PECB ISO-9001-Lead-Auditor QMS ISO 9001:2015 Lead Auditor Exam Exam Practice Test

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 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.

Approve Certification Body: Accreditation Body

Award certification: Certification Body

Recommend certification: Audit Team Leader

Maintain certification:

Comprehensive Detailed ExplanationIn the context of a third-party ISO 9001 audit, different entities play specific roles in the certification process. Here's a detailed explanation of the responsibilities:

Approve Certification Body: Accreditation BodyThe Accreditation Body is responsible for approving Certification Bodies. Accreditation Bodies are independent entities that evaluate the competence of Certification Bodies, ensuring they meet international standards like ISO/IEC 17021, which sets out the criteria for bodies providing audit and certification of management systems. In this role, they confirm that the Certification Body is capable of conducting ISO 9001 audits and granting certifications in accordance with international guidelines.

Award Certification: Certification BodyThe Certification Body is the entity that ultimately awards the certification to an organization after verifying that it meets the ISO 9001 standards. Certification Bodies conduct audits, either directly or through a team of auditors, and based on the audit outcomes, they issue the certification, indicating that the organization complies with ISO 9001.

Recommend Certification: Audit Team LeaderThe Audit Team Leader is responsible for leading the audit and making a recommendation to the Certification Body. This recommendation is based on the audit findings—whether the organization meets the ISO 9001 requirements or if there are areas of non-compliance that need corrective action. The final decision on certification is not made by the Audit Team Leader but by the Certification Body.

Maintain Certification: Certification BodyMaintaining certification refers to the ongoing process of ensuring that an organization continues to comply with ISO 9001 requirements. The Certification Body conducts regular surveillance audits (e.g., annually) and may also perform recertification audits (typically every three years). This ongoing monitoring ensures that the certified organization continues to adhere to the quality management standards over time.

This breakdown clearly assigns responsibility based on the defined roles of Accreditation Bodies, Certification Bodies, and Audit Teams in the ISO 9001 certification process.

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:

•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.

•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.

•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.

•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.

•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.

In this case, the evidence statements that demonstrate a nonconformity with clause 8.4 are A and C, because they show that the organization did not retain documented information of the selection and evaluation of the external provider, and the monitoring of the external provider’s performance. These are requirements of the standard and essential for ensuring the quality of the externally provided processes, products, and services. The other options are not directly related to clause 8.4, although they may indicate other nonconformities or weaknesses in the organization’s QMS. For example, option B may relate to clause 7.1.3 on contingency planning, option D may relate to clause 8.2.3 on review of requirements, option E may relate to clause 8.6 on release of products and services, and option F may relate to clause 5.1.1 on leadership and commitment. References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems

According to the ISO - Management system standards page, the key benefits of an effective management system include improved operational effectiveness and efficiency, improved risk management and protection of people and the environment, and enhanced drive for innovation. The Integrated Use of Management System Standards (IUMSS) handbook also states that the purpose and objectives of management system standards are to help organizations improve their performance by specifying repeatable steps that organizations consciously implement to achieve their goals and objectives.

Therefore, the complete sentence is:

“The purpose of a management system standard is to improve the performance of an organisation.”

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

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

Focusing on enhancing customer satisfaction.

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

According to the ISO 9001:2015 document, the organisation must continually improve the suitability, adequacy, and effectiveness of the quality management system1. However, among the six options given, only effectiveness is directly mentioned as an aspect of the quality management system that must be continually improved. Therefore, C is one of the correct answers.

Efficiency, on the other hand, is not explicitly stated as an aspect of the quality management system that must be continually improved, but it is implied by the quality management principle of improvement, which states that successful organisations have an ongoing focus on improvement2. One of the key benefits of applying this principle is improving operational effectiveness and efficiency2. Therefore, E is another correct answer.

Suitability, adaptability, responsiveness, and applicability are not aspects of the quality management system that must be continually improved, according to the ISO 9001:2015 document. They may be related to the quality management system, but they are not the focus of continual improvement.

Therefore, the correct answer is C and E.

References: 1: ISO 9001:2015 - Quality management systems — Requirements 2: ISO - Quality management principles

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.

According to ISO 19011:2018, clause 6.7, the audit follow-up is the process of verifying the completion and effectiveness of corrective actions taken by the auditee as a result of an audit. The audit follow-up can include two main activities:

Verifying the effectiveness of the implemented corrective actions: this means checking whether the actions taken by the auditee have addressed the root causes of the nonconformities and prevented their recurrence or occurrence in other areas. The verification can be done by reviewing documents, records, data, or other evidence provided by the auditee, or by conducting a follow-up audit on site or remotely.

