ISO-9001-Lead-Auditor Valid Exam Labs, PECB Positive ISO-9001-Lead-Auditor Feedback: QMS ISO 9001:2015 Lead Auditor Exam Latest Released

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q130-Q135):

NEW QUESTION # 130
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. A quality objective to achieve lower reject rates by quality control.
B. Considering results from the analysis of the effectiveness of corrective actions to determine improvement opportunities.
C. An enhanced customer satisfaction survey score than in the previous year.
D. Removing expensive external providers from the database.
E. Automate the fabrication process to increase profitability.
F. An increase in the number of quality staff.
G. The certification body auditor reporting fewer nonconformities.
H. Outsource more processes to external providers

Answer: A,B,C

NEW QUESTION # 131
Select one of the options that best describes the purpose of conducting a document review:

A. To detect any nonconformity of the system, if documented, with audit criteria and to identify information to support the audit plan.
B. To decide about the conformity of the documented system with audit standards and to gather findings to support the audit process.
C. To establish nonconformity in the documented system with audit criteria and to gather information to compile the audit report.
D. To reveal whether the documented system is nonconforming with audit criteria and to gather evidence to support the audit report.
E. To determine the conformity of the system, as far as documented, with audit criteria and to gather information to support the audit activities.
F. To confirm the conformity of the system, where documented, with audit criteria and to gather information to support the audit findings.

Answer: E

Explanation:
The purpose of conducting a document review is to determine the conformity of the system, as far as documented, with audit criteria and to gather information to support the audit activities. A document review is a systematic and objective examination of the documented information that is relevant to the audit objectives and scope. It can help the auditor to verify if the documented information is complete, accurate, consistent, and up-to-date. It can also help the auditor to identify any gaps, errors, or nonconformities in the documented information that may affect the audit findings or conclusions.
The other options are not correct because they do not reflect the true purpose of a document review. Option A describes the purpose of an audit report, which is to communicate the audit results and recommendations to the management and other interested parties. Option B describes the purpose of an audit plan, which is to define the scope, objectives, criteria, methods, resources, and schedule of an audit. Option C describes the purpose of an audit evidence report, which is to provide evidence of nonconformities or opportunities for improvement identified during an audit. Option D describes the purpose of an audit decision report, which is to justify or explain why certain decisions were made during an audit.
I hope this answer helps you understand why option F is correct and why options A-C-D are incorrect. If you want to learn more about ISO 9001 Lead Auditor exam questions and answers, you can check out some of these resources:
ISO 9001 Lead Auditor Sample Exam Questions and Answers: This article provides some sample questions and answers for each section of the ISO 9001 Lead Auditor exam.
ISO 9001 (QMS) Lead Auditor Quiz Questions and Answers: This article provides some quiz questions and answers on various topics related to ISO 9001 QMS.
ISO 9001 Lead Auditor - Exam Practice Tests: This course offers practice tests with explanations for each question.
Irca Lead Auditor Exam Questions And Answers Pdf: This document contains some exam questions and answers in PDF format.

NEW QUESTION # 132
Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.
The auditor samples the design records for a recently completed course for the 247 Insurance organisation.
Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.
The auditor decides to review the training course design process in more depth.
Select three options that provide a meaningful audit trail for this process.

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

Answer: D,G,H

Explanation:
According to clause 8.3 of ISO 9001:2015, the organization should establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. The design and development process should include the following activities:
*Determining the requirements for the products and services to be designed and developed, considering the intended use, the statutory and regulatory requirements, the customer and other relevant interested parties' needs and expectations, and the potential risks and opportunities.
*Defining the design and development objectives, stages, responsibilities, and authorities, and ensuring the availability of adequate resources and competence.
*Implementing design and development controls, such as reviews, verification, and validation, to ensure that the design and development outputs meet the design and development inputs, and to identify and resolve any problems or errors.
*Maintaining documented information on the design and development inputs, outputs, reviews, verification, validation, and changes, and ensuring the traceability and conformity of the products and services to the requirements.
*Managing the design and development changes, by identifying, reviewing, and controlling them, and evaluating their effects on the products and services and the QMS.
In this case, the evidence statements that provide a meaningful audit trail for the design and development process are B, E, and F, because they relate to the design and development controls, the documented information, and the verification activities that are required by the standard. These options can help the auditor to assess the effectiveness and conformity of the design and development process, and to identify any nonconformities or opportunities for improvement. The other options are not directly related to clause 8.3, although they may be relevant for other aspects of the QMS, such as clause 7.2 on competence, clause 7.3 on awareness, clause 7.4 on communication, clause 8.2 on requirements for products and services, clause 8.4 on externally provided processes, products, and services, and clause 8.7 on control of nonconforming outputs.
References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Design and Development, ISO
9001 Clause 8.3 Design and development of products and services

NEW QUESTION # 133
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. Performance of business processes
C. Business improvement
D. Competence of top management

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 # 134
How much time is usually spent on the Stage 1 audit?

A. 40% of the total audit time
B. 20% of the total audit time
C. 30% of the total audit time

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015 (Conformity Assessment - Requirements for Certification Bodies), Clause 9.3.1.2, the Stage 1 Audit typically consumes around 30% of the total audit time.
This time is allocated to:
* Reviewing documented information.
* Assessing the readiness for Stage 2.
* Identifying potential nonconformities.
A 20% allocation (Answer A) is too low, and 40% (Answer C) is excessive, as the majority of the audit should be spent on Stage 2 (on-site verification).

NEW QUESTION # 135
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ISO-9001-LEAD-AUDITOR VALID EXAM LABS, PECB POSITIVE ISO-9001-LEAD-AUDITOR FEEDBACK: QMS ISO 9001:2015 LEAD AUDITOR EXAM LATEST RELEASED

ISO-9001-Lead-Auditor Valid Exam Labs, PECB Positive ISO-9001-Lead-Auditor Feedback: QMS ISO 9001:2015 Lead Auditor Exam Latest Released