ISO-9001-Lead-Auditor QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

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To certify an organization's ISO 9001:2015-based Quality Management System (QMS) for the first time, the correct sequence of activities would be:

Establish the management system (already in place).

Supplier audit

Internal audit

Management review

Initial certification audit – stage 1

Initial certification audit – stage 2 (already in place).

This sequence follows the typical path for preparing and ensuring that a QMS is functioning as required, leading up to certification.

Comprehensive and Detailed In-Depth Explanation:

Stratified sampling is the best method when the population consists of different groups or categories. In this case:

ME has two areas of operations (electrical and mechanical services).

Complaints were collected separately for each area.

By choosing representative samples from each category (electrical & mechanical complaints), Li Na ensured a balanced approach.

Systematic sampling selects samples at fixed intervals, which does not ensure proportional representation of both groups.

Block selection sampling is used when focusing on a specific time period or section, which does not apply here.

Thus, stratified sampling (B) is the correct answer.

Comprehensive and Detailed Explanation From Exact Extract:

According to ISO 19011:2018 – Guidelines for Auditing Management Systems, which is referenced in ISO 9001 Lead Auditor training and practice, auditor competence is defined by a combination of knowledge, skills, and personal attributes. Here's how each selected option aligns:

D. Determining what evidence to gather: This activity is rooted in knowledge of audit principles, criteria, and risk-based thinking. It requires an understanding of which types of evidence (documents, records, interviews, observations) are necessary to evaluate conformity to the audit criteria (Clause 7.2.3 of ISO 19011:2018).

E. Evaluate proposals of corrective actions: This task involves applying knowledge of ISO 9001 requirements, root cause analysis methods, and risk controls to assess whether proposed actions are suitable to prevent recurrence. It demands comprehension of quality management principles and corrective action methodologies, linking it firmly to knowledge.

Other options such as A (Communicate with auditee) and B (Conduct audit meetings) are predominantly skills-based, requiring interpersonal and communication abilities, not theoretical or regulatory knowledge.

C (Determine how to seek evidence) and F (Identify findings) involve both knowledge and skill but are more action-oriented and tied to situational judgment and auditor behavior.

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

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

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

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

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

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

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

 A → 8.4.3.a

 B → 7.2.b

 C → 10.2.2

 D → 10.2.1

 E → 6.2

Comprehensive and Detailed Explanation From Exact Extract:

✅ A. There is no specification for incoming materials → 8.4.3.a

Clause 8.4.3(a) relates to the control of externally provided processes, products, and services, specifically the requirement to communicate appropriate specifications and requirements to suppliers:

“The organization shall ensure the adequacy of requirements prior to their communication to the external provider.”

Failure to specify requirements for incoming materials (e.g., what is acceptable waste plastic) risks compromising product quality.

✅ B. The picking operators have been trained → 7.2.b

Clause 7.2(b) relates to Competence and mandates:

“Ensure that these persons are competent on the basis of appropriate education, training, or experience.”

Training is a critical part of establishing and maintaining operator competence in quality-affecting tasks.

✅ C. The picked reject materials are not documented → 10.2.2

This clause focuses on the retention of documented information regarding nonconformities and actions taken:

“The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken…”

If rejects are not recorded, traceability and root cause analysis for quality failures are weakened.

✅ D. The rejected materials are segregated → 10.2.1

Clause 10.2.1 relates to nonconformity and corrective action, including containment activities such as:

“Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment…”

Segregation ensures nonconforming material doesn’t contaminate acceptable output.

✅ E. Management has set an objective for the level of rejects → 6.2

Clause 6.2 is about quality objectives. It requires organizations to:

“Establish quality objectives at relevant functions... The quality objectives shall be measurable…”

Setting a measurable reject-level target aligns with improving process control and reducing waste.

Comprehensive and Detailed In-Depth Explanation:

Clause References:

ISO 19011:2018 (Guidelines for Auditing Management Systems), Clause 5.3 – Establishing the Audit Objectives

ISO/IEC 17021-1:2015, Clause 9.1.2 – Audit Planning

Why is the Correct Answer C?

Audit objectives must be clearly defined in the audit offer to ensure that the scope, criteria, and purpose are agreed upon in advance.

ISO/IEC 17021-1:2015 (which governs certification bodies) requires that audit objectives be established before the audit begins to ensure transparency and effectiveness.

Sending audit objectives after an agreement has been reached could lead to misalignment between the auditee’s expectations and the audit’s purpose.

Why are the Other Options Incorrect?

A (Audit objectives should be known only after agreement) → Incorrect because objectives must be pre-defined in the audit offer.

B (Only the auditee should know the objectives) → Incorrect because both the auditor and auditee must align on objectives.

D (Approval from the lead auditor is sufficient) → Incorrect because audit planning follows formal procedures defined by ISO/IEC 17021-1.

Questions no: 1 Verified Answer: = C, D, E Comprehensive But Short Explanation: = Potential threats to impartiality in an audit context include familiarity (having a close relationship with the auditee), intimidation (being coerced or feeling pressured), and self-audit (auditing one’s own work). These factors can compromise the auditor’s objectivity and the audit’s integrity. References: = The information is based on the ISO 9001 Auditing Practices Group documents which discuss threats to auditor impartiality and how they may compromise an auditor’s objectivity123.

