PECB ISO-9001-Lead-Auditor Dumps

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​.

According to ISO 19011:2018, clause 6.6.2, a nonconformity is the non-fulfilment of a requirement. A nonconformity can be classified as either major or minor, depending on the nature and extent of the deviation from the audit criteria. A major nonconformity is a nonconformity that affects the ability or the integrity of the organization’s management system to achieve the intended results. A minor nonconformity is a nonconformity that does not affect the ability or the integrity of the organization’s management system to achieve the intended results, but is a deviation from the audit criteria1.

According to ISO/IEC 17021-1:2015, clause 9.4.9, the organization is required to analyze the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time. The organization is also required to provide the certification body with records and evidence of the implementation and effectiveness of the correction and corrective actions taken. The certification body will then verify the correction and corrective actions taken by the organization and decide on the certification status2.

Therefore, the two options of when the organization is required to act in response to reported findings are D and F, as they indicate the presence of nonconformities that need to be corrected and prevented from recurring. The other options are not correct, as they do not require the organization to act in response to reported findings:

•A. A recommendation is given in the report: A recommendation is a suggestion for improvement that is not related to a nonconformity. A recommendation is not binding for the organization and does not affect the certification status. The organization may choose to accept or reject the recommendation, but it is not required to act on it.

•B. A finding of good practice is reported: A finding of good practice is a positive observation that indicates a strength or a best practice of the organization’s management system. A finding of good practice is not related to a nonconformity and does not affect the certification status. The organization may choose to acknowledge or share the finding of good practice, but it is not required to act on it.

•C. An opportunity for improvement is raised: An opportunity for improvement is a potential area where the organization’s management system can be enhanced or optimized. An opportunity for improvement is not related to a nonconformity and does not affect the certification status. The organization may choose to pursue or ignore the opportunity for improvement, but it is not required to act on it.

•E. A finding of conformity is reported: A finding of conformity is a confirmation that the organization’s management system fulfils the audit criteria. A finding of conformity is not related to a nonconformity and does not affect the certification status. The organization may choose to celebrate or communicate the finding of conformity, but it is not required to act on it.

Comprehensive and Detailed In-Depth Explanation:

ISO 19011:2018 requires auditors to conduct audits professionally and diligently.

Clause References:

ISO 19011:2018, Clause 4.4 – Professional Care: Auditors must exercise due diligence in conducting audits.

ISO 9001:2015, Clause 9.2 – Internal Audit: Requires objective and systematic audits to evaluate QMS effectiveness.

Why is the Correct Answer A?

The audit team followed best practices by gathering verifiable audit evidence through interviews, document reviews, and observations.

They ensured fair presentation of findings in the final audit report.

They complied with ISO 9001 and ISO 19011 guidelines for audit procedures.

Why are the Other Options Incorrect?

B (Ordinary negligence) → No evidence of negligence; the team followed structured audit processes.

C (Gross negligence) → No indication that the auditors ignored important responsibilities.

D (Willful misconduct) → The auditors acted professionally and did not intentionally disregard rules.

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.

In a third-party certification audit, auditors are responsible for maintaining confidentiality as part of their professional duties. Here’s how they can demonstrate it:

A. Adhere to the CQI Professional Code of Conduct: The CQI (Chartered Quality Institute) Code of Conduct outlines ethical principles, including confidentiality. Auditors must adhere to professional standards, ensuring sensitive information is protected and not disclosed improperly.

B. Confirm the confidentiality arrangements with the auditee regarding the use of mobile devices/cameras: Before using mobile devices or cameras, auditors must seek explicit permission from the auditee and agree on confidentiality terms, preventing unauthorized recording or sharing of sensitive information.

Options C, D, and E involve breaching confidentiality and are not acceptable practices in an ISO 9001:2015 certification audit. Sharing sensitive information, removing evidence without consent, or discussing it with unauthorized parties violates audit principles and the standard's confidentiality requirements​.

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.

D. I would look for evidence that the actions resulting from the risk assessment had been taken.

According to ISO 9001:2015, Clause 6.1.2 requires the organization to plan actions to address risks and opportunities. The organization must integrate and implement these actions into its quality management system and evaluate their effectiveness. The auditor should seek evidence that the organization has assessed the risks and taken appropriate actions.

B. I would ask to audit the Technical Manager by phone.

As the Technical Manager is responsible for this process and is absent due to illness, it is reasonable to attempt to contact him to obtain accurate information. This ensures that the audit process is not unduly delayed and that the information is obtained from the appropriate person.

A. I would not accept the legal compliance expert answering the question.

While the legal compliance expert might not be the best source for technical details, outright rejecting their input is not appropriate. It is better to first verify if the expert can provide relevant information.

C. I would delay the audit until the return of the Technical Manager.

This would be an inefficient approach. Contacting the Technical Manager by phone is a more practical and reasonable option.

E. I would ask for a different guide instead of the legal compliance expert.

The guide's role is not necessarily to answer technical questions but to facilitate the audit. Since Jack is already familiar with the situation, replacing him may not add value.

F. I would ask the consultant to leave the meeting since he is not an employee of the organization.

This is inappropriate and could disrupt the audit process. There is no rule in ISO 9001 preventing a consultant from assisting in the audit if authorized by the organization.

Why Not the Other Options:

Comprehensive and Detailed In-Depth Explanation:

A horizontal audit examines one process across multiple departments to assess consistency.

