PECB QMS ISO 9001:2015 Lead Auditor Exam

You are conducting a Stage 1 audit at an organisation that services refrigeration equipment for a large customer base.

The scope of certification is "Provision of refrigeration equipment maintenance and repair services". You are interviewing

the Managing Director to learn more about the organisation and to explore how the requirements for policy, objectives,

and risks and opportunities in ISO 9001 are addressed.

The Managing Director explains that they only use sub-contract refrigeration engineers and do not have any full-time

refrigeration engineers, which helps to optimise overhead costs. The full-time staff employed are essentially a small team

of office staff who process customer enquiries, schedule jobs and process invoices.

The Managing Director adds that the ISO 9001 requirements for competence of personnel extends to both sub-contract

and full-time staff. He also states that the full-time staff are aware of the Quality Policy, objectives and plans to address

risk and opportunities.

You ask if the sub-contract engineers have been informed of the Quality Policy, objectives and plans to address risks and

opportunities, to which the Managing Director replies that this is not applicable as they only use sub-contractors who

operate ISO 9001 certificated quality management systems. The documented information provided to the auditor

confirms this.

Which clause in ISO 9001 is most likely not to have been fulfilled in this instance?

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Which one of the following is not an ISO 9000:2015 quality management principle?

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You have been just hired as the Internal Lead Auditor of a large organisation, responsible for internal audits. Your first job is to analyse the answers to nonconformities included in the report of a recent internal audit to Top Management.

The report contained one nonconformity as follows:

There is no evidence of Top Management ensuring the availability of resources to operate the QMS, the establishment of objectives, the promotion of continual improvement, and the promoting of the process approach.

Which four of the following Top Management actions can be considered 'corrections to the nonconformity'?

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TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important

customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit

team discussed and agreed both nonconformities with TIX's quality manager. The Closing meeting was planned for 6pm with the general manager,

quality manager and service manager at the meeting room.

At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the

warehouse supervisor. Neither have participated in the audit.

The dialogue among them is as follows:

Audit team leader: "Good evening, could you please inform the three managers that we are ready to start with the Closing meeting?"

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 the emergency."

Warehouse supervisor: "They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message

from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed."

Which one of the following options would be your preferred response to the final comment made by the warehouse manager?

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A Health Trust has contracted with Servitup, a catering services organisation that has been certified to ISO 9001 for one year. It provides services to

10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals, and loading heated

trolleys for Ward Service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager

(DCM).

DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff."

You: "I see. It really shouldn't affect the QMS so the audit can progress as normal."

DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is."

You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?"

DCM: "Give me a minute. I need to look at the Quality Policy on the noticeboard in his office."

As the audit progresses, it is clear that the DCM has a very low knowledge of the QMS. He continually has to look up the answers to your questions

or ask staff members about their processes. You decide to raise a nonconformity.

Select one of the following options that best describes the nonconformity.

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