PECB ISO-9001 Lead Auditor QMS ISO 9001:2015 Lead Auditor Online Training

Question #21

DRAG DROP

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

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

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

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

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

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

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

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

You decide to raise a nonconformity.

To complete the nonconformity report click on the blank section you want to complete se it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

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Question #22

DRAG DROP

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.

You raised a nonconformity against clause 8.5.1 of 150 9001. Select the words that best complete the sentence;

To complete the sentence click on the blank section you want to complete so it is highlighted in red and then dick on the applicable text from the options below., Alternatively, drag and drop the options to the appropriate blank section.

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Question #23

DRAG DROP

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).

To compete the table click on the blank section you want to complete so itis highlighted in red and then Click on the applicable text form the options below.

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Correct Answer:

Explanation:

Quality management principles:

Customer focus = Increased revenue and market share

Engagement of people = Enhanced trust and collaboration throughout the organisation

Improvement = Enhanced drive for innovation

Evidence-based decision-making = Increased ability to demonstrate effectiveness of past actions

According to the Quality management principles document published by ISO, each quality management principle has a statement, a rationale, key benefits, and actions you can take to apply it. Based on these descriptions, the potential benefits can be matched to the corresponding principles as follows:

Customer focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. The key benefits of this principle include increased customer value, customer satisfaction, customer loyalty, repeat business, reputation, customer base, revenue and market share.

Engagement of people: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value. The key benefits of this principle include improved understanding of the organization’s objectives and values, increased involvement in improvement activities, enhanced personal development, increased motivation and empowerment, enhanced trust and collaboration, and increased recognition and rewards. Improvement: Successful organizations have an ongoing focus on improvement. The key benefits of this principle include improved organizational capabilities, alignment of improvement activities at all levels, increased ability to anticipate and react to opportunities and threats, enhanced drive for innovation, and increased levels of satisfaction.

Evidence-based decision-making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. The key benefits of this principle include improved decision-making processes, increased ability to demonstrate the effectiveness of past decisions, increased ability to review, challenge and change opinions and decisions, and increased ability to improve performance.

Question #24

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 #25

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 #26

Which one of the following options best describes the purpose of a Stage 1 third-party audit?

A . To determine the auditees understanding of ISO 9001.
B . To get to know the organisation’s customers.
C . To learn about the organisation’s procurement processes.
D . To introduce the audit team to the client.

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Correct Answer: A
A

Explanation:

The purpose of a Stage 1 third-party audit is to determine an organization’s readiness for their Stage 2 Certification Audit. During the Stage 1, the auditor will review the organization’s management system documented information, evaluate the site-specific conditions, and have discussions with personnel. The objective is to assess the alignment of the organization’s design with ISO 9001 requirements and to identify any areas of concern that could be classified as a nonconformance during the Stage 2 Audit. The auditor will also use the Stage 1 Audit to complete Stage 2 Audit planning, including a review of the allocation of resources and details for the next phase of the audit. Therefore, the option that best describes the purpose of a Stage 1 third-party audit is A, to determine the auditees understanding of ISO 9001.

The other options are not correct, as they are not the main focus of a Stage 1 audit:

• B. To get to know the organization’s customers: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization’s customers, but rather in the organization’s ability to meet customer and applicable statutory and regulatory requirements.

• C. To learn about the organization’s procurement processes: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization’s procurement processes, but rather in the organization’s ability to control externally provided processes, products and services.

• D. To introduce the audit team to the client: This is not the purpose of a Stage 1 audit, as the auditor is not there to make introductions, but rather to conduct a preliminary examination of the organization’s compliance with ISO 9001 standards.

Reference: What is the difference between Stage 1 and Stage 2 Audits? – ISO Update, The ISO 9001 Audit Process Explained | ISO Explained, What is an ISO Stage 2 Audit? ― RiskOptics – Reciprocity

Question #27

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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Correct Answer: A,F
A,F

Explanation:

A first-party audit is an internal audit conducted by auditors who are employed by the organization being audited but who have no vested interest in the audit results of the area being audited1. The purpose of a first-party audit is to assess the conformity of the organization’s quality management system to the requirements of ISO 9001 and to identify opportunities for improvement2.

Therefore, the two auditors who would not participate in a first-party audit are:

• A. An auditor employed by an external consultancy organization: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit (if the external consultancy organization is a customer or supplier of the organization being audited) or a third-party audit (if the external consultancy organization is a certification body or registrar).

• F. An auditor from a customer: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit, as a customer is an interested party that has specific requirements for the organization being audited.

The other options are not correct, as they could participate in a first-party audit, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited:

• B. An auditor from an interested party: This auditor could be a first-party auditor, as long as the interested party is within the organization being audited. For example, an auditor from the finance department could audit the production department, as long as they are not involved in the production process or affected by its outcomes.

• C. An auditor trained in-house: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The source of the auditor’s training is not relevant for determining the type of audit, as long as the auditor is competent and qualified to perform the audit.

• D. An auditor trained in the IRCA scheme: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The IRCA scheme is a professional certification scheme for auditors of management systems, which provides recognition of the auditor’s competence and credibility3. However, being trained in the IRCA scheme does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.

• E. An auditor certified by IRCA: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. Being certified by IRCA means that the auditor has met the requirements of the IRCA scheme and has demonstrated their competence and credibility as an auditor of management systems3. However, being certified by IRCA does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.

Reference: First Party Audits: The 5 Steps to Success – Sync Resource Inc, ISO 9001 Auditing Practices

Group, IRCA – International Register of Certificated Auditors

Question #28

Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

A . Consistently provide products that meet customers’ requirements
B . Decreased number of management system nonconformities
C . Decreased number of warranty claims
D . Decreased number of nonconforming products in all stages of the manufacturing cycle
E . Enhanced customer satisfaction
F . Increased profits

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Question #29

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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Correct Answer:

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 #30

DRAG DROP

In the context of a third-party certification audit, match the roles with the following responsibilities:

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

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