Thus, A is the correct answer.

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.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 17021-1:2015, Clause 9.4.10 (Corrective Actions for Major Nonconformities):

If a major nonconformity is not corrected within six months, the certification body must reject the certification request.

Another Stage 2 audit (C) is not required unless the organization reapplies for certification.

Restarting all audit activities (B) is unnecessary; instead, certification is denied.

Thus, A is the correct answer.

Nonconformity report

ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - “The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met.” Evidence: 40 cleaning records are available for 63 batches.

Clause 8.2.4 of ISO 9001:2015 – Changes to Requirements for Products and Services:ISO 9001:2015 Clause 8.2.4 states that when changes to requirements for products or services are made, they must be communicated and agreed upon with relevant interested parties (in this case, the Health Trust). The lack of communication and agreement for substituting the cleaning chemical represents a clear violation of this clause.

Analysis of the Corrective Action Proposed:The organization proposed "obtaining a concession from the Health Trust for the use of the new chemical." This action is reactive and assumes approval from the Health Trust without addressing the systemic issue: the lack of a defined change control process for managing contract changes.

Option Analysis:

A. The substitute chemical has not been used before in the Health Trust:Incorrect. While this may be a concern, it is not directly relevant to the root cause of the nonconformity, which is the absence of a process to handle contract changes.

B. The action assumes that the Health Trust will agree to the change:Incorrect. Although this is true, it is not the primary issue. The nonconformity lies in the lack of a structured approach to obtain agreement, not whether the Health Trust agrees.

C. Staff have not been trained in the use of the new chemical:Incorrect. This is a separate issue related to staff competence (Clause 7.2), but it is not the main reason why the corrective action is unacceptable under Clause 8.2.4.

D. The process for making changes to the contract has not been addressed:Correct. The fundamental issue is the organization's failure to follow or establish a change control process for amending contracts, including gaining formal agreement from the Health Trust. The proposed corrective action does not ensure that such issues will be systematically prevented in the future.

E. The substitute chemical may not be as effective as the original:Incorrect. The effectiveness of the substitute chemical is secondary to the primary issue, which is the lack of a change management process.

ISO 9001 References Supporting the Correct Answer:

Clause 8.2.4: Requires that changes to product/service requirements be reviewed, communicated, and agreed upon with the customer.

Clause 10.2 (Nonconformity and Corrective Action): Requires the organization to address the root cause of the nonconformity and take actions to ensure it does not recur. In this case, the root cause is the absence of a change control process.

Why D is the Best Answer:The core issue is that the organization did not have a formalized process for managing and agreeing upon changes to contract requirements. Addressing this process gap is essential to prevent recurrence of similar nonconformities. Merely seeking a concession from the Health Trust is a one-off solution that does not address the systemic issue.

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:

ISO 9001:2015, Clause 6.2 (Quality Objectives and Planning to Achieve Them) states that an organization must establish measurable and relevant quality objectives to improve QMS effectiveness.

Bell's strategy for handling customer complaints aligns with this requirement because it includes specific, measurable goals (biweekly customer surveys) to enhance customer satisfaction and service quality.

Other options are not directly related to defining quality objectives:

Option B (Implementing a QMS) refers to the overall system, not specific objectives.

Option C (Creating a QMS team) is an implementation step, not an objective.

Option D (Assigning responsibilities) is necessary for QMS but does not define objectives.

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.

Comprehensive and Detailed In-Depth Explanation:

The Stage 2 audit (ISO 17021-1:2015, Clause 9.3.1.3) is conducted to:

Verify whether the QMS is effectively implemented and operational.

Ensure compliance with ISO 9001 requirements in actual practice.

Identify nonconformities that may impact certification.

Reviewing documented information (Answer B) is part of Stage 1, and gathering scope information (Answer C) is done before the certification audit.

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.

According to ISO 19011:2018, clause 6.3.2, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the following information1:

•the audit objectives, scope and criteria

•the audit team members and their roles and responsibilities

•the audit schedule, including the date, time and location of each audit activity

•the expected time and duration of meetings and interviews

•the allocation of appropriate resources to critical areas of the audit

•the identification of the audit client and the auditee

•the identification of the guides and observers, if any

•the documents and records to be reviewed before and during the audit

•the audit methods and tools to be used

•the audit language and terminology

•the audit report content, format, distribution and expected completion date

•the risk to achieving audit objectives and the contingency plan, if any

Therefore, the issue which is not expected to be included in the audit plan is C, expectations of the organisation’s management. This issue is not relevant to the conduct of the audit, as the audit is based on the audit criteria, not on the management’s expectations. The management’s expectations may be considered during the audit initiation or the audit programme management, but they are not part of the audit plan.

According to clause 8.3 of ISO 9001:2015, the organization should establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. The design and development process should include the following activities:

•Determining the requirements for the products and services to be designed and developed, considering the intended use, the statutory and regulatory requirements, the customer and other relevant interested parties’ needs and expectations, and the potential risks and opportunities.

•Defining the design and development objectives, stages, responsibilities, and authorities, and ensuring the availability of adequate resources and competence.

•Implementing design and development controls, such as reviews, verification, and validation, to ensure that the design and development outputs meet the design and development inputs, and to identify and resolve any problems or errors.

•Maintaining documented information on the design and development inputs, outputs, reviews, verification, validation, and changes, and ensuring the traceability and conformity of the products and services to the requirements.

