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ISO-9001-Lead-Auditor Questions and Answers

Question # 6

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 # 7

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements. The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.

You are interviewing the Training Manager (TM).

You: "What quality objectives apply to the training process?"

TM: "One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses."

You: "How do you measure this objective?"

The Training Manager shows you a record on her computer and you see the following:

Which two of the following statements are true?

A.

You would check the training of personnel.

B.

You would determine how the exam pass rate figures were analysed.

C.

You would determine the relative difficulty of each training course by reviewing them.

D.

You would determine what corrective action was being taken to address the low pass rates.

E.

You would raise a nonconformity as a requirement in clause 10.2 has not been fulfilled.

F.

You would raise a nonconformity as a requirement in clause 8.7 has not been fulfilled.

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Question # 8

Scenario 4:

TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.

To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.

After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.

Anne reviewed the document and approved the audit mandate. The certification body and TD’s top management signed the certification agreement.

Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.

In scenario 4, the audit team determined the audit feasibility by considering only the resources available for the audit. Is this acceptable?

A.

No, the audit feasibility should be determined by TD’s top management.

B.

No, because other factors should be considered when determining the audit feasibility, such as information needed to plan the audit, the cooperation of the auditee, duration of the audit, etc.

C.

Yes, considering only the resources available for the audit is sufficient for determining the audit feasibility.

D.

Yes, because the audit team leader has final authority over audit feasibility.

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Question # 9

What should the auditor document during the Stage 1 audit?

A.

The main processes of the auditee

B.

The interviews with the auditee’s employees

C.

The observations that could result in nonconformities during the on-site audit

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Question # 10

Which statement regarding the drafting of the audit conclusions is correct?

A.

The audit conclusions must be drafted based on observation

B.

The audit conclusions must be based on evidence that is examined and evaluated in terms of quantity and quality

C.

The audit conclusions must not include the revisions that resulted from the closing meeting

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Question # 11

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."

This scenario presents a number of audit trails to different ISO 9001 requirements.

Which three of the following requirements would be relevant audit trails for this scenario?

A.

Organisational knowledge

B.

Control of externally provided processes, products, and services

C.

Design and development of products and services

D.

Documented information

E.

Measurement traceability

F.

Organisation roles and responsibilities

G.

Preservation of product

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Question # 12

An organisation wants to certify their ISO 9001:2015-based QMS for the first time. Arrange the activities in the correct sequence from 2 to 5.

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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Question # 13

When should the certification body accept the audit?

A.

After considering the integrity and reputation of the auditee.

B.

After considering the nature of the operations of the auditee.

C.

Both A and B.

D.

Only if the auditee has no previous major nonconformities.

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Question # 14

When monitoring customer perceptions, which analysis is helpful to use?

A.

PEST analysis

B.

Market-share analysis

C.

Gap analysis

D.

Competitive benchmarking

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Question # 15

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Pro’s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company’s working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

Which statement below represents the level of responsibility demonstrated by the audit team in scenario 3?

A.

No negligence, the audit team has demonstrated diligence during the audit and followed the best practices.

B.

Ordinary negligence, the audit team has demonstrated lack of diligence.

C.

Gross negligence, the audit team has demonstrated a total lack of diligence.

D.

Willful misconduct, the audit team intentionally disregarded audit procedures.

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Question # 16

XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented. 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.

Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?

A.

The consultant has not interpreted ISO 9001 correctly.

B.

Quality objectives were not established in alignment with the organisation's quality policy.

C.

Quality objectives are not maintained as documented information.

D.

Establishing quality objectives did not include top management.

E.

The organisation cannot afford to undertake quality objectives all at once.

F.

Quality objectives are not being implemented by the organisations' personnel.

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Question # 17

Which of the options below is an example of minor nonconformity?

A.

Some of the nonconformities were not closed as planned (on time) and no justification was provided or documented

B.

Lack of commitment from the top management

C.

