Important PECB ISO-9001-Lead-Auditor Exam Questions

Answer: B, F

Explanation:

Comprehensive and Detailed Explanation From Exact Extract:

Correct Option B -- ''Communicate a policy commitment to continual improvement''

This aligns directly with Clause 5.2.1(d) of ISO 9001:2015, which states that the quality policy shall include a commitment to continual improvement of the QMS:

''Top management shall establish, implement and maintain a quality policy that... includes a commitment to continual improvement of the quality management system.''

A clearly communicated policy sets expectations and a strategic direction that cascades throughout the organization, promoting a culture that values ongoing enhancement.

Correct Option F -- ''Use the management review process to identify improvements''

This is based on Clause 9.3.3 of ISO 9001:2015, which specifies that outputs of management reviews must include decisions and actions related to:

''a) opportunities for improvement;

b) any need for changes to the quality management system;

c) resource needs.''

The management review process is a structured mechanism to analyze data, monitor performance, assess risks and opportunities, and drive continual improvement initiatives.

Why the Other Options Are Incorrect:

A (Appoint external consultants to train staff): While training may help improve competence, ISO 9001 emphasizes internal process evaluation and strategic improvement. This option is not directly aligned with the systematic improvement of the QMS.

C (Require higher standards): Higher standards alone don't ensure continual improvement unless supported by a structured QMS approach involving evaluation, planning, and measurement.

D (Require fewer mistakes): Unrealistic or unqualified demands like 'make fewer mistakes' don't support structured process-based improvement and may conflict with ISO's emphasis on risk-based thinking and root cause analysis.

E (Send Chief Executive on a course): While leadership involvement is vital (Clause 5), this action by itself does not constitute a continual improvement mechanism for the QMS.

ISO 9001:2015 Clause 5.2.1(d) -- Establishing the Quality Policy

ISO 9001:2015 Clause 9.3.3 -- Management Review Outputs

ISO 9001:2015 Clause 10.3 -- Continual Improvement

Answer: C

Explanation:

Comprehensive and Detailed In-Depth

Group interviews allow auditors to gather more information in less time by:

Obtaining input from multiple participants simultaneously.

Encouraging discussions that might highlight inconsistencies.

Reducing the number of individual interviews needed.

While auditors strive for fairness, equal time for each interviewee is not guaranteed, and paying attention to each individual is more difficult in a group setting.

ISO 19011:2018, Clause 6.4.6 (Conducting Interviews)

Answer: A

Explanation:

Comprehensive and Detailed In-Depth

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.

ISO 9001:2015, Clause 4.3 -- Determining the Scope of the QMS

ISO 9001:2015, Clause 4.2 -- Understanding the Needs and Expectations of Interested Parties

Answer: B, D

Explanation:

According to ISO 19011:2018, clause 6.3, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the information listed in my previous response, such as the audit objectives, scope, criteria, schedule, team, methods, report, etc. The audit plan should be prepared and completed prior to the on-site audit, and should be communicated to the audit team and the auditee1.

According to ISO 19011:2018, clause 6.4.3, the checklist / prompts are documents that list the questions or topics that need to be covered during an audit. The checklist / prompts can help the auditor to collect and verify information relevant to the audit criteria, and to ensure the consistency and completeness of the audit. The checklist / prompts should be prepared and completed prior to the on-site audit, and should be based on the audit plan and the audit scope and objectives1.

Therefore, the two documents that an auditor needs to prepare and complete prior to the on-site audit are B and D, as they are essential for planning and conducting the audit. The other options are not correct, as they are either prepared or completed after the on-site audit, or not required by the standard:

*A. Audit Report: The audit report is a document that provides a complete, accurate, concise, and clear record of the audit. The audit report should include the information listed in my previous response, such as the audit objectives, scope, criteria, findings, conclusions, etc. The audit report should be prepared and completed after the on-site audit, and should be distributed to the audit client and the auditee1.

*C. Procedures: Procedures are documents that specify the way activities are to be performed. Procedures may be part of the audit criteria, if they are part of the organization's management system, or part of the audit programme, if they are part of the certification body's or registrar's requirements. Procedures are not prepared or completed by the auditor prior to the on-site audit, but rather reviewed or followed by the auditor during the audit1.

*E. Risk Matrices: Risk matrices are tools that help to assess and prioritize the risks and opportunities associated with the audit programme or the audit. Risk matrices may be part of the audit programme management, if they are used to determine and evaluate the audit programme risks and opportunities, or part of the audit preparation, if they are used to determine and evaluate the audit risks and opportunities. Risk matrices are not prepared or completed by the auditor prior to the on-site audit, but rather used or updated by the auditor during the audit programme management or the audit preparation1.

*F. Findings: Findings are the results of the evaluation of the collected audit evidence against the audit criteria. Findings can indicate either conformity or nonconformity, as well as positive aspects or opportunities for improvement. Findings are not prepared or completed by the auditor prior to the on-site audit, but rather generated and recorded by the auditor during the audit activities1.

Answer: B

Explanation:

Comprehensive and Detailed In-Depth

According to ISO 17021-1:2015, Clause 9.6.2 (Surveillance Activities):

The certification body is responsible for planning and conducting surveillance audits to ensure continued compliance.

The auditee's top management (A) does not develop surveillance activities, but they must participate.

The audit team leader (C) conducts the surveillance audit, but they do not develop the program.

Thus, B is the correct answer.

ISO 17021-1:2015, Clause 9.6.2 (Surveillance Activities)