•Managing the design and development changes, by identifying, reviewing, and controlling them, and evaluating their effects on the products and services and the QMS.

In this case, the evidence statements that provide a meaningful audit trail for the design and development process are B, E, and F, because they relate to the design and development controls, the documented information, and the verification activities that are required by the standard. These options can help the auditor to assess the effectiveness and conformity of the design and development process, and to identify any nonconformities or opportunities for improvement. The other options are not directly related to clause 8.3, although they may be relevant for other aspects of the QMS, such as clause 7.2 on competence, clause 7.3 on awareness, clause 7.4 on communication, clause 8.2 on requirements for products and services, clause 8.4 on externally provided processes, products, and services, and clause 8.7 on control of nonconforming outputs. References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Design and Development, ISO 9001 Clause 8.3 Design and development of products and services

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 recognizes change management as essential for maintaining process integrity and preventing nonconformities.

Clause References:

Clause 6.3 (Planning of Changes) → Focuses on long-term changes that may impact QMS integrity.

Clause 8.5.6 (Control of Changes) → Focuses on changes occurring during production and service provision to ensure conformity.

Why is the Correct Answer A?

Clause 8.5.6 applies specifically to operational changes, ensuring that modifications in production or service processes do not compromise quality.

Organizations must document who approves changes, how they are controlled, and how they affect product/service conformity.

Why are the Other Options Incorrect?

B (Changes during design and development) → Covered under Clause 8.3 (Design and Development), not 8.5.6.

C (Changes to legal and regulatory requirements) → Addressed under Clause 4.2 (Interested Parties' Requirements).

D (Leadership responsibilities) → Covered under Clause 5.1 (Leadership and Commitment), not 8.5.6.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 6.4.11 (Closing Meeting):

The audit team must proceed with the audit report, even if the auditee disagrees with findings.

Disagreements do not invalidate audit results.

The auditee has the right to file a complaint or appeal, but this is handled after the audit report is submitted.

Thus, the audit team acted correctly by proceeding with the audit report despite top management’s disagreement.

Comprehensive and Detailed In-Depth Explanation:

Auditors must have competence in risk-based auditing to effectively assess an organization’s QMS performance and compliance.

Clause References:

ISO 19011:2018, Clause 7.2.3 – Determining Auditor Competence:

Auditors must have knowledge of risk-based thinking to assess risk impact on processes.

ISO 9001:2015, Clause 0.3.3 – Risk-Based Thinking:

The standard emphasizes proactive risk management, which auditors must understand.

Why is the Correct Answer B?

Risk-based auditing ensures audits focus on high-risk areas, improving audit effectiveness.

Auditors must assess how organizations apply risk-based thinking in decision-making, process control, and improvement.

Why are the Other Options Incorrect?

A (Industry knowledge) → While helpful, it is not mandatory for all auditors.

C (Expertise in all domains) → Auditors are not required to be experts in all areas, just in audit methodology.

D (Formal degree in quality management) → ISO does not require a formal degree, just competence in audit principles and methods.

Comprehensive and Detailed In-Depth Explanation:

Audit evidence includes information collected through different methods to assess compliance with ISO 9001:2015 requirements.

Clause References:

ISO 19011:2018, Clause 6.4.6 – Audit Evidence: Audit evidence must be objective, verifiable, and based on facts.

ISO 9001:2015, Clause 9.1.1 – Monitoring, Measurement, Analysis, and Evaluation: Requires organizations to collect and analyze data from multiple sources to verify effectiveness.

Types of Audit Evidence Collected in Scenario 3:

Verbal Evidence – Employee interviews regarding training and awareness sessions.

Documentary Evidence – Organizational charts, job descriptions, training records.

Physical Evidence – Workplace observations to assess working conditions.

Why is the Correct Answer B?

The audit team used a combination of verbal (interviews), documentary (records), and physical (site observations) evidence.

This triangulation approach enhances audit reliability and ensures compliance verification.

Why are the Other Options Incorrect?

A (Confirmative evidence) → Not a formal audit term in ISO 9001 or ISO 19011.

C (Analytical evidence) → Incorrect, as analysis was not a primary method used.

D (Qualitative evidence only) → Incorrect because the audit involved both qualitative (interviews) and quantitative (documents, physical) evidence.

Comprehensive and Detailed Explanation: = According to the web search results from my internal tool, a witness audit is a technique used during an accreditation audit, where the accreditation body observes the performance and competence of the certification body auditors in conducting an audit12. A witness audit can also be used by a certification body to monitor and evaluate its own auditors3. During a witness audit, the following roles can be defined:

•An auditor: This is the person who is being witnessed by the accreditation body or the certification body. The auditor is responsible for conducting the audit according to the audit plan, criteria, and standards, and for providing audit evidence and findings123.

•An assessor for the accreditation body: This is the person who witnesses the auditor on behalf of the accreditation body. The assessor is responsible for evaluating the auditor’s performance and competence, and for providing feedback and recommendations to the accreditation body123.

The other options are not defined as witnesses during a witness audit, according to the web search results from my internal tool. They are:

•Someone with a qualification from the certification body: This is not a specific role in a witness audit, as anyone who is involved in the audit process should have a qualification from the certification body. Moreover, having a qualification does not necessarily mean that the person is a witness or an auditor4.

•An existing member of the audit team: This is not a specific role in a witness audit, as the audit team consists of the auditors who are conducting the audit, not the ones who are witnessing it. The witness audit is a separate activity from the audit itself, and the witness should not interfere with the audit process or influence the audit outcome123.

