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

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 emphasizes the importance of communication as part of an effective Quality Management System (QMS).

Clause References:

Clause 7.4 (Communication): This requires organizations to establish what, when, with whom, and how communication should take place to ensure effectiveness.

Quality Management Principle – Engagement of People: Effective communication allows stakeholders (employees, suppliers, customers) to fully participate and contribute to quality objectives.

Why is the Correct Answer A?

Appropriate communication means ensuring that messages are clear, relevant, and accessible to the intended audience.

Different stakeholders (employees, customers, regulatory bodies, suppliers) may require different formats, languages, or media to ensure they fully understand and engage.

This aligns with ISO 9001:2015, which emphasizes that communication must be tailored to the needs of the recipient for maximum effectiveness.

Why are the Other Options Incorrect?

B (Timely responses) → Important but does not specifically refer to appropriateness in communication.

C (Communicating processes and assumptions to all interested parties) → Communication should be relevant; sharing all details might not be necessary or appropriate.

D (Only top management handling external communication) → Communication must be distributed across relevant functions, not restricted to leadership.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015, Clause 5.2.1 (Establishing the Quality Policy) states that top management must establish, implement, and maintain a quality policy.

In the scenario, the quality manager (Leslie) created the policy, but top management did not establish it themselves, which violates Clause 5.2.1. While the policy can be drafted by a team, top management must take full ownership of its development and approval.

Clause 8.2.4 of ISO 9001:2015 – Changes to Requirements for Products and Services:ISO 9001:2015 Clause 8.2.4 states that when changes to requirements for products or services are made, they must be communicated and agreed upon with relevant interested parties (in this case, the Health Trust). The lack of communication and agreement for substituting the cleaning chemical represents a clear violation of this clause.

Analysis of the Corrective Action Proposed:The organization proposed "obtaining a concession from the Health Trust for the use of the new chemical." This action is reactive and assumes approval from the Health Trust without addressing the systemic issue: the lack of a defined change control process for managing contract changes.

Option Analysis:

A. The substitute chemical has not been used before in the Health Trust:Incorrect. While this may be a concern, it is not directly relevant to the root cause of the nonconformity, which is the absence of a process to handle contract changes.

B. The action assumes that the Health Trust will agree to the change:Incorrect. Although this is true, it is not the primary issue. The nonconformity lies in the lack of a structured approach to obtain agreement, not whether the Health Trust agrees.

C. Staff have not been trained in the use of the new chemical:Incorrect. This is a separate issue related to staff competence (Clause 7.2), but it is not the main reason why the corrective action is unacceptable under Clause 8.2.4.

D. The process for making changes to the contract has not been addressed:Correct. The fundamental issue is the organization's failure to follow or establish a change control process for amending contracts, including gaining formal agreement from the Health Trust. The proposed corrective action does not ensure that such issues will be systematically prevented in the future.

E. The substitute chemical may not be as effective as the original:Incorrect. The effectiveness of the substitute chemical is secondary to the primary issue, which is the lack of a change management process.

ISO 9001 References Supporting the Correct Answer:

Clause 8.2.4: Requires that changes to product/service requirements be reviewed, communicated, and agreed upon with the customer.

Clause 10.2 (Nonconformity and Corrective Action): Requires the organization to address the root cause of the nonconformity and take actions to ensure it does not recur. In this case, the root cause is the absence of a change control process.

Why D is the Best Answer:The core issue is that the organization did not have a formalized process for managing and agreeing upon changes to contract requirements. Addressing this process gap is essential to prevent recurrence of similar nonconformities. Merely seeking a concession from the Health Trust is a one-off solution that does not address the systemic issue.