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Question # 4

Put the following steps of a third-party audit into the correct sequence in which they happen.

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Question # 5

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."

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Question # 6

Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.

A.

To facilitate auditing for proof of conformity to the standard.

B.

To provide confidence in the effectiveness of the quality management system.

C.

To safeguard the integrity of the quality management system.

D.

To support the operation of the processes of the quality management system.

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Question # 7

In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.

A.

Number of sites to be audited

B.

Risk to achieving audit objectives

C.

Expectations of the organisation's management

D.

Scope of the audit

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Question # 8

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

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Question # 9

Which two of the following are included in the objectives of the 'Stage 1 initial certification audit'?

A.

To evaluate the performance of monitoring and reviewing activities.

B.

To evaluate the preparedness of the organisation for a Stage 2 audit.

C.

To evaluate the internal audit and management review processes.

D.

To review the quality manual.

E.

To make a decision on certification to ISO 9001:2015.

F.

To evaluate the operational processes of the organisation.

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Question # 10

During a second-party audit of a dairy farm (by a potential customer) complying with ISO 9001:2015, the auditor verifies that there is large variability in the daily production of the milking yard. The current agreement with their only customer is to provide 2,000 litres per day. However, in the last two years, they have noticed an increasing variability in daily production.

If they produce less than 2,000 litres, they are penalised with a fine of 1.5 pesos for every litre that they do not provide. If they produce more than 2,000 litres, they use the extra milk to feed the pigs.

This process has been in operation for decades. The dairy farm was founded by the grandfather of the current owners, who did not want to alter the established practices.

The auditor raises a nonconformity on the basis that the process is not under control (Clause 8.1).

If you had been the auditor, which one of the following actions would you have accepted?

A.

Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement with a second customer.

B.

Apply the existing process of addressing the risks and opportunities of milk production.

C.

Retain the current contract and try to sell the occasional surplus milk to a second customer.

D.

Analyse the daily dispatch of milk for 7 days to determine its variability.

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Question # 11

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.

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Question # 12

You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.

You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.

You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?"

TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry."

You: "How is their regulatory competence maintained?"

TD: "They are dedicated individuals with lots of contacts in the sector."

You: "How does the business enable them to maintain their understanding of current regulatory requirements?"

TD: "We leave that up to them."

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Question # 13

You are conducting a third-party Stage 1 audit at ABC Ltd, a single-site organisation that manufactures wooden furniture. You interview the Technical Director to learn more about the organisation. The Technical Director explains that they have had a successful year and that obtaining ISO 9001 certification will support the further growth of the business. You ask for an overview of the organisation's structure and its interrelationships with external interested parties.

The Technical Director shows you a document detailing all business processes and interrelationships. You notice in this document that another organisation called Teak Ltd manufactures wooden furniture on behalf of ABC Ltd. The Technical Director confirms this capability has been accounted for in the scope of the quality management system. You learn that the furniture manufactured by Teak Ltd has accounted for 40% of the sales revenue over the previous 12 months.

Which two of the following options best describe how you would plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd?

A.

Verify Teak Ltd supply arrangements as described in the ABC Ltd quality management system

B.

Verify if Teak Ltd are certified to ISO 9001

C.

Verify the controls concerning customer property implemented by Teak Ltd

D.

Verify how ABC Ltd evaluates the performance of Teak Ltd

E.

Verify the quality management system at Teak Ltd by conducting an audit at their site

F.

Verify whether the design processes of Teak Ltd comply with ISO 9001

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Question # 14

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

A.

Suitability

B.

Adaptability

C.

Effectiveness

D.

Responsiveness

E.

Efficiency

F.

Applicability

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Question # 15

You have been nominated audit team leader of a third-party audit. Which of the following could be the two most relevant objectives of this audit?

A.

Evaluate the satisfaction interested parties

B.

Evaluate the effectiveness of the management system

C.

Identify the need of resources

D.

Evaluate the capability of the management system to establish and achieve objectives

E.

Identify opportunities for improvement

F.

Evaluate the benefits obtained since the implementation of the management system

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Question # 16

Match the process descriptions below to the process names:

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Question # 17

Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?

A.

During the Stage 1 audit, the audit team:

B.

Verifies the degrees of customer satisfaction

C.

Evaluates the conditions of all sites

D.

Reviews the client's management system documented information

E.

Evaluates the results of the last management review

F.

Verifies the compliance with legal requirements

G.

Reviews the processes with high level of risk

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Question # 18

Select six tasks you would expect to be completed at the audit team meeting of a third-party audit team leader and his audit team in preparation for a Closing meeting for a four-day initial certification audit.

A.

Audit team leader informs the individual(s) managing the audit programme that the closing meeting is ready to be held.

B.

Hold daily audit team meeting to review any timetable issues and potential findings and their impact on the audit for other team members.

C.

Final audit team meeting to agree findings and categories including clarification of any uncertainties.

D.

Agree the roles of each audit team member for the closing meeting.

E.

Audit team review any points raised by the auditee nominated representative.

F.

Audit team agree final audit outcome recommendation.

G.

Audit team leader completes final report, including individual findings and certification recommendation.

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