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?

Which of the following subjects should an auditor discuss when communicating with the auditee’s top management?

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.