Vce ISO-9001-Lead-Auditor Questions Latest

Comprehensive and Detailed Explanation From Exact Extract:

✅ Correct Option D – “I will sign all the purchase orders now.”

This response represents an immediate correction in accordance with ISO 9001:2015 Clause 8.4.3 – Information for external providers, which requires control over procurement documentation. The absence of required authorisation (signature) is a nonconformity in executing the organization’s purchasing procedure.

Clause 8.4.3 specifically mandates that the organization:

“Shall communicate to external providers its requirements for:

a) the processes, products and services to be provided;

b) the approval of:

products and services;

methods, processes, and equipment;

the release of products and services.”

The purchase order process includes documented approval, which in this case was defined internally as a signature by the Purchasing or Production Manager. Signing the documents retroactively, while not ideal, is a correction to bring the documentation back into compliance and resolve the immediate issue.

❌ Why Other Options Are Incorrect:

A. "No correction needed": Dismissing the nonconformity based on product performance fails to address the lack of documented control, violating Clause 8.4.3 and internal procedures.

B. "I will ask the Production Manager to sign them now": This option shows intention but lacks immediacy and ownership. Also, backdating signatures without traceability can be ethically questionable.

C. "I do not accept the nonconformity": This reflects noncompliance and a poor quality culture, contradicting ISO 9001’s Clause 5.1.1 (Leadership commitment).

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:

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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.

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).