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

Comprehensive and Detailed In-Depth Explanation:

According to ISO 9001:2015, Clause 7.5.2 (Creating and Updating Documented Information), the criteria for reviewing documented information include:

Content – The accuracy and relevance of the information.

Format – Ensuring readability and proper structuring (e.g., language, versioning).

Procedure for managing documented information – Ensuring control, access, and updates.

Other options, such as internal audit reports and client feedback, are important for overall QMS evaluation but are not the main criteria for reviewing documented information.

Comprehensive and Detailed In-Depth Explanation:

ISO 19011:2018, Clause 5.4 (Audit Records Management) states that the audit schedule must be maintained as a key record.

Thus, C is the correct answer.

ISO 9001:2015 clause 7.3 requires persons doing work under the organisation’s control to be aware of their contribution to the effectiveness of the quality management system, including the benefits of improved performance.

The subcontract refrigeration engineers are performing work under the organisation’s control because they deliver the maintenance and repair services included in the certification scope. Their own ISO 9001 certification does not remove the organisation’s responsibility to ensure they understand their contribution to the QMS.

The evidence shows that two subcontract engineers stated they were not sure how they could contribute because they had not been told. This directly indicates a failure of clause 7.3 Awareness.

A is less accurate because the issue is not simply communication method; it is the required awareness outcome. B is not supported because there is no evidence that the engineers lack technical competence. D is not the best answer because ISO 9001 does not specifically require “QMS awareness training records” in this scenario.

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Identifying the source of information

Sampling available data

Gathering audit evidence

Verifying objective evidence

Evaluating evidence against the audit criteria

Making audit conclusions

Evaluating against the audit criteria

According to ISO 19011:2018, clause 6.4, the process of collecting and verifying information during an audit involves the following steps1:

Identifying the source of information: The audit team should identify the sources of information that are relevant to the audit objectives, scope and criteria. These sources may include documents, records, personnel, processes, activities, facilities, equipment, etc. The audit team should also determine the methods and tools for accessing and collecting the information, such as interviews, observations, document review, sampling, etc.

Sampling available data: The audit team should select a representative sample of the available data to verify the conformity and effectiveness of the management system. The sample size and selection method should be based on the audit objectives, scope and criteria, as well as the level of confidence and risk. The audit team should also consider the validity, reliability, relevance and sufficiency of the data.

Gathering audit evidence: The audit team should use the methods and tools identified in the previous step to collect audit evidence, which is the records, statements of fact or other information that are relevant to the audit criteria and verifiable. The audit team should record the audit evidence in a clear, concise and objective manner, using notes, checklists, photographs, audio or video recordings, etc.

Verifying objective evidence: The audit team should verify the accuracy, completeness and authenticity of the audit evidence collected. This may involve cross-checking different sources of information, confirming the identity and authority of the persons providing the information, examining the original documents or records, etc. The audit team should also identify any discrepancies, inconsistencies or gaps in the audit evidence.

Evaluating evidence against the audit criteria: The audit team should compare the audit evidence with the audit criteria to determine the extent of conformity and nonconformity. The audit team should also identify any opportunities for improvement, best practices, positive aspects or potential risks. The audit team should use professional judgement and apply the principles of auditing when evaluating the audit evidence.

Making audit conclusions: The audit team should consolidate the audit findings and evaluate the overall performance and effectiveness of the management system. The audit team should also consider the audit objectives, scope and criteria, as well as the context and expectations of the auditee and other interested parties. The audit team should provide a clear, concise and objective statement of the audit conclusions, which may include the degree of conformity, the achievement of the intended outcomes, the need for corrective actions, the suitability for certification, etc.

Evaluating against the audit criteria: The audit team should review the audit conclusions and ensure that they are consistent with the audit criteria and supported by sufficient and appropriate audit evidence. The audit team should also ensure that the audit conclusions are communicated to the auditee and other relevant parties in a timely and effective manner, using the agreed audit report format and distribution method.

According to the ISO 9000:2015 quality management principles document1, risk-based approach is not one of the seven quality management principles that ISO 9000, ISO 9001 and other related quality management standards are based on. The seven quality management principles are:

Customer focus

Leadership

Engagement of people

Process approach

Improvement

Evidence-based decision making

Relationship management

Therefore, risk-based approach is not a quality management principle under ISO 9001:2015.

