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

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Question # 9

Scenario 4:

TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.

To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.

After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.

Anne reviewed the document and approved the audit mandate. The certification body and TD’s top management signed the certification agreement.

Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.

Scenario 4 mentions that Anne received a document that contained the audit scope, criteria, duration, and the limits to the audit engagement. What did Anne receive in this case?

A.

The certification agreement.

B.

The audit plan.

C.

The audit offer.

D.

The audit mandate.

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Question # 10

In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.

A.

Number of sites to be audited

B.

Risk to achieving audit objectives

C.

Expectations of the organisation's management

D.

Scope of the audit

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Question # 11

Confidence in the audit process and its ability to achieve its objectives depends on the competence of those involved in performing audits:

According to ISO 19011, select the two participants who need to be competent in performing audits.

A.

Auditor(s)

B.

Auditee

C.

Guides

D.

Observers

E.

Translators

F.

Audit team leaders

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Question # 12

Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit

of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.

The auditor samples the design records for a recently completed course for the 247 Insurance organisation. Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage

was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.

The auditor raises a nonconformity against ISO 9001. Which one of the following options is the basis for the nonconformity?

A.

8.3.5 - The improvements made to course designs are not documented. Feedback from customers is not always actioned.

B.

8.3.2.c - Design planning does not include design validation. Design verification is part of the planning process.

C.

8.3.4.d - Design validation is not always conducted. It is omitted about half of the time.

D.

8.6 - Course materials are released without proper approval. A course for 247 Insurance was released on an urgent basis.

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Question # 13

Scenario 4:

TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.

To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.

After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.

Anne reviewed the document and approved the audit mandate. The certification body and TD’s top management signed the certification agreement.

Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.

The audit team members were selected based on their knowledge of the legal and other regulations that TD is subject to. Is this acceptable?

A.

No, because only one audit team member is required to have knowledge of legal and other regulatory requirements that TD is subject to.

B.

No, because there is no need to have knowledge of the legal and other requirements that TD is subject to.

C.

Yes, to ensure effective conduct of the audit, each audit team member should have knowledge of legal and other requirements that TD is subject to.

D.

Yes, but only the lead auditor needs to have knowledge of legal and other regulatory requirements.

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Question # 14

Scenario 5: Mechanical-Electro (ME) Audit Stages

Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.

Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.

In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.

A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.

Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.

Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME’s QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.

To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.

The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.

Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.

After reviewing the documented information, Li Na claimed that it was not necessary to report the minor nonconformities that were identified; instead, they would be discussed in the next audit phase. Is this acceptable?

A.

Yes, during the review of documented information, only major nonconformities need to be documented if detected.

B.

Yes, all identified nonconformities throughout the audit need to be documented and communicated at the end of the audit.

C.

No, identification of minor nonconformities or areas of concern that could become nonconformities need to be documented and communicated to the auditee before proceeding to the next audit phase.

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Question # 15

Match the following potential audit client options to the type of audit.

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Question # 16

Scenario 2:

Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.

To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.

Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.

The team defined the QMS scope as:

"The scope of the QMS includes all activities related to food processing."

Leslie established a quality policy and presented it to the team for review before top management approval. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.

Which situation presented in scenario 2 is NOT compliant with ISO 9001?

A.

The QMS implementation team comprised five middle managers.

B.

The QMS implementation team did not include a representative from top management.

C.

The responsibilities and authorities for QMS roles were assigned by Leslie, the quality manager.

D.

The quality policy was reviewed by the implementation team before top management approval.

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