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

A → 8.4.3.a

B → 7.2.b

C → 10.2.2

D → 10.2.1

E → 6.2

F → 5.2.2.c

8.4.3.a – No specification is issued to the suppliers of waste plastic:This clause refers to the information provided to external providers, including requirements for products and services. If no specification is issued, it means the organization is not complying with this clause, which states:

“The organization shall ensure that the requirements for the products and services to be provided are adequately defined prior to communication to the external provider.”

7.2.b – The picking operators have been trained:This falls under Competence requirements. Clause 7.2(b) requires that persons are competent on the basis of education, training, or experience:

“Ensure that these persons are competent on the basis of appropriate education, training, or experience.”

10.2.2 – No documentation is retained for rejected materials:This relates to corrective action documentation. Clause 10.2.2 requires organizations to retain documented information as evidence of nonconformities and actions taken:

“The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken…”

10.2.1 – The rejected materials are segregated:This links to the treatment of nonconforming outputs. Clause 10.2.1 discusses actions such as containment or segregation for nonconforming outputs:

“Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment…”

6.2 – Management has set an objective for the level of recycling:This refers to quality objectives. Clause 6.2 requires that measurable quality objectives be established, and this includes setting performance targets:

“The organization shall establish quality objectives at relevant functions… The quality objectives shall be measurable…”

5.2.2.c – The quality policy appears in promotional material:Clause 5.2.2(c) requires the quality policy to be available to relevant interested parties. Using it in promotional material ensures that it is communicated externally:

“The quality policy shall be… available to relevant interested parties, as appropriate.”

According to the ISO - Management system standards page, the key benefits of an effective management system include improved operational effectiveness and efficiency, improved risk management and protection of people and the environment, and enhanced drive for innovation. The Integrated Use of Management System Standards (IUMSS) handbook also states that the purpose and objectives of management system standards are to help organizations improve their performance by specifying repeatable steps that organizations consciously implement to achieve their goals and objectives.

Therefore, the complete sentence is:

“The purpose of a management system standard is to improve the performance of an organisation.”

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.

Comprehensive and Detailed Explanation From Exact Extract:

According to ISO 19011:2018 – Guidelines for Auditing Management Systems, which is referenced in ISO 9001 Lead Auditor training and practice, auditor competence is defined by a combination of knowledge, skills, and personal attributes. Here's how each selected option aligns:

D. Determining what evidence to gather: This activity is rooted in knowledge of audit principles, criteria, and risk-based thinking. It requires an understanding of which types of evidence (documents, records, interviews, observations) are necessary to evaluate conformity to the audit criteria (Clause 7.2.3 of ISO 19011:2018).

E. Evaluate proposals of corrective actions: This task involves applying knowledge of ISO 9001 requirements, root cause analysis methods, and risk controls to assess whether proposed actions are suitable to prevent recurrence. It demands comprehension of quality management principles and corrective action methodologies, linking it firmly to knowledge.

Other options such as A (Communicate with auditee) and B (Conduct audit meetings) are predominantly skills-based, requiring interpersonal and communication abilities, not theoretical or regulatory knowledge.

C (