Match the process descriptions below to the process names:

The process by which the accuracy of test equipment is checked against a known standard. = Calibration

The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation

The process by which data is examined in detail to reach a specific answer or answers. = Analysis

The process by which a parameter of a product or service is examined to determine a specific value. = Measurement

According to the ISO 9000:2015 - Quality management systems — Fundamentals and vocabulary, the definitions of the process names are as follows:

Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.

Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.

Analysis: detailed examination of the elements or structure of something.

Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.

Therefore, the process descriptions can be matched to the process names based on these definitions.

Comprehensive and Detailed In-Depth Explanation:

Policies and guidelines are considered documentary evidence because they are written records that demonstrate how an organization complies with ISO 9001 requirements.

Clause References:

ISO 19011:2018, Clause 6.4.6 – Audit Evidence:

Documentary evidence includes manuals, procedures, and policies.

Why is the Correct Answer C?

Documentary evidence includes written records such as policies, procedures, and documented instructions that support QMS implementation.

Auditors review policies to verify conformance with ISO 9001.

Why are the Other Options Incorrect?

A (Confirmative evidence) → Not a recognized category in ISO auditing.

B (Technical evidence) → Technical evidence refers to measurements, test results, or product data, not policies.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting):

The certification body retains ownership of the audit report as it is responsible for the certification decision.

The auditee may receive a copy, but it does not own the report.

The audit team leader compiles the report but does not own it.

Thus, C is the correct answer.

Nonconformity report

ISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 - “Top management shall review the organization’s quality management system at planned intervals.” Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.

Comprehensive and Detailed In-Depth Explanation:

ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions) states:

The auditor can set a reasonable deadline for corrective actions.

10 to 60 days is a best practice timeframe for the auditee to respond.

The auditee must propose corrective actions, but the audit team has the authority to set the deadline.

A 7-day deadline (A) is too short, and the audit team—not the auditee—determines the timeframe (B).

In the context of a third-party audit, the activities and the parties responsible can be matched as follows:

Review the organization’s processes: This is typically the responsibility of the audit team. They examine the processes to ensure they comply with the specified standards1.

Review the audit results: The audit team leader usually reviews the audit findings to ensure accuracy and completeness before they are finalized1.

Issue the certificate: The certification body is responsible for issuing the certificate if the audit is successful and the organization meets the required standards1.

Select the audit team: The individual(s) managing the audit programme are responsible for selecting the audit team. This ensures that the team has the appropriate skills and knowledge for the audit1.

These roles are essential to maintain the integrity and effectiveness of the audit process. The audit team conducts the actual audit, the team leader oversees the audit process, the certification body grants the certification, and the management of the audit program ensures that the right team is in place to conduct the audit1.

Based on the description of the image you’ve provided, here’s how the activities match with the responsible parties in the context of a third-party audit:

Review the organization’s processes: This activity is typically the responsibility of the Audit Team. They are tasked with examining the processes to ensure they meet the requirements of the standard being audited.

Review the audit results: The Audit Team Leader is usually responsible for this activity. They oversee the audit process and are in charge of reviewing the findings and ensuring that the audit objectives are met.

Issue the certificate: The Certification Body is responsible for issuing the certificate if the organization’s management system is found to be in compliance with the standard.

Select the audit team: The Individual(s) managing the audit programme are responsible for selecting the audit team. They ensure that the team has the appropriate competence and resources to effectively conduct the audit.

These roles are defined within the framework of ISO 9001:2015 and are essential for the proper conduct of a third-party audit. The audit team and its leader play a critical role in the operational aspects of the audit, while the certification body and those managing the audit programme have overarching responsibilities for the audit’s governance and integrity.

To demonstrate top management’s leadership and commitment with respect to the quality management system, the following four actions would be indicative:

B. Briefing staff on the development of an improvement culture: This shows that top management is actively involved in promoting a culture of continuous improvement, which is a key aspect of the quality management system1.

C. Chairing management review meetings: By leading these meetings, top management demonstrates their involvement in the quality management system’s ongoing performance and commitment to its continual improvement1.

E. Investing time and money in corrective actions arising from nonconformities: This indicates that top management is committed to addressing issues and ensuring that the quality management system is effective and continually improving1.

G. Promoting the importance of following procedures: When top management emphasizes the importance of adherence to procedures, it reinforces the significance of the quality management system and its processes1.

These actions align with the requirements of ISO 9001:2015, which emphasizes the need for top management to take accountability for the effectiveness of the quality management system and to promote a focus on continual improvement and customer satisfaction123. Approving company car budgets, conducting disciplinary meetings, and not attending the audit closing meeting do not directly demonstrate leadership and commitment to the quality management system1.

Based on the scenario provided, there is evidence of nonconformity with the requirements defined in:

C. Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.

E. Clause 7.5.3 Control of documented information: The Operations Director’s approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.

These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system. The scenario described shows a casual approach to managing critical software updates, which could affect the organization’s ability to consistently meet customer and regulatory requirements.

In the context of ISO 9001:2015 audits, it is the audit team leader who holds the responsibility for assigning work to the audit team. According to ISO 19011:2018 (Guidelines for auditing management systems, which complements ISO 9001:2015), the audit team leader is responsible for the organization and direction of the audit, including assigning specific roles and responsibilities to audit team members. This includes preparation of the audit plan, leading the audit, and ensuring that each team member understands their tasks.

