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Question #41

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers regulatory consultancy services to manufacturers of cosmetics. The business operates from ten regional offices.

You are nearing the end of the audit and need to decide if sufficient evidence of top management leadership and commitment with respect to the quality management system has been gathered.

Which four of the following would demonstrate top management leadership and commitment with respect to the quality management system?

A . Approving company car budgets for the fiscal year
B . Briefing staff on the development of an improvement culture
C . Chairing management review meetings
D . Conducting staff disciplinary meetings
E . Investing time and money in corrective actions arising from nonconformities
F . Not attending audit closing meeting
G . Promoting the importance of following procedures

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Question #42

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 #43

The Closing meeting of a second-party audit was planned for 6 pm with the general manager and the quality manager.

At 6 pm, when the audit team enters the meeting room, only the Quality Manager is present and walting for them.

The dialogue among them is as follows:

Auditor team leader: "Good evening, could you please inform the general manager that we are ready to start with the closing meeting?"

Quality manager: "Good evening. I am sorry to inform you that the general manager will not be able to attend the meeting. He will try to participate virtually to make some closing remarks."

Auditor team leader: "OK. We identified seven nonconformities – these are the reports. Could you please review them and sign them?"

Quality manager: "OK. As you know, I reviewed them after yesterday’s meeting and accept of all them, where shall I sign?"

General manager (from speakers in the room and addressing the quality manager): "Hold on! Do not sign the two nonconformities related to ABC

Bank! I have just checked, and we did not provide any services to ABC Bank during September! You can sign the remaining five nonconformities."

How would you proceed with the audit? Select one.

A . I will discuss this issue with our corporate quality manager and will let you know what we will do
B . I will include the seven nonconformities in the report, considering that we identified objective evidence on which all these nonconformities are based
C . I will review this issue at length with the audit team tonight and will phone you tomorrow to let you know our decision
D . I withdraw the two nonconformities related to service to ABC and will present the report with the remaining five nonconformities

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Question #44

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.

A . Settle the court case by negotiation with the customer.
B . Report the situation to the customer with suggested remedial action.
C . Make an offer to replace the coat with a new one.
D . Give an explanation to the customer of what went wrong.

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Richtige Antwort: B
B

Explanation:

According to the ISO 9001:2015 standard, clause 10.2 requires organizations to review nonconformities, including any arising from customer complaints, and to take appropriate actions to determine the cause, implement corrections and preventive actions, and verify their effectiveness. The organization must also monitor the effectiveness of the actions taken and make changes if necessary.

In this scenario, the auditee is facing a legal dispute with a customer over damage to an expensive cashmere coat. This is a nonconformity that arises from customer complaint and has a significant impact on customer satisfaction and reputation. Therefore, clause 10.2 applies to this situation. The best option for how this should be handled by the Quality Management System is B.

B means that the organization should report the situation to the customer with suggested remedial action. This option follows the principle of transparency and accountability, as well as respecting the customer’s rights and expectations. The organization should also investigate the root cause of the damage and prevent it from happening again in other shops or products.

The other options are not appropriate because:

A means that the organization should settle the court case by negotiation with the customer. This option may not be feasible or satisfactory for both parties, especially if there is a large amount of compensation involved or if there are legal implications for other customers.

C means that the organization should make an offer to replace the coat with a new one. This option may not be sufficient or acceptable for both parties, especially if there is evidence of negligence or

poor quality on behalf of the organization.

D means that the organization should give an explanation to the customer of what went wrong. This option may not be enough or convincing for both parties, especially if there is no evidence of negligence or poor quality on behalf of the organization.

Question #45

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 . Reviews the processes with high level of risk
C . Verifies the degrees of customer satisfaction
D . Evaluates the conditions of all sites
E . Evaluates the results of the last management review
F . Reviews the client’s management system documented information
G . Verifies the compliance with legal requirements

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Question #46

DRAG DROP

You are conducting 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

You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.

You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

To complete the table click on the blank section you want to complete so it is highlighted in red and then click on the ISO 9001 Clause 8.3 extracts listed below. Alternatively, drag and drop each clause to the audit evidence that applies.

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Question #47

DRAG DROP

In the context of a management system audit, identify the sequence of a typical process for collecting and verifying information. The first one has been done for you.

To complete the sequence 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.

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Richtige Antwort:

Explanation:

Identifying the source of information

Sampling available data

Gathering audit evidence

Verifying objective evidence

Evaluating evidence against the audit criteria

Making audit conclusions

Evaluating against the audit criteria

According to ISO 19011:2018, clause 6.4, the process of collecting and verifying information during an audit involves the following steps1:

Identifying the source of information: The audit team should identify the sources of information that are relevant to the audit objectives, scope and criteria. These sources may include documents, records, personnel, processes, activities, facilities, equipment, etc. The audit team should also determine the methods and tools for accessing and collecting the information, such as interviews, observations, document review, sampling, etc. Sampling available data: The audit team should select a representative sample of the available data to verify the conformity and effectiveness of the management system. The sample size and selection method should be based on the audit objectives, scope and criteria, as well as the level of confidence and risk. The audit team should also consider the validity, reliability, relevance and sufficiency of the data.

Gathering audit evidence: The audit team should use the methods and tools identified in the previous step to collect audit evidence, which is the records, statements of fact or other information that are relevant to the audit criteria and verifiable. The audit team should record the audit evidence in a clear, concise and objective manner, using notes, checklists, photographs, audio or video recordings, etc.

