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

During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at

a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance

expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.

You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?"

GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal

requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon,

shortage of chemicals for the analysis. It was quite a good experience."

You: "Did you document these issues?"

GM: "No. Jack said that ISO 9001 does not require us to document these issues."

You: "How did you determine the risks associated with the issues and did you plan actions to address them?"

GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence."

Select two options for how you would respond to the General Manager's suggestion:

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?

In the context of a second-party audit, match the activity with the party responsible for conducting it.

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The

organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product

packaging. Sales turnover has increased significantly over the past five years. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.

You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:

You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is

responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).

You: "Good afternoon."

OD: "Good afternoon."

You: "What responsibility do you have concerning the SWIFT database?"

OD: "I maintain it. If anyone wishes to propose an update to the database, they send me an email with

details of their proposal. I then either process the database update myself, or I send the request to the

consultant who designed the database 20 years ago. The necessary software changes are made, and the

amended software is immediately released to users."

You: "Would you explain how the software amendments are controlled?"

OD: "Of course. I personally update every computer myself."

You: "Do you inform the database users of the changes?"

OD: "No I don't. They find out for themselves by using the software, or they come to see me if they have

any questions."

You: "How do you ensure that the database users use the latest version?"

OD: "That's easy, I update every computer myself."

You: "During the audit, I noted there were several versions of SWIFT in use (you refer to your audit

notes)."

OD: "I know. That's because some versions work better than others, and depending on user needs and

experiences, we allow users to revert to using an earlier version if they find it works better for them."

Based on the scenario, which two of the following statements are true? There is evidence of

nonconformity with a requirement defined in ...

During an internal audit, it was discovered that the calibration of a spectrometer used daily for production had expired, causing a nonconformance under Clause 7.1.5.2 of ISO 9001:2015. The root cause was the organization not considering the risk of the calibration provider leaving the country.

Which corrective action is the best one?

Whistlekleen is a national dry cleaning and laundry company 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 these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn

that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.

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.

When reviewing the customer complaint file, you find that the organisation is facing a legal dispute with a customer over damage to an expensive cashmere coat.

Select the best option for how this should be handled by the Quality Management System.

Match each of the following statements into the table below to show whether they apply to first-party audits, second-party audits or third-party audits:

You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing

structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the

adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.

You: "How do you tell when the billet is ready for the rolling stage?"

Operator: "I've done this job for 20 years. I can tell by the bright red colour."

You: "What happens if the colour is wrong?"

Operator: "The billet goes back into the furnace."

You: "Is the pyrometer ever used?"

Operator: "Only in borderline cases."

You continue to interview the operator and find that around 25% of the billets are sent back to the furnace. This includes 80% of the borderline cases.

Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.

A small deaning services organisation is about to start work on a hospital dleaning 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 are carrying out an annual audit at an organisation that has been certificated to ISO 9001 for two years. The organisation offers home security

services. The scope of the quality management system covers alarm installation, alarm servicing, alarm monitoring and response. The business

operates from a single office and employs subcontract installers and service technicians across the country.

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

You: "I would like to gain an understanding of how the quality management system has been supporting your business and its strategic direction."

MD: "We are continuing to face difficult times. The market is extremely competitive, and customers typically look for the least expensive option when

choosing home security services. We have not yet seen any business benefit from our quality management system."

You: "Tell me how you determine external and internal issues."

MD: "We use SWOT analysis (Strengths Weaknesses, Opportunities, Threats)."

You: "How have the outputs from your SWOT been used?"

Select two of the following audit trails would you take to explore the extent to which the SWOT analysis and the outputs from this

have been used to enable the business to achieve the intended results(s) of its quality management system according to ISO 9001.