In ISO 9001:2015, the responsibility for managing the audit program lies with those overseeing the entire audit process rather than the Audit Team Leader. During the planning stage, before involving the Audit Team Leader, key actions for managing the audit program include:

1. Providing the Resources Needed: According to clause 7.1 (Resources), the audit program manager must ensure that the necessary resources are in place to conduct the audit effectively. This encompasses logistical support, personnel, and other required resources for the audit to proceed smoothly.

2. Reviewing Reports of Previous Audits: As per clause 9.2.2 (Internal Audit), it is essential to consider the results of previous audits to plan effectively for the upcoming audit. This helps identify areas that require particular attention, ensuring continuity and focusing on recurring issues or improvements since the last audit.

These actions ensure that the audit is thoroughly prepared and that there is continuity and focus on any areas that might need closer inspection. The other options, such as preparing the audit plan, assigning responsibilities, preparing checklists, and selecting the audit team members, generally fall under the duties of the Audit Team Leader once they are appointed and engaged in the planning process.

Comprehensive and Detailed In-Depth Explanation:

Toning down (or de-escalation) is a conflict resolution technique where:

Common agreements are emphasized to reduce tension.

Disagreements are addressed with a rational and constructive approach.

Option A describes compromise, and Option B describes authoritative resolution, which are different conflict resolution techniques.

According to ISO 9001:2015, clause 6.2.1, the organization is required to establish quality objectives at relevant functions, levels, and processes for the quality management system (QMS). The quality objectives must be consistent with the quality policy, measurable, monitored, communicated, and updated as appropriate. The organization is also required to maintain documented information on the quality objectives, as per clause 7.5.1.

Therefore, in the scenario given, the quality objectives defined by the external consultant are not in alignment with the organization’s quality policy, as they are based on those of a competitor, rather than the organization’s own purpose, strategic direction, and customer requirements. This creates a mismatch between the organization’s vision and goals, and the quality objectives that are supposed to guide and measure the QMS performance. Moreover, the quality objectives are not maintained as documented information, which makes it difficult to communicate, monitor, and update them, as well as to demonstrate evidence of their implementation and achievement.

Hence, the circumstances in which a nonconformity against clause 6.2 of ISO 9001 could be raised are B and C, as they indicate a failure to comply with the requirements of clause 6.2.1. The other options are either irrelevant or not directly related to clause 6.2, as they do not pertain to the establishment and documentation of quality objectives.

According to the ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities1, an improvement opportunity is a suggestion made by the auditor for the auditee to consider that, if implemented, may enhance the performance of the QMS. Improvement opportunities are not mandatory, but they should be based on objective evidence and aligned with the audit criteria and objectives. Improvement opportunities should also be realistic, feasible, and beneficial for the auditee. In this case, the evidence statements that represent acceptable improvement opportunities in the report are A, C, and E, because they address the potential causes and effects of the spelling errors in the print run, and propose possible actions that may improve the quality of the products and services, and the effectiveness of the QMS. These options are consistent with the requirements and principles of ISO 9001, such as clause 6.1 on actions to address risks and opportunities, clause 8.1 on operational planning and control, clause 8.5.1 on control of production and service provision, and clause 10.2 on nonconformity and corrective action. The other options are not appropriate improvement opportunities, because they are either irrelevant, unrealistic, or unhelpful for the auditee. For example, option B may contradict the audit objective and scope, option D may imply a lack of auditor competence or impartiality, option F may not address the root cause of the problem, option G may not be applicable or effective, and option H may not be feasible or justified. References: ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities, ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Audit Evidence

Comprehensive and Detailed In-Depth Explanation:

One of the common misconceptions about ISO 9001 is that it only applies to manufacturing companies producing tangible goods. However, ISO 9001:2015 is designed for all types of organizations, including service providers such as financial, healthcare, and IT companies.

Clause 1 (Scope) clearly states that ISO 9001 is applicable to any organization, regardless of type, size, or the products and services it provides. AL-TAX, being a financial services company, is equally eligible for implementing a QMS under ISO 9001.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 5.2 (Audit Program Management):

The audit committee is responsible for establishing the internal audit program.

The audit schedule (A) is determined within the program, but it is not the main role of the committee.

Thus, C is the correct answer.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 emphasizes risk-based thinking, which helps organizations identify factors that could prevent achieving planned results and take preventive action. Clause 6.1 (Actions to Address Risks and Opportunities) requires organizations to determine risks and opportunities and implement actions to mitigate potential negative impacts.

In the scenario, AL-TAX identified potential risks and implemented preventive actions, aligning with risk-based thinking. ISO 9001:2015 integrates risk management throughout the standard, ensuring processes are designed to minimize uncertainties.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 Clause 5.1.1 (Leadership and Commitment) states that top management must demonstrate leadership and commitment to the QMS by actively participating in QMS implementation, integration, and effectiveness.

In scenario 2, top management refused to be directly involved in the QMS implementation team, which violates Clause 5.1.1 because leadership involvement is essential for the system’s success.

Other options do not indicate nonconformance:

Option A (Middle managers in the QMS team) is acceptable.

Option C (Leslie assigning roles) is valid if competence is ensured (Clause 5.3 – Organizational Roles, Responsibilities, and Authorities).

Option D (Team reviewing the policy before approval) aligns with best practices.

