Pass Your ISO 9001 ISO-9001-Lead-Auditor Exam on Mar 27, 2026 with 250 Questions
ISO-9001-Lead-Auditor Free Exam Study Guide! (Updated 250 Questions)
PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:
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NEW QUESTION # 130
When monitoring customer perceptions, which analysis is helpful to use?
- A. Competitive benchmarking
- B. Gap analysis
- C. PEST analysis
- D. Market-share analysis
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to measure and monitor customer perceptions to determine whether customer requirements are being met.
Clause Reference:
* Clause 9.1.2 - Customer Satisfaction states that organizations must monitor customer perceptions using relevant methods such as customer surveys, feedback forms, and complaint analysis.
* One of the most effective ways to do this is gap analysis, which identifies differences between customer expectations and actual service or product performance.
Why is the Correct Answer C?
* Gap analysis helps determine discrepancies between current performance and customer expectations, allowing organizations to improve quality.
* It is a standard quality improvement tool used to assess customer satisfaction.
Why are the Other Options Incorrect?
* A (PEST analysis) # Focuses on external macroeconomic factors (Political, Economic, Social, Technological) rather than customer satisfaction.
* B (Market-share analysis) # Examines business performance relative to competitors, not customer perceptions.
* D (Competitive benchmarking) # Involves comparing processes with competitors but does not directly monitor customer perceptions.
Reference:
ISO 9001:2015, Clause 9.1.2 - Customer Satisfaction
NEW QUESTION # 131
How can an organization ensure the objectivity and impartiality of the internal audit function?
- A. By assigning internal auditors that do not have operational roles related to the QMS
- B. By always outsourcing the internal audit function to a third party
- C. By having a representative of top management involved during the internal audit process
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 5.1 (Impartiality):
* Internal auditors must not audit areas where they have direct responsibilities to avoid conflicts of interest.
* Outsourcing (C) is not required, as long as impartiality is maintained internally.
Thus, B is the correct answer.
NEW QUESTION # 132
You are auditing a manufacturer of specialty tea products during a Stage 2 certification audit. In the quality laboratory, you interview one of three operatives conducting sensory testing of a batch from the production line.
Select three options of evidence which could demonstrate conformance with clause 9.1.1 of ISO 9001:2015.
- A. Independent experts were brought in to review test processes
- B. Outsourcing the sensory testing to an accredited laboratory
- C. Laboratory staff routinely tested for respiratory ailments
- D. Safe disposal of the tested product
- E. Analysis of the results of sensory tests
- F. Sensory testing results are recorded
- G. Operatives having a university degree in food science
- H. The Hedonic Method is used to monitor the quality of the product
Answer: E,F,H
Explanation:
Comprehensive and Detailed Explanation From Exact Extract:
Clause 9.1.1 - Monitoring, measurement, analysis and evaluation (General) requires the organization to:
"Determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results, and when results shall be analyzed and evaluated." The goal is to ensure valid, reliable, and consistent measurement of process and product performance. Here's how each correct option supports compliance:
# B. Analysis of the results of sensory tests
This directly aligns with the requirement for analysis and evaluation of monitoring results. Clause 9.1.3 also supports the use of such data for evaluating product conformity and process effectiveness.
# G. Sensory testing results are recorded
This supports documented evidence of monitoring results, as required under 9.1.1(e), to verify that quality checks (such as flavor and aroma assessments) are being done consistently.
# H. The Hedonic Method is used to monitor the quality of the product
Use of a standardized measurement method like the Hedonic Scale aligns with 9.1.1(b), which requires defined methods to ensure valid and reproducible results.
Why the Other Options Are Incorrect or Less Relevant:
A). University degrees # Related to competence (Clause 7.2), not monitoring and measurement (Clause 9.1.1).
C). Independent expert review # Not part of regular monitoring unless it's built into the process.
D). Respiratory testing # Irrelevant to product quality monitoring.
E). Outsourcing # Would shift responsibility but doesn't demonstrate internal conformance.
F). Safe disposal # Pertains to Clause 8.5.4 (Preservation), not Clause 9.1.1.
References:
ISO 9001:2015 Clause 9.1.1 - Monitoring, measurement, analysis and evaluation ISO 9001:2015 Clause 9.1.3 - Analysis and evaluation ISO 9001:2015 Clause 7.2 - Competence (for contrast)
NEW QUESTION # 133
An organization has decided to implement a QMS based on ISO 9001. What should they consider when determining internal issues?
