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Viewing questions 71-80 out of questions

Questions # 71:

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.

Options:

Settle the court case by negotiation with the customer.

Report the situation to the customer with suggested remedial action.

Make an offer to replace the coat with a new one.

Give an explanation to the customer of what went wrong.

Answer

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.

Questions # 72:

An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:

"The reject rate of the finished product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%."

As the third-party auditor reviewing the internal audit process, you come across the nonconformity. For corrective action, the Quality Manager conducted an investigation into the reject rates. He reported that the collection baskets for products ejecting from the moulding machines were not large enough. About 6% of products fell onto the wet and dirty factory floor. Management stated that replacing the baskets was too costly and ordered the Maintenance Manager to ensure that the floor was kept clean and dry to prevent rejects. The auditor later checked the factory floor, which was wet and dirty in places.

From the following nonconformities, select three that the auditor could raise to ISO 9001.

Options:

10.3 - The organisation did not continuously improve. Reject rates were unchanged.

7.1.4 - The factory environment is not suitably maintained to prevent dirty products.

7.1.1 - The organisation failed to provide the required resources to prevent nonconforming products.

9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3).

8.6 - Dirty products were released to the customer.

7.3 - Staff were not aware that products were falling onto the factory floor.

10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity.

Answer

A, B, C

Explanation

The auditor could raise the following nonconformities to ISO 9001 based on the scenario:

•Option A: 10.3 - The organisation did not continuously improve. Reject rates were unchanged. This option is correct because ISO 9001:2015 clause 10.3 requires the organization to improve the suitability, adequacy and effectiveness of the quality management system. The organization did not demonstrate any improvement in reducing the reject rate of the finished product, which was a stated objective of top management. The corrective action taken by the organization was not effective in addressing the root cause of the problem and preventing its recurrence.

•Option B: 7.1.4 - The factory environment is not suitably maintained to prevent dirty products. This option is correct because ISO 9001:2015 clause 7.1.4 requires the organization to determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. The organization did not ensure that the factory floor was clean and dry, which affected the quality of the products and increased the risk of nonconformity.

•Option C: 7.1.1 - The organization failed to provide the required resources to prevent nonconforming products. This option is correct because ISO 9001:2015 clause 7.1.1 requires the organization to determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. The organization did not provide adequate collection baskets for the products ejecting from the moulding machines, which resulted in products falling onto the factory floor and becoming nonconforming.

The following options are not correct:

•Option D: 9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3). This option is not correct because ISO 9001:2015 clause 9.2.2 does not specify the requirements for the wording of nonconformities in internal audit reports. The nonconformity (NC 3) stated by the internal auditor was clear and relevant to the audit criteria and audit evidence. The issue is not with the report, but with the corrective action taken by the organization.

•Option E: 8.6 - Dirty products were released to the customer. This option is not correct because ISO 9001:2015 clause 8.6 requires the organization to implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. The scenario does not indicate that the dirty products were released to the customer, but that they were recalled and repaired then returned to the customers. The issue is not with the release, but with the production process and the environment.

•Option F: 7.3 - Staff were not aware that products were falling onto the factory floor. This option is not correct because ISO 9001:2015 clause 7.3 requires the organization to ensure that the persons doing work under its control are aware of the quality policy, relevant quality objectives, their contribution to the effectiveness of the quality management system, and the implications of not conforming with the quality management system requirements. The scenario does not indicate that the staff were not aware of these aspects, but that the management did not provide adequate resources and environment for the staff to perform their work. The issue is not with the awareness, but with the management responsibility and resource provision.

•Option G: 10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity. This option is not correct because ISO 9001:2015 clause 10.2.1 requires the organization to react to the nonconformity and, as applicable, take action to control and correct it and deal with the consequences. The scenario indicates that the Quality Manager conducted an investigation into the reject rates and identified the cause of the nonconformity. The issue is not with the investigation, but with the corrective action taken by the management.

•Option H: 8.5.1 - Production operations were not properly controlled to avoid reject products. This option is not correct because ISO 9001:2015 clause 8.5.1 requires the organization to implement production and service provision under controlled conditions. The scenario indicates that the production operations were controlled by the moulding machines, which ejected the products into the collection baskets. The issue is not with the production operations, but with the size of the collection baskets and the condition of the factory floor.

[References:, •ISO 9001:2015 Quality management systems - Requirements, •ISO 9001 Lead Auditor Course Material, Module 6: Reporting Audit Findings, Slide 14: Writing Nonconformity Statements, •ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 6.2: Reporting Audit Findings, •Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies, , , ]

Questions # 73:

Which of the following is a principle of maintaining audit work documents?

Options:

Transparency

Fair presentation

Completeness

Questions # 74:

Select the phrase that best describes the purpose of a quality management system to ISO 9001 in relation to the performance of an organization.