Therefore, the correct answer is B and D.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires specific roles and responsibilities for audit leaders and certification bodies.

Clause References:

ISO 19011:2018, Clause 5.5 – Conducting the Audit: Defines audit team leader responsibilities.

ISO/IEC 17021-1:2015, Clause 9.1.2 – Audit Planning: Defines certification body responsibilities, including the certification agreement.

Why is the Correct Answer D?

The certification agreement is signed between the certification body and the auditee (TD Advertising).

Anne (audit team leader) does NOT have authority to sign the agreement—that is the responsibility of the certification body’s management.

Why are the Other Options Incorrect?

A (Establishing audit criteria and objectives) → Correct responsibility of the audit leader as per ISO 19011.

B (Determining audit feasibility) → Audit leaders assess feasibility but do not sign agreements.

C (Assigning responsibilities for the audit team) → This is part of the audit leader’s role in planning audits.

Sequence:

Stage 1 Audit

Stage 2 Opening Meeting

Interviews

Stage 2 Closing Meeting

Close-out of Stage 2 Audit Findings

Issue Certificate

Surveillance Audit

Follow-up Audit

To complete the sequence, you can drag and drop the options to the appropriate blank section.

Here is a brief explanation of each step:

Stage 1 Audit: This is the initial audit that aims to assess the readiness of the organization for the stage 2 audit. It involves reviewing the documentation of the quality management system, evaluating the scope and objectives of the audit, and identifying any major gaps or nonconformities34.

Stage 2 Opening Meeting: This is the meeting that marks the start of the stage 2 audit. It involves confirming the audit plan, the audit criteria, the audit scope, and the audit team. It also provides an opportunity for the auditee to ask any questions or raise any concerns34.

Interviews: This is the main activity of the stage 2 audit, where the audit team collects evidence by interviewing the personnel involved in the quality management system, observing the processes and activities, and examining the records and documents. The audit team uses various techniques, such as sampling, measurement, analysis, and evaluation, to verify the conformity and effectiveness of the quality management system345.

Stage 2 Closing Meeting: This is the meeting that marks the end of the stage 2 audit. It involves presenting the audit findings, the audit conclusions, and the audit report to the auditee. It also provides an opportunity for the auditee to provide feedback, ask questions, or dispute any findings34.

Close-out of Stage 2 Audit Findings: This is the process of verifying that the auditee has taken appropriate corrective actions to address any nonconformities or opportunities for improvement identified during the stage 2 audit. The audit team may request evidence or conduct a follow-up visit to confirm the effectiveness of the corrective actions34.

Issue Certificate: This is the process of issuing a certificate of conformity to the auditee, if the audit team is satisfied that the quality management system meets the requirements of the standard and that there are no major nonconformities or unresolved issues. The certificate is valid for a specified period, usually three years, and is subject to periodic surveillance audits34.

Surveillance Audit: This is the process of conducting periodic audits, usually once a year, to monitor the continued conformity and effectiveness of the quality management system. It involves reviewing the changes, improvements, and performance of the quality management system, and identifying any new nonconformities or opportunities for improvement34.

Follow-up Audit: This is the process of conducting an additional audit, usually in response to a significant change, a complaint, or a major nonconformity, to verify the impact and the corrective actions taken by the auditee. It may result in the suspension, withdrawal, or renewal of the certificate, depending on the outcome of the audit34.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires organizations to ensure that auditors have the necessary competence and knowledge to conduct audits effectively.

Clause References:

ISO 19011:2018, Clause 7.2.1 – Determining Competence of Auditors: Auditors must have knowledge of applicable legal and regulatory requirements that affect the scope of the audit.

ISO/IEC 17021-1:2015, Clause 7.1.2 – Competence Requirements: Certification bodies must ensure that auditors assigned to the audit team possess relevant knowledge in areas such as legal and regulatory compliance.

Why is the Correct Answer C?

Each audit team member should have sufficient knowledge of relevant legal and regulatory requirements to ensure compliance.

This helps auditors identify gaps or nonconformities related to compliance obligations.

Having multiple team members with knowledge reduces reliance on a single expert and ensures a comprehensive assessment.

Why are the Other Options Incorrect?

A (Only one team member needs knowledge) → Incorrect because audits involve various aspects, and all auditors should have basic awareness of legal and regulatory requirements.

B (Legal knowledge is not necessary) → Incorrect because compliance is essential for QMS effectiveness.

D (Only the lead auditor needs legal knowledge) → Incorrect because ISO requires all auditors to be competent in applicable laws, not just the leader.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence), technical experts:

Provide specialized knowledge in an audit.

Must operate under the supervision of an auditor to ensure compliance with audit protocols.

Cannot work independently or under the auditee’s supervision, as they are not responsible for the audit's findings.

The audit team leader has overall responsibility, but technical experts are supervised by an auditor during the audit process.

Comprehensive and Detailed In-Depth Explanation:

A technical expert is someone with specialized knowledge that helps the audit team understand specific technical aspects of the auditee’s processes.

Clause References:

ISO 19011:2018, Clause 7.3.4 – Use of Technical Experts:

Technical experts support the audit team with specialized knowledge but do not perform the audit themselves.

Why is the Correct Answer B?

A technical expert is needed when auditors lack deep expertise in specific areas, such as engineering, software, or medical devices.