According to clause 10.2.1.b of ISO 9001:2015, the organization should evaluate the need for action to eliminate the causes of nonconformities, in order to prevent their recurrence. This means that the organization should identify and address the root causes and contributing factors of the nonconformities, and implement appropriate corrective actions that are effective and proportional to the impact of the nonconformities. In this case, the evidence statement that supports the finding of nonconformance is C, because it shows that the organization did not take effective actions to prevent the recurrence of the spelling errors in the print run, which resulted in repeated customer rejections and dissatisfaction. The other options are not directly related to clause 10.2.1.b, although they may indicate other nonconformities or weaknesses in the organization’s QMS. For example, option A may relate to clause 7.2 on competence, option B may relate to clause 8.6 on release of products and services, and option D may relate to clause 7.1 on resources. References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Nonconformity and Corrective Action], ISO 9001 Clause 10. Improvement - ISO-templates.com

Comprehensive and Detailed In-Depth Explanation:

Minor nonconformities are isolated issues that do not significantly impact the QMS but still require correction.

Failure to close nonconformities on time (Answer A) is a procedural issue and is considered minor unless it leads to repeated failures.

Major nonconformities include:

Lack of top management commitment (Answer B), which affects leadership and strategic direction.

Failure to take corrective actions for recurrent issues (Answer C), which indicates systemic failure.

Comprehensive and Detailed In-Depth Explanation:

Reliability in service quality refers to the consistent and dependable delivery of promised services.

ISO 9001:2015 emphasizes reliability through:

Clause 8.2.1 (Customer Communication) – Ensuring clarity in service commitments.

Clause 8.5.1 (Control of Service Provision) – Ensuring processes meet requirements consistently.

Other options do not fully define reliability:

Option A (Safe services) relates to safety, not reliability.

Option B (Readiness and goodwill) relates to responsiveness, not reliability.

Option D (Low cost) focuses on pricing, not quality.

According to ISO 9001:2015, clause 4.3, the organization is required to determine the scope of its quality management system (QMS) by considering the external and internal issues referred to in clause 4.1. Clause 4.1 requires the organization to determine the external and internal issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of its QMS. These issues can include positive and negative factors or conditions for consideration, such as legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. The organization is also required to monitor and review these issues.

Therefore, the correct answer is C, as external issues of the organization’s context are one of the factors that must be considered when determining the scope of the QMS. The other options are either not directly related to the scope of the QMS, or are not explicitly mentioned in clause 4.3.

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.

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According to the ISO 9000:2015 document, the seven quality management principles are:

Customer focus

Leadership

Engagement of people

Process approach

Improvement

Evidence-based decision making

Relationship management

For each principle, the document provides a statement, a rationale, key benefits, and actions you can take to apply the principle in your organization.

Based on the document, here is a possible way to match a potential benefit to each of the four quality management principles you mentioned:

Table

Quality management principle

Potential benefit

Customer focus

Increased revenue and market share

Engagement of people

Enhanced trust and collaboration throughout the organization

Improvement

Enhanced drive for innovation

Evidence-based decision making

Increased ability to demonstrate effectiveness of past actions

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.

Top management is responsible for establishing, implementing, and maintaining the quality policy. The quality policy provides a framework for setting quality objectives and must be compatible with the context of the organization and support its strategic direction. It should also provide a commitment to satisfy applicable requirements and to continuous improvement.

Understanding Clause 6.2 of ISO 9001:2015:Clause 6.2 (Quality Objectives and Planning to Achieve Them) specifies that organizations must:

Establish measurable and relevant quality objectives consistent with the quality policy (Clause 6.2.1).

Include objectives applicable to product/service conformity and customer satisfaction.

Document these objectives and their planning as documented information (Clause 6.2.1 & 6.2.2).

Plan how to achieve the objectives, including defining actions, resources, responsibilities, timelines, and methods for evaluation.

Analysis of Options:

A. Quality objectives are not being implemented by the organisation's personnel:Incorrect. While implementation is critical, this relates more to operational aspects rather than the direct requirements of Clause 6.2. Implementation issues would typically raise concerns under Clause 9.1 (Performance Evaluation).

B. The consultant has not interpreted ISO 9001 correctly:Incorrect. The consultant's interpretation of ISO 9001 is irrelevant in terms of Clause 6.2 compliance. The focus is on whether the organization aligns with the requirements, not the consultant's role.

C. Establishing quality objectives did not include top management:Incorrect. While top management involvement is vital for QMS effectiveness (Clause 5.1), this is not a direct requirement of Clause 6.2. Top management alignment is implied but not explicitly mandated for establishing quality objectives.

D. Quality objectives were not established in alignment with the organisation's quality policy:Correct. Clause 6.2.1 requires that quality objectives be consistent with the organization’s quality policy, ensuring they reflect its purpose, strategic direction, and commitment to continual improvement. Misalignment would constitute a nonconformity.

E. The organisation cannot afford to undertake quality objectives all at once:Incorrect. Financial constraints are not directly addressed in Clause 6.2. The clause focuses on planning to achieve objectives, which includes defining the necessary resources but does not demand achieving all objectives simultaneously.

F. Quality objectives are not maintained as documented information:Correct. Clause 6.2.1 specifically requires that quality objectives be maintained as documented information. Failure to document the objectives is a direct violation of this clause.

Why Options D and F Are Correct:

D: Misalignment between the quality objectives and the quality policy directly violates Clause 6.2.1, which mandates that objectives support the strategic direction of the organization.

F: Lack of documentation for quality objectives breaches the requirement to maintain them as documented information under Clause 6.2.1.

Relevant References:

Clause 6.2.1: Establishing quality objectives aligned with the quality policy.

