ISO-9001-Lead-Auditor Exam Dumps - QMS ISO 9001:2015 Lead Auditor Exam

Analyzing Each Statement:

A.Incorrect. The audit team leader must communicate concerns as they arise, not just during the closing meeting. Per ISO 19011:2018 Clause 6.4.9, significant concerns should be shared promptly with the auditee and audit client during the audit process to allow for immediate understanding and potential resolution.

B.Incorrect. The auditor or team leader is not specifically required to inform the general manager about uncontrolled documents. Instead, the issue is communicated within the framework of the audit findings to the audit client or auditee, as appropriate.

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).

Match the process descriptions below to the process names:

The process by which the accuracy of test equipment is checked against a known standard. = Calibration

The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation

The process by which data is examined in detail to reach a specific answer or answers. = Analysis

The process by which a parameter of a product or service is examined to determine a specific value. = Measurement

According to the ISO 9000:2015 - Quality management systems — Fundamentals and vocabulary, the definitions of the process names are as follows:

Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.

Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.

Analysis: detailed examination of the elements or structure of something.

Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.

Therefore, the process descriptions can be matched to the process names based on these definitions.

D. I would look for evidence that the actions resulting from the risk assessment had been taken.

According to ISO 9001:2015, Clause 6.1.2 requires the organization to plan actions to address risks and opportunities. The organization must integrate and implement these actions into its quality management system and evaluate their effectiveness. The auditor should seek evidence that the organization has assessed the risks and taken appropriate actions.

B. I would ask to audit the Technical Manager by phone.

As the Technical Manager is responsible for this process and is absent due to illness, it is reasonable to attempt to contact him to obtain accurate information. This ensures that the audit process is not unduly delayed and that the information is obtained from the appropriate person.

A. I would not accept the legal compliance expert answering the question.

While the legal compliance expert might not be the best source for technical details, outright rejecting their input is not appropriate. It is better to first verify if the expert can provide relevant information.

C. I would delay the audit until the return of the Technical Manager.

This would be an inefficient approach. Contacting the Technical Manager by phone is a more practical and reasonable option.

E. I would ask for a different guide instead of the legal compliance expert.

The guide's role is not necessarily to answer technical questions but to facilitate the audit. Since Jack is already familiar with the situation, replacing him may not add value.

F. I would ask the consultant to leave the meeting since he is not an employee of the organization.

This is inappropriate and could disrupt the audit process. There is no rule in ISO 9001 preventing a consultant from assisting in the audit if authorized by the organization.

Why Not the Other Options:

The activities that are specifically required by ISO 17021-1 as part of third-party (Certification Body) surveillance audit processes are:

•Option A: Audit use of certification marks on marketing materials. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to audit the client’s use of marks and/or any other reference to certification, as applicable, to ensure conformity with the certification requirements.

•Option B: Review changes to the QMS since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review any changes affecting the client’s quality management system and its ability to continue to fulfil the requirements of the standard used for certification.

•Option C: Confirm effectiveness of internal audit and management review. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to confirm the continuing effectiveness of the client’s quality management system, including the effectiveness of the internal audit and management review processes.

•Option F: Review the status of previously raised findings and audit effectiveness of any outstanding findings. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the status of findings and any corrective actions taken by the client in response to previous audits, and to verify the effectiveness of the implemented corrective actions.

•Option H: Verify legal compliance. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to verify the client’s compliance with applicable statutory and regulatory requirements related to the scope of certification.

•Option I: Handling of customer complaints since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the client’s handling of customer complaints related to the certified activities since the last audit.

The following options are not correct:

•Option D: Complete a full document review of the quality management system. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to complete a full document review of the quality management system during surveillance audits. A full document review is only required during the initial certification audit or when there are significant changes to the quality management system or the certification requirements.

•Option E: Failing to meet financial responsibilities. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to audit the client’s financial responsibilities during surveillance audits. The certification body may have contractual arrangements with the client regarding the payment of fees, but this is not part of the surveillance audit process.

•Option G: Review the calibration status of the instrumentation. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to review the calibration status of the instrumentation during surveillance audits. The certification body may audit the client’s monitoring and measuring resources as part of the quality management system requirements, but this is not a specific activity required by ISO 17021-1.

•Option J: Conduct a minimum number of annual surveillance audits during the certification period. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to conduct a minimum number of annual surveillance audits during the certification period. The certification body may determine the frequency and duration of surveillance audits based on the risk and performance of the client, but this is not a specific activity required by ISO 17021-1.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015, Clause 5.1.2 (Customer Focus) states that top management must ensure customer satisfaction by monitoring customer perceptions.

In scenario 2, top management initiated customer surveys, demonstrating their commitment to customer focus as required by Clause 5.1.2.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015, Clause 4.3 (Determining the Scope of the Quality Management System) states that when determining the QMS scope, an organization must consider:

External and internal issues (Clause 4.1)

The needs and expectations of interested parties (Clause 4.2)

The products and services provided by the organization

In the scenario, Bell only considered top management's input, which fails to address Clause 4.2 (interested parties' expectations)—such as customers, suppliers, and regulatory authorities.