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

Relevant ISO 9001 Requirement

Clause 7.3 – Awareness states that persons doing work under the organisation’s control shall be aware of:

The quality policy;

Relevant quality objectives;

Their contribution to the effectiveness of the QMS;

The implications of not conforming with QMS requirements.

A critical point is that ISO 9001 uses the phrase:

“persons doing work under the organisation ' s control”

This includes:

Employees,

Temporary personnel,

Agency personnel,

Subcontractors performing work on behalf of the organisation.

Why Option B is Correct

In the scenario:

The refrigeration engineers performing the actual maintenance and repair services are all subcontractors.

The Managing Director states that these subcontractors have not been informed of:

the Quality Policy,

quality objectives,

plans to address risks and opportunities.

The justification given is that the subcontractors themselves have ISO 9001-certified management systems.

However, ISO 9001 certification of a subcontractor does not remove the organisation ' s responsibility to ensure persons working under its control are aware of the organisation ' s own QMS requirements.

Therefore, the organisation has failed to demonstrate compliance with Clause 7.3 Awareness .

Why the Other Options Are Incorrect

A. Clause 7.4 – Communication

The scenario does not primarily indicate a failure of communication processes.

The issue is not whether communication methods exist, but whether the subcontractors have the required awareness.

C. Clause 7.2 – Competence

The Managing Director explicitly states that competence requirements are applied to both full-time staff and subcontractors.

No evidence is presented that competence has not been determined or evaluated.

Therefore, a competence failure is not the strongest conclusion.

D. Clause 7.5 – Documented Information

The scenario indicates documented information exists and was reviewed by the auditor.

No evidence suggests documented information is missing, uncontrolled, or unavailable.

Therefore, Clause 7.5 is not the most likely issue.

ISO-Aligned Conclusion

The organisation relies entirely on subcontracted refrigeration engineers to deliver its certified services. Because these personnel perform work under the organisation ' s control, ISO 9001 requires them to be aware of the organisation ' s quality policy, objectives, and relevant QMS requirements.

The evidence shows this awareness has not been established.

Answer: B. 7.3 Awareness

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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.

Table

Statement

First-party audits

Second-party audits

Third-party audits

The audit scope is typically determined by the organisation being audited.

Yes

No

No

The outcome of the audit is typically certification to a recognised standard.

No

No

Yes

The audit scope is typically confined to service/product provision capability.

No

Yes

No

Here is a brief explanation of each statement:

The audit scope is typically determined by the organisation being audited: This statement applies to first-party audits, also known as internal audits, where the organisation audits its own processes and activities to ensure conformity and improvement1. The organisation can decide the scope of the audit based on its own needs and objectives2. This statement does not apply to second-party audits, where the customer audits the supplier, or third-party audits, where an independent body audits the organisation. In these cases, the audit scope is determined by the customer or the certification body, respectively34.

The outcome of the audit is typically certification to a recognised standard: This statement applies to third-party audits, where an independent body audits the organisation to verify that it meets the requirements of a specific standard, such as ISO 9001, and issues a certificate of conformity if the audit is successful34. This statement does not apply to first-party audits or second-party audits, where the outcome of the audit is not certification, but rather self-improvement or supplier qualification13.

The audit scope is typically confined to service/product provision capability: This statement applies to second-party audits, where the customer audits the supplier to ensure that they are meeting the requirements specified in the contract, such as service or product quality, delivery, or performance34. The audit scope is usually focused on the specific aspects of the service or product that are of interest to the customer3. This statement does not apply to first-party audits or third-party audits, where the audit scope is broader and covers the entire quality management system or the relevant clauses of the standard14.