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PECB ISO-9001-Lead-Auditor Prüfungsplan:

Thema	Einzelheiten
Thema 1	Quality management system (QMS) requirements: It assesses your abilities to point out and explain different requirements for a quality management system based on ISO 9001.
Thema 2	Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
Thema 3	Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.
Thema 4	Fundamental principles and concepts of a quality management system: The main objective of this domain is to evaluate your skills of explaining and applying ISO 9001 principles and concepts.

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PECB QMS ISO 9001:2015 Lead Auditor Exam ISO-9001-Lead-Auditor Prüfungsfragen mit Lösungen (Q160-Q165):

160. Frage
Which one of the following options is the definition of the context of an organisation?

A. Coordination of internal and external issues that can have a positive or negative effect on an organisation's success.
B. Combination of internal and external issues that can have an effect on an organisation's approach to developing and achieving its objectives.
C. Complexity of internal and external issues that can have an effect on an organisation's approach to developing and achieving its purpose.
D. Comparison of internal and external issues that can have an effect on an organisation's desire to achieve its objectives.

Antwort: B

Begründung:
Understanding "Context of the Organization":
The term "context of the organization" is defined in ISO 9001:2015 Clause 4.1, which states:
"The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system." The definition emphasizes identifying both internal and external issues that influence the organization's approach to developing and achieving its objectives.
Option Analysis:
Option A:Correct. This option aligns with the standard definition as it explicitly mentions the combination of internal and external issues that affect the organization's approach to achieving its objectives, which is the essence of Clause 4.1.
Option B:Incorrect. The term "comparison of internal and external issues" does not reflect the ISO 9001 requirements. The standard does not require a comparison but rather an understanding of these issues.
Option C:Incorrect. Although it mentions "complexity," the focus of ISO 9001:2015 is on identifying relevant issues rather than the complexity of those issues.
Option D:Incorrect. This option mentions "coordination" and focuses only on the positive or negative effects.
ISO 9001 requires identifying issues but does not emphasize coordination.
Clause Reference and Relevance:
ISO 9001:2015 requires organizations to understand their context because internal and external factors can influence the Quality Management System's effectiveness. Understanding this context helps in:
Addressing risks and opportunities (Clause 6.1).
Aligning the QMS with the organization's strategic direction.
Why A is Correct:
"Combination of internal and external issues" captures the essence of Clause 4.1, making it the accurate definition of the context of the organization.

161. Frage
Will the auditee be subject to an audit follow-up if a minor nonconformity has been reported by the audit team leader in the audit conclusions?

A. No, the audit team should suggest a recommendation only, in which it suggests an adequate corrective action for the nonconformity
B. No, the auditee will be subject to an audit follow-up only if a major nonconformity is detected
C. Yes, there should be an audit follow-up regardless of the type of nonconformities that are detected during the audit

Antwort: B

Begründung:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions):
* Minor nonconformities do not require a follow-up audit but must be corrected before the next surveillance audit.
* Follow-up audits are required only for major nonconformities.
* The audit team should recommend corrective actions, not enforce immediate follow-ups for minor nonconformities.
Thus, A is the correct answer.
Reference:
ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions for Minor Nonconformities)

162. Frage
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

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

Antwort: B,F

Begründung:
The key expected results of a quality management system that conforms to the requirements of ISO 9001:
2015 are stated in clause 0.1 of the standard, which says: "The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this International Standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements." Therefore, the two options that best match these benefits are A and E, as they directly relate to providing products and services that meet customer requirements and enhancing customer satisfaction. The other options are not explicitly mentioned as key expected results, although they may be possible outcomes of implementing a quality management system. References: ISO 9001:2015 - Quality management systems - Requirements, Key Elements of an ISO 9001:2015 Quality Management System, What is ISO 9001 2015 as a Quality Management Systems?

163. Frage
Which of the following is a responsibility of a guide in an audit?

A. Witnessing the audit process on behalf of the certification body
B. Filling any potential gaps in the auditor's knowledge
C. Maintaining logistics

Antwort: C

Begründung:
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.

164. Frage
In the context of a second-party audit, match the activity with the party responsible for conducting it.

Antwort:

Begründung:

Explanation:
Here is the correct matching of the activities with the responsible parties in the context of a second-party audit:
* Define the audit scope: Customer
* Develop the audit plan: Audit team leader
* Respond to the audit findings: External provider
* Conduct the audit: Audit team
This reflects the typical division of responsibilities in a second-party audit, where the customer (the party commissioning the audit) sets the scope, the audit team leader manages the planning, the external provider responds to findings, and the audit team carries out the audit.

165. Frage
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