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

Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit

of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.

The auditor samples the design records for a recently completed course for the 247 Insurance organisation. Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage

was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.

The auditor raises a nonconformity against ISO 9001. Which one of the following options is the basis for the nonconformity?

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.

Based on the last paragraph of scenario 3, which audit principle did the audit team follow?

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.