ISO-9001-Lead-Auditor PECB QMS ISO 9001:2015 Lead Auditor Exam exact Exam Questions

QMS ISO 9001:2015 Lead Auditor Exam

Last Update 14 hours ago Total Questions : 267

The QMS ISO 9001:2015 Lead Auditor Exam content is now fully updated, with all current exam questions added 14 hours ago. Deciding to include ISO-9001-Lead-Auditor practice exam questions in your study plan goes far beyond basic test preparation.

You'll find that our ISO-9001-Lead-Auditor exam questions frequently feature detailed scenarios and practical problem-solving exercises that directly mirror industry challenges. Engaging with these ISO-9001-Lead-Auditor sample sets allows you to effectively manage your time and pace yourself, giving you the ability to finish any QMS ISO 9001:2015 Lead Auditor Exam practice test comfortably within the allotted time.

Question # 51

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.

Question # 52

You are conducting a third-party audit to ISO 9001 and the next item on your audit plan is ' internal auditing ' .

When reviewing a sample of audit records up to 5 years previously, you find that many contain non-conformance reports and no actions have been taken. You interview the Quality Manager.

You: " I have noted that many of the older files contain non-conformances that have not had any corrective action taken. "

Quality Manager: " Because the business is always changing, the departmental managers tell me that the non-conformances are no longer applicable. I made a decision that any non-conformance over 3 years old is automatically closed "

You: " Do you obtain any confirmation beforehand from the appropriate departments that the non-conformances are no longer applicable. "

Quality Manager: " No, because they are so old I consider that they are no longer appropriate. Please remember that we take a risk-based approach which means we audit where and when it is considered important to do so.

Select one course of action you would now take from the options.

Interview Top management to determine whether they were aware of and agreed the actions of the Quality Manager

Review all non-conformances reports related to clause 9.2 of ISO 9001

Interview relevant Departmental managers to assess whether the older non-conformances are still valid.

Raise a non-conformance report against clause 9.2.2.e of ISO 9001

Question # 53

You are leading a Stage 2 certification audit of a multi-site organisation and have received the audit schedule below;

Head Office and Site 1 – Day 1

Site 2 (150 km from HQ) – Days 2 and 3

During Day 1 of the audit, the client informs you that the laboratory at Site 2 has been closed for decontamination due to a serious outbreak of an infectious disease among workers. In Site 2, all other functions could be audited as planned.

As the audit team leader, what would you do?

Choose the best acceptable action you could take:

Immediately cancel the audit since the audit plan cannot be completed.

Complete the audit on day 3 and report back to the certification body for a certification decision.

Ask the audit Programme Manager for direction.

Continue the audit on days 2 and 3 and return later to audit the Site 2 laboratory.

Question # 54

At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only two people

are present and waiting for them: the Health and Safety supervisor and the administrative officer. Neither has participated in

the audit. However, the team had previously agreed with the auditee Quality Manager on two nonconformities identified

during the audit (NC1 and NC2).

They said:

Health and Safety supervisor: " Good evening. We are sorry to inform you that the general manager was involved in a

serious car accident, and the other two managers have had to leave urgently to attend to the emergency. "

Administration officer: " Our quality manager, before leaving, left a written message about ' NC2 ' . He declares that the

correction and corrective action have been already implemented and has attached some documents to the message as

evidence of these actions. Therefore, he expects that ' NC2 ' will not be included in the report. "

Which one of the following would be your preferred answer to the Quallty Manager ' s request?

Let me review the message and documents, and I will give you my answer in a few minutes

OK. I will record in the audit report that ' nonconformity 2 ' was closed during the Closing meeting

OK. Let ' s all go to the workshop to see the supervisor. I hope he will be able to explain what they did to correct the nonconformity and prevent its recurrence

The scope of the audit does not allow auditors to review actions taken in response to the nonconformity. There would not be enough time for the full cycle of corrective action to take effect

Question # 55

The procedures of an organisation require that all purchase orders have to be signed by the Purchasing Manager, or, in her absence, by the Production Manager. During an audit carried out in November 2020, an auditor determined that during three weeks in February 2020, the purchase orders were not signed. You raise a nonconformance under Clause 8.4.3 of ISO 9001:2015.