Options:

Manages the performance

Monitors the performance

Dictates the performance

Improves the performance

Answer

Explanation

Understanding the Purpose of a Quality Management System (QMS):The primary objective of ISO 9001:2015 is to improve the overall performance of the organization by:

Ensuring consistent delivery of products and services that meet customer and regulatory requirements.

Focusing on enhancing customer satisfaction.

Promoting continual improvement of the organization’s processes and practices.

[Reference:Clause 0.1 (General) of ISO 9001:2015 specifies that a QMS enables organizations to achieve better performance by consistently meeting customer needs and improving their processes. It further highlights that continual improvement is a cornerstone of the standard (Clause 10.3)., Option Analysis:, A. Manages the performance:Incorrect. A QMS provides a framework to manage processes, not directly manage performance. The improvement of performance is an outcome of managing processes effectively., B. Monitors the performance:Incorrect. Monitoring is a component of performance evaluation (Clause 9.1) but does not define the overall purpose of the QMS., C. Dictates the performance:Incorrect. ISO 9001 does not "dictate" performance but allows organizations to set their own objectives and improve their operations based on their specific context and goals., D. Improves the performance:Correct. The fundamental purpose of a QMS as per ISO 9001 is continual improvement of the organization’s performance. This includes improving operational efficiency, customer satisfaction, and product/service quality., Why Option D is Correct:ISO 9001:2015 emphasizes the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking, which are designed to drive improvements in organizational performance. Continuous assessment of processes and customer feedback ensures that the organization can adapt, innovate, and improve its effectiveness over time., Relevant Clauses Supporting the Answer:, Clause 0.1: Purpose of the QMS., Clause 10.3: Continual improvement ensures that the QMS remains effective and aligned with organizational objectives., Clause 4.1: Context of the organization, which requires the QMS to align with organizational strategies and improve outcomes., , , ]

Questions # 75:

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.

Question # 75

Options:

Questions # 76:

An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against

section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:

"The reject rate of 'finished' product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%."

Just before the Closing meeting of a third-party audit, the audit team leader is invited to a meeting with the Quality Manager. He tells

the audit team leader that a member of the audit team was seen taking photographs of the factory on his phone during the day and

wants him suspended from the Closing meeting with any nonconformities raised by him rescinded. The issue of photographs was not

discussed during the opening meeting.

Select the three options for how the audit team leader might deal with this situation.

Options:

Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done

Advise the Quality Manager that the auditor will be reported to Head Office

Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting

Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office

Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered

State that the auditor will take no further part in the audit and all his photographs will be deleted

Answer

A, D, E

Explanation

This option reflects a balanced and professional approach. The audit team leader should first gather information directly from the involved auditor to understand the situation before making any decisions. It demonstrates due diligence and fairness.

This ensures that the situation is properly escalated and handled in accordance with the auditing body’s procedures. Consulting the audit programme manager helps ensure consistency in handling such incidents.

The nonconformity raised is based on objective evidence, independent of the incident with the photographs. ISO 9001 audits are evidence-based, and the validity of the findings should not be compromised by unrelated issues.

1. A. Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done:2. D. Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office:3. E. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered:

B. Advise the Quality Manager that the auditor will be reported to Head Office:

Reporting the auditor directly without first investigating the situation is premature and unprofessional. It might escalate the issue unnecessarily.

C. Apologize for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting:

Deleting evidence without proper consultation could be seen as tampering or unprofessional conduct. It’s essential to understand the context of the photographs first.

F. State that the auditor will take no further part in the audit and all his photographs will be deleted:

This is an extreme response without first investigating the situation. Taking unilateral action without gathering facts can damage the audit's integrity.

Why Not the Other Options:

Questions # 77:

An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001 certificate to cover the new contract.

During the audit, a team member finds that a number of print jobs have been rejected by several clients over a number of months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract. The auditor raises a nonconformance against clause 10.2.1.b of ISO 9001.

Which one of the evidence statements would support this finding?

Options:

There was no record that the organisation evaluated the effectiveness of the training given to new employees.

There was no evidence that a check of spelling took place before the release of printing to the client.

The actions taken to deal with customer complaints did not prevent recurrence of the problem.

The organisation did not provide the correct resources to prevent nonconformity.

Questions # 78:

manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001

certificate to cover the new contract.

Which one of the options is the correct response by the auditor?

Options:

Do you realise that this involves an extension to the scope of the audit and will require an application process?

How can we audit this area when we do not have an IT specialist in the team?

Would you like a separate certificate for the IT packages to show your new client?

Would you mind writing to my programme manager with this request?

Questions # 79:

Which one of the following documents addresses audit time calculation for third-party certification audits?

Options:

ISO 17021-1

ISO 19011

ISO 9000

ISO 9001

Questions # 80:

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.

You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.

Question # 80