Lack of corrective actions to address recurrent incidents

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Question # 18

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

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Question # 19

You are leading a Stage 2 certification audit of a multi-site organisation and have received the audit schedule below;

Head Office and Site 1 - Day 1

Site 2 (150 Km from HQ) - Days 2 and 3

During Day 1 of the audit, the dient informs you that the laboratory at Site 2 has been dosed for decontamination due to a serious outbreak of an infectious disease among workers. In Site 2, all other functions could be audited as planned.

As the audit team leader, what would you do?

Choose the best acceptable action you could take:

® Ask the audit Programme Manager for direction.

Complete the audit on day 3 and report back to the certification body for a certification decision.

Continue the audit on days 2 and 3 and return later to audit the Site 2 laboratory.

Immediately cancel the audit since the audit plan cannot be completed.

Who has the responsibility for assigning work to the audit team?

A.

The audit team leader

B.

The audit team member

C.

The auditee organisation

D.

The certification body

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Question # 20

Read the following role descriptions. Select two roles that are not directly involved in the audit process.

A.

An auditor-in-training - a person who accompanies the audit team leader or team members during the audit.

B.

A technical expert - a person who provides specific knowledge or expertise to the audit team but is not normally an auditor.

C.

An audit team leader - a person responsible for managing an audit until the audit is completed.

D.

An interpreter - a person who witnesses the audit to assist the auditors with language issues.

E.

An observer - a person who sees the performance of the audit team leader, audit team members and/or auditee.

F.

A guide - a person who is appointed by the auditee to assist the audit team during the audit.

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Question # 21

Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.

A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.

In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.

Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.

Based on the scenario above, answer the following question:

The audit team delayed audit activities until DC’s top management submitted their action plans. Is this acceptable?

A.

No, the audit report should be prepared and submitted to the certification body prior to the submission of action plans by the auditee

B.

Yes, the audit report can be prepared once the auditee submits the action plans in cases of minor nonconformities

C.

Yes, DC’s top management promised the submission of action plans within a short period of time

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Question # 22

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

A.

Concession

B.

Correction

C.

Corrective action

D.

Preventive action

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Question # 23

Who maintains ownership of the audit report?

A.

The audit team leader

B.

The auditee

C.

The certification body

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Question # 24

Which quality management principle does an organization fulfill when it assesses risks, consequences, and impacts before taking action?

A.

Process approach

B.

Leadership

C.

Improvement

D.

Relationship management

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Question # 25

In the context of a third-party audit, match the event with the responsibility for conducting it.

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Question # 26

Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.

A.

Requirements of ISO 9001

B.

ISO 19011 Audit principles

C.

Organisation's market sector

D.

Organisation's invoicing and profits of the last 5 years

E.

Organisation's processes

F.

Requirements of auditee's interested parties other than customers

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Question # 27

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 # 28

You are conducting a third-party audit to ISO 9001 and interviewing the Training Manager. She explains that training is more

important than ever because the organisation has had to reduce the number of staff employed. Many of the remaining staff

are now required to be 'multi-skilled'. You ask to see plans for the multi-skilling training and are shown plans that look

comprehensive, and include both 'on the job" training and internal and external training courses.

The records indicate that several staff required parts of their training to be repeated one month after the first training was

provided. You ask why this was needed and are told that an investigation of customer complaints identified that several staff

members did not complete certain tasks in the correct manner. The extra training was therefore recommended as a

corrective action.

Based on this interview, which two of the tollowing audit trails would be the most appropriate to follow?

Select the two most appropriate audit trails from the following.

A.

Ask if customer complaints had ceased since the multi-skilled training finished.

B.

Ask the members of staff whether they found the training received useful.

C.

Assess whether Quality objectives are being met.

D.

Determine whether customers were consulted about the risks associated with the multi-skilling training.

E.

Determine whether management has assessed the impact of staff reduction on the organisation's ability to meet its objectives.

F.

Review records to assess if all planned training has been completed.

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Question # 29

Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.

Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled. The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.

The top management, in cooperation with Sean, assigned 10 more employees to the audit team. Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.

Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting

The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.

Based on the scenario above, answer the following question:

Scenario 7 states that Sean planned audit activities on his own. Is this acceptable?