Which one of the following answers would you accept as a ' correction ' from the Purchasing Manager?

All products related to those purchase orders have already been successfully used during the first quarter of 2020, therefore there is no need for correction. We will only take corrective action.

During those weeks, as I was on holiday, the production manager should have signed those purchase orders. As a correction to this particular nonconformity, I will ask him to sign them.

I do not accept the nonconformity. Anything I may ask my employees to do will be seen as another piece of evidence that complying with ISO 9001 requirements is a bureaucratic valueless burden.

I will sign all the purchase orders now. It will take some time to print them since they are on a backup disk, but I will get them done before the end of the audit.

Question # 56

Which statement regarding the drafting of the audit conclusions is correct?

The audit conclusions must be drafted based on observation

The audit conclusions must be based on evidence that is examined and evaluated in terms of quantity and quality

The audit conclusions must not include the revisions that resulted from the closing meeting

Question # 57

An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:

" The reject rate of the finished product of 9.7% needs improvement as it doesn ' t meet the stated objective of top management of 5%. "

As the third-party auditor reviewing the internal audit process, you come across the nonconformity. For corrective action, the Quality Manager conducted an investigation into the reject rates. He reported that the collection baskets for products ejecting from the moulding machines were not large enough. About 6% of products fell onto the wet and dirty factory floor. Management stated that replacing the baskets was too costly and ordered the Maintenance Manager to ensure that the floor was kept clean and dry to prevent rejects. The auditor later checked the factory floor, which was wet and dirty in places.

From the following nonconformities, select three that the auditor could raise to ISO 9001.

10.3 - The organisation did not continuously improve. Reject rates were unchanged.

7.1.4 - The factory environment is not suitably maintained to prevent dirty products.

7.1.1 - The organisation failed to provide the required resources to prevent nonconforming products.

9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3).

8.6 - Dirty products were released to the customer.

7.3 - Staff were not aware that products were falling onto the factory floor.

10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity.

Answer:

A, B, C

Explanation:

The auditor could raise the following nonconformities to ISO 9001 based on the scenario:

•Option A: 10.3 - The organisation did not continuously improve. Reject rates were unchanged. This option is correct because ISO 9001:2015 clause 10.3 requires the organization to improve the suitability, adequacy and effectiveness of the quality management system. The organization did not demonstrate any improvement in reducing the reject rate of the finished product, which was a stated objective of top management. The corrective action taken by the organization was not effective in addressing the root cause of the problem and preventing its recurrence.

•Option B: 7.1.4 - The factory environment is not suitably maintained to prevent dirty products. This option is correct because ISO 9001:2015 clause 7.1.4 requires the organization to determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. The organization did not ensure that the factory floor was clean and dry, which affected the quality of the products and increased the risk of nonconformity.

•Option C: 7.1.1 - The organization failed to provide the required resources to prevent nonconforming products. This option is correct because ISO 9001:2015 clause 7.1.1 requires the organization to determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. The organization did not provide adequate collection baskets for the products ejecting from the moulding machines, which resulted in products falling onto the factory floor and becoming nonconforming.

The following options are not correct:

•Option D: 9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3). This option is not correct because ISO 9001:2015 clause 9.2.2 does not specify the requirements for the wording of nonconformities in internal audit reports. The nonconformity (NC 3) stated by the internal auditor was clear and relevant to the audit criteria and audit evidence. The issue is not with the report, but with the corrective action taken by the organization.

•Option E: 8.6 - Dirty products were released to the customer. This option is not correct because ISO 9001:2015 clause 8.6 requires the organization to implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. The scenario does not indicate that the dirty products were released to the customer, but that they were recalled and repaired then returned to the customers. The issue is not with the release, but with the production process and the environment.

