ABC is a worldwide fast-food organisation. One of the branches, in downtown Cape Town, decided to implement an ISO 9001 quality management system and you are the audit team leader (with two other auditors) that will carry out the certification audits, Stage 2.

ABC receive the orders by phone or internet; some of the employees deliver the ordered food to indicated

addresses. The normal menu includes 15 different types of hamburgers; however, in the last two weeks,

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

During the internal meeting of the audit team, you ask one of the auditors to describe what she has observed. She audited the reception of orders from customers (via phone or internet) and the communication of the orders to the kitchen. She noticed that the menu offering food on the website is still the normal one, with 15 different hamburgers, and during a 30-minute period, she observed many customers reluctantly accepting something other than the hamburger they preferred.

You, as audit team leader, inform the Quality Manager of your concern about the major nonconformity, since you consider this a serious breach of the basic principles of quality that lasted two weeks without action being taken.

Right at the beginning of the Closing meeting, you discuss the nonconformity with the General Manager.

She got quite upset and said she was going to make a complaint to the certification body and left the room; the Quality Manager was the only member of ABC left with the audit team. The Quality Manager said the General Manager would not come back to the meeting.

What would you do? Choose the best from the following options:

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Which two of the following aspects of a quality management system must the organisation continually improve?

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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?

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DRAG DROP

You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM)

You: "Would you tell me about your management review process?"

QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained."

You: "May I see the records from the last two management reviews?"

Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.

The Quality Manager then gives you the previous management review record, which took place one year before the latest review.

You: "Are there any other review reports in the last two years?

QM: "No, these are the only ones."

You decide to raise a nonconformity.

To complete the nonconformity report click on the blank section you want to complete se 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.

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Richtige Antwort:

Explanation:

Nonconformity report

ISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at

the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 – “Top management shall review the organization’s quality management system at planned intervals.” Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.

The following actions need to be carried out during a third-party audit planning stage.

Which two actions correspond to the individual(s) managing the audit program before the involvement of the audit team leader?

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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. 80% of complaints originate from five shops in the same region. Most of these complaints relate to customer laundry not being cleaned as customers require. 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 now. You learn that the shop managers were told to dismiss most of the complaints because 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.

You raised a nonconformity against clause 8.5.1 of ISO 9001.

Based on the scenario, select the three options which best describe the evidence for raising such a nonconformity.

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Which two of the following should be included in an audit plan?

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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.

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DRAG DROP

The following are stages of an audit, put them in the order they would be conducted.

The first and last stages have been done for you

To complete the sequence click on the bank section you want to complete so it is highlighted in red and then click on the applicable text from the options below.

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Richtige Antwort:

Explanation:

Establishing the audit programme objectives

Determining and evaluating the audit programme risks and opportunities

Establishing the audit programme

Initiating the audit

Preparing all audit activity

Conducting the audit activities

According to ISO 19011:2018, clause 5, the audit programme is a set of one or more audits planned for a specific time frame and directed towards a specific purpose. The audit programme includes all activities necessary to plan, organize, and conduct the audits. The audit programme management involves the following steps1:

Establishing the audit programme objectives: The audit programme objectives define the intended outcomes of the audit programme, such as verifying conformity, evaluating performance, identifying improvement opportunities, etc. The audit programme objectives should be aligned with the strategic direction and policies of the organization and the needs and expectations of the interested parties.

Determining and evaluating the audit programme risks and opportunities: The audit programme

risks and opportunities are the factors that can affect the achievement of the audit programme objectives, such as changes in the internal or external context, availability of resources, competence of auditors, etc. The audit programme risks and opportunities should be identified, analyzed, and evaluated to determine the appropriate actions to address them.

Establishing the audit programme: The audit programme is established by defining the audit programme scope, criteria, methods, and resources. The audit programme scope defines the extent and boundaries of the audit programme, such as the processes, functions, sites, activities, etc. that will be audited. The audit programme criteria are the set of policies, procedures, or requirements used as a reference for the audits. The audit programme methods are the techniques used to conduct the audits, such as interviews, observations, document review, sampling, etc. The audit programme resources are the human, technical, and financial resources needed to implement the audit programme.

Initiating the audit: The audit initiation is the process of formally establishing the arrangements for an individual audit within the audit programme. The audit initiation involves contacting the auditee and the audit client, confirming the audit objectives, scope, and criteria, and obtaining the necessary information and access for the audit.

Preparing all audit activity: The audit preparation is the process of developing the audit plan and the audit work documents for an individual audit. The audit plan is a document that provides the basis for agreement regarding the conduct of the audit, such as the audit schedule, the audit team, the audit methods, the audit language, the audit report, etc. The audit work documents are the records that provide evidence of the audit activities, such as the audit checklist, the audit notes, the audit findings, etc.

Conducting the audit activities: The audit activities are the processes of collecting and verifying audit evidence and evaluating it against the audit criteria to make the audit conclusions. The audit activities include the opening meeting, the communication during the audit, the roles and responsibilities of the audit team and the auditee, the audit evidence collection and verification, the audit findings generation and recording, the closing meeting, and the audit report preparation and distribution.

Reference: ISO 19011:2018(en), Guidelines for auditing management systems

Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.

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