A.

No, audit activities should be planned by top management

B.

Yes, it is the responsibility of the audit team leader to plan audit activities

C.

No, the audit team leader should always cooperate with the other members of the team to plan audit activities

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Question # 30

Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).

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Question # 31

Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.

Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled. The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.

The top management, in cooperation with Sean, assigned 10 more employees to the audit team. Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.

Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting

The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.

Based on the scenario above, answer the following question:

According to Scenario 7, one of the auditors requested permission from Sean to audit the department in which he worked on a daily basis. Should Sean grant the auditor permission?

A.

No, internal auditors should be independent of the processes being audited

B.

Yes, Sean should grant the auditor permission

C.

Yes, but Sean himself must be present in every audit activity

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Question # 32

What is a combined audit?

A.

Two or more management systems audited together at a single auditee.

B.

Two or more auditing organizations cooperating to audit a single auditee.

C.

Two or more management systems audited simultaneously at several auditees.

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Question # 33

Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.

Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled. The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.

The top management, in cooperation with Sean, assigned 10 more employees to the audit team. Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.

Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting

The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.

Based on the scenario above, answer the following question:

Based on Scenario 7, the team worked together to draft the final audit report. Is this acceptable?

A.

Yes, audit team members should contribute to drafting one general report for the findings and conclusions

B.

No, audit team members should draft separate reports for their findings and conclusions

C.

No, it is the responsibility of the audit team leader to draft the audit report

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Question # 34

For a third-party, match the Activity with the Responsibility for conducting it.

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Question # 35

Match the process descriptions below to the process names:

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Question # 36

Scenario 5: Mechanical-Electro (ME) Audit Stages

Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.

Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.

In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.

A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.

Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.

Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME’s QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.

To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.

The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.

Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.

According to scenario 5, Li Na conducted group interviews with departmental managers and top management by herself. Is this in accordance with audit best practices?

A.

Yes, only the audit team leader should conduct group interviews.

B.

Yes, the auditee’s top management is always interviewed by the audit team leader only.

C.

No, two auditors should be present in case of group interviews.

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Question # 37

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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Question # 38

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’

A.

Prepare the audit plan

B.

Assign responsibilities within the audit team

C.

Prepare the checklists

D.

Provide the resources needed

E.

Review the reports of previous audits

F.

Select the audit team members

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Question # 39

What are the criteria for reviewing documented information?

A.

Content, format, and the procedure for managing documented information

B.

Language of documented information, internal audit reports, client feedback

C.

Archive, volume, and confidentiality of documented information

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Question # 40

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.

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Question # 41

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Pro’s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company’s working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

Based on the last paragraph of scenario 3, which audit principle did the audit team follow?

A.

Fair presentation.

B.

Integrity.

C.

Confidentiality.

D.

Objectivity.

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Question # 42

What type of audit evidence are policies and guidelines?

A.

Confirmative evidence.

B.

Technical evidence.

C.

Documentary evidence.

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Question # 43

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.

A.

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

B.

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

C.

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

D.

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

E.

8.6 - Dirty products were released to the customer.

F.

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

G.

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

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Question # 44

Which of the following is a record related to the audit program that should be managed and maintained?

A.

Objective audit evidence and findings

B.

Maintenance and improvement of competence

C.

Schedule of audits

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Question # 45

You are a member of the audit team of a second-party audit of an organisation with 625 employees. The audit procedure recommends using sampling criteria which requires the review of the documented competence for 25 personnel. The audit team leader developed an audit plan allocating one hour to audit the Human Resources department (from 11:30 am to 12:30 pm). She told you that she could not allocate any additional time.

What would you do?

A.

Extend the audit until 1.00pm and ask for a quick lunch later.

B.

Plan to review less than 25 cases.

C.

Plan to review as many as possible and see if you can extend the audit duration by one day.

D.

Plan to miss lunch and review as many as possible.

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Question # 46

Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.

A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.

In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.

Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.

Based on the scenario above, answer the following question:

According to Scenario 6, the audit team required DC’s top management to submit corrective action plans within two weeks. Is this action acceptable?