They assist in interpreting complex technical requirements but do not act as auditors.

Why are the Other Options Incorrect?

A (Observer) → Observers do not contribute expertise; they only watch the audit (e.g., trainees).

C (Guide) → Guides help with logistics but do not provide technical expertise.

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).

Here is the correct matching of actions to the statements in the context of leading the internal audit:

If practicablecarry out a formal opening meeting

You should notaudit production (as you are a supervisor in that area, and this would compromise audit objectivity)

You need notchange the audit team (unless there is a specific reason, such as conflict of interest)

You mustraise audit findings if necessary (this is a key responsibility of an auditor when nonconformities are found)

You must notsend the audit report to the Quality Manager (the audit report must be reviewed first; it is typically part of the internal audit process to go through necessary channels before final submission)

You shouldsend the audit report to the Quality Manager (after appropriate reviews and approvals)

This reflects key principles of conducting an internal audit according to ISO 9001:2015, ensuring objectivity, proper documentation, and clear reporting procedures.

According to ISO 19011:2018, clause 6.3.2, an audit plan should include the following information:

The audit objectives, scope, and criteria

The audit team members and their roles and responsibilities

The audit schedule, including the sequence and timings of audit activities, such as opening meeting, document review, interviews, observations, closing meeting, etc.

The expected time and duration of each audit activity and location

The name and contact details of the auditee’s representative and other relevant parties

The allocation of appropriate resources to support the audit activities

The audit methods and techniques to be used, such as interviews, observations, sampling, etc.

The audit documents and records to be prepared and retained

The audit language and communication methods

The audit risks and opportunities and how to address them

The audit follow-up arrangements, if applicable

Therefore, the correct answer is D and F, as they are essential elements of an audit plan. The other options are either irrelevant or optional for an audit plan. References:

ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.2

ISO 19011: Guidelines for Auditing Management Systems | ASQ, section “Making audit arrangements”

ISO 19011 Management Systems Audit Checklist | Process Street, task 6.3.2

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

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

A Stage 1 audit is a preliminary assessment to evaluate the readiness of the organisation for the Stage 2 certification audit. The audit scope is defined by the audit client and the certification body based on the application and the contract. If the organisation wants to include a new work area that was not part of the original scope, the auditor should advise the Quality Manager that an extension of the scope is possible but will have to go through established procedures, such as submitting a formal request, providing relevant information, and paying additional fees. The auditor should also suggest that the Quality Manager will advise the programme manager, who is responsible for managing the audit programme, that the audit scope should be revised to include the new work area. The programme manager will then decide whether to approve or reject the request, and communicate the decision to the auditor and the Quality Manager. The auditor should not proceed with the audit of the new work area without the approval of the programme manager and the confirmation of the audit scope. 1234 References:

1: ISO 19011:2018 - Guidelines for auditing management systems

2: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified

3: What is the difference between Stage 1 and Stage 2 Audits? - ISO Update

4: Getting Certified to ISO 9001 - the Stage 1 Audit

Comprehensive and Detailed Explanation From Exact Extract:

Clause 9.1.1 – Monitoring, measurement, analysis and evaluation (General) requires the organization to:

“Determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results, and when results shall be analyzed and evaluated.”

The goal is to ensure valid, reliable, and consistent measurement of process and product performance. Here's how each correct option supports compliance:

✅ B. Analysis of the results of sensory tests

This directly aligns with the requirement for analysis and evaluation of monitoring results. Clause 9.1.3 also supports the use of such data for evaluating product conformity and process effectiveness.

✅ G. Sensory testing results are recorded

This supports documented evidence of monitoring results, as required under 9.1.1(e), to verify that quality checks (such as flavor and aroma assessments) are being done consistently.

✅ H. The Hedonic Method is used to monitor the quality of the product

Use of a standardized measurement method like the Hedonic Scale aligns with 9.1.1(b), which requires defined methods to ensure valid and reproducible results.

Why the Other Options Are Incorrect or Less Relevant:

A. University degrees → Related to competence (Clause 7.2), not monitoring and measurement (Clause 9.1.1).

C. Independent expert review → Not part of regular monitoring unless it’s built into the process.

D. Respiratory testing → Irrelevant to product quality monitoring.

E. Outsourcing → Would shift responsibility but doesn’t demonstrate internal conformance.

F. Safe disposal → Pertains to Clause 8.5.4 (Preservation), not Clause 9.1.1.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires collaboration between the auditee (TD Advertising), the certification body, and the audit leader when making changes to audit scope.

Clause References:

ISO/IEC 17021-1:2015, Clause 9.2.3 – Conducting the Audit: Any change in audit scope must be agreed upon by all parties before proceeding.

Why is the Correct Answer C?

TD cannot unilaterally change the scope without agreement from the certification body and audit leader.

The certification body must ensure the scope remains relevant and that resources are allocated properly.

Why are the Other Options Incorrect?

A (Anne cannot withdraw) → Incorrect, Anne CAN withdraw if the changes make the audit unfeasible, but she must consult with the certification body first.

B (TD cannot change the scope) → Incorrect, scope changes are allowed but must be formally approved.

D (Anne has full authority to reject scope changes) → Incorrect, scope changes require mutual agreement among all parties.

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.

