ISO-9001-Lead-Auditor Practice Exam Questions and Answers

You are conducting a third-party audit to ISO 9001 and interviewing the Training Manager. She explains that training is more

important than ever because the organisation has had to reduce the number of staff employed. Many of the remaining staff

are now required to be 'multi-skilled'. You ask to see plans for the multi-skilling training and are shown plans that look

comprehensive, and include both 'on the job" training and internal and external training courses.

The records indicate that several staff required parts of their training to be repeated one month after the first training was

provided. You ask why this was needed and are told that an investigation of customer complaints identified that several staff

members did not complete certain tasks in the correct manner. The extra training was therefore recommended as a

corrective action.

Based on this interview, which two of the tollowing audit trails would be the most appropriate to follow?

Select the two most appropriate audit trails from the following.

Which quality management principle does an organization fulfill when it assesses risks, consequences, and impacts before taking action?

How much time is usually spent on the Stage 1 audit?

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."

This scenario presents a number of audit trails to different ISO 9001 requirements.

Which three of the following requirements would be relevant audit trails for this scenario?

Which of the following three options could be considered potential threats to impartiality in an audit context?

ABC is a fast food shop that receives orders by phone or the internet. The normal menu includes 15 different types of hamburgers; however, in the

last two days, due to a shortage of a special type of meat, they can only prepare six of the 15 varieties.

You are performing a third-party audit of ABC; you observed that the menu offering food on the website is still the normal one, with 15 different

hamburgers. During a 30-minute period, you observed several customers reluctantly accepting other than the hamburger they preferred. You decided

to raise the following nonconformity as follows:

"There is evidence that ABC has not reviewed the ability to provide customers the offered products".

The restaurant manager does not accept the nonconformity. She says that ABC had an extensive training programme for all personnel, which you have already seen when auditing Human Resources. This shortage of some hamburgers cannot be considered a management system failure.

Which one would be your answer from the following options?

What are the criteria for reviewing documented information?

A Health Trust has contracted with Servitup, a catering services company 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.

You find that two internal audits have been carried out in the first year by the Catering Manager. One of

them indicates that complaints from patients are increasing in number, mainly due to food being served

too cold. The DCM comments that the trolley thermometer is often unreliable.

Which two of the following actions would be "correction" in dealing with the complaints?

Select one of the options that best describes the purpose of conducting a document review:

ISO 9001 requires that the organisation shall continually improve the quality management system.

Select the two options for how this can best be achieved.