Clause 6.2.2: Maintaining documented information for quality objectives and planning to achieve them.

Clause 5.1.1: Top management's responsibility to ensure alignment between the QMS and strategic direction.

Clause 8.3.4.d of ISO 9001:2015 requires that design and development validation be performed to ensure that the resulting products or services meet the requirements for their specified application or intended use. Validation is critical to confirm that the product works as intended in real-world conditions.

In this case, Noitol omitted the design validation step approximately 50% of the time, which is a direct violation of Clause 8.3.4.d. Although they collect feedback after the fact, this is not a substitute for formal validation before the product is released. The nonconformity arises because the process of validation was neglected, not the recording of improvements or feedback.

Other options, such as documenting improvements (A) or issues with planning verification (B), are important but do not directly address the primary concern: the lack of consistent design validation before product release. Option D (8.6) concerns product release, but this nonconformity focuses on the validation stage, not just approval for release​.

 Responsibilities of the Audit Team Leader:

ISO 19011:2018 (guidelines for auditing management systems), which supports the principles in ISO 9001:2015, specifies the responsibilities of an audit team leader. These responsibilities include:

Planning the audit and establishing effective communication between the audit team and auditee.

Ensuring that formal communication channels are agreed upon and followed.

Reporting the audit progress, significant findings, and any concerns to the auditee or audit client as necessary.

Managing the audit team and ensuring adherence to the defined objectives and scope.

 Analysis of Options:

A. Reporting unattainable audit objectives to the accreditation body:Incorrect. This is not the responsibility of the audit team leader. The accreditation body oversees the certification body and is not directly involved in specific audits. If objectives are unattainable, the audit team leader would report them to the audit client (the certification body), not the accreditation body.

B. Planning formal communication arrangements:Correct. This is one of the responsibilities of the audit team leader. They ensure auditees can communicate with auditors as needed during the audit process.

C. Confirming communication channels during the opening meeting:Correct. During the opening meeting, the audit team leader must establish clear communication protocols to ensure effective information exchange between the audit team and auditee.

D. Communicating progress, findings, and concerns:Correct. Keeping the auditee and audit client informed about progress and significant findings is a critical responsibility of the audit team leader to maintain transparency and ensure the audit objectives are met.

 Why Option A is Correct:

The audit team leader does not have any obligation to report unattainable objectives to the accreditation body. Instead, they are responsible for communicating issues to the audit client (typically the certification body). The accreditation body operates at a higher level and is concerned with overseeing certification bodies, not individual audits.

 Relevant References:

ISO 19011:2018, Clause 6.4 (Conducting the Audit): Emphasizes the responsibilities of the audit team leader, including communication with the auditee and client.

ISO 9001:2015, Clause 9.2 (Internal Audit): Highlights the importance of planning and communication during audits, which is reflected in third-party audits as well.

In this scenario, the organization has set a quality objective of achieving a 90% minimum exam pass rate for all courses. The auditor’s task is to assess whether this objective is being monitored effectively and if appropriate actions are taken when the objective is not met.

B. You would determine how the exam pass rate figures were analysed: ISO 9001:2015, particularly Clause 9.1 (Monitoring, measurement, analysis, and evaluation), requires organizations to evaluate performance data. The auditor should verify how the organization analyses the pass rate data to ensure trends are identified, and corrective actions are planned based on this analysis.

D. You would determine what corrective action was being taken to address the low pass rates: When performance falls short of the objective, as seen with Course 4 (where the pass rate is below 90% in all months), Clause 10.2 (Nonconformity and corrective action) requires organizations to take corrective actions to address issues. The auditor would need to check if corrective actions have been initiated to address consistently low pass rates.

Statements A, C, E, and F do not directly address the monitoring and corrective action required under ISO 9001:2015 in this context​​.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 17021-1:2015, Clause 9.6.2 (Surveillance Activities):

The certification body is responsible for planning and conducting surveillance audits to ensure continued compliance.

The auditee’s top management (A) does not develop surveillance activities, but they must participate.

The audit team leader (C) conducts the surveillance audit, but they do not develop the program.

Thus, B is the correct answer.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires organizations to measure and monitor customer perceptions to determine whether customer requirements are being met.

Clause Reference:

Clause 9.1.2 – Customer Satisfaction states that organizations must monitor customer perceptions using relevant methods such as customer surveys, feedback forms, and complaint analysis.

One of the most effective ways to do this is gap analysis, which identifies differences between customer expectations and actual service or product performance.

Why is the Correct Answer C?

Gap analysis helps determine discrepancies between current performance and customer expectations, allowing organizations to improve quality.

It is a standard quality improvement tool used to assess customer satisfaction.

Why are the Other Options Incorrect?

A (PEST analysis) → Focuses on external macroeconomic factors (Political, Economic, Social, Technological) rather than customer satisfaction.

B (Market-share analysis) → Examines business performance relative to competitors, not customer perceptions.

D (Competitive benchmarking) → Involves comparing processes with competitors but does not directly monitor customer perceptions.

Comprehensive and Detailed Explanation From Exact Extract:

Correct Option B – “Communicate a policy commitment to continual improvement”

This aligns directly with Clause 5.2.1(d) of ISO 9001:2015, which states that the quality policy shall include a commitment to continual improvement of the QMS:

“Top management shall establish, implement and maintain a quality policy that... includes a commitment to continual improvement of the quality management system.”