When conducting a third-party audit to ISO 9001, especially in the context of training and corrective actions taken due to customer complaints, the most appropriate audit trails to follow would be:

A. Ask if customer complaints had ceased since the multi-skilled training finished. This audit trail is relevant because it directly relates to the effectiveness of the corrective action taken. If customer complaints have decreased or ceased, it could indicate that the additional training was effective1.

F. Review records to assess if all planned training has been completed. This trail is important to ensure that the training plan has been fully implemented and to verify that all staff members have received the necessary training. It also helps in assessing the adequacy of the training in terms of content, frequency, and outcomes1.

These two trails, A and F, are closely linked to the issue of customer complaints and the organization’s response to them. They provide insight into whether the actions taken were suitable and whether they have led to improvements in staff performance and customer satisfaction1. The other options, while potentially useful, do not directly address the immediate concern of the effectiveness of the corrective actions taken in response to the customer complaints1.

Comprehensive and Detailed In-Depth Explanation:

Auditors must report findings truthfully and accurately to ensure an unbiased assessment of the QMS.

Clause References:

ISO 19011:2018, Clause 4 – Principles of Auditing:

Fair Presentation → Requires auditors to report truthfully and accurately, without bias or omission.

Integrity → Ensures auditors adhere to ethical conduct.

Why is the Correct Answer A?

The audit team reported findings truthfully, based on collected evidence.

Fair presentation ensures that both positive and negative findings are included in the audit report.

Objective evidence was gathered through interviews, document reviews, and observations.

Why are the Other Options Incorrect?

B (Integrity) → Related to ethics and professional conduct, but not specifically about presenting findings.

C (Confidentiality) → Important, but does not apply to the principle of reporting findings accurately.

D (Objectivity) → Ensures impartiality, but "fair presentation" directly addresses accurate reporting of findings.

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.

Here is the correct matching of ISO 9001:2015 clauses to the steps mentioned in the change management process:

We identified risks and opportunities and fed these into our risk management processes.

Clause 6.1 (Actions to address risks and opportunities)

We found a suitable supplier.

Clause 8.4 (Control of externally provided processes, products, and services)

We monitored customer feedback and noticed an increase in negative feedback about lead times.

Clause 9.1.2 (Customer satisfaction)

We put together a plan for implementation.

Clause 6.2.2 (Planning to achieve quality objectives)

We monitored the performance of the new supplier.

Clause 8.4.2 (Type and extent of control of external providers)

We noticed that productivity targets were being missed.

Clause 9.1.1 (Monitoring, measurement, analysis, and evaluation)

We communicated the plan internally.

Clause 7.4 (Communication)

We looked at the data at the management review and decided we needed to do something different.

Clause 9.3.2 (Management review inputs)

We reorganised the staffing and implemented redundancies.

Clause 7.1.2 (People)

We set an objective to effectively implement the transition and outsource manufacturing.

Clause 6.2.1 (Quality objectives and planning to achieve them)

This aligns the steps of the change process with relevant ISO 9001:2015 clauses related to risk, planning, communication, and monitoring.

Non-Conformity Report:

ISO 9001 Clause Number

Nature of Problem

ISO 9001 Requirement That Has Not Been Fulfilled

6.1.1

Several risks and opportunities have not been determined.

"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed."

6.1.2 (a)

Actions to address risks and opportunities not planned.

"The organization shall plan actions to address risks and opportunities."

Step-by-Step Reasoning:

Clause 6.1.1 - Determining Risks and Opportunities:

Requirement: The organization must determine risks and opportunities that are relevant to its Quality Management System (QMS). This ensures that the QMS achieves intended results and prevents undesired effects.

Problem Identified: While some risks and opportunities were discussed, the organization did not perform a systematic evaluation of all risks (e.g., health and safety legislation changes, retiring trainers).

Clause 6.1.2 (a) - Planning Actions for Risks and Opportunities:

Requirement: The organization must plan actions to address identified risks and opportunities. These actions should be integrated into the QMS processes to ensure continuous improvement.

Problem Identified: The Quality Systems Manager confirmed that no plans were made to address the risks and opportunities because the Managing Director deemed it unnecessary. This violates the requirement to plan actions.

Correct Options Selected:

Clause 6.1.1 with the nature of the problem as: "Several risks and opportunities have not been determined."

Clause 6.1.2 (a) with the nature of the problem as: "Actions to address risks and opportunities not planned."

ISO 9001 Requirements Not Fulfilled:

For 6.1.1:"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed."

For 6.1.2 (a):"The organization shall plan actions to address risks and opportunities."

The tasks that are expected to be completed at the audit team meeting of a third-party audit team leader and his audit team in preparation for a Closing meeting for a four-day initial certification audit are:

•Option C: Final audit team meeting to agree findings and categories including clarification of any uncertainties. This option is correct because the audit team meeting is an opportunity for the audit team leader and the audit team members to review and consolidate the audit findings, to ensure that they are clear, accurate, objective, and supported by sufficient audit evidence. The audit team should also agree on the categories of the findings, such as nonconformity, observation, or opportunity for improvement, and resolve any uncertainties or disagreements among the audit team members.

•Option D: Agree the roles of each audit team member for the closing meeting. This option is correct because the audit team meeting is an opportunity for the audit team leader to assign the roles and responsibilities of each audit team member for the closing meeting, such as presenting the audit findings, answering questions, or taking notes. The audit team leader should also ensure that the audit team members are prepared and confident to perform their roles and to communicate effectively with the auditee.

