New ISO-9001-Lead-Auditor Braindumps Questions & ISO-9001-Lead-Auditor Test Simulator Free
New ISO-9001-Lead-Auditor Braindumps Questions & ISO-9001-Lead-Auditor Test Simulator Free
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New New ISO-9001-Lead-Auditor Braindumps Questions | Latest ISO-9001-Lead-Auditor Test Simulator Free: QMS ISO 9001:2015 Lead Auditor Exam
We are conscious of the fact that most of the candidates have a tight schedule which makes it tough to prepare for the QMS ISO 9001:2015 Lead Auditor Exam exam preparation. 2Pass4sure provides you PECB ISO-9001-Lead-Auditor Exam Questions in 3 different formats to open up your study options and suit your preparation tempo.
PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q133-Q138):
NEW QUESTION # 133
The following list gives examples of records that may be evidence of how an organisation has fulfilled the requirements of clause 8.4 of ISO 9001. Match the records to the appropriate requirement of clause 8.4.
Answer:
Explanation:
Explanation:
The following table shows the possible matching of the records to the requirements of clause 8.4:
Table
Requirements
Records
Define product requirements
Product specification
Criteria for selection
List of requirements to be met by the external provider
Evaluation of potential external provider
External provider questionnaire
External provider selection
Approved external provider list
Communicate requirements
Purchase order
Monitoring of performance
External provider delivery times and quality issues
Comprehensive and Detailed Explanation: = According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:
Define the product requirements that are relevant for the external provision, such as specifications, drawings, standards, codes, etc. These should be documented and communicated to the external provider. A record of the product specification can be used as evidence of this requirement.
Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently. A record of the list of requirements to be met by the external provider can be used as evidence of this requirement.
Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed. A record of the external provider questionnaire can be used as evidence of this requirement.
Select the external providers that have demonstrated their competence and conformity to the requirements. The selection should be based on the evaluation results and the organization's needs. The selection should be documented and approved. A record of the approved external provider list can be used as evidence of this requirement.
Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely. A record of the purchase order can be used as evidence of this requirement.
Monitor the performance and conformity of the external provider, using the established criteria and methods. The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed. A record of the external provider delivery times and quality issues can be used as evidence of this requirement.
References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems
NEW QUESTION # 134
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management. The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
How would you respond with the following options? Select three.
- A. Suggest that all employees undertake a training course on ISO 9001.
- B. Suggest asking the certification body for guidance on this matter.
- C. Indicate that ISO 9001 requires a minimum of two quality objectives.
- D. Suggest that the Quality Manager obtains external consultancy on the use of quality objectives.
- E. Inform the Quality Manager that you will comment on the subject in your audit report.
- F. Advise the Quality Manager that, as an auditor, you cannot provide advice to the organisation on how it should operate its QMS.
- G. Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organisation's requirements.
- H. Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly.
Answer: E,G,H
Explanation:
According to the ISO 9001:2015 standard, clause 6.2.1 requires organizations to establish quality objectives at relevant functions, levels, and processes needed for the quality management system. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The quality objectives must also be measurable, monitored, communicated, and updated as appropriate.
In this scenario, the Quality Manager of XYZ Corporation has set quality objectives for every employee in the organization except top management. This has created a lot of resistance to the QMS, and the Chief Executive is asking questions about the cost and the method of setting objectives. The Quality Manager asks for your opinion as an auditor on whether this is the correct method of setting objectives.
As an auditor, you cannot provide advice to the organization on how it should operate its QMS. Your role is to assess the conformity and effectiveness of the QMS against the requirements of the standard and the organization's own policies and objectives. Therefore, you should respond with the following options:
B: Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organization's requirements: You can suggest that the Quality Manager should familiarize himself with the requirements of clause 6.2.1 and understand how they apply to his organization. He should also consider the context and the needs and expectations of interested parties when setting quality objectives. He should ensure that the quality objectives are aligned with the quality policy and the strategic direction of the organization.
C: Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly: You can inform the Quality Manager that you will evaluate the quality objectives during the audit and check whether they meet the requirements of clause 6.2.1. If you find any gaps or weaknesses in the quality objectives, you will raise an opportunity for improvement to help the organization improve its QMS. You will also verify whether the quality objectives are monitored, communicated, and updated as appropriate.
D: Inform the Quality Manager that you will comment on the subject in your audit report: You can inform the Quality Manager that you will document your findings and observations on the quality objectives in your audit report. You will also provide a summary of the audit results and any recommendations for improvement.
You will also indicate the level of conformity and effectiveness of the QMS.
These three options would help you to maintain your impartiality and professionalism as an auditor and to provide constructive feedback to the organization
NEW QUESTION # 135
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top- notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS.
They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS.
AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
According to scenario 1, AL-TAX determined the factors that could hinder their processes from achieving the planned results and implemented preventive actions. This means they employed:
- A. Risk-based thinking
- B. Compliance requirements and regulations
- C. The process approach
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 emphasizes risk-based thinking, which helps organizations identify factors that could prevent achieving planned results and take preventive action. Clause 6.1 (Actions to Address Risks and Opportunities) requires organizations to determine risks and opportunities and implement actions to mitigate potential negative impacts.
In the scenario, AL-TAX identified potential risks and implemented preventive actions, aligning with risk- based thinking. ISO 9001:2015 integrates risk management throughout the standard, ensuring processes are designed to minimize uncertainties.
Reference:
ISO 9001:2015, Clause 6.1 - Actions to Address Risks and Opportunities
ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking
NEW QUESTION # 136
What does an auditor evaluate during an audit follow-up?
- A. The auditee's site-specific conditions
- B. The effectiveness of all corrections and corrective actions taken
- C. If internal audits and management reviews are being planned and performed
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 6.6 (Audit Follow-Up):
* The primary focus of an audit follow-up is verifying that corrective actions were effectively implemented.
* Internal audits and management reviews (B) are part of routine QMS operations, not the main objective of follow-ups.
* Site conditions (C) are relevant but secondary to verifying corrective action effectiveness.
Thus, A is the correct answer.
Reference:
ISO 19011:2018, Clause 6.6 (Audit Follow-Up)
NEW QUESTION # 137
According to the ISO 9001 standard, which one of the following is a defined responsibility of top management?
- A. Establishing the Quality Management System quality policy.
- B. Ensuring customer requirements are consistently met.
- C. Planning actions to address risks and opportunities.
- D. Communicating the quality objectives needed for the Quality Management System.
Answer: A
Explanation:
Top management is responsible for establishing, implementing, and maintaining the quality policy. The quality policy provides a framework for setting quality objectives and must be compatible with the context of the organization and support its strategic direction. It should also provide a commitment to satisfy applicable requirements and to continuous improvement.
References: ISO 9001:2015, Clause 5.2
NEW QUESTION # 138
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