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PECB ISO-9001-Lead-Auditor Prüfungsplan:

Thema	Einzelheiten
Thema 1	Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
Thema 2	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.
Thema 3	Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.
Thema 4	Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
Thema 5	Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.

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PECB ISO-9001-Lead-Auditor: QMS ISO 9001:2015 Lead Auditor Exam braindumps PDF & Testking echter Test

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PECB QMS ISO 9001:2015 Lead Auditor Exam ISO-9001-Lead-Auditor Prüfungsfragen mit Lösungen (Q91-Q96):

91. Frage
A person who provides specific knowledge or expertise to the audit team during the audit is known as a
/an:

A. Guide.
B. Observer.
C. Technical expert.

Antwort: C

Begründung:
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.
Reference:
ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts

92. Frage
What should the auditor document during the Stage 1 audit?

A. The interviews with the auditee's employees
B. The main processes of the auditee
C. The observations that could result in nonconformities during the on-site audit

Antwort: C

Begründung:
Comprehensive and Detailed In-Depth Explanation:Stage 1 Audit (ISO 9001:2015, Clause 9.2.2) is a documentation review to assess the readiness for a Stage 2 Audit. The auditor must document:
* Observations that could lead to nonconformities, ensuring they are addressed before Stage 2.
* Areas needing improvement, such as missing documented information or unclear process definitions
.
While understanding the auditee's main processes is important, documenting interviews is not a requirement at Stage 1.

93. Frage
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.

Antwort:

Begründung:

Explanation:
Nonconformity report
ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met." Evidence: 40 cleaning records are available for 63 batches.

94. Frage
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
The audit team members were selected based on their knowledge of the legal and other regulations that TD is subject to. Is this acceptable?

A. No, because there is no need to have knowledge of the legal and other requirements that TD is subject to.
B. No, because only one audit team member is required to have knowledge of legal and other regulatory requirements that TD is subject to.
C. Yes, but only the lead auditor needs to have knowledge of legal and other regulatory requirements.
D. Yes, to ensure effective conduct of the audit, each audit team member should have knowledge of legal and other requirements that TD is subject to.

Antwort: D

Begründung:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to ensure that auditors have the necessary competence and knowledge to conduct audits effectively.
Clause References:
* ISO 19011:2018, Clause 7.2.1 - Determining Competence of Auditors: Auditors must have knowledge of applicable legal and regulatory requirements that affect the scope of the audit.
* ISO/IEC 17021-1:2015, Clause 7.1.2 - Competence Requirements: Certification bodies must ensure that auditors assigned to the audit team possess relevant knowledge in areas such as legal and regulatory compliance.
Why is the Correct Answer C?
* Each audit team member should have sufficient knowledge of relevant legal and regulatory requirements to ensure compliance.
* This helps auditors identify gaps or nonconformities related to compliance obligations.
* Having multiple team members with knowledge reduces reliance on a single expert and ensures a comprehensive assessment.
Why are the Other Options Incorrect?
* A (Only one team member needs knowledge) # Incorrect because audits involve various aspects, and all auditors should have basic awareness of legal and regulatory requirements.
* B (Legal knowledge is not necessary) # Incorrect because compliance is essential for QMS effectiveness.
* D (Only the lead auditor needs legal knowledge) # Incorrect because ISO requires all auditors to be competent in applicable laws, not just the leader.
Reference:
ISO 19011:2018, Clause 7.2.1 - Competence of Auditors
ISO/IEC 17021-1:2015, Clause 7.1.2 - Competence Requirements

95. Frage
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.

Antwort:

Begründung:

96. Frage
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