A clearly communicated policy sets expectations and a strategic direction that cascades throughout the organization, promoting a culture that values ongoing enhancement.

Correct Option F – “Use the management review process to identify improvements”

This is based on Clause 9.3.3 of ISO 9001:2015, which specifies that outputs of management reviews must include decisions and actions related to:

“a) opportunities for improvement;

b) any need for changes to the quality management system;

c) resource needs.”

The management review process is a structured mechanism to analyze data, monitor performance, assess risks and opportunities, and drive continual improvement initiatives.

Why the Other Options Are Incorrect:

A (Appoint external consultants to train staff): While training may help improve competence, ISO 9001 emphasizes internal process evaluation and strategic improvement. This option is not directly aligned with the systematic improvement of the QMS.

C (Require higher standards): Higher standards alone don’t ensure continual improvement unless supported by a structured QMS approach involving evaluation, planning, and measurement.

D (Require fewer mistakes): Unrealistic or unqualified demands like "make fewer mistakes" don’t support structured process-based improvement and may conflict with ISO’s emphasis on risk-based thinking and root cause analysis.

E (Send Chief Executive on a course): While leadership involvement is vital (Clause 5), this action by itself does not constitute a continual improvement mechanism for the QMS.

Comprehensive and Detailed In-Depth Explanation:

Understanding Audit Stages Based on ISO/IEC 17021-1:2015

ISO certification audits consist of two main stages:

Stage 1 Audit (Readiness Review)

The organization’s documented information is reviewed to assess readiness for Stage 2.

This ensures that the QMS is developed, implemented, and prepared for full assessment.

Stage 2 Audit (On-Site Evaluation)

Auditors assess process implementation and effectiveness through interviews, observations, and evidence collection.

The audit team verifies if the organization meets ISO 9001 requirements in practice.

Why is the Correct Answer B?

The audit team reviewed ME’s documents, which is a Stage 1 activity.

The audit team performed interviews, sampling, and on-site verification, which is a Stage 2 activity.

There was no mention of an audit follow-up or a surveillance audit, which occur post-certification.

Why are the Other Options Incorrect?

A (Audit follow-up and Stage 1 Audit) → Follow-up audits occur after certification, which was not the case here.

C (Stage 2 Audit and Surveillance Audit) → Surveillance audits are post-certification audits and were not conducted yet.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 9001:2015, Clause 7.5.2 (Creating and Updating Documented Information), the criteria for reviewing documented information include:

Content – The accuracy and relevance of the information.

Format – Ensuring readability and proper structuring (e.g., language, versioning).

Procedure for managing documented information – Ensuring control, access, and updates.

Other options, such as internal audit reports and client feedback, are important for overall QMS evaluation but are not the main criteria for reviewing documented information.

As the audit team leader, it is crucial to manage differing opinions constructively and ensure that the correct clause is selected for the nonconformity based on solid evidence. Here’s how the situation should be handled:

E. Invite you and the second auditor to fully explain your point of view and then decide which clause to select: This promotes collaboration and transparency, allowing both auditors to present their rationale for choosing the specific clause.

F. Review the evidence with you and the second auditor, and then decide which clause of ISO 9001 would best apply: Reviewing the evidence in relation to the specific requirements of ISO 9001 is essential for determining which clause is most appropriate.

H. Try to obtain a consensus between you and the second auditor after a discussion of the different opinions: Consensus-building is a crucial skill for an audit team leader. Achieving agreement ensures the nonconformity is addressed accurately and with full team support.

Options such as overruling immediately (D) or deferring the decision without full discussion (B) could undermine team dynamics and the audit process. Consulting the quality manager (A) or selecting an entirely different clause (G) is unnecessary, as the team should resolve the issue internally​​.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires organizations to identify and control nonconforming outputs to prevent unintended use or delivery.

Clause References:

Clause 8.7 (Control of Nonconforming Outputs): Organizations must ensure that nonconforming outputs are identified and controlled to prevent unintended use or delivery.

Clause 10.2 (Nonconformity and Corrective Action): Requires organizations to take appropriate actions when nonconformities are found, including during or after service provision.

Why is the Correct Answer C?

If nonconforming products or services are identified after delivery or during service, organizations must take corrective actions to protect customers and stakeholders.

Actions may include recalls, rework, customer notifications, compensation, or process improvements.

This approach aligns with ISO 9001:2015, ensuring that products/services consistently meet requirements.

Why are the Other Options Incorrect?

A (Retaining documentation only) → While documentation is required, it alone does not ensure proper handling of nonconforming outputs.

B (Verifying conformity before correction) → While verification is good practice, ISO 9001 prioritizes corrective action over mere verification.

D (Allowing employees to handle nonconformities without structure) → ISO 9001 requires documented procedures for handling nonconformities (Clause 8.7).

Comprehensive and Detailed In-Depth Explanation:

ISO 19011:2018, Clause 5.4 (Audit Records Management) states that the audit schedule must be maintained as a key record.

Thus, C is the correct answer.

The purpose of conducting a document review is to determine the conformity of the system, as far as documented, with audit criteria and to gather information to support the audit activities. A document review is a systematic and objective examination of the documented information that is relevant to the audit objectives and scope. It can help the auditor to verify if the documented information is complete, accurate, consistent, and up-to-date. It can also help the auditor to identify any gaps, errors, or nonconformities in the documented information that may affect the audit findings or conclusions.

