations to understand their context and to use this understanding as an input to planning the quality management system. Tools such as PESTLE are acceptable methods, but auditors must verify how the outputs are used, not simply that the analysis exists.

Relevant ISO 9001 requirements:

Clause 4.1 – Understanding the organisation and its contextThe organisation shall determine external and internal issues that are relevant to its purpose and strategic direction and that affect its ability to achieve the intended results of the QMS.

Clause 6.1 – Actions to address risks and opportunitiesThe organisation shall plan actions to address risks and opportunities identified from context analysis and integrate these actions into the QMS processes.

Explanation of the correct audit trails:

C. What actions have been taken to address the risks and opportunities from the PESTLE analysis?

This audit trail directly links PESTLE outputs to Clause 6.1. It allows the auditor to determine whether the organisation has translated identified political, economic, social, technological, legal, and environmental issues into concrete actions within planning, operational control, or resource allocation. Without actions, the PESTLE analysis has no impact on QMS planning.

E. How has the PESTLE analysis contributed to the improvement of the QMS?

ISO 9001 requires context analysis to support improvement and strategic alignment of the QMS. This audit trail confirms whether PESTLE outputs are used as inputs to improvement activities, management review, or changes to processes, supporting Clauses 4.1, 6.1, and 10.3.

Explanation of why the other options are not selected:

A: Review by a specific manager is not a requirement of ISO 9001 and does not demonstrate impact on QMS planning.

B: PESTLE does not require consultation with external interested parties; that relates to Clause 4.2, not planning impact.

D: Training in SWOT is irrelevant, as ISO 9001 does not mandate any specific analysis tool.

F: Sharing information with external interested parties relates to communication, not to how PESTLE affects QMS planning.

ISO-aligned conclusion:

To determine how PESTLE analysis affects planning of a QMS, the auditor must follow audit trails that demonstrate:

Conversion of identified issues into risk-based actions, and

Use of those outputs to improve and adapt the QMS.

Therefore, the correct answers are C and E.