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

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Question # 9

Consultancy ABC, which is a subsidiary of a certification body called ABC-CERT, provided consultancy services regarding the implementation of a QMS based on ISO 9001 to an organization. Considering this, can ABC-CERT provide certification services to the organization which obtained consultancy services from Consultancy ABC?

Yes, after a minimum period of two years has passed.

Yes, if both parties sign an agreement which states that previous services by Consultancy ABC will not impact the judgment of auditors.

No, ABC-CERT is not allowed to provide certification services to that organization ever, as this would be a conflict of interest.

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Question # 10

An ISO 9001 certified organization sells packaged food. To maximize the benefits of third-party certification to the organization and stakeholders, the organization has labelled their product 'ISO 9001 certified product' and is selling it as 'quality food'.

Which TWO of the following describes this situation in the context of the purpose and benefits of third-party ISO 9001 certification?

ISO 9001 certification can be used to identify opportunities for improvement of the management system.

ISO 9001 certified food can increase customer confidence and satisfaction.

ISO 9001 certified food can increase revenue.

ISO 9001 is not for product certification.

The organization will be able to increase its market share.

The product from an ISO 9001 certified organization will taste better.

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Question # 11

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:

The CEO of AL-TAX hired an experienced consultant to help with the implementation of the QMS. Is this required from ISO 9001?

Yes, especially for companies that do not have competent personnel.

No, contracting external consultants is not required.

Yes, external advice is necessary for an effective implementation.

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Question # 12

Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

Consistently provide products that meet customers' requirements

Decreased number of management system nonconformities

Decreased number of warranty claims

Decreased number of nonconforming products in all stages of the manufacturing cycle

Enhanced customer satisfaction

Increased profits

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Question # 13

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Proâ€™s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the companyâ€™s working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

Based on the last paragraph of scenario 3, which audit principle did the audit team follow?

Fair presentation.

Integrity.

Confidentiality.

Objectivity.

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Question # 14

Select the two statements that are true.

The audit team leader shall only communicate any concerns to the auditee during the closing meeting.

Inform the general manager if the auditor finds uncontrolled documents.

Where the available audit evidence indicates that the audit objectives are unattainable, the individual(s) managing the audit programme shall be immediately informed.

Changes to the audit scope, which become apparent during the audit, shall be approved with the auditee.

During the audit, the audit team leader shall periodically assess audit progress.

An immediate and significant risk to the audit shall be informed to the auditee and if possible to the certification body.

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Answer:

Explanation:

Analyzing Each Statement:

A.Incorrect. The audit team leader must communicate concerns as they arise, not just during the closing meeting. Per ISO 19011:2018 Clause 6.4.9, significant concerns should be shared promptly with the auditee and audit client during the audit process to allow for immediate understanding and potential resolution.

B.Incorrect. The auditor or team leader is not specifically required to inform the general manager about uncontrolled documents. Instead, the issue is communicated within the framework of the audit findings to the audit client or auditee, as appropriate.

[Reference: ISO 19011:2018, Clause 6.6.2., D.Incorrect. Changes to the audit scope require the approval of the audit client (e.g., the certification body), not just the auditee. The scope is agreed upon in advance, and significant changes must be communicated with all stakeholders., E.Correct. The audit team leader is responsible for periodically assessing the audit progress to ensure it aligns with the audit objectives and planned scope.Reference: ISO 19011:2018, Clause 6.4.5., F.Incorrect. While immediate and significant risks should be communicated to the auditee, notifying the certification body is not an immediate responsibility of the audit team leader. The communication process depends on the procedures defined by the audit programme manager., Why Options C and E Are Correct:, C: Communicating unattainable audit objectives ensures the audit remains effective and prevents unnecessary effort or misalignment with goals., E: Periodic assessments by the team leader help in maintaining alignment with the scope, objectives, and time constraints, ensuring the audit's success., Relevant References from ISO Standards:, ISO 19011:2018, Clause 6.6.2: Describes procedures for when audit objectives are unattainable., ISO 19011:2018, Clause 6.4.5: Emphasizes the audit team leader's responsibility for ongoing assessment of audit progress., , , , ]

Question # 15

For a third-party, match the Activity with the Responsibility for conducting it.

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Answer:

Explanation:

Approve Certification Body: Accreditation Body

Award certification: Certification Body

Recommend certification: Audit Team Leader

Maintain certification:

Comprehensive Detailed Explanation

In the context of a third-party ISO 9001 audit, different entities play specific roles in the certification process. Here's a detailed explanation of the responsibilities:

Approve Certification Body: Accreditation BodyThe Accreditation Body is responsible for approving Certification Bodies. Accreditation Bodies are independent entities that evaluate the competence of Certification Bodies, ensuring they meet international standards like ISO/IEC 17021, which sets out the criteria for bodies providing audit and certification of management systems. In this role, they confirm that the Certification Body is capable of conducting ISO 9001 audits and granting certifications in accordance with international guidelines.

Award Certification: Certification BodyThe Certification Body is the entity that ultimately awards the certification to an organization after verifying that it meets the ISO 9001 standards. Certification Bodies conduct audits, either directly or through a team of auditors, and based on the audit outcomes, they issue the certification, indicating that the organization complies with ISO 9001.

Recommend Certification: Audit Team LeaderThe Audit Team Leader is responsible for leading the audit and making a recommendation to the Certification Body. This recommendation is based on the audit findingsâ€”whether the organization meets the ISO 9001 requirements or if there are areas of non-compliance that need corrective action. The final decision on certification is not made by the Audit Team Leader but by the Certification Body.

Maintain Certification: Certification BodyMaintaining certification refers to the ongoing process of ensuring that an organization continues to comply with ISO 9001 requirements. The Certification Body conducts regular surveillance audits (e.g., annually) and may also perform recertification audits (typically every three years). This ongoing monitoring ensures that the certified organization continues to adhere to the quality management standards over time.

This breakdown clearly assigns responsibility based on the defined roles of Accreditation Bodies, Certification Bodies, and Audit Teams in the ISO 9001 certification process.

Question # 16

According to the guidance provided in ISO 19011, a second-party opening meeting should cover many elements.

From the following options, select the four items that should not be included in the opening meeting.

Analysis of the corrective actions pending from the previous audit

Audit objectives

Audit team leaders' email address

Conditions under which the audit may be terminated

How far is the auditee able to apply to the National Quality Award

Introduction of the Audit team

Risks to the organization resulting from the presence of the auditors

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