The other options are not correct because they do not reflect the true purpose of a document review. Option A describes the purpose of an audit report, which is to communicate the audit results and recommendations to the management and other interested parties. Option B describes the purpose of an audit plan, which is to define the scope, objectives, criteria, methods, resources, and schedule of an audit. Option C describes the purpose of an audit evidence report, which is to provide evidence of nonconformities or opportunities for improvement identified during an audit. Option D describes the purpose of an audit decision report, which is to justify or explain why certain decisions were made during an audit.

I hope this answer helps you understand why option F is correct and why options A-C-D are incorrect. If you want to learn more about ISO 9001 Lead Auditor exam questions and answers, you can check out some of these resources:

ISO 9001 Lead Auditor Sample Exam Questions and Answers: This article provides some sample questions and answers for each section of the ISO 9001 Lead Auditor exam.

ISO 9001 (QMS) Lead Auditor Quiz Questions and Answers: This article provides some quiz questions and answers on various topics related to ISO 9001 QMS.

ISO 9001 Lead Auditor - Exam Practice Tests: This course offers practice tests with explanations for each question.

Irca Lead Auditor Exam Questions And Answers Pdf: This document contains some exam questions and answers in PDF format.

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.

The following table shows the possible matching of the records to the requirements of clause 8.4:

Table

Requirements

Records

Define product requirements

Product specification

Criteria for selection

List of requirements to be met by the external provider

Evaluation of potential external provider

External provider questionnaire

External provider selection

Approved external provider list

Communicate requirements

Purchase order

Monitoring of performance

External provider delivery times and quality issues

Comprehensive and Detailed Explanation: = According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:

Define the product requirements that are relevant for the external provision, such as specifications, drawings, standards, codes, etc. These should be documented and communicated to the external provider. A record of the product specification can be used as evidence of this requirement.

Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently. A record of the list of requirements to be met by the external provider can be used as evidence of this requirement.

Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed. A record of the external provider questionnaire can be used as evidence of this requirement.

Select the external providers that have demonstrated their competence and conformity to the requirements. The selection should be based on the evaluation results and the organization’s needs. The selection should be documented and approved. A record of the approved external provider list can be used as evidence of this requirement.

Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely. A record of the purchase order can be used as evidence of this requirement.

Monitor the performance and conformity of the external provider, using the established criteria and methods. The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed. A record of the external provider delivery times and quality issues can be used as evidence of this requirement.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 17021-1:2015 (Conformity Assessment – Requirements for Certification Bodies), Clause 9.3.1.2, the Stage 1 Audit typically consumes around 30% of the total audit time.

This time is allocated to:

Reviewing documented information.

Assessing the readiness for Stage 2.

Identifying potential nonconformities.

A 20% allocation (Answer A) is too low, and 40% (Answer C) is excessive, as the majority of the audit should be spent on Stage 2 (on-site verification).

Comprehensive and Detailed In-Depth Explanation:

A combined audit is when multiple management systems (e.g., ISO 9001 for Quality, ISO 14001 for Environmental Management, and ISO 45001 for Occupational Health & Safety) are audited together in a single organization.

Clause References:

ISO 19011:2018, Clause 5.4 – Combined Audits:

A combined audit is performed when two or more management systems are assessed simultaneously at the same auditee.

Why is the Correct Answer A?

A combined audit reduces duplication of effort by auditing multiple standards together at a single organization.

Example: A company certified to both ISO 9001 and ISO 14001 can have one audit covering both standards.

Why are the Other Options Incorrect?

B (Two or more auditing organizations cooperating on a single auditee) → This is a joint audit, not a combined audit.

C (Two or more management systems audited at multiple auditees) → This is a multiple-site audit, not a combined audit.

 Understanding "Context of the Organization":

The term "context of the organization" is defined in ISO 9001:2015 Clause 4.1, which states:

"The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system."

The definition emphasizes identifying both internal and external issues that influence the organization's approach to developing and achieving its objectives.

 Option Analysis:

Option A:Correct. This option aligns with the standard definition as it explicitly mentions the combination of internal and external issues that affect the organization’s approach to achieving its objectives, which is the essence of Clause 4.1.

Option B:Incorrect. The term "comparison of internal and external issues" does not reflect the ISO 9001 requirements. The standard does not require a comparison but rather an understanding of these issues.

Option C:Incorrect. Although it mentions "complexity," the focus of ISO 9001:2015 is on identifying relevant issues rather than the complexity of those issues.

Option D:Incorrect. This option mentions "coordination" and focuses only on the positive or negative effects. ISO 9001 requires identifying issues but does not emphasize coordination.

 Clause Reference and Relevance:

ISO 9001:2015 requires organizations to understand their context because internal and external factors can influence the Quality Management System's effectiveness. Understanding this context helps in:

Addressing risks and opportunities (Clause 6.1).

Aligning the QMS with the organization’s strategic direction.

 Why A is Correct:

"Combination of internal and external issues" captures the essence of Clause 4.1, making it the accurate definition of the context of the organization.

The individual(s) managing the audit programme and the auditee are both roles that contribute to the audit outcomes. The individual(s) managing the audit programme are responsible for planning, conducting, and reporting on the audit activities, as well as ensuring that they are aligned with the organization’s quality objectives and risk management processes1. The auditee is the person or entity that is subject to an audit, and their participation, cooperation, and feedback are essential for achieving a successful audit outcome2. References:

ISO 9001 Lead Auditor Reference Materials

ISO 9001 Lead Auditor Candidate Handbook

ISO 9001 Lead Auditor Course Material

ISO 9001 Lead Auditor Training Course IRCA Certified

Comprehensive and Detailed In-Depth Explanation:

Before accepting an audit, the certification body must assess the integrity of the auditee and the nature of its operations to ensure compliance feasibility.

