[Q15-Q30] Dumps for Free PECB ISO-9001-Lead-Auditor Practice Exam Questions [Apr 02, 2024]

Dumps for Free PECB ISO-9001-Lead-Auditor Practice Exam Questions [Apr 02, 2024] 

ISO-9001-Lead-Auditor Dumps PDF And Certification Training

NEW QUESTION # 15
Which one of the following options best describes the purpose of a Stage 1 third-party audit?

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

Answer: D

Explanation:
The purpose of a Stage 1 third-party audit is to determine an organization's readiness for their Stage 2 Certification Audit. During the Stage 1, the auditor will review the organization's management system documented information, evaluate the site-specific conditions, and have discussions with personnel. The objective is to assess the alignment of the organization's design with ISO 9001 requirements and to identify any areas of concern that could be classified as a nonconformance during the Stage 2 Audit. The auditor will also use the Stage 1 Audit to complete Stage 2 Audit planning, including a review of the allocation of resources and details for the next phase of the audit. Therefore, the option that best describes the purpose of a Stage 1 third-party audit is A, to determine the auditees understanding of ISO 9001. The other options are not correct, as they are not the main focus of a Stage 1 audit:
*B. To get to know the organization's customers: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization's customers, but rather in the organization's ability to meet customer and applicable statutory and regulatory requirements.
*C. To learn about the organization's procurement processes: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization's procurement processes, but rather in the organization's ability to control externally provided processes, products and services.
*D. To introduce the audit team to the client: This is not the purpose of a Stage 1 audit, as the auditor is not there to make introductions, but rather to conduct a preliminary examination of the organization's compliance with ISO 9001 standards.
References: What is the difference between Stage 1 and Stage 2 Audits? - ISO Update, The ISO 9001 Audit Process Explained | ISO Explained, What is an ISO Stage 2 Audit? - RiskOptics - Reciprocity

NEW QUESTION # 16
You work as an external quality consultant for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, 'B', to ISO
9001 which provides packaging materials to your organisation. It is 4 pm and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled at 5 pm.
You, as Audit Team Leader, audited top management. You explain to the audit team that you identified two nonconformities:
a. There is no documented information on Top Management Reviews, as required in clause 9.3 of ISO
9001:2015.
b. There is no evidence of Top Management Commitment as required in clause 5.1 of ISO 9001:2015. (e.g., not ensuring the availability of resources to operate the QMS, not ensuring the establishment of objectives, no promotion of improvement, no promotion of the process approach).
All agreed to present these two nonconformities. They went to meet the Top Management of 'B' and noticed that the General Manager and three other managers (Production, Human Resources, and Sales) were present in the meeting room.
Considering the seriousness of the two nonconformities to Top Management, as audit team leader, from the following select the best option:

• A. Ask the General Manager to have a private conversation in which you present the nonconformities only to him because of their sensitive nature.
• B. Present the nonconformities to the managers, inform them that the report will be sent within 10 days, close the meeting and leave the site.
• C. Present the nonconformities to the whole group and inform that you will recommend your company to remove them from the approved suppliers list.
• D. Present the nonconformities to the whole group and analyse with them how to overcome this situation.

Answer: D

Explanation:
According to the guidance on conducting the audit closing meeting1, the audit team leader should provide a summary of the audit findings and conclusions, invite discussions, and agree on timelines for any corrective actions. The audit team leader should also be respectful, constructive, and objective when presenting the nonconformities, and avoid any personal or emotional comments. The audit team leader should also consider the impact of the disruptive event (such as the Covid-19 pandemic) on the auditee's context, interested parties, and risks2, and acknowledge any good practices or improvements observed during the audit. Therefore, option D is the best option, as it follows the best practices for the closing meeting and allows the auditee to understand the nonconformities and their implications, and to participate in the analysis and resolution of the issues. Option A is not correct, as it is not respectful, constructive, or objective, and it does not invite any discussion or feedback from the auditee. It also assumes that the audit team leader has the authority to recommend the removal of the supplier from the approved list, which may not be the case. Option B is not correct, as it does not provide enough information or explanation to the auditee, and it does not allow any discussion or feedback from the auditee. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, acknowledging any good practices, and agreeing on timelines for corrective actions. Option C is not correct, as it does not involve the other managers who are responsible for the functions or processes that were audited, and who may have valuable input or information to share. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, inviting discussions, and agreeing on timelines for corrective actions. References: 1: Conducting the Audit Closing Meeting: Sharing the Results2: Auditing ISO 9001:2015 in the Context of a Disruptive Event.