Verifying corrections taken to fix the reported non-conformities: this means checking whether the auditee has corrected the nonconformities identified during the audit and eliminated their immediate effects. The verification can be done by reviewing documents, records, data, or other evidence provided by the auditee, or by conducting a follow-up audit on site or remotely.

The audit follow-up can be conducted as a separate audit or as part of a subsequent audit, depending on the audit programme, the audit objectives, the audit criteria, the audit scope, the audit risks, and the audit findings. The audit follow-up should be planned and conducted in accordance with the same principles and processes as the initial audit, and the results should be documented and reported accordingly. References:

ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.7

ISO 19011 Management Systems Audit Checklist | Process Street, task 6.7.1 and 6.7.2

Conducting the Audit Follow-Up: When to Verify - The Auditor, section “Conducting the audit follow-up”

According to the ISO 9001:2015 standard, clause 8.4.1 requires organizations to ensure that externally provided processes, products and services conform to requirements. Controls must be applied to externally provided processes, products and services when:

The products and services are intended for incorporation into the organization’s own products and services.

They are provided directly to customers by the external provider on behalf of the organization.

A process, or part of a process, is provided by an external provider as a result of a decision by the organization.

In this scenario, the auditee has chosen a supplier to manufacture their own brand products based on their design drawings, supplier questionnaire and trial batches. This means that the supplier is providing a process (manufacturing) as a result of a decision by the organization (the auditee). Therefore, clause 8.4.1 applies to this situation.

According to ISO 19011:2018, clause 6.3, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the information listed in my previous response, such as the audit objectives, scope, criteria, schedule, team, methods, report, etc. The audit plan should be prepared and completed prior to the on-site audit, and should be communicated to the audit team and the auditee1.

According to ISO 19011:2018, clause 6.4.3, the checklist / prompts are documents that list the questions or topics that need to be covered during an audit. The checklist / prompts can help the auditor to collect and verify information relevant to the audit criteria, and to ensure the consistency and completeness of the audit. The checklist / prompts should be prepared and completed prior to the on-site audit, and should be based on the audit plan and the audit scope and objectives1.

Therefore, the two documents that an auditor needs to prepare and complete prior to the on-site audit are B and D, as they are essential for planning and conducting the audit. The other options are not correct, as they are either prepared or completed after the on-site audit, or not required by the standard:

•A. Audit Report: The audit report is a document that provides a complete, accurate, concise, and clear record of the audit. The audit report should include the information listed in my previous response, such as the audit objectives, scope, criteria, findings, conclusions, etc. The audit report should be prepared and completed after the on-site audit, and should be distributed to the audit client and the auditee1.

•C. Procedures: Procedures are documents that specify the way activities are to be performed. Procedures may be part of the audit criteria, if they are part of the organization’s management system, or part of the audit programme, if they are part of the certification body’s or registrar’s requirements. Procedures are not prepared or completed by the auditor prior to the on-site audit, but rather reviewed or followed by the auditor during the audit1.

•E. Risk Matrices: Risk matrices are tools that help to assess and prioritize the risks and opportunities associated with the audit programme or the audit. Risk matrices may be part of the audit programme management, if they are used to determine and evaluate the audit programme risks and opportunities, or part of the audit preparation, if they are used to determine and evaluate the audit risks and opportunities. Risk matrices are not prepared or completed by the auditor prior to the on-site audit, but rather used or updated by the auditor during the audit programme management or the audit preparation1.

•F. Findings: Findings are the results of the evaluation of the collected audit evidence against the audit criteria. Findings can indicate either conformity or nonconformity, as well as positive aspects or opportunities for improvement. Findings are not prepared or completed by the auditor prior to the on-site audit, but rather generated and recorded by the auditor during the audit activities1.

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

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.

Analyzing Each Statement:

A.Incorrect. The audit team leader must communicate concerns as they arise, not just during the closing meeting. Per ISO 19011:2018 Clause 6.4.9, significant concerns should be shared promptly with the auditee and audit client during the audit process to allow for immediate understanding and potential resolution.

B.Incorrect. The auditor or team leader is not specifically required to inform the general manager about uncontrolled documents. Instead, the issue is communicated within the framework of the audit findings to the audit client or auditee, as appropriate.

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

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

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

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

The following options are not correct:

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

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

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

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

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

References:

•ISO 9001:2015 Quality management systems - Requirements

•ISO 9001 Lead Auditor Course Material, Module 6: Reporting Audit Findings, Slide 14: Writing Nonconformity Statements

•ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 6.2: Reporting Audit Findings

•Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies

Here is the correct matching of the activities with the responsible parties in the context of a second-party audit:

Define the audit scope: Customer

Develop the audit plan: Audit team leader

Respond to the audit findings: External provider

Conduct the audit: Audit team

This reflects the typical division of responsibilities in a second-party audit, where the customer (the party commissioning the audit) sets the scope, the audit team leader manages the planning, the external provider responds to findings, and the audit team carries out the audit.

