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?

A small cleaning services organisation is about to start work on a hospital cleaning contract for the local Health Trust. You,

as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract

requires that a cleaning plan is produced.

You: " How was the cleaning plan for the contract developed? "

Service Manager: " We have a basic template that covers the materials, labour requirements and cleaning methods to be

employed. Some of that is specified by the customer. "

You: " How does the plan deal with locations like the intensive care wards and the operating theatres, which are included

in the contract? "

Service Manager: " The basic plan covers general wards, but we will do more frequent cleaning in those areas if the

hospital requests it. "

You: " Are you aware of the regulatory requirements for cleaning standards in hospitals? "

Service Manager: " No. We depend on the hospital to look after that side of things in the contract. "

You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001.

You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the

cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was

substituted to that specified in the contract. At the follow-up audit, the corrective action proposed was to

" obtain a concession from the Health Trust for use of the new chemical. "

Which one of the following options is the reason why you did not accept this action taken?

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.