NEW QUESTION # 17
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.
You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?" GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon, shortage of chemicals for the analysis. It was quite a good experience." You: "Did you document these issues?" GM: "No. Jack said that ISO 9001 does not require us to document these issues." You: "How did you determine the risks associated with the issues and did you plan actions to address them?" GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence." Select two options for how you would respond to the General Manager's suggestion:

• A. I would look for evidence that the actions resulting from the risk assessment had been taken.
• B. I would ask to audit the Technical Manager by phone.
• C. I would not accept the legal compliance expert answering the question.
• D. I would ask the consultant to leave the meeting since he is not an employee of the organisation.
• E. I would delay the audit until the return of the technical manager
• F. I would ask for a different guide instead of the legal compliance expert.

Answer: A,C

Explanation:
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

NEW QUESTION # 18
Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.

• A. Corrective action
• B. Preventive action
• C. Correction
• D. Concession

Answer: C

Explanation:
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

NEW QUESTION # 19
In the context of a management system audit, identify the sequence of a typical process for collecting and verifying information. The first one has been done for you.
To complete the sequence click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

Answer:

Explanation:

Explanation:
Identifying the source of information
Sampling available data
Gathering audit evidence
Verifying objective evidence
Evaluating evidence against the audit criteria
Making audit conclusions
Evaluating against the audit criteria
According to ISO 19011:2018, clause 6.4, the process of collecting and verifying information during an audit involves the following steps1:
Identifying the source of information: The audit team should identify the sources of information that are relevant to the audit objectives, scope and criteria. These sources may include documents, records, personnel, processes, activities, facilities, equipment, etc. The audit team should also determine the methods and tools for accessing and collecting the information, such as interviews, observations, document review, sampling, etc.
Sampling available data: The audit team should select a representative sample of the available data to verify the conformity and effectiveness of the management system. The sample size and selection method should be based on the audit objectives, scope and criteria, as well as the level of confidence and risk. The audit team should also consider the validity, reliability, relevance and sufficiency of the data.
Gathering audit evidence: The audit team should use the methods and tools identified in the previous step to collect audit evidence, which is the records, statements of fact or other information that are relevant to the audit criteria and verifiable. The audit team should record the audit evidence in a clear, concise and objective manner, using notes, checklists, photographs, audio or video recordings, etc.
Verifying objective evidence: The audit team should verify the accuracy, completeness and authenticity of the audit evidence collected. This may involve cross-checking different sources of information, confirming the identity and authority of the persons providing the information, examining the original documents or records, etc. The audit team should also identify any discrepancies, inconsistencies or gaps in the audit evidence.
Evaluating evidence against the audit criteria: The audit team should compare the audit evidence with the audit criteria to determine the extent of conformity and nonconformity. The audit team should also identify any opportunities for improvement, best practices, positive aspects or potential risks. The audit team should use professional judgement and apply the principles of auditing when evaluating the audit evidence.
Making audit conclusions: The audit team should consolidate the audit findings and evaluate the overall performance and effectiveness of the management system. The audit team should also consider the audit objectives, scope and criteria, as well as the context and expectations of the auditee and other interested parties. The audit team should provide a clear, concise and objective statement of the audit conclusions, which may include the degree of conformity, the achievement of the intended outcomes, the need for corrective actions, the suitability for certification, etc.
Evaluating against the audit criteria: The audit team should review the audit conclusions and ensure that they are consistent with the audit criteria and supported by sufficient and appropriate audit evidence.
The audit team should also ensure that the audit conclusions are communicated to the auditee and other relevant parties in a timely and effective manner, using the agreed audit report format and distribution method.
References: ISO 19011:2018(en), Guidelines for auditing management systems

NEW QUESTION # 20
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?