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.

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.

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

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

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

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.

References: ISO/IEC 17021-1; IAF Mandatory Document for the Determination of Audit Time of Quality and Environmental Management Systems Certification

According to clause 4.1 of ISO 9001:2015, the organization should determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended results of its quality management system. The organization should monitor and review these issues and update them as necessary. Although the standard does not explicitly require documented information of these issues, it does require documented information as evidence of the implementation of the actions taken to address risks and opportunities, as per clause 6.1. The organization should also retain documented information as evidence of the results of the monitoring, measurement, analysis and evaluation of its QMS, as per clause 9.1. Therefore, the auditor should not accept the legal compliance expert answering the question, as he is not the person responsible for the process and may not have the necessary competence or knowledge of the QMS. The auditor should also look for evidence that the actions resulting from the risk assessment had been taken, as this is a requirement of the standard and a way to verify the effectiveness of the QMS. The other options are not appropriate courses of action for the auditor, because they do not address the audit objective or criteria, or they may compromise the audit integrity or impartiality. For example, option B may not be feasible or reliable, as the Technical Manager may not be available or able to provide the necessary evidence by phone. Option C may cause unnecessary delay and inconvenience for the audit process and the auditee. Option E may not solve the problem, as the guide is not the main source of evidence or information for the audit. Option F may be disrespectful or unprofessional, as the consultant may have a legitimate role or interest in the audit. References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Context of the Organization, ISO 9001 Auditing Practices Group Guidance on Audit Evidence

The audit team leader should deal with this situation in a professional and ethical manner, while maintaining the integrity and credibility of the audit process and the audit findings. The audit team leader should also try to resolve the conflict with the Quality Manager in a constructive and respectful way, without compromising the audit objectives or the audit team’s independence and impartiality. According to the ISO 9001 Lead Auditor Reference Materials guides and documents, the possible actions that the audit team leader might take are:

•A. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered. This action is consistent with the principle of evidence-based approach, which states that the audit team should collect and verify information that is appropriate, sufficient, and reliable to support the audit findings and conclusions. The audit team leader should explain to the Quality Manager that the nonconformities are not based solely on the photographs, but on other audit evidence that corroborates them. The audit team leader should also remind the Quality Manager that the nonconformities are subject to review and approval by the certification body, and that any attempt to influence or interfere with the audit results would be considered a breach of the audit agreement and the certification rules.

•D. State that the auditor will take no further part in the audit and all his photographs will be deleted. This action is consistent with the principle of confidentiality, which states that the audit team should exercise discretion in the use and protection of information acquired during the audit. The audit team leader should acknowledge that the auditor’s behavior was inappropriate and unprofessional, and that he violated the audit rules and the auditee’s rights. The audit team leader should apologize for the inconvenience and the discomfort caused by the auditor, and assure the Quality Manager that the auditor will be removed from the audit team and that his photographs will be erased from his phone and any other device or media. The audit team leader should also inform the auditor of his misconduct and the consequences, and report the incident to the audit program manager and the certification body.

•F. 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. This action is consistent with the principle of communication, which states that the audit team should exchange information with the auditee in a timely, open, honest, and respectful manner. The audit team leader should express his concern and his willingness to address the issue with the auditor, and ask for the Quality Manager’s patience and cooperation. The audit team leader should also explain that the audit process is not finished yet, and that the Closing meeting is an opportunity to present and discuss the audit findings and conclusions, and to seek feedback and clarification from the auditee. The audit team leader should then speak to the auditor privately, and follow the steps described in action D.

The other options are not appropriate or effective ways to deal with this situation, because they either:

•B. Delay the Closing meeting until the audit team leader has consulted his audit program manager at Head Office. This action would disrupt the audit schedule and the audit plan, and create unnecessary delays and costs for both the audit team and the auditee. It would also show a lack of leadership and decision-making skills from the audit team leader, and undermine his authority and credibility. The audit team leader should be able to handle the situation on site, and consult his audit program manager only if the situation escalates or becomes unmanageable.

•C. Advise the Quality Manager that the auditor will be reported to Head Office. This action would escalate the conflict and create a hostile and defensive atmosphere between the audit team and the auditee. It would also imply that the audit team leader is not capable or willing to resolve the issue himself, and that he is threatening or punishing the auditee for raising a legitimate concern. The audit team leader should try to defuse the tension and restore the trust and the rapport with the Quality Manager, and report the auditor to Head Office only after the audit is completed and the audit report is submitted.

•E. Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting. This action would not address the root cause of the problem, and would not prevent the auditor from taking more photographs or using them for other purposes. It would also expose the audit team and the auditee to unnecessary risks and liabilities, and compromise the confidentiality and the security of the audit information. The audit team leader should delete the photographs as soon as possible, and not wait until the Closing meeting.