- A. The expectations of suppliers
- B. The competitive environment
- C. The social and economic environments
- D. Knowledge
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to assess both internal and external issues that could impact the effectiveness of their Quality Management System (QMS).
Clause Reference:
* Clause 4.1 - Understanding the Organization and Its Context states that organizations must determine external and internal issues that affect their ability to achieve intended results.
* Internal issues include:
* Knowledge within the organization (documented or undocumented)
* Organizational culture
* Resource availability
* Technological advancements
* Infrastructure and capabilities
Why is the Correct Answer C?
* Knowledge (Clause 7.1.6) is a critical internal factor that directly affects the implementation and maintenance of a QMS.
* Organizations must identify, maintain, and make available the necessary knowledge to achieve quality objectives and meet customer requirements.
Why are the Other Options Incorrect?
* A (Social and economic environments) # These are considered external issues rather than internal.
* B (Competitive environment) # Competition is external, not an internal issue affecting the QMS.
* D (Expectations of suppliers) # Supplier expectations relate to external interested parties, covered under Clause 4.2 (Understanding the Needs and Expectations of Interested Parties).
Reference:
ISO 9001:2015, Clause 4.1 - Understanding the Organization and Its Context ISO 9001:2015, Clause 7.1.6 - Organizational Knowledge
NEW QUESTION # 134
Scenario 3:
Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.
To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.
The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.
The audit team began by gathering information about Fin-Pro's understanding of ISO 9001 requirements.
While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.
The team also reviewed the organizational chart and job descriptions to confirm employee competence.
They observed the company's working environment (social, psychological, and physical conditions).
The audit team analyzed the evidence and prepared an audit report with findings and conclusions.
Based on the last paragraph of scenario 3, which audit principle did the audit team follow?
- A. Fair presentation.
- B. Objectivity.
- C. Integrity.
- D. Confidentiality.
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Auditors must report findings truthfully and accurately to ensure an unbiased assessment of the QMS.
Clause References:
* ISO 19011:2018, Clause 4 - Principles of Auditing:
* Fair Presentation # Requires auditors to report truthfully and accurately, without bias or omission.
* Integrity # Ensures auditors adhere to ethical conduct.
Why is the Correct Answer A?
* The audit team reported findings truthfully, based on collected evidence.
* Fair presentation ensures that both positive and negative findings are included in the audit report.
* Objective evidence was gathered through interviews, document reviews, and observations.
Why are the Other Options Incorrect?
* B (Integrity) # Related to ethics and professional conduct, but not specifically about presenting findings.
* C (Confidentiality) # Important, but does not apply to the principle of reporting findings accurately.
* D (Objectivity) # Ensures impartiality, but "fair presentation" directly addresses accurate reporting of findings.
Reference:
ISO 19011:2018, Clause 4 - Principles of Auditing (Fair Presentation)
NEW QUESTION # 135
In the context of a third-party audit, match the activity with the party responsible in relation to the audit process.
Answer:
Explanation:
Explanation:
In the context of a third-party audit, the activities and the parties responsible can be matched as follows:
* Review the organization's processes: This is typically the responsibility of the audit team. They examine the processes to ensure they comply with the specified standards1.
* Review the audit results: The audit team leader usually reviews the audit findings to ensure accuracy and completeness before they are finalized1.
* Issue the certificate: The certification body is responsible for issuing the certificate if the audit is successful and the organization meets the required standards1.
* Select the audit team: The individual(s) managing the audit programme are responsible for selecting the audit team. This ensures that the team has the appropriate skills and knowledge for the audit1.
These roles are essential to maintain the integrity and effectiveness of the audit process. The audit team conducts the actual audit, the team leader oversees the audit process, the certification body grants the certification, and the management of the audit program ensures that the right team is in place to conduct the audit1.
Based on the description of the image you've provided, here's how the activities match with the responsible parties in the context of a third-party audit:
* Review the organization's processes: This activity is typically the responsibility of the Audit Team.
They are tasked with examining the processes to ensure they meet the requirements of the standard being audited.
* Review the audit results: The Audit Team Leader is usually responsible for this activity. They oversee the audit process and are in charge of reviewing the findings and ensuring that the audit objectives are met.