•Option E: Audit team review any points raised by the auditee nominated representative. This option is correct because the audit team meeting is an opportunity for the audit team to review any points raised by the auditee nominated representative during the audit, such as requests for clarification, feedback, or complaints. The audit team should consider the validity and relevance of the points raised and decide how to address them in the closing meeting or in the audit report.

•Option F: Audit team agree final audit outcome recommendation. This option is correct because the audit team meeting is an opportunity for the audit team to agree on the final audit outcome recommendation, based on the audit findings and the audit criteria. The audit team should also consider the implications and consequences of the audit outcome recommendation for the auditee and the certification body, and ensure that the recommendation is consistent and justified.

•Option H: Audit team complete final version of their individual findings. This option is correct because the audit team meeting is an opportunity for the audit team to complete the final version of their individual findings, based on the agreement and feedback from the audit team meeting. The audit team should ensure that their individual findings are written in a clear, concise, and factual manner, and that they include the audit criteria, the audit evidence, and the audit conclusion. The audit team should also submit their individual findings to the audit team leader for review and approval.

•Option I: Re-audit corrective actions taken to correct findings found during the audit. This option is correct because the audit team meeting is an opportunity for the audit team to re-audit the corrective actions taken by the auditee to correct the findings found during the audit, if applicable and feasible. The audit team should verify the effectiveness and adequacy of the corrective actions and update the audit findings accordingly. The audit team should also document the results of the re-audit and communicate them to the auditee.

The following options are not correct:

•Option A: Audit team leader informs the individual(s) managing the audit programme that the closing meeting is ready to be held. This option is not correct because this task is not part of the audit team meeting, but part of the communication between the audit team leader and the individual(s) managing the audit programme. The audit team leader should inform the individual(s) managing the audit programme that the closing meeting is ready to be held after the audit team meeting, when the audit team has completed all the tasks and is ready to present the audit results to the auditee.

•Option B: Hold daily audit team meeting to review any timetable issues and potential findings and their impact on the audit for other team members. This option is not correct because this task is not part of the final audit team meeting, but part of the daily audit team meetings that are held during the audit. The daily audit team meetings are opportunities for the audit team to review the progress and performance of the audit, to identify and resolve any issues or problems, and to coordinate and adjust the audit plan and activities as needed.

•Option G: Audit team leader completes final report, including individual findings and certification recommendation. This option is not correct because this task is not part of the audit team meeting, but part of the audit reporting process. The audit team leader should complete the final report, including the individual findings and the certification recommendation, after the closing meeting, when the audit team has received and considered the feedback and comments from the auditee. The audit team leader should also ensure that the final report is reviewed and approved by the appropriate authorities before issuing it to the auditee and the certification body.

•Option J: Write the audit finding report out when detected and obtain signature of the auditee. This option is not correct because this task is not part of the audit team meeting, but part of the audit evidence collection and documentation process. The audit team should write the audit finding report out when detected and obtain the signature of the auditee during the audit, when the audit team has observed and verified the audit evidence and has communicated the audit finding to the auditee. The signature of the auditee does not indicate acceptance or agreement with the audit finding, but only acknowledgement of receipt.

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.

Evaluate the effectiveness of the management system: This objective involves verifying that the quality management system meets the requirements of a specific standard, such as ISO 9001:2015, and that it achieves the intended results and outcomes. The audit team will collect and analyse audit evidence to determine the degree of conformity and performance of the quality management system23.

•Evaluate the capability of the management system to establish and achieve objectives: This objective involves verifying that the quality management system supports the strategic direction and policies of the organization, and that it addresses the needs and expectations of the interested parties. The audit team will assess the suitability, adequacy, and alignment of the quality management system objectives, and the effectiveness of the planning and implementation processes to achieve them23.

The other options are not the most relevant objectives of a third-party audit, according to the web search results from my internal tool. They may be related to other aspects or types of audits, but they are not the focus of a third-party audit.

Therefore, the correct answer is B and D.

Comprehensive and Detailed In-Depth Explanation:

ISO 9000:2015 defines quality as "the degree to which a set of inherent characteristics of an object fulfills requirements."

Clause 3.6.2 (Quality) confirms this definition.

Quality is determined by how well an object (product, service, or process) meets defined requirements (customer, regulatory, or internal).

The other options do not align with the official ISO definition:

Option A refers to performance capability but does not define quality.

Option C describes work conditions, not quality.

Option D focuses on efficiency rather than fulfilling requirements.

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

In this scenario, the auditee is facing a legal dispute with a customer over damage to an expensive cashmere coat. This is a nonconformity that arises from customer complaint and has a significant impact on customer satisfaction and reputation. Therefore, clause 10.2 applies to this situation.

The best option for how this should be handled by the Quality Management System is B.

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

The other options are not appropriate because:

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

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

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

Questions no: 16 Verified Answer: = C. 7.4 Communication Comprehensive But Short Explanation: = Clause 7.4 of ISO 9001:2015 requires the organization to determine the internal and external communications relevant to the quality management system, including what will be communicated, when, with whom, and how. The scenario indicates a potential gap in communication with subcontractors regarding the Quality Policy, objectives, and plans to address risks and opportunities, which is a requirement even if the subcontractors have their own ISO 9001 certified systems123. References: = This response is based on the general requirements of ISO 9001:2015 related to communication with external parties, such as subcontractors, as outlined in various resources discussing Clause 7.4123.

