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ISO-9001-Lead-Auditor QMS ISO 9001:2015 Lead Auditor Exam is now Stable and With Pass Result | Test Your Knowledge for Free

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ISO-9001-Lead-Auditor Practice Questions

QMS ISO 9001:2015 Lead Auditor Exam

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Total Questions : 249

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Question # 51

XYZ Corporation is an organisation that employs 100 people. As 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.

Three months after Stage 1, you return to XYZ Corporation to conduct a Stage 2 certification audit as Audit

Team Leader with one other auditor. You find that the Quality Manager has cancelled the previous quality

objectives for all employees and replaced them with a single objective for himself. This states that "The

Quality Manager will drive multiple improvements in the QMS in the next year". The Quality Manager indicates

that this gives him the authority to issue instructions to department managers when quality improvement is

needed. He says that this approach has the full backing of senior management. He shows you the latest

Quality Improvement Request that was included in the last management review.

Question # 51

After further auditing, the issues below were found. Select three statements that apply to the term 'audit trail'

Options:

A.  

Decisions on improvement action timescales not involving departmental managers.

B.  

Evaluation of the results of the improvement action not always documented by the Quality Manager.

C.  

Limited knowledge of the content of Quality Improvement Requests by departmental staff.

D.  

Quality improvements not aligning with the quality policy.

E.  

The single quality objective set for the organisation by the Quality Manager.

F.  

Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the Quality Manager.

Discussion 0
Question # 52

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-Pro’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 company’s working environment (social, psychological, and physical conditions).

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

In scenario 3, the audit team required access to see the organizational chart and job descriptions to verify the employees’ competence. Based on audit best practices, is this acceptable?

Options:

A.  

Yes, because that would be sufficient evidence to verify competence.

B.  

No, because the audit evidence would not be relevant.

C.  

Yes, because auditors should see the organizational chart and job descriptions to verify competence.

D.  

No, because competence should only be verified through direct observation.

Discussion 0
Question # 53

Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. 80% of complaints originate from five shops in the same region. Most of these complaints

relate to customer laundry not being cleaned as customers require. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it now. You learn that the shop managers were

told to dismiss most of the complaints because of the poor quality of the laundered materials.

On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.

You raised a nonconformity against clause 8.5.1 of ISO 9001.

Based on the scenario, select the three options which best describe the evidence for raising such a nonconformity.

Options:

A.  

Customer complaints are not taken seriously by the organisation.

B.  

Shop managers were told to make excuses to customers with complaints.

C.  

Some equipment used was not suitable for the laundry process.

D.  

The management failed in planning to replace obsolete equipment.

E.  

The operators did not check the condition of the customer's product upon receipt.

F.  

The operators did not check the laundry before release to the customer.

G.  

The organisation failed to control the laundry operations in 5 shops adequately.

Discussion 0
Question # 54

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.

You are interviewing the Quality Systems Manager (QSM).

You: "What risks and opportunities have the business identified?"

QSM: "I'1l show you. This was discussed with the Managing Director at the latest management review."

Narrative: The QSM shows you the latest management review record and points to the following table:

Question # 54

You: "How is the business planning to address these risks and opportunities?"

QSM: "The MD said that they already knew about them so it was not necessary."

Question # 54

Options:

Discussion 0
Question # 55

What should the auditor document during the Stage 1 audit?

Options:

A.  

The main processes of the auditee

B.  

The interviews with the auditee’s employees

C.  

The observations that could result in nonconformities during the on-site audit

Discussion 0
Question # 56

A Health Trust has contracted with Servitup, a catering services organisation which has been certified to ISO 9001 for 1 year. It provides services to ten, small rural

hospitals in remote locations involving purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital

staff. An auditor is conducting the first sole surveillance audit at one site with the Deputy Catering Manager (DCM).

At the closing meeting attended solely by the DCM, the auditor informs him that he has found numerous gaps in the QMS processes which lead him to consider

recommending suspension of the organisation's certification. He is particularly concerned with the evidence that patient health is being adversely affected by produce

stored beyond its safe consumption date, poor kitchen hygiene and undercooked meals. The DCM says that he cannot make any decisions about these issues in the

absence of the Catering Manager due to illness but will write everything down and report to the Catering Manager.

Which two actions should you take in the context of the audit?

Options:

A.  

Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit.

B.  

Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body.

C.  

Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course.

D.  

Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work.

E.  

Recommend that all personnel should be given urgent in-depth training in the QMS.

F.  

Thank the DCM for his time and express an expectation that improvements will be made in the QMS.

Discussion 0
Question # 57

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

processes waste plastics into raw material 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."

After further auditing, you have gathered additional evidence.

Question # 57

Options:

Discussion 0
Question # 58

You work for organisation

A.  

You are asked to lead an internal audit of A's quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to

A.  

There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.

Which of the following actions would you consider appropriate when planning the internal audit of A's quality management system?

Options:

A.  

Visit Plant A2 to interview personnel of company B

B.  

Visit Plant A2 to interview B's quality manager

C.  

Visit Plant A2 to interview A's security personnel and B's maintenance department

D.  

Interview the A2 plant manager, now working in Plant A1

Discussion 0
Question # 59

According to the ISO 9001 standard, which one of the following is a defined responsibility of top management?

Options:

A.  

Communicating the quality objectives needed for the Quality Management System.

B.  

Ensuring customer requirements are consistently met.

C.  

Establishing the Quality Management System quality policy.

D.  

Planning actions to address risks and opportunities.

Discussion 0
Question # 60

You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.

You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.

You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

Question # 60

Options:

Discussion 0
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