• A. During the Stage 1 audit, the audit team:
• B. Evaluates the conditions of all sites
• C. Verifies the compliance with legal requirements
• D. Reviews the client's management system documented information
• E. Verifies the degrees of customer satisfaction
• F. Evaluates the results of the last management review
• G. Reviews the processes with high level of risk

Answer: D,G

Explanation:
* Reviews the client's management system documented information: This activity involves checking the documentation of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team also evaluates the client's understanding and implementation of the standard, and identifies any gaps or nonconformities that need to be addressed before the Stage 2 audit123.
*Reviews the processes with high level of risk: This activity involves assessing the processes that have a significant impact on the quality of the products or services, or that pose a high risk of nonconformity or customer dissatisfaction123. The audit team also verifies the client's risk management approach, and evaluates the effectiveness of the controls and actions taken to mitigate the risks123.
The other options are not statements that are true for the Stage 1 audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.
Therefore, the correct answer is D and G.
References: 1: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified 2: Stage 1 of your Audit
| NQA Blog 3: Getting Certified to ISO 9001 - the Stage 1 Audit

NEW QUESTION # 21
Select six tasks you would expect 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.

• A. Agree the roles of each audit team member for the closing meeting.
• B. Audit team leader informs the individual(s) managing the audit programme that the closing meeting is ready to be held.
• C. Write the audit finding report out when detected and obtain signature of the auditee.
• D. Audit team review any points raised by the auditee nominated representative.
• E. Hold daily audit team meeting to review any timetable issues and potential findings and their impact on the audit for other team members.
• F. Audit team complete final version of their individual findings.
• G. Audit team leader completes final report, including individual findings and certification recommendation.
• H. Final audit team meeting to agree findings and categories including clarification of any uncertainties.
• I. Audit team agree final audit outcome recommendation.
• J. Re-audit corrective actions taken to correct findings found during the audit.

Answer: A,D,F,H,I,J

Explanation:
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.
References:
*ISO 19011:2018 Guidelines for auditing management systems, Clause 6.4.2: Conducting audit activities, Subclause i) and j)
*ISO 9001 Lead Auditor Course Material, Module 5: Conducting an Audit, Slide 19: Audit Team Meeting
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 5.4: Audit Team Meeting
*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

NEW QUESTION # 22
Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.
The auditor samples the design records for a recently completed course for the 247 Insurance organisation.
Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.
The auditor decides to review the training course design process in more depth.
Select three options that provide a meaningful audit trail for this process.

• A. What risks and opportunities have been notified to interested parties?
• B. How is the cost of the course calculated?
• C. How is customer feedback integrated into the course?
• D. How is the tutor trained to deliver the completed course?
• E. How is design documentation controlled and managed?
• F. What are the qualifications of the administrative staff?
• G. How are students advised about prior learning requirements?
• H. How is technical content of courses verified as correct?

Answer: C,E,H

Explanation:
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

NEW QUESTION # 23
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

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

Answer: D,E

Explanation:
According to the ISO 9001:2015 document, the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015 are:
*the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
*the enhancement of customer satisfaction.
These results are derived from the quality management principles of customer focus and process approach, which are the basis of the ISO 9000 family of standards1. Customer focus means understanding and meeting customer needs and expectations, as well as exceeding them when possible1. Process approach means managing activities as interrelated processes that function as a coherent system, which leads to consistent and predictable results1.
Therefore, the correct answer is C and F.
References: 2: ISO 9001:2015 - Quality management systems - Requirements 1: ISO - Quality management principles

NEW QUESTION # 24
You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.
You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?" TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry." You: "How is their regulatory competence maintained?" TD: "They are dedicated individuals with lots of contacts in the sector." You: "How does the business enable them to maintain their understanding of current regulatory requirements?" TD: "We leave that up to them."

Answer:

Explanation:

Explanation:
A screenshot of a computer Description automatically generated

NEW QUESTION # 25
You are conducting a third-party Stage 1 audit at ABC Ltd, a single-site organisation that manufactures wooden furniture. You interview the Technical Director to learn more about the organisation. The Technical Director explains that they have had a successful year and that obtaining ISO 9001 certification will support the further growth of the business. You ask for an overview of the organisation's structure and its interrelationships with external interested parties.
The Technical Director shows you a document detailing all business processes and interrelationships. You notice in this document that another organisation called Teak Ltd manufactures wooden furniture on behalf of ABC Ltd. The Technical Director confirms this capability has been accounted for in the scope of the quality management system. You learn that the furniture manufactured by Teak Ltd has accounted for 40% of the sales revenue over the previous 12 months.
Which two of the following options best describe how you would plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd?