References: ISO 9001:2015, ISO 19011:2018, PECB Certified ISO 9001 Lead Auditor, Common Audit Problems and How to Deal with Them, The Auditor’s Guide to Conflict Resolution, Conflict Resolution in your Audit Career, How to Be a Good Auditor as a Team Leader

According to ISO 9001:2015, clause 8.4, an organization is required to control the processes, products and services provided by external providers, including those that affect the quality of the organization’s own products and services. This includes determining the controls to be applied to the external provision of processes, products and services, as well as the information to be communicated to the external providers. The organization is also required to monitor, measure, and evaluate the performance of the external providers and retain documented information of these activities.

Therefore, in the scenario given, ABC Ltd is responsible for controlling the processes, products and services provided by Teak Ltd, as they affect the quality of ABC Ltd’s own products and services. This means that ABC Ltd should have established criteria and methods for evaluating the performance of Teak Ltd, as well as documented information of the results of such evaluation. ABC Ltd should also have defined the supply arrangements with Teak Ltd, including the specifications, requirements, and verification activities related to the products and services provided by Teak Ltd.

Hence, the best options to describe how to plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd are A and D, as they are aligned with the requirements of ISO 9001:2015, clause 8.4. The other options are either irrelevant or beyond the scope of the audit, as they do not pertain to the control of external provision by ABC Ltd.

References:

ISO 9001:2015(en), Quality management systems — Requirements, clause 8.4

ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.1 and 6.4.2

ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section “Learning objectives”

ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6

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.

References:

ISO 9000:2015 - Quality management systems — Fundamentals and vocabulary

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

In this scenario, the audit team leader must balance maintaining the integrity of the audit plan while considering the auditee’s request. The two best responses allow for flexibility without compromising the audit's rigor:

A. I could audit the other laboratories virtually at the end of this audit: Virtual audits can be a valid option, especially in multi-site audits. ISO 9001:2015 does not prohibit virtual audits, and in certain situations, they are practical for reviewing documentation or observing operations remotely.

C. I could try to revise the audit programme to see if I can audit all laboratories: Revising the audit programme to accommodate additional site visits is a reasonable compromise. ISO 9001:2015 audits are based on risk and sampling, but the audit team leader has the flexibility to adjust the audit scope if it fits within the audit duration and resources.

The other options, such as extending the audit duration (B, F) or strictly adhering to the original plan (D, E), may not be practical or necessary. Revising the plan to audit all laboratories or using virtual auditing ensures that the audit remains efficient while addressing the organization's concerns​.

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.

References:

ISO 9001:2015(en), Quality management systems — Requirements, clause 6.2.1 and 7.5.1

ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2

ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section “Learning objectives”

ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6

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

References: ISO 9000:2015 - Quality management systems — Fundamentals and vocabulary, ISO 9001 nonconforming product: How to understand dispositions - Advisera

Based on the scenario and the concept of an ‘audit trail’ within the context of ISO 9001, the three statements that apply would likely be:

A. Decisions on improvement action timescales not involving departmental managers. This indicates a lack of involvement and communication with those responsible for implementing the improvements, which is a key part of an effective audit trail1.

B. Evaluation of the results of the improvement action not always documented by the Quality Manager. Proper documentation is essential for an audit trail, as it provides evidence that actions have been evaluated and are effective1.

C. Limited knowledge of the content of Quality Improvement Requests by departmental staff. An audit trail should ensure that all relevant parties are aware of and understand the actions being taken, which is not the case here1.

These points suggest issues with the communication, documentation, and involvement of relevant personnel in the quality management system processes, which are crucial for maintaining an effective audit trail and, by extension, a robust quality management system.

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

The correct answer is:

Event

Selecting audit team = Individual(s) managing the audit programme

Conducting the audit = Audit team

Preparing the audit plan = Audit team leader

Requesting the audit = Audit client

To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below. Alternatively, drag and drop each option to the appropriate blank section. Responsibility:- Individual(s) managing the audit programme

Audit team

Audit team leader

Audit client

According to ISO 19011:2018, clause 5.3, the individual(s) managing the audit programme are responsible for selecting the audit team, taking into account the competence and availability of the auditors and any experts needed. 1

According to clause 6.2, the audit team is responsible for conducting the audit, which includes collecting and verifying audit evidence, evaluating audit findings, and preparing the audit report. 1

According to clause 6.1, the audit team leader is responsible for preparing the audit plan, which includes defining the audit objectives, scope, criteria, and duration, as well as assigning roles and responsibilities to the audit team members. 1

According to clause 5.2, the audit client is the person or organization that requests the audit, which can be the auditee (the person or organization being audited) or any other person or organization that has an interest in the audit results. 1

References:

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