Verifying objective evidence: The audit team should verify the accuracy, completeness and authenticity of the audit evidence collected. This may involve cross-checking different sources of information, confirming the identity and authority of the persons providing the information, examining the original documents or records, etc. The audit team should also identify any discrepancies, inconsistencies or gaps in the audit evidence.

Evaluating evidence against the audit criteria: The audit team should compare the audit evidence with the audit criteria to determine the extent of conformity and nonconformity. The audit team should also identify any opportunities for improvement, best practices, positive aspects or potential risks. The audit team should use professional judgement and apply the principles of auditing when evaluating the audit evidence.

Making audit conclusions: The audit team should consolidate the audit findings and evaluate the overall performance and effectiveness of the management system. The audit team should also consider the audit objectives, scope and criteria, as well as the context and expectations of the auditee and other interested parties. The audit team should provide a clear, concise and objective statement of the audit conclusions, which may include the degree of conformity, the achievement of the intended outcomes, the need for corrective actions, the suitability for certification, etc. Evaluating against the audit criteria: The audit team should review the audit conclusions and ensure that they are consistent with the audit criteria and supported by sufficient and appropriate audit evidence. The audit team should also ensure that the audit conclusions are communicated to the auditee and other relevant parties in a timely and effective manner, using the agreed audit report format and distribution method.

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

Question #48

XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management. The Quality Manager complains that this has created a lot of resistance

to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.

How would you respond with the following options? Select three.

A . Suggest asking the certification body for guidance on this matter.
B . Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organisation’s requirements.
C . Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly.
D . Inform the Quality Manager that you will comment on the subject in your audit report.
E . Indicate that ISO 9001 requires a minimum of two quality objectives.
F . Suggest that all employees undertake a training course on ISO 9001.
G . Advise the Quality Manager that, as an auditor, you cannot provide advice to the organisation on how it should operate its QMS.
H . Suggest that the Quality Manager obtains external consultancy on the use of quality objectives.

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Richtige Antwort: BCD
BCD

Explanation:

According to the ISO 9001:2015 standard, clause 6.2.1 requires organizations to establish quality objectives at relevant functions, levels, and processes needed for the quality management system. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The quality objectives must also be measurable, monitored, communicated, and updated as appropriate.

In this scenario, the Quality Manager of XYZ Corporation has set quality objectives for every employee in the organization except top management. This has created a lot of resistance to the QMS, and the Chief Executive is asking questions about the cost and the method of setting objectives. The Quality Manager asks for your opinion as an auditor on whether this is the correct method of setting objectives.

As an auditor, you cannot provide advice to the organization on how it should operate its QMS. Your role is to assess the conformity and effectiveness of the QMS against the requirements of the standard and the organization’s own policies and objectives. Therefore, you should respond with the following options:

B. Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organization’s requirements: You can suggest that the Quality Manager should familiarize himself with the requirements of clause 6.2.1 and understand how they apply to his organization. He should also consider the context and the needs and expectations of interested parties when setting quality objectives. He should ensure that the quality objectives are aligned with the quality policy and the strategic direction of the organization.

C. Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly: You can inform the Quality Manager that you will evaluate the quality objectives during the audit and check whether they meet the requirements of clause 6.2.1. If you find any gaps or weaknesses in the quality objectives, you will raise an opportunity for improvement to help the organization improve its QMS. You will also verify whether the quality objectives are monitored, communicated, and updated as appropriate.

D. Inform the Quality Manager that you will comment on the subject in your audit report: You can inform the Quality Manager that you will document your findings and observations on the quality objectives in your audit report. You will also provide a summary of the audit results and any recommendations for improvement. You will also indicate the level of conformity and effectiveness of the QMS.

These three options would help you to maintain your impartiality and professionalism as an auditor and to provide constructive feedback to the organization

Question #49

DRAG DROP

Match the process descriptions below to the process names:

To complete the table 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 you may drag and drop each of the following process names to the descriptions:

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Question #50

You work for an organisation, ‚ABC‘, which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit an external provider, ‚XYZ‘, which provides packaging materials to your organisation. It is 4 pm, and the audit is dlose to an end;

you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled for 5 pm.

‚XYZ‘ has two manufacturing lines: M1 is a clean room for primary packaging materials (i.e. will be in direct contact with the food), and M2 is for secondary materials (i.e. will not be in direct contact with food).

Auditor 1 audited the two manufacturing lines.

You: "What findings would you report?"

Auditor 1: "I have one issue. Earlier today in the morning I saw some secondary material stocked in

the clean room. I would propose raising a

nonconformity."

You: "How would you write the nonconformity?"

Auditor 1: "In the clean room, there was a pallet with secondary materials."

What additional information would you add to this text to complete the nonconformity report? Select six.

A . Batch number of the secondary material
B . Description of any primary material close to this pallet
C . Description of the ISO 9001:2015 requirement not being complied with and the clause number
D . Description of the secondary material
E . Evidence that the secondary material was approved ready to be used
F . More information in the place within the clean room where secondary material was found
G . Name of the forklift driver that was moving the pallet
H . The date on which the evidence was identified
I . The signature of the clean room’s supervisor accepting the nonconformity
J . The type of nonconformity (major or minor)

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