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

ï‚· Responsibilities of the Audit Team Leader:

ISO 19011:2018 (guidelines for auditing management systems), which supports the principles in ISO 9001:2015, specifies the responsibilities of an audit team leader. These responsibilities include:

Planning the audit and establishing effective communication between the audit team and auditee.

Ensuring that formal communication channels are agreed upon and followed.

Reporting the audit progress, significant findings, and any concerns to the auditee or audit client as necessary.

Managing the audit team and ensuring adherence to the defined objectives and scope.

ï‚· Analysis of Options:

A. Reporting unattainable audit objectives to the accreditation body:Incorrect. This is not the responsibility of the audit team leader. The accreditation body oversees the certification body and is not directly involved in specific audits. If objectives are unattainable, the audit team leader would report them to the audit client (the certification body), not the accreditation body.

B. Planning formal communication arrangements:Correct. This is one of the responsibilities of the audit team leader. They ensure auditees can communicate with auditors as needed during the audit process.

C. Confirming communication channels during the opening meeting:Correct. During the opening meeting, the audit team leader must establish clear communication protocols to ensure effective information exchange between the audit team and auditee.

D. Communicating progress, findings, and concerns:Correct. Keeping the auditee and audit client informed about progress and significant findings is a critical responsibility of the audit team leader to maintain transparency and ensure the audit objectives are met.

ï‚· Why Option A is Correct:

The audit team leader does not have any obligation to report unattainable objectives to the accreditation body. Instead, they are responsible for communicating issues to the audit client (typically the certification body). The accreditation body operates at a higher level and is concerned with overseeing certification bodies, not individual audits.

ï‚· Relevant References:

ISO 19011:2018, Clause 6.4 (Conducting the Audit): Emphasizes the responsibilities of the audit team leader, including communication with the auditee and client.

ISO 9001:2015, Clause 9.2 (Internal Audit): Highlights the importance of planning and communication during audits, which is reflected in third-party audits as well.

In this scenario, the time allocated by the audit team leader for the Human Resources audit is fixed, and as an auditor, you must work within that constraint. Although the sampling criteria suggests reviewing 25 personnel files, it is acceptable to adjust the sample size based on time and resource limitations. ISO 9001:2015 emphasizes risk-based thinking and practical resource management (Clause 7.1), so it is reasonable to review a smaller sample if the time is insufficient.

Option B is a pragmatic approach, allowing you to focus on quality over quantity by reviewing as many cases as time allows without compromising the audit schedule.

Options like extending the audit (A, C, D) are impractical in a structured audit environment, especially for second-party audits where maintaining the agreed schedule is important​​.

To demonstrate top management’s leadership and commitment with respect to the quality management system, the following four actions would be indicative:

B. Briefing staff on the development of an improvement culture: This shows that top management is actively involved in promoting a culture of continuous improvement, which is a key aspect of the quality management system1.

C. Chairing management review meetings: By leading these meetings, top management demonstrates their involvement in the quality management system’s ongoing performance and commitment to its continual improvement1.

E. Investing time and money in corrective actions arising from nonconformities: This indicates that top management is committed to addressing issues and ensuring that the quality management system is effective and continually improving1.

G. Promoting the importance of following procedures: When top management emphasizes the importance of adherence to procedures, it reinforces the significance of the quality management system and its processes1.

These actions align with the requirements of ISO 9001:2015, which emphasizes the need for top management to take accountability for the effectiveness of the quality management system and to promote a focus on continual improvement and customer satisfaction123. Approving company car budgets, conducting disciplinary meetings, and not attending the audit closing meeting do not directly demonstrate leadership and commitment to the quality management system1.

Comprehensive and Detailed In-Depth Explanation:

Auditors must have competence in risk-based auditing to effectively assess an organization’s QMS performance and compliance.

Clause References:

ISO 19011:2018, Clause 7.2.3 – Determining Auditor Competence:

Auditors must have knowledge of risk-based thinking to assess risk impact on processes.

ISO 9001:2015, Clause 0.3.3 – Risk-Based Thinking:

The standard emphasizes proactive risk management, which auditors must understand.

Why is the Correct Answer B?

Risk-based auditing ensures audits focus on high-risk areas, improving audit effectiveness.

Auditors must assess how organizations apply risk-based thinking in decision-making, process control, and improvement.

Why are the Other Options Incorrect?