•Option F: 7.3 - Staff were not aware that products were falling onto the factory floor. This option is not correct because ISO 9001:2015 clause 7.3 requires the organization to ensure that the persons doing work under its control are aware of the quality policy, relevant quality objectives, their contribution to the effectiveness of the quality management system, and the implications of not conforming with the quality management system requirements. The scenario does not indicate that the staff were not aware of these aspects, but that the management did not provide adequate resources and environment for the staff to perform their work. The issue is not with the awareness, but with the management responsibility and resource provision.

•Option G: 10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity. This option is not correct because ISO 9001:2015 clause 10.2.1 requires the organization to react to the nonconformity and, as applicable, take action to control and correct it and deal with the consequences. The scenario indicates that the Quality Manager conducted an investigation into the reject rates and identified the cause of the nonconformity. The issue is not with the investigation, but with the corrective action taken by the management.

•Option H: 8.5.1 - Production operations were not properly controlled to avoid reject products. This option is not correct because ISO 9001:2015 clause 8.5.1 requires the organization to implement production and service provision under controlled conditions. The scenario indicates that the production operations were controlled by the moulding machines, which ejected the products into the collection baskets. The issue is not with the production operations, but with the size of the collection baskets and the condition of the factory floor.

[References:, •ISO 9001:2015 Quality management systems - Requirements, •ISO 9001 Lead Auditor Course Material, Module 6: Reporting Audit Findings, Slide 14: Writing Nonconformity Statements, •ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 6.2: Reporting Audit Findings, •Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies, , , ]

Question # 58

You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The organisation processes

waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.

You: " Why are these plastic items being rejected at this stage? "

Auditee: " They do not meet our processing standards. "

You: " What is the reason for that? "

Auditee: " These items are likely to damage the machinery down the line. They can also compromise our

quality standards. We need to protect our reputation for good quality output materials. "

You: " What happens to the rejected items? "

Auditee: " Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled. "

You: " What happens to the waste products? "

Auditee: " I ' m not sure. I suppose they go to landfill. "

Which two. of the following actions would you take to investigate further?

Check the process for handling nonconforming items.

Ask to review the percentage of waste materials.

Find out if operators have regular hearing tests.

Determine what happens to the waste products.

Ask about operator PPE (Personal Protective Equipment).

Determine whether there are quality objectives for reducing rejected material.

Answer:

A, D

Explanation:

According to the ISO 9001:2015 standard, clause 8.7 requires that an organization identify and control any nonconforming outputs that do not conform to the requirements of the customer or other relevant requirements. Nonconforming outputs are any outputs from the process, product or service that do not meet the specified quality criteria. Nonconforming outputs must be dealt with in one or more of the following ways:

Correction of the nonconformity

Segregation, containment, return or suspension of provision of products and services

Informing the customer

Authorisation for acceptance under concession

The organization must also retain documented information on the description of the nonconformity, the actions taken, any concessions obtained, and the identification of the authority deciding the action to resolve the nonconformity.

In this scenario, you have interviewed a line supervisor who is responsible for managing a manual picking line where operators are removing contaminant materials from incoming products. The supervisor has explained that these plastic items are rejected at this stage because they do not meet their processing standards and they can damage their machinery and compromise their quality standards. The supervisor has also mentioned that some of these rejected items are melted down in another process later on and some are disposed of as waste products that cannot be recycled.

Based on this information, you can investigate further by taking two actions:

A. Check the process for handling nonconforming items: You can verify whether there is a documented procedure for identifying, segregating, containing, returning or suspending provision of nonconforming items at this stage. You can also check whether there is a system for informing customers about any nonconforming items that may affect their satisfaction or expectations.

D. Determine what happens to the waste products: You can verify whether there is a documented procedure for disposing of waste products that cannot be recycled as per environmental regulations and customer requirements.

These two actions would help you to determine whether there are any nonconforming outputs at this stage and how they are controlled by the organization.

Question # 59

You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as an internal auditor. The Quality Manager asks you to lead the next internal audit of Production and Logistics Dispatch. The audit team includes two other internal auditors.