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

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Question # 57

Will the auditee be subject to an audit follow-up if a minor nonconformity has been reported by the audit team leader in the audit conclusions?

A.

No, the auditee will be subject to an audit follow-up only if a major nonconformity is detected

B.

Yes, there should be an audit follow-up regardless of the type of nonconformities that are detected during the audit

C.

No, the audit team should suggest a recommendation only, in which it suggests an adequate corrective action for the nonconformity

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Question # 58

Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

A.

Consistently provide products that meet customers' requirements

B.

Decreased number of management system nonconformities

C.

Decreased number of warranty claims

D.

Decreased number of nonconforming products in all stages of the manufacturing cycle

E.

Enhanced customer satisfaction

F.

Increased profits

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Question # 59

You work for organisation A. You are asked to lead an internal audit of A's quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.

Which of the following actions would you consider appropriate when planning the internal audit of A's quality management system?

A.

Visit Plant A2 to interview personnel of company B

B.

Visit Plant A2 to interview B's quality manager

C.

Visit Plant A2 to interview A's security personnel and B's maintenance department

D.

Interview the A2 plant manager, now working in Plant A1

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Question # 60

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?"

The auditor asks to speak to the purchasing manager about the selection of the subcontractor to

manufacture the company's own brand products.

You: "How did you choose a supplier to manufacture your products?"

Auditee: "We have had a long-term relationship with a supplier ABC Ltd - we gave them our design

drawings, got them to complete a supplier questionnaire and run a couple of trial batches for us. We were

happy with the result and we have used them ever since."

ISO 9001:2015, clause 8.4.1 outlines situations when controls need to be applied to externally provided processes, products and services. Which one of the following situations is applicable to this scenario?

A.

Products and services for which the customer(s) supplies materials

B.

A process or part of a process is provided by an external provider as a result of a decision by the organisation.

C.

Products and services are provided directly to the customer(s) by external providers on behalf of the organisation.

D.

Raw materials from external providers are intended for incorporation into the organisation's own products.

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Question # 61

Put the following steps of a third-party audit into the correct sequence in which they happen.

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Question # 62

At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only

two people are present and waiting for them: the Health and Safety supervisor and the Administrative Officer.

Neither has participated in the audit. However, the team had previously agreed with the auditee Quality

Manager on two nonconformities identified during the audit (NC1 and NC2).

They said:

Health and Safety Supervisor: "Good evening. We are sorry to inform you that the general manager was

involved in a serious car accident, and the other two managers have had to leave urgently to attend to the

emergency."

The Administration Officer: "Concerning 'nonconformity 2', the General Manager left a message asking us

to tell you that he does not accept it and requests you not to include it in the audit report. Here is a note in

which he explains why."

Which one of the following would be your preferred answer (as team leader) to the General

Manager's request?

A.

OK. I will get in contact with my company tomorrow to ask for instructions on what to do with

this non-conformity.

B.

OK. Please, let me review the message. I will try to see if I can change the text of the

nonconformity if necessary. Let's take a 10-minute break, as I would like to discuss this issue with

the audit team.

C.

Please tell him that I will phone him in two days and will discuss the issue. Could you please give

me his mobile phone number?

D.

Please tell him that this nonconformity has been previously accepted by the quality manager

during the audit and will stand. I will include it in the report, along with the concern of the

General Manager about it.

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Question # 63

The certification body has not been able to verify the implementation of corrective actions for any identified major nonconformity within six months after the last day of the Stage 2 audit. What must the certification body do in this case?

A.

It must issue an unfavorable recommendation of certification

B.

It must conduct all audit activities from the beginning

C.

It must conduct another Stage 2 audit before granting certification

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