* Issue the certificate: The Certification Body is responsible for issuing the certificate if the organization's management system is found to be in compliance with the standard.
* Select the audit team: The Individual(s) managing the audit programme are responsible for selecting the audit team. They ensure that the team has the appropriate competence and resources to effectively conduct the audit.
These roles are defined within the framework of ISO 9001:2015 and are essential for the proper conduct of a third-party audit. The audit team and its leader play a critical role in the operational aspects of the audit, while the certification body and those managing the audit programme have overarching responsibilities for the audit' s governance and integrity.
NEW QUESTION # 136
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).
Answer:
Explanation:
Explanation:
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.
NEW QUESTION # 137
For a third-party, match the Activity with the Responsibility for conducting it.
Answer:
Explanation:
Explanation:
* 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.
NEW QUESTION # 138
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 how ABC Ltd evaluates the performance of Teak Ltd
- C. Verify Teak Ltd supply arrangements as described in the ABC Ltd quality management system
- D. Verify if Teak Ltd are certified to ISO 9001
- E. Verify whether the design processes of Teak Ltd comply with ISO 9001
- F. Verify the quality management system at Teak Ltd by conducting an audit at their site
Answer: B,C
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 # 139
How can an organization ensure the objectivity and impartiality of the internal audit function?
- A. By assigning internal auditors that do not have operational roles related to the QMS
- B. By always outsourcing the internal audit function to a third party
- C. By having a representative of top management involved during the internal audit process
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.1 (Impartiality):
Internal auditors must not audit areas where they have direct responsibilities to avoid conflicts of interest.
Outsourcing (C) is not required, as long as impartiality is maintained internally.
Thus, B is the correct answer.
Reference:
ISO 19011:2018, Clause 5.1 (Impartiality)
NEW QUESTION # 140
Which of the following is a responsibility of a guide in an audit?
- A. Filling any potential gaps in the auditor's knowledge
- B. Maintaining logistics
- C. Witnessing the audit process on behalf of the certification body
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
A guide is assigned by the auditee to assist the audit team by:
* Managing logistics, such as ensuring that relevant documents are available and arranging interviews.
* Assisting in the coordination of meetings and access to facilities.
* Helping the auditors navigate the organization during the audit.
However, the guide does not fill gaps in the auditor's knowledge or witness the audit for the certification body. Their primary function is logistical support, not providing interpretations or assessments.
Reference:
ISO 19011:2018, Clause 6.4.3 (Roles and Responsibilities of Guides and Observers)
NEW QUESTION # 141
Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
Answer:
Explanation:
Explanation:
The quality system failed to control the laundry services provided for customers in five shops.
The equipment used was not capable of consistently producing the required service.
NEW QUESTION # 142
Which of the following is a responsibility of a guide in an audit?
- A. Filling any potential gaps in the auditor's knowledge
- B. Maintaining logistics
- C. Witnessing the audit process on behalf of the certification body
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:A guide is assigned by the auditee to assist the audit team by:
* Managing logistics, such as ensuring that relevant documents are available and arranging interviews.
* Assisting in the coordination of meetings and access to facilities.
* Helping the auditors navigate the organization during the audit.
However, the guide does not fill gaps in the auditor's knowledge or witness the audit for the certification body. Their primary function is logistical support, not providing interpretations or assessments.
NEW QUESTION # 143
Read the following role descriptions. Select two roles that are not directly involved in the audit process.
- A. An observer - a person who sees the performance of the audit team leader, audit team members and/or auditee.
- B. An audit team leader - a person responsible for managing an audit until the audit is completed.
- C. An interpreter - a person who witnesses the audit to assist the auditors with language issues.
- D. A guide - a person who is appointed by the auditee to assist the audit team during the audit.
- E. An auditor-in-training - a person who accompanies the audit team leader or team members during the audit.
- F. A technical expert - a person who provides specific knowledge or expertise to the audit team but is not normally an auditor.
Answer: A,C
NEW QUESTION # 144
What are the criteria for reviewing documented information?
- A. Content, format, and the procedure for managing documented information
- B. Archive, volume, and confidentiality of documented information
- C. Language of documented information, internal audit reports, client feedback
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 9001:2015, Clause 7.5.2 (Creating and Updating Documented Information), the criteria for reviewing documented information include:
* Content - The accuracy and relevance of the information.
