2024 Updated Verified ISO-9001-Lead-Auditor dumps Q&As - Pass Guarantee or Full Refund [Q36-Q56]

新问题 36
Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.

To facilitate auditing for proof of conformity to the standard.

To safeguard the integrity of the quality management system.

To support the operation of the processes of the quality management system.

To provide confidence in the effectiveness of the quality management system.

新问题 37
The following are stages of an audit, put them in the order they would be conducted.

解释：

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
To complete the sequence, you can drag and drop the options to the appropriate blank section.
Here is a brief explanation of each stage:
Establishing the audit programme objectives: This is the first stage of the audit process, where the purpose, scope, and criteria of the audit programme are defined. The audit programme objectives should be aligned with the strategic direction and policies of the organization, and should address the needs and expectations of the interested parties12.
Determining and evaluating the audit programme risks and opportunities: This is the second stage of the audit process, where the factors that can affect the achievement of the audit programme objectives are identified and assessed. The audit programme risks and opportunities should consider the internal and external issues, the requirements and changes of the interested parties, and the results and feedback from previous audits12.
Establishing the audit programme: This is the third stage of the audit process, where the audit programme is designed and implemented. The audit programme should include the audit programme procedures, the audit programme resources, the audit methods and techniques, the audit frequency and schedule, and the audit programme performance indicators12.
Initiating the audit: This is the fourth stage of the audit process, where the audit is prepared and planned. The audit initiation involves selecting the audit team, establishing the contact with the auditee, defining the audit objectives, scope, and criteria, developing the audit plan, and conducting the document review123.
Preparing all audit activity: This is the fifth stage of the audit process, where the audit activities are organized and coordinated. The audit preparation involves assigning the audit tasks, communicating with the auditee and the audit team, arranging the logistics, preparing the working documents, and conducting the opening meeting123.
Conducting the audit activities: This is the sixth and final stage of the audit process, where the audit evidence is collected and evaluated. The audit conduct involves performing the audit activities, such as interviews, observations, document reviews, and tests, documenting the audit findings, preparing the audit conclusions, and conducting the closing meeting123.
I hope this helps you with your ISO 9001 Lead Auditor objectives and content. If you have any further questions, please feel free to ask.
References: 1: ISO 19011:2018 – Guidelines for auditing management systems 2: Audit Process | Flowchart | Summary – Accountinguide 3: What are the Stages of the Auditing Process & Why it is Important …

新问题 38
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?

During the Stage 1 audit, the audit team:

Verifies the degrees of customer satisfaction

Evaluates the conditions of all sites

Reviews the client’s management system documented information

Evaluates the results of the last management review

Verifies the compliance with legal requirements

Reviews the processes with high level of risk

新问题 39
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.

How are students advised about prior learning requirements?

How is customer feedback integrated into the course?

How is the cost of the course calculated?

What risks and opportunities have been notified to interested parties?

How is design documentation controlled and managed?

How is technical content of courses verified as correct?

How is the tutor trained to deliver the completed course?

What are the qualifications of the administrative staff?

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

新问题 40
An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
“The reject rate of the finished product of 9.7% needs improvement as it doesn’t meet the stated objective of top management of 5%.” As the third-party auditor reviewing the internal audit process, you come across the nonconformity. For corrective action, the Quality Manager conducted an investigation into the reject rates. He reported that the collection baskets for products ejecting from the moulding machines were not large enough. About 6% of products fell onto the wet and dirty factory floor. Management stated that replacing the baskets was too costly and ordered the Maintenance Manager to ensure that the floor was kept clean and dry to prevent rejects. The auditor later checked the factory floor, which was wet and dirty in places.
From the following nonconformities, select three that the auditor could raise to ISO 9001.

10.3 – The organisation did not continuously improve. Reject rates were unchanged.

7.1.4 – The factory environment is not suitably maintained to prevent dirty products.

7.1.1 – The organisation failed to provide the required resources to prevent nonconforming products.

9.2.2 – Report IA202 contained a poorly worded nonconformity (NC 3).

8.6 – Dirty products were released to the customer.

7.3 – Staff were not aware that products were falling onto the factory floor.

10.2.1 – Conduct of an investigation was not sufficient to understand the cause of the nonconformity.

8.5.1 – Production operations were not properly controlled to avoid reject products.

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.
参考资料
*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

新问题 41
The following list gives examples of records that may be evidence of how an organisation has fulfilled the requirements of clause 8.4 of ISO 9001. Match the records to the appropriate requirement of clause 8.4.

新问题 42
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

新问题 43
Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.

To facilitate auditing for proof of conformity to the standard.

To provide confidence in the effectiveness of the quality management system.

To safeguard the integrity of the quality management system.

To support the operation of the processes of the quality management system.

新问题 44
Which two of the following aspects of a quality management system must the organisation continually improve?

Suitability

Adaptability

Effectiveness

Responsiveness

Efficiency

Applicability

新问题 45
During a second-party audit, the auditor examines the records that are available for the external provider, ABC Forgings, to whom manufacturing has recently been outsourced.
There are standard external provider checklists for three competitors for the contract and there are inspection records from the trial manufacturing batches produced by ABC Forgings. There is no documented evidence of the criteria used to confirm the appointment of ABC Forgings, and no contract or terms and conditions.
Ongoing monitoring indicates that external provider performance is satisfactory, but no documented information has been retained.
Select two options for the evidence which demonstrates a nonconformity with clause 8.4 of ISO 9001.

There was no documentation which provided evidence of any monitoring of the external provider.

The auditee required the outsourced products on an urgent basis before the completion of the paperwork.

The auditee did not retain documentation on the selection and evaluation of the external provider.