A.

No, because the deadline for the client to present a corrective action plan is at least within 7 days

B.

No, because the decision for the deadline should have been suggested by the top management

C.

Yes, because a deadline from 10 to 60 days is a best practice for the submission of action plans

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Question # 47

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 # 48

Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top-notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.

In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.

Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS. They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.

During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS. AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.

Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.

Based on the scenario above, answer the following question:

The CEO of AL-TAX hired an experienced consultant to help with the implementation of the QMS. Is this required from ISO 9001?

A.

Yes, especially for companies that do not have competent personnel.

B.

No, contracting external consultants is not required.

C.

Yes, external advice is necessary for an effective implementation.

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Question # 49

Scenario 5: Mechanical-Electro (ME) Audit Stages

Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.

Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.

In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.

A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.

Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.

Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME’s QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.

To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.

The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.

Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.

After reviewing the documented information, Li Na claimed that it was not necessary to report the minor nonconformities that were identified; instead, they would be discussed in the next audit phase. Is this acceptable?

A.

Yes, during the review of documented information, only major nonconformities need to be documented if detected.

B.

Yes, all identified nonconformities throughout the audit need to be documented and communicated at the end of the audit.

C.

No, identification of minor nonconformities or areas of concern that could become nonconformities need to be documented and communicated to the auditee before proceeding to the next audit phase.

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Question # 50

Which of the following is correct with regard to the internal audit?

A.

It considers only the effectiveness of the QMS

B.

It has no advisory role within the organization for the improvement of the QMS

C.

It may be conducted on an ongoing basis

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Question # 51

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?

A.

The substitute chemical has not been used before in the Health Trust.

B.

The action assumes that the Health Trust will agree to the change.

C.

Staff have not been trained in the use of the new chemical.

D.

The process for making changes to the contract has not been addressed.

E.

The substitute chemical may not be as effective as the original.

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Question # 52

An audit team leader arrives at a printing company 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. The Quality Manager wants the ISO 9001 certificate to cover the new contract.

During the audit, a team member found that some print jobs had been rejected by several clients over some 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 finds that the responsibility for checking spelling errors is placed on the printer that sets up the print run.

In line with the policy of the certification body, the audit team raise improvement opportunities in the audit report. Which

three of the following options would represent acceptable opportunities for improvement in the report?

A.

Operational planning activities may benefit from a clearer risk-based approach.

B.

The organisation needs to delay its certification to gain more experience of the QMS.

C.

The responsibility for checking printing needs to be independent of the operators.

D.

A business consultant can be recommended for advice on improving operations.

E.

A plan to determine why the errors occur and to prevent them.

F.

An intensive training plan that involves all production personnel.

G.

The recruitment process to include spelling tests to filter out unsuitable candidates.

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Question # 53

Scenario 5: Mechanical-Electro (ME) Audit Stages

Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.

Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.

In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.

A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.

Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.

Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME’s QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.

To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.

The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.

Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.

Li Na chose a sampling method that sufficiently represents customer complaints from both areas of ME’s operations. Which sampling method fits that description?

A.

Systematic sampling

B.

Stratified sampling

C.

Block selection sampling

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Question # 54

Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.

A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.

In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.

Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.

Based on the scenario above, answer the following question:

Is it acceptable for the certification body and Eva to make the certification decision together?

A.

Yes, because the audit team leader must be involved in the certification decision

B.

No, only the audit team leader must make the certification decision

C.

No, auditors that take part in the audit should never take part in the certification decision

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Question # 55

Which two of the following auditors would not participate in a first-party audit?

A.

An auditor employed by an external consultancy organisation

B.

An auditor from an interested party

C.

An auditor trained in-house

D.

An auditor trained in the IRCA scheme

E.

An auditor certified by IRCA

F.

An auditor from a customer

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Question # 56

Scenario 5: Mechanical-Electro (ME) Audit Stages

Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.

Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.

In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.

A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.

Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.

Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME’s QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.

To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.

The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.

Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.

According to general principles of sampling procedure, did the audit team select a valid sample for electrical services?

