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New Release ISO-9001-Lead-Auditor ISO 9001 Questions

QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Question 21

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

manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members

of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging

time."

You: "I'm sure. 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. Match the ISO 9001 clauses to the steps.

To complete the table, click on the blank section you want to complete so it is highlighted in red and then

click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which step the

requirement applies to.

Options:

Question 22

Which action indicates that an organization is meeting the requirements of ISO 9001 regarding nonconforming outputs?

Options:

A.

Retaining documented information only on the actions taken.

B.

Verifying conformity to the applicable requirements prior to correction of the nonconforming outputs.

C.

Taking appropriate action to nonconforming products and services detected after the delivery of products, during or after the provision of services.

D.

Allowing employees to handle nonconformities based on their own judgment without structured procedures.

Question 23

Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.

Options:

A.

Audit use of certification marks on marketing materials.

B.

Review changes to the QMS since last visit.

C.

Confirm effectiveness of internal audit and management review.

D.

Complete a full document review of the quality management system.

E.

Failing to meet financial responsibilities.

F.

Review the status of previously raised findings and audit effectiveness of any outstanding findings.

G.

Review the calibration status of the instrumentation.

Question 24

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 statement related to the last paragraph of scenario 2 is correct?

Options:

A.

Customer surveys are the best method for obtaining and monitoring customer perceptions.

B.

Top management demonstrated leadership and commitment with respect to customer satisfaction.

C.

Customer surveys should be conducted every week to have a clear understanding of the needs and expectations of customers.

D.

Customer satisfaction is only measured through complaints, making surveys unnecessary.