A (Industry knowledge) → While helpful, it is not mandatory for all auditors.

C (Expertise in all domains) → Auditors are not required to be experts in all areas, just in audit methodology.

D (Formal degree in quality management) → ISO does not require a formal degree, just competence in audit principles and methods.

According to ISO 9001:2015, clause 9.1.1, the organization is required to determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results, and when the monitoring and measuring shall be performed. The organization is also required to retain appropriate documented information as evidence of the results.

Therefore, in the scenario given, the organization should have planned for monitoring and measuring the billet temperature, as it is a critical factor for the quality of the product and the process. The organization should also have established a procedure that provides instruction in taking billet temperature, using the pyrometer or other suitable methods, to ensure consistency and accuracy. The organization should also have performed periodic analysis of the results of temperature checks, to identify trends, problems, and opportunities for improvement.

Hence, the options that would provide evidence of conformance with clause 9.1.1 of ISO 9001 are A, E, and F, as they are aligned with the requirements of the clause. The other options are either irrelevant or not directly related to clause 9.1.1, as they do not pertain to the monitoring and measurement of the billet temperature.

The following table shows the possible matching of the records to the requirements of clause 8.4:

Table

Requirements

Records

Define product requirements

Product specification

Criteria for selection

List of requirements to be met by the external provider

Evaluation of potential external provider

External provider questionnaire

External provider selection

Approved external provider list

Communicate requirements

Purchase order

Monitoring of performance

External provider delivery times and quality issues

Comprehensive and Detailed Explanation: = According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:

Define the product requirements that are relevant for the external provision, such as specifications, drawings, standards, codes, etc. These should be documented and communicated to the external provider. A record of the product specification can be used as evidence of this requirement.

Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently. A record of the list of requirements to be met by the external provider can be used as evidence of this requirement.

Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed. A record of the external provider questionnaire can be used as evidence of this requirement.

Select the external providers that have demonstrated their competence and conformity to the requirements. The selection should be based on the evaluation results and the organization’s needs. The selection should be documented and approved. A record of the approved external provider list can be used as evidence of this requirement.

Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely. A record of the purchase order can be used as evidence of this requirement.

Monitor the performance and conformity of the external provider, using the established criteria and methods. The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed. A record of the external provider delivery times and quality issues can be used as evidence of this requirement.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions):

Minor nonconformities do not require a follow-up audit but must be corrected before the next surveillance audit.

Follow-up audits are required only for major nonconformities.

The audit team should recommend corrective actions, not enforce immediate follow-ups for minor nonconformities.

Thus, A is the correct answer.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 emphasizes the importance of communication as part of an effective Quality Management System (QMS).

Clause References:

Clause 7.4 (Communication): This requires organizations to establish what, when, with whom, and how communication should take place to ensure effectiveness.

Quality Management Principle – Engagement of People: Effective communication allows stakeholders (employees, suppliers, customers) to fully participate and contribute to quality objectives.

Why is the Correct Answer A?

Appropriate communication means ensuring that messages are clear, relevant, and accessible to the intended audience.

Different stakeholders (employees, customers, regulatory bodies, suppliers) may require different formats, languages, or media to ensure they fully understand and engage.

This aligns with ISO 9001:2015, which emphasizes that communication must be tailored to the needs of the recipient for maximum effectiveness.

Why are the Other Options Incorrect?

B (Timely responses) → Important but does not specifically refer to appropriateness in communication.

C (Communicating processes and assumptions to all interested parties) → Communication should be relevant; sharing all details might not be necessary or appropriate.

D (Only top management handling external communication) → Communication must be distributed across relevant functions, not restricted to leadership.

Comprehensive and Detailed In-Depth Explanation:

Audit risks are categorized into different types based on where failures may occur in the QMS audit process.

Clause References:

ISO 19011:2018, Clause 6.3 – Managing Audit Risk: Defines different audit risks, including control risk.

Why is the Correct Answer A?

Control risk occurs when internal controls fail to prevent or detect nonconformities.

Even if controls exist, the risk remains if the QMS fails to identify or correct defects.

Why are the Other Options Incorrect?

B (Inherent risk) → This refers to risks naturally present in processes, even before controls are applied.

C (Detection risk) → This is the risk that an auditor fails to detect nonconformities.

D (Operational risk) → This refers to risks related to day-to-day business operations, not QMS audits.