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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 # 31

What does the application of the process approach in a QMS enable?

A.

The improvement of processes based on the needs and expectations of interested parties

B.

The consideration of processes in terms of financial value

C.

The achievement of effective process performance

D.

The reduction of resource consumption

Question # 32

You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.

You: “I’d like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months?”

Auditee: “We have made some strategic changes, the main one being that we no longer manufacture our own products in-house.”

You: “That sounds like quite a significant change. What has been the impact of that?”

Auditee: “We now mainly sell other manufacturers’ products, under their brand names, and have outsourced the manufacture of our own brand products to one of our suppliers.”

You: “What were the reasons for making the change?”

Auditee: “Our manufacturing section was a small operation, and we struggled to cope with fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods, we had staff with little to do. This was having an impact on customer satisfaction, and meant we had to charge premium prices that made our product uncompetitive.”

You: “How did you go about the change?”

In relation to the auditor’s question about how the change was managed, the auditee mentions the steps listed below. The steps represent different elements of the Plan/Do/Check/Act cycle.

Select three steps which apply to the ‘check’ element of the cycle.

A.

We put together a plan for implementation.

B.

We looked at the data at the management review and decided we needed to make improvements.

C.

We monitored customer feedback and noticed an increase in negative feedback about lead times.

D.

We monitored the performance of the new supplier.

E.

We communicated the plan internally.

F.

We found a suitable supplier.

G.

We noticed that productivity targets were being missed.

Question # 33

You are leading a team that is auditing a fruit juice manufacturer (ORANGE+), which markets its products in bottles of 0.5 and 1 litre. It is 4 pm, and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the closing meeting. The closing meeting was scheduled for 5 pm.

ORANGE+ has two manufacturing lines: M1 is a clean room for manufacturing and bottling the juices, and M2 is for packing and labelling the filled bottles in packets of 50 bottles each to be sent to retailers.

Auditor 1 audited the two manufacturing lines.

You: “What findings would you report?”

Auditor 1: “I have one issue. Earlier today, in the morning in M1, I observed a batch of ‘sugarless orange juice’ being filled into bottles with the label ‘standard orange juice’ on them.”

You: “How would you write the non-conformity?”

Auditor 1: “Some bottles from a batch of ‘sugarless orange juice’ were labelled as ‘standard orange juice’.”

What information would you add to this text to complete the non-conformity report? Select six.

A.

The regulatory requirements that apply to the juice being bottled.

B.

If any of the ORANGE+ procedures for bottling and labelling products were not being met.

C.

The grade of nonconformity (major or minor).

D.

The date on which the evidence was identified.

E.

Composition of both sugar and sugarless juices.

F.

Batch number audited.

G.

Name of the supervisor and of the workers who were responsible for the bottling process.

Question # 34

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.

A.

The management failed in planning to replace obsolete equipment.

B.

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

C.

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

D.

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

E.

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

F.

Customer complaints are not taken seriously by the organisation.

G.

The organisation failed to maintain all of its equipment to an adequate standard.

Question # 35

Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?

A.

During the Stage 1 audit, the audit team:

B.

Verifies the degrees of customer satisfaction

C.

Evaluates the conditions of all sites

D.

Reviews the client ' s management system documented information

E.

Evaluates the results of the last management review

F.

Verifies the compliance with legal requirements

G.

Reviews the processes with high level of risk

Question # 36

During an internal audit, it was discovered that the calibration of a spectrometer used daily for production had expired, causing a nonconformance under Clause 7.1.5.2 of ISO 9001:2015. The root cause was the organization not considering the risk of the calibration provider leaving the country.

Which corrective action is the best one?

A.

We will select one sample, which we will send to an external laboratory and will use it as our internal standard.

B.

We will look for a local company to provide this service.

C.

We will have the results on one out of ten of our routine production samples double-checked by an external local laboratory.

D.

We will add this to our external issue register, assess its associated risk, and plan action to address that risk.

Question # 37

XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented. 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.

Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?

A.

The consultant has not interpreted ISO 9001 correctly.

B.

Quality objectives were not established in alignment with the organisation ' s quality policy.

C.

Quality objectives are not maintained as documented information.

D.

Establishing quality objectives did not include top management.

E.

The organisation cannot afford to undertake quality objectives all at once.

F.

Quality objectives are not being implemented by the organisations ' personnel.

Question # 38

What does an auditor evaluate during an audit follow-up?

A.

The effectiveness of all corrections and corrective actions taken

B.

If internal audits and management reviews are being planned and performed

C.

The auditee’s site-specific conditions

Question # 39

Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.

Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled. The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean ' s requirements.

The top management, in cooperation with Sean, assigned 10 more employees to the audit team. Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.

Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting

The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.

Based on the scenario above, answer the following question:

According to Scenario 7, one of the auditors requested permission from Sean to audit the department in which he worked on a daily basis. Should Sean grant the auditor permission?

A.

No, internal auditors should be independent of the processes being audited

B.

Yes, Sean should grant the auditor permission

C.

Yes, but Sean himself must be present in every audit activity

Question # 40

You are auditing an organisation that has been certificated to ISO 9001 for ten years. The organisation is a privately-owned, multi-site car tyre fitting

organisation. You are auditing one of the sites. You are auditing the car tyre fitting service. You are interviewing the Site Manager (SM).

You: " Would you explain the car tyre fitting service? "

SM: " Of course. Customers typically call us by phone with their requirements. We ask them what they want. We check whether we have the tyres

they need in stock. If we don ' t have the tyres in stock, we contact our supplier to confirm when they would be able to supply the tyres. We then

determine the cost. We then check what availability we have in our busy schedule to fit the new tyres. We then inform the customer with details of

cost and when we can fit the tyres. If the customer is happy to proceed with the booking, we update our Work Schedule. The same process applies

for customers who walk into our office and for online requests. "

You: " What information do you retain should there be a defect reported by a manufacturer of tyres that you have fitted? "

SM: " We maintain records of customer names, addresses and contact phone numbers. We maintain a record of the type of tyre fitted and the tyre

manufacturers batch information. We also maintain a record of the registration numbers of the vehicles we have fitted tyres to. All records are in our

Work Schedule. "

Which two of the following options you would take to enable you to gather further audit evidence to validate what the Site Manager

has told you?

A.

Interview a customer to determine how satisfied they are with the service.

B.

Interview a tyre fitter to determine how long they have worked for the organisation.

C.

Interview a tyre fitter to determine the type and batch of each tyre fitted to a car.

D.

Review the training record of the site manager.

E.

Review the Work Schedule dated three years ago and verify what information has been recorded.

F.

Review the Work Schedule for the past three weeks and verify what information has been recorded.

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