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

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Question # 9

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 of the following indicates that Bell has defined its quality objectives?

A.

Establishing a new strategy for handling customer complaints and requests

B.

Implementing a QMS to increase efficiency in the manufacturing process and customer satisfaction

C.

Establishing a QMS implementation team of middle managers from various departments

D.

Assigning responsibilities for QMS roles

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Question # 10

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation manufactures cosmetics for major retailers.

You are interviewing the Manufacturing Manager (MM).

You: " I would like to begin by looking at the cleaning controls. "

MM: " We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside. "

Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

You decide to raise a non-conformity.

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Question # 11

In the context of a second-party audit, match the activity with the party responsible for conducting it.

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Question # 12

Auditor competence is a combination of knowledge and skills. Which two of the following activities are predominately related to ' knowledge ' ?

A.

Communicate with the auditee

B.

Conduct audit meetings

C.

Determine how to seek evidence from the auditee

D.

Determining what evidence to gather

E.

Evaluate proposals of corrective actions

F.

Identify findings

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Question # 13

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.

According to scenario 5, Li Na conducted group interviews with departmental managers and top management by herself. Is this in accordance with audit best practices?

A.

Yes, only the audit team leader should conduct group interviews.

B.

Yes, the auditee’s top management is always interviewed by the audit team leader only.

C.

No, two auditors should be present in case of group interviews.

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Question # 14

Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.

A.

Concession

B.

Correction

C.

Corrective action

D.

Preventive action

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Question # 15

You are preparing for interviews with two members of top management. Based on the information that you gathered about the organization, you conclude that it is the top management who takes all the important decisions and closely supervises and controls employees. Based on this, which management style is practiced in the organization?

A.

Autocratic

B.

Laissez-faire

C.

Centralized

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Question # 16

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements. The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.

You have just completed the opening meeting. You are interviewing the Managing Director (MD).

You: “Good morning. I would like to gain an understanding of your business and its strategic direction.”

MD: “Of course. We are facing challenging times. The market is extremely competitive, and customers typically look for the least expensive option when arranging health and safety training. Our annual sales revenue has struggled to grow over the past two years. Most of our employed trainers are planning to retire over the next 12 months, and we are looking for more subcontract trainers. Achieving ISO 9001 certification will, I hope, give us the capability to improve our operational performance. Also, many of our competitors do not have any form of management system certification, so I hope it will give us that competitive edge needed to secure orders. We intend to promote our ISO 9001 certification on our website and across all other customer-facing media.”

Which three of the following audit trails would you take to explore the extent to which external and internal issues have been determined and used to enable the business to achieve the intended result(s) of its quality management system?

A.

Establish how the organisation determines its relevant interested parties.

B.

Establish how the organisation determined the scope of its quality management system.

C.

Establish how the organisation documents its external and internal issues.

D.

Establish how the organisation reviews information about external and internal issues.

E.

Establish how the organisation determines employed trainer competence.

F.

Establish how the organisation maintains its training products up to date.

G.

Establish how the organisation determines subcontractor trainer competence.

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