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NEW QUESTION # 47
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.
Answer: A,E,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 # 48
A person who provides specific knowledge or expertise to the audit team during the audit is known as a
/an:
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
A technical expert is someone with specialized knowledge that helps the audit team understand specific technical aspects of the auditee's processes.
Clause References:
* ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts:
* Technical experts support the audit team with specialized knowledge but do not perform the audit themselves.
Why is the Correct Answer B?
* A technical expert is needed when auditors lack deep expertise in specific areas, such as engineering, software, or medical devices.
* They assist in interpreting complex technical requirements but do not act as auditors.
Why are the Other Options Incorrect?
* A (Observer) # Observers do not contribute expertise; they only watch the audit (e.g., trainees).
* C (Guide) # Guides help with logistics but do not provide technical expertise.
NEW QUESTION # 49
Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.
Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled.
The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.
The top management, in cooperation with Sean, assigned 10 more employees to the audit team.
Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.
Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.
Based on the scenario above, answer the following question:
Scenario 7 states that Sean planned audit activities on his own. Is this acceptable?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 6.2.2 (Audit Planning):
* The audit team leader is responsible for planning the audit and assigning roles.
* Top management (A) does not plan the audit, but they provide resources.
* While team members may provide input, the leader has the final authority.
Thus, B is the correct answer.
Reference:
ISO 19011:2018, Clause 6.2.2 (Audit Planning)
NEW QUESTION # 50
In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.
Answer: A,F
Explanation:
According to ISO 19011:2018, clause 6.6.2, a nonconformity is the non-fulfilment of a requirement. A nonconformity can be classified as either major or minor, depending on the nature and extent of the deviation from the audit criteria. A major nonconformity is a nonconformity that affects the ability or the integrity of the organization's management system to achieve the intended results. A minor nonconformity is a nonconformity that does not affect the ability or the integrity of the organization's management system to achieve the intended results, but is a deviation from the audit criteria1.
According to ISO/IEC 17021-1:2015, clause 9.4.9, the organization is required to analyze the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time. The organization is also required to provide the certification body with records and evidence of the implementation and effectiveness of the correction and corrective actions taken. The certification body will then verify the correction and corrective actions taken by the organization and decide on the certification status2.
Therefore, the two options of when the organization is required to act in response to reported findings are D and F, as they indicate the presence of nonconformities that need to be corrected and prevented from recurring. The other options are not correct, as they do not require the organization to act in response to reported findings:
*A. A recommendation is given in the report: A recommendation is a suggestion for improvement that is not related to a nonconformity. A recommendation is not binding for the organization and does not affect the certification status. The organization may choose to accept or reject the recommendation, but it is not required to act on it.
*B. A finding of good practice is reported: A finding of good practice is a positive observation that indicates a strength or a best practice of the organization's management system. A finding of good practice is not related to a nonconformity and does not affect the certification status. The organization may choose to acknowledge or share the finding of good practice, but it is not required to act on it.
*C. An opportunity for improvement is raised: An opportunity for improvement is a potential area where the organization's management system can be enhanced or optimized. An opportunity for improvement is not related to a nonconformity and does not affect the certification status. The organization may choose to pursue or ignore the opportunity for improvement, but it is not required to act on it.
*E. A finding of conformity is reported: A finding of conformity is a confirmation that the organization's management system fulfils the audit criteria. A finding of conformity is not related to a nonconformity and does not affect the certification status. The organization may choose to celebrate or communicate the finding of conformity, but it is not required to act on it.
References: ISO 19011:2018(en), Guidelines for auditing management systems, ISO/IEC 17021-1:2015(en), Conformity assessment - Requirements for bodies providing audit and certification of management systems
- Part 1: Requirements
NEW QUESTION # 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).
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 # 52
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