• A. Verify the controls concerning customer property implemented by Teak Ltd
• B. Verify whether the design processes of Teak Ltd comply with ISO 9001
• C. Verify how ABC Ltd evaluates the performance of Teak Ltd
• D. Verify if Teak Ltd are certified to ISO 9001
• E. Verify the quality management system at Teak Ltd by conducting an audit at their site
• F. Verify Teak Ltd supply arrangements as described in the ABC Ltd quality management system

Answer: C,F

Explanation:
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

NEW QUESTION # 26
In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.

• A. Number of sites to be audited
• B. Scope of the audit
• C. Expectations of the organisation's management
• D. Risk to achieving audit objectives

Answer: C

Explanation:
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.
References: ISO 19011:2018(en), Guidelines for auditing management systems, How to create an ISO 9001 internal audit plan - Advisera

NEW QUESTION # 27
Match the process descriptions below to the process names:

Answer:

Explanation:

Explanation:
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

NEW QUESTION # 28
The following are stages of an audit, put them in the order they would be conducted.

Answer:

Explanation:

Explanation:
Establishing the audit programme objectives
Determining and evaluating the audit programme risks and opportunities
Establishing the audit programme
Initiating the audit
Preparing all audit activity
Conducting the audit activities
According to ISO 19011:2018, clause 5, the audit programme is a set of one or more audits planned for a specific time frame and directed towards a specific purpose. The audit programme includes all activities necessary to plan, organize, and conduct the audits. The audit programme management involves the following steps1:
Establishing the audit programme objectives: The audit programme objectives define the intended outcomes of the audit programme, such as verifying conformity, evaluating performance, identifying improvement opportunities, etc. The audit programme objectives should be aligned with the strategic direction and policies of the organization and the needs and expectations of the interested parties.
Determining and evaluating the audit programme risks and opportunities: The audit programme risks and opportunities are the factors that can affect the achievement of the audit programme objectives, such as changes in the internal or external context, availability of resources, competence of auditors, etc. The audit programme risks and opportunities should be identified, analyzed, and evaluated to determine the appropriate actions to address them.
Establishing the audit programme: The audit programme is established by defining the audit programme scope, criteria, methods, and resources. The audit programme scope defines the extent and boundaries of the audit programme, such as the processes, functions, sites, activities, etc. that will be audited. The audit programme criteria are the set of policies, procedures, or requirements used as a reference for the audits. The audit programme methods are the techniques used to conduct the audits, such as interviews, observations, document review, sampling, etc. The audit programme resources are the human, technical, and financial resources needed to implement the audit programme.
Initiating the audit: The audit initiation is the process of formally establishing the arrangements for an individual audit within the audit programme. The audit initiation involves contacting the auditee and the audit client, confirming the audit objectives, scope, and criteria, and obtaining the necessary information and access for the audit.
Preparing all audit activity: The audit preparation is the process of developing the audit plan and the audit work documents for an individual audit. The audit plan is a document that provides the basis for agreement regarding the conduct of the audit, such as the audit schedule, the audit team, the audit methods, the audit language, the audit report, etc. The audit work documents are the records that provide evidence of the audit activities, such as the audit checklist, the audit notes, the audit findings, etc.
Conducting the audit activities: The audit activities are the processes of collecting and verifying audit evidence and evaluating it against the audit criteria to make the audit conclusions. The audit activities include the opening meeting, the communication during the audit, the roles and responsibilities of the audit team and the auditee, the audit evidence collection and verification, the audit findings generation and recording, the closing meeting, and the audit report preparation and distribution.
References: ISO 19011:2018(en), Guidelines for auditing management systems

NEW QUESTION # 29
Who would be defined as a witness during a witness audit?
Choose two of the following options:

• A. An existing member of the audit team
• B. An assessor for the accreditation body
• C. Someone with a qualification from the certification body
• D. An auditor

Answer: B,D

Explanation:
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.
References: 1: DQS Inc. | Witness Audits | Auditor Training 2: Have you ever been involved with a witness audit? - IFSQN 3: Certac - Witness Audit of Certification Bodies 4: ISO 19011:2018 - Guidelines for auditing management systems

NEW QUESTION # 30
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