Clause References:

ISO/IEC 17021-1:2015, Clause 9.1.2 – Audit Planning:

The certification body must review the auditee’s background, reputation, and operational complexity before accepting the audit.

Why is the Correct Answer C?

The auditee’s integrity and reputation impact the credibility of certification.

The nature of operations determines audit complexity and resource allocation.

Why are the Other Options Incorrect?

A (Integrity and reputation only) → Correct but incomplete; nature of operations is equally important.

B (Nature of operations only) → Integrity is also a factor, not just operations.

D (No previous major nonconformities required) → Auditees with past major nonconformities can still be audited if corrective actions are taken.

Documented information is a means by which an organization demonstrates compliance. It communicates what we do and how we do things, it communicates what happened and what results were achieved. It is, essentially, a tool for communication. ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. The standard states that the organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. Therefore, the purpose of retaining documented information is to support the operation of the processes of the QMS, not to facilitate auditing, provide confidence or safeguard integrity, which are secondary benefits of documented information. References: Guidance on the requirements for Documented Information of ISO 9001:2015, ISO 9001:2015 documented information | CQI | IRCA, Documented Information Required by ISO 9001:2015 - 9000 Store

Comprehensive and Detailed In-Depth Explanation:

An audit’s feasibility must be assessed using multiple factors, not just resource availability.

Clause References:

ISO 19011:2018, Clause 5.3 – Establishing the Audit Program: Requires consideration of logistical, technical, and cooperation factors when assessing audit feasibility.

ISO/IEC 17021-1:2015, Clause 9.1.3 – Determining Feasibility of the Audit: Requires evaluating more than just resources to ensure a successful audit.

Why is the Correct Answer B?

Audit feasibility should consider:

Availability of information (documents, records).

Cooperation from the auditee.

Operational conditions that might affect the audit.

Scope and complexity of the QMS being audited.

Resource availability alone is not enough to determine feasibility.

Why are the Other Options Incorrect?

A (Top management determines feasibility) → Incorrect because feasibility is determined by the certification body, not the auditee.

C (Resources alone are sufficient) → Incorrect because other key factors must be evaluated.

D (Final authority lies with the audit leader) → Incorrect because ISO requires multiple factors to be considered, not just an auditor’s decision.

Understanding Clause 7.1.5.2 – Measurement Traceability:ISO 9001:2015 requires organizations to ensure that measuring equipment (e.g., spectrometers) is calibrated and traceable to recognized standards. The failure to maintain calibration within valid dates directly violates this clause and raises concerns about the reliability of the measurement results.

Root Cause of the Nonconformity:The organization failed to plan for the possibility that the calibration service provider (X-TECH) might become unavailable, leading to expired calibration. This indicates inadequate risk-based thinking, which is required under Clause 6.1 of ISO 9001:2015.

Option Analysis:

A. Select one sample for external lab analysis to use as an internal standard:Incorrect. While using an internal standard could provide short-term verification of results, this action does not address the root cause (failure to consider risks associated with external providers).

B. Look for a local company to provide this service:Incorrect. While finding a new local service provider resolves the immediate calibration issue, it does not address the risk of future provider unavailability.

C. Double-check one out of ten samples externally:Incorrect. This corrective action ensures some quality assurance for batch release but does not resolve the nonconformance related to expired calibration.

D. Add this issue to the external issue register, assess its associated risk, and plan action to address that risk:Correct. This approach directly addresses the root cause (failure to anticipate the calibration provider leaving) and ensures proper risk management. ISO 9001:2015 emphasizes risk-based thinking under Clause 6.1, requiring organizations to identify risks and opportunities and implement plans to mitigate them.

Why D is the Best Option:

By adding the issue to the external issue register, the organization ensures it is monitored and tracked.

Assessing the risk ensures proactive measures are in place for similar issues in the future.

Planning actions to address the risk ensures a sustainable solution is implemented, such as identifying multiple service providers or ensuring backup plans for calibration services.

ISO 9001 References:

Clause 6.1 (Actions to Address Risks and Opportunities): Requires organizations to consider risks and opportunities that could affect the intended results of the QMS.

Clause 7.1.5.2 (Measurement Traceability): Mandates that measuring equipment must be calibrated and traceable to ensure valid results.

Clause 10.2 (Nonconformity and Corrective Action): Requires organizations to determine the root cause of nonconformities and take actions to ensure they do not recur.

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

Responsibilities:

Conduct the audit to the assigned area.= Auditors

Assist the auditors in identifying personnel to participate in the audit.= Guide

Assign each team member’s responsibility for the audit.= Audit team leader

Respond to questions and provide evidence to the auditor.= Auditee

According to ISO 19011:2018, clause 3, the definitions of the roles are as follows1:

Auditors: persons with the competence to conduct an audit

Guide: person appointed by the auditee to assist the audit team

Auditee: organization being audited

Audit team leader: member of an audit team appointed to manage the audit or an audit team

Therefore, the roles can be matched to the responsibilities based on these definitions and the description of the audit process in clause 6 of the standard1.

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.