* Format - Ensuring readability and proper structuring (e.g., language, versioning).
* Procedure for managing documented information - Ensuring control, access, and updates.
Other options, such as internal audit reports and client feedback, are important for overall QMS evaluation but are not the main criteria for reviewing documented information.
Reference:
ISO 9001:2015, Clause 7.5.2 (Creating and Updating Documented Information)
NEW QUESTION # 145
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 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.
Answer:
Explanation:
NEW QUESTION # 146
Which of the following three options could be considered potential threats to impartiality in an audit context?
- A. Familiarity
- B. Competence
- C. Intimidation
- D. Experience
- E. Self-audit
Answer: A,C,E
Explanation:
Questions no: 1 Verified : = 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.
NEW QUESTION # 147
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top- notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS.
They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS.
AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
The CEO of AL-TAX hired an experienced consultant to help with the implementation of the QMS. Is this required from ISO 9001?
- A. Yes, especially for companies that do not have competent personnel.
- B. Yes, external advice is necessary for an effective implementation.
- C. No, contracting external consultants is not required.
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 does not require an organization to hire external consultants for the implementation of a Quality Management System (QMS). Clause 7.2 (Competence) states that an organization must ensure that personnel are competent based on education, training, or experience. However, it does not mandate hiring an external consultant. The organization can choose to develop internal competency or seek external assistance at its discretion.
Additionally, Clause 5.1.1 (Leadership and Commitment) specifies that top management is accountable for the effectiveness of the QMS, including ensuring sufficient resources and competent personnel. Hiring an external consultant is an option, not a requirement.
Reference:
ISO 9001:2015, Clause 7.2 - Competence
ISO 9001:2015, Clause 5.1.1 - Leadership and Commitment
NEW QUESTION # 148
Select one option that must be considered when determining the scope of a QMS to ISO 9001.
- A. External issues of the organisation's context
- B. Competence of top management
- C. Performance of business processes
- D. Business improvement
Answer: A
Explanation:
According to ISO 9001:2015, clause 4.3, the organization is required to determine the scope of its quality management system (QMS) by considering the external and internal issues referred to in clause 4.1. Clause
4.1 requires the organization to determine the external and internal issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of its QMS. These issues can include positive and negative factors or conditions for consideration, such as legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. The organization is also required to monitor and review these issues.
Therefore, the correct answer is C, as external issues of the organization's context are one of the factors that must be considered when determining the scope of the QMS. The other options are either not directly related to the scope of the QMS, or are not explicitly mentioned in clause 4.3.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 4.1 and 4.3 ISO 9001:2015 - How to determine the scope of your QMS - Advisera, section "Considerations for determining the scope of the QMS in ISO 9001" ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 4
NEW QUESTION # 149
Which of the following is correct with regard to the internal audit?
- A. It considers only the effectiveness of the QMS
- B. It may be conducted on an ongoing basis
- C. It has no advisory role within the organization for the improvement of the QMS
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 9001:2015, Clause 9.2 (Internal Audit):
* Internal audits can be conducted on an ongoing basis as part of continual improvement.
* Audits consider both conformity and effectiveness (A is incorrect).
Thus, C is the correct answer.
NEW QUESTION # 150
Takitup is a small fabrication organisation that manufactures steel fencing, stairs and platforms for the construction sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager.
The audit plan during a surveillance audit covers the organisation's improvement actions and the auditor asks to see the most recent management review meeting minutes.
The auditor finds that the management review report records that none of the improvement actions set by the previous review has been realised for a second time. A new Quality Manager has been brought in at the middle management level to rectify the situation as the organisation is concerned that it might lose its certification.
Select three options that would provide evidence of conformance with clause 10.3 of ISO 9001.
- A. The certification body auditor reporting fewer nonconformities.
- B. An enhanced customer satisfaction survey score than in the previous year.
- C. Considering results from the analysis of the effectiveness of corrective actions to determine improvement opportunities.
- D. Automate the fabrication process to increase profitability.
- E. A quality objective to achieve lower reject rates by quality control.
- F. Outsource more processes to external providers
- G. Removing expensive external providers from the database.
- H. An increase in the number of quality staff.
Answer: B,C,E
NEW QUESTION # 151
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