A.

No, the selected sample size is low compared to the population, as for a population from 13 to 52 the minimum sample size should be 5.

B.

No, the selected sample size is high compared to the population, as for a population from 13 to 52 the minimum sample size should be 10.

C.

Yes, the selected sample size is proportionate to the population.

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Question # 57

Which of the following is a responsibility of a guide in an audit?

A.

Maintaining logistics

B.

Filling any potential gaps in the auditor's knowledge

C.

Witnessing the audit process on behalf of the certification body

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Question # 58

You have been just hired as the Internal Lead Auditor of a large organisation, responsible for internal audits. Your first job is to analyse the answers to nonconformities included in the report of a recent internal audit to Top Management.

The report contained one nonconformity as follows:

There is no evidence of Top Management ensuring the availability of resources to operate the QMS, the establishment of objectives, the promotion of continual improvement, and the promoting of the process approach.

Which four of the following Top Management actions can be considered 'corrections to the nonconformity'?

A.

Top Management appoints a senior manager to oversee the quality manangement system

B.

Top Management completed a course on ISO 9001

C.

All these actions will be reviewed during the Top Management meetings

D.

Improvement action has been promoted

E.

Objectives have been established

F.

Process approach has been communicated to the personnel

G.

Resources have been provided

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Question # 59

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

A.

List of findings from the last audit

B.

Name of the auditee general manager

C.

Signature of Certification Body Technical Reviewer

D.

Sequence and timings of audit activities

E.

Date of next audit

F.

Name of auditees and auditors

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Question # 60

Select the two statements that are true.

A.

The audit team leader shall only communicate any concerns to the auditee during the closing meeting.

B.

Inform the general manager if the auditor finds uncontrolled documents.

C.

Where the available audit evidence indicates that the audit objectives are unattainable, the individual(s) managing the audit programme shall be immediately informed.

D.

Changes to the audit scope, which become apparent during the audit, shall be approved with the auditee.

E.

During the audit, the audit team leader shall periodically assess audit progress.

F.

An immediate and significant risk to the audit shall be informed to the auditee and if possible to the certification body.

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Question # 61

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Pro’s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company’s working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

In scenario 3, the audit team required access to see the organizational chart and job descriptions to verify the employees’ competence. Based on audit best practices, is this acceptable?

A.

Yes, because that would be sufficient evidence to verify competence.

B.

No, because the audit evidence would not be relevant.

C.

Yes, because auditors should see the organizational chart and job descriptions to verify competence.

D.

No, because competence should only be verified through direct observation.

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Question # 62

You are conducting a third-party audit to ISO 9001 and the next item on your audit plan is 'internal auditing'.

When reviewing a sample of audit records up to 5 years previously, you find that many contain non-conformance reports and no actions have been taken. You interview the Quality Manager.

You: "I have noted that many of the older files contain non-conformances that have not had any corrective action taken."

Quality Manager: "Because the business is always changing, the departmental managers tell me that the non-conformances are no longer applicable. I made a decision that any non-conformance over 3 years old is automatically closed"

You: "Do you obtain any confirmation beforehand from the appropriate departments that the non-conformances are no longer applicable."

Quality Manager: " No, because they are so old I consider that they are no longer appropriate. Please remember that we take a risk-based approach which means we audit where and when it is considered important to do so.

Select one course of action you would now take from the options.

A.

Interview Top management to determine whether they were aware of and agreed the actions of the Quality Manager

B.

Review all non-conformances reports related to clause 9.2 of ISO 9001

C.

Interview relevant Departmental managers to assess whether the older non-conformances are still valid.

D.

Raise a non-conformance report against clause 9.2.2.e of ISO 9001

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Question # 63

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Pro’s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company’s working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

ACB sent the audit objectives to the audit team after an agreement was reached. Is this acceptable?

A.

Yes, the audit objectives should be known only after an agreement is reached.

B.

No, only the auditee should know the audit objectives.

C.

No, the audit objectives should be part of the audit offer.

D.

Yes, as long as the audit team leader approves.

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