The external provider asked for the contract details to be verbal only.

There were no receipt inspection records of the incoming materials.

The auditee trusted the external provider because of a long-standing relationship with them.

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

新问题 46
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: “I would like to begin by looking at the cleaning controls.”
MM: “We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside.” Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

新问题 47
You work for organisation A. You are asked to lead an internal audit of A’s quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.
Which of the following actions would you consider appropriate when planning the internal audit of A’s quality management system?

Visit Plant A2 to interview personnel of company B

Visit Plant A2 to interview B’s quality manager

Visit Plant A2 to interview A’s security personnel and B’s maintenance department

Interview the A2 plant manager, now working in Plant A1

In this scenario, the organisation A has two plants, A1 and A2, but the production in A2 was discontinued due to the COVID-19 pandemic and the plant was rented to another organisation B. There are no A employees working in A2, and the organisation A expects to reassume production in A2 as soon as possible. Therefore, the appropriate action to plan the internal audit of A’s quality management system is:
*Interview the A2 plant manager, now working in Plant A1: This action involves interviewing the person who is responsible for the management and operation of the plant A2, and who is currently working in the plant A1. The interview should aim to gather information about the status and condition of the plant A2, the impact of the COVID-19 pandemic on the quality management system, the arrangements and agreements with the organisation B, and the plans and actions to resume production in the plant A25 . This action is relevant and necessary for the internal audit, as it can help to assess the readiness and effectiveness of the quality management system, and to identify any gaps or nonconformities that need to be addressed.
The other options are not appropriate actions to plan the internal audit of A’s quality management system, according to the web search results from my internal tool. They are:
*Visit Plant A2 to interview personnel of company B: This action involves visiting the plant A2 and interviewing the personnel of the organisation B, who are not related to the organisation A and who are not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
*Visit Plant A2 to interview B’s quality manager: This action involves visiting the plant A2 and interviewing the quality manager of the organisation B, who is not related to the organisation A and who is not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
*Visit Plant A2 to interview A’s security personnel and B’s maintenance department: This action involves visiting the plant A2 and interviewing the security personnel of the organisation A and the maintenance department of the organisation B, who are not directly involved in the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
Therefore, the correct answer is D.
References: 1: Quality audit – Wikipedia 2: A step-by-step guide to internal quality audits 3: ISO 9001:2015 – Quality management systems – Requirements 4: ISO 19011:2018 – Guidelines for auditing management systems 5: Audit Process | Flowchart | Summary – Accountinguide : What are the Stages of the Auditing Process & Why it is Important …

新问题 48
In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.

Number of sites to be audited

Risk to achieving audit objectives

Expectations of the organisation’s management

Scope of the audit

新问题 49
Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?

Audit Report

Audit Plan

程序

Checklist / Prompts

Risk Matrices

Findings

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

新问题 50
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

Consistently provide products that meet customers’ requirements

Decreased number of management system nonconformities

Decreased number of warranty claims

Decreased number of nonconforming products in all stages of the manufacturing cycle

Enhanced customer satisfaction

Increased profits

新问题 51
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).

解释：
Quality management principles:
Customer focus = Increased revenue and market share
Engagement of people = Enhanced trust and collaboration throughout the organisation Improvement = Enhanced drive for innovation Evidence-based decision-making = Increased ability to demonstrate effectiveness of past actions According to the Quality management principles document published by ISO, each quality management principle has a statement, a rationale, key benefits, and actions you can take to apply it. Based on these descriptions, the potential benefits can be matched to the corresponding principles as follows:
Customer focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. The key benefits of this principle include increased customer value, customer satisfaction, customer loyalty, repeat business, reputation, customer base, revenue and market share.
Engagement of people: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value. The key benefits of this principle include improved understanding of the organization’s objectives and values, increased involvement in improvement activities, enhanced personal development, increased motivation and empowerment, enhanced trust and collaboration, and increased recognition and rewards.
Improvement: Successful organizations have an ongoing focus on improvement. The key benefits of this principle include improved organizational capabilities, alignment of improvement activities at all levels, increased ability to anticipate and react to opportunities and threats, enhanced drive for innovation, and increased levels of satisfaction.
Evidence-based decision-making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. The key benefits of this principle include improved decision-making processes, increased ability to demonstrate the effectiveness of past decisions, increased ability to review, challenge and change opinions and decisions, and increased ability to improve performance.

新问题 52
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures
cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: “I would like to begin by looking at the cleaning controls.”
MM: “We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside.” Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

新问题 53
The following are stages of an audit, put them in the order they would be conducted.

解释：
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

新问题 54
Which one of the following options best describes the purpose of a Stage 1 third-party audit?

To determine the auditees understanding of ISO 9001.

To get to know the organisation’s customers.

To learn about the organisation’s procurement processes.

To introduce the audit team to the client.

新问题 55
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:

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

I would ask to audit the Technical Manager by phone.

I would delay the audit until the return of the technical manager

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

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

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

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

新问题 56
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.

Audit team leader informs the individual(s) managing the audit programme that the closing meeting is ready to be held.

Hold daily audit team meeting to review any timetable issues and potential findings and their impact on the audit for other team members.

Final audit team meeting to agree findings and categories including clarification of any uncertainties.

Agree the roles of each audit team member for the closing meeting.

Audit team review any points raised by the auditee nominated representative.

Audit team agree final audit outcome recommendation.

Audit team leader completes final report, including individual findings and certification recommendation.

Audit team complete final version of their individual findings.

Re-audit corrective actions taken to correct findings found during the audit.

Write the audit finding report out when detected and obtain signature of the auditee.

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.
参考资料
*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