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

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

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

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

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

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

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

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

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

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

Why Not the Other Options:

Comprehensive and Detailed In-Depth Explanation:

The PDCA (Plan-Do-Check-Act) cycle is a continuous improvement model used in ISO 9001:2015. The "Check" phase involves monitoring, measuring, and analyzing the results to assess if the planned actions have been effective.

In scenario 1, AL-TAX tested the effectiveness of the intended actions, which aligns with the Check stage of the PDCA cycle. Clause 9.1.1 (Monitoring, Measurement, Analysis, and Evaluation) requires organizations to evaluate their QMS and determine whether improvements are necessary.

According to the ISO 9000:2015 - Quality management systems — Fundamentals and vocabulary, correction is defined as “action to eliminate a detected nonconformity”. A nonconformity is defined as “non-fulfilment of a requirement”. Therefore, the process of modifying a non-conforming product to bring it within acceptance criteria is a correction, as it eliminates the non-fulfilment of the product specification. The other options are not correct, as they have different definitions and purposes:

•Concession: permission to release or use a nonconforming product, service or process

•Corrective action: action to eliminate the cause of a nonconformity and to prevent recurrence

•Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation

ISO/IEC 17021-1 is the standard that specifies requirements for bodies providing audit and certification of management systems. It includes provisions for determining audit time for third-party certification audits, ensuring that the audits are conducted in a consistent, comparable, and reliable manner, which can be applied to a variety of management systems, including ISO 9001.

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.

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.

Comprehensive and Detailed In-Depth Explanation:

During communication with top management, the auditor should discuss:

The quality policy (ISO 9001:2015, Clause 5.2.1), ensuring that it is established, communicated, and understood.

Internal audits (ISO 9001:2015, Clause 9.2), verifying that they are planned and effectively implemented.

These discussions help assess leadership commitment and the effectiveness of the QMS.

According to the ISO 9001:2015 standard, clause 10.2.1 defines nonconformity as the non-fulfilment of a requirement. A requirement can be related to the quality management system, the products and services, the customer expectations, or the applicable statutory and regulatory requirements. Nonconformities can be detected through various sources, such as audits, inspections, tests, customer complaints, or internal reviews. Nonconformities must be addressed by taking appropriate actions to correct them and prevent their recurrence.

In this scenario, the auditee has shown several issues that indicate nonconformities in their quality management system. Two statements that apply to the term nonconformity are:

A. No quality objectives planned for the top management team: According to ISO 9001, clause 6.2.1, the organization must establish quality objectives at relevant functions, levels, and processes. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The top management team is responsible for providing leadership and direction for the quality management system and ensuring its alignment with the organization’s purpose and context. Therefore, the absence of quality objectives for the top management team is a nonconformity as it violates the requirement of clause 6.2.1.

E. Quality improvements not aligning with the quality policy: According to ISO 9001, clause 5.2.1, the quality policy is a statement of the organization’s intentions and direction regarding quality, as formally expressed by top management. The quality policy must provide a framework for setting quality objectives and be compatible with the context and strategic direction of the organization. The quality policy must also be communicated, understood, and applied within the organization. Therefore, if the quality improvements are not aligned with the quality policy, it is a nonconformity as it violates the requirement of clause 5.2.1.

When an organization wishes to extend the scope of their current certification to include new services or activities, such as the printing and compilation of computer documentation packages, it requires an extension to the scope of the audit. This involves a formal application process with the certification body to ensure that the new activities are included in the audit plan and that the organization’s quality management system encompasses these new processes12. References: = The answer is based on the ISO 9001 Auditing Practices Group guidance on scope and applicability, which outlines the need for a formal application process when there is a change in the scope of the quality management system that affects the certification1. Additionally, the UKAS guide on the extension to scope (ETS) process provides information on how changes to the scope, including the addition of new services, require a formal application2.

Comprehensive and Detailed In-Depth Explanation:

A guide is assigned by the auditee to assist the audit team by:

Managing logistics, such as ensuring that relevant documents are available and arranging interviews.

Assisting in the coordination of meetings and access to facilities.

Helping the auditors navigate the organization during the audit.

However, the guide does not fill gaps in the auditor’s knowledge or witness the audit for the certification body. Their primary function is logistical support, not providing interpretations or assessments.

The ISO 9001 Lead Auditor exam requires the auditor to have a thorough understanding of the ISO 9001:2015 standard and its requirements, as well as the organization’s context, processes, risks, opportunities, and performance. Therefore, the auditor needs to ask for additional information that can help them verify these aspects during the audit planning stage. Some of the information that can be useful are:

A description of responsibilities and authorities of the key roles of XYZ: This can help the auditor to identify who is accountable for what in the organization and how they communicate with each other.

The number of personnel involved in activities related to the quality management system: This can help the auditor to assess if there are enough resources and competencies to support the QMS implementation and operation.

Information to understand XYZ’s operations: This can help the auditor to understand how XYZ produces or delivers its products or services and what are its main processes and inputs.

The results of XYZ’s last internal audit: This can help the auditor to evaluate if XYZ has implemented corrective actions based on previous audit findings and if it has maintained its QMS effectiveness.

The results of the last two management reviews: This can help the auditor to determine if XYZ has monitored its QMS performance against its objectives and if it has identified any significant changes or opportunities for improvement.

The quality manual (B) is not a required document for ISO 9001 certification, but it may be useful for internal reference or training purposes. It is not necessary for audit planning.

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.