The responsibilities of an Audit Team Leader in a third-party certification audit are defined primarily in ISO 19011:2018 and reinforced by ISO/IEC 17021-1 for certification audits.

The Audit Team Leader is responsible for managing the audit process, coordinating the audit team, and maintaining communication with the auditee.

Correct Responsibilities

A. Holding the audit team meeting

The Audit Team Leader is responsible for:

Organising and leading audit team meetings.

Ensuring auditors understand their assignments.

Reviewing findings and audit conclusions.

Preparing the team for opening and closing meetings.

Therefore, this is a responsibility of the Audit Team Leader.

B. Adopting a risk-based approach to planning the audit

ISO 19011 promotes the use of a risk-based approach when:

Developing the audit programme.

Planning audit activities.

Allocating resources and audit time.

Determining audit priorities.

The Audit Team Leader applies this approach when preparing and managing the audit.

Therefore, this is a responsibility of the Audit Team Leader.

D. Chairing the audit opening and audit closing meeting

The Audit Team Leader normally:

Conducts the opening meeting.

Explains audit objectives, scope and methods.

Conducts the closing meeting.

Presents audit conclusions and findings.

Therefore, this is a responsibility of the Audit Team Leader.

F. Establishing contact with the auditee

Before and during the audit, the Audit Team Leader:

Establishes communication channels.

Confirms audit arrangements.

Coordinates schedules and logistics.

Clarifies audit activities.

Therefore, this is a responsibility of the Audit Team Leader.

Why the Other Options Are Incorrect

C. Issuing the management system certificate

Certification decisions and certificate issuance are the responsibility of the Certification Body , not the Audit Team Leader.

ISO/IEC 17021 requires certification decisions to be made independently of the audit team.

E. Auditing top management

The Audit Team Leader may audit top management, but this is not a management responsibility of leading the audit team . It is simply an audit assignment that could be performed by any competent auditor.

G. Selecting the audit team

Selection of auditors is normally the responsibility of the:

Audit Programme Manager,

Certification Body,

Individual(s) managing the audit programme.

Not the Audit Team Leader.

H. Preparing the audit nonconformity reports

Each auditor normally prepares and documents their own findings and nonconformities. The Audit Team Leader reviews, coordinates, and approves them, but does not necessarily prepare all nonconformity reports.

Therefore, this is not considered one of the key management responsibilities listed.

ISO-Aligned Summary

Option

Audit Team Leader Responsibility?

Holding the audit team meeting

Yes

Adopting a risk-based approach to planning the audit

Yes

Issuing the management system certificate

No

Chairing the audit opening and audit closing meeting

Yes

Auditing top management

No

Establishing contact with the auditee

Yes

Selecting the audit team

No

Preparing the audit nonconformity reports

No

Answer: A, B, D, F

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Comprehensive and Detailed In-Depth Explanation:

An audit’s feasibility must be assessed using multiple factors, not just resource availability.

Clause References:

ISO 19011:2018, Clause 5.3 – Establishing the Audit Program: Requires consideration of logistical, technical, and cooperation factors when assessing audit feasibility.

ISO/IEC 17021-1:2015, Clause 9.1.3 – Determining Feasibility of the Audit: Requires evaluating more than just resources to ensure a successful audit.

Why is the Correct Answer B?

Audit feasibility should consider:

Availability of information (documents, records).

Cooperation from the auditee.

Operational conditions that might affect the audit.

Scope and complexity of the QMS being audited.

Resource availability alone is not enough to determine feasibility.

Why are the Other Options Incorrect?

A (Top management determines feasibility) → Incorrect because feasibility is determined by the certification body, not the auditee.

C (Resources alone are sufficient) → Incorrect because other key factors must be evaluated.

D (Final authority lies with the audit leader) → Incorrect because ISO requires multiple factors to be considered, not just an auditor’s decision.

In the context of ISO 9001:2015 audits, it is the audit team leader who holds the responsibility for assigning work to the audit team. According to ISO 19011:2018 (Guidelines for auditing management systems, which complements ISO 9001:2015), the audit team leader is responsible for the organization and direction of the audit, including assigning specific roles and responsibilities to audit team members. This includes preparation of the audit plan, leading the audit, and ensuring that each team member understands their tasks.