ISO-9001-Lead-Auditor Practice Questions

ISO 9001 is based on quality management principles. Match each of the following quality management principles to the related activity.

Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.

A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.

In the closing meeting, which was held between the audit team and the top management of D

C.  

Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.

Based on the scenario above, answer the following question:

Why is it important to discuss the audit findings with DC’s top management prior to the closing meeting and the submission of the final audit report?

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."

Administration officer: "Our quality manager, before leaving, left a written message about 'NC2'. He declares that the

correction and corrective action have been already implemented and has attached some documents to the message as

evidence of these actions. Therefore, he expects that 'NC2' will not be included in the report."

Which one of the following would be your preferred answer to the Quallty Manager's request?

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements. The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.

You have just completed the opening meeting. You are interviewing the Managing Director (MD).

You: “Good morning. I would like to gain an understanding of your business and its strategic direction.”

MD: “Of course. We are facing challenging times. The market is extremely competitive, and customers typically look for the least expensive option when arranging health and safety training. Our annual sales revenue has struggled to grow over the past two years. Most of our employed trainers are planning to retire over the next 12 months, and we are looking for more subcontract trainers. Achieving ISO 9001 certification will, I hope, give us the capability to improve our operational performance. Also, many of our competitors do not have any form of management system certification, so I hope it will give us that competitive edge needed to secure orders. We intend to promote our ISO 9001 certification on our website and across all other customer-facing media.”

Which three of the following audit trails would you take to explore the extent to which external and internal issues have been determined and used to enable the business to achieve the intended result(s) of its quality management system?

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?

To complete the non-conformity report, click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

XYZ Corporation employs 100 people, and during a Stage 1 certification audit, certain issues are identified with the Quality Management System (QMS). Which two options describe the circumstances in which you could raise a nonconformity against Clause 6.2 of ISO 9001:2015?

Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.

A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.

In the closing meeting, which was held between the audit team and the top management of D

C.  

Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.

Based on the scenario above, answer the following question:

The audit team delayed audit activities until DC’s top management submitted their action plans. Is this acceptable?

An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer

manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001

certificate to cover the new contract.

Which one of the options is the correct response by the auditor?

Whistlekleen is a national dry cleaning and laundry organization with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that those are the oldest shops in the organization. The cleaning equipment needs replacing, but the organization cannot afford it now. Complaining customers are offered a financial incentive to close the complaint.

On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.

Select the one option which correctly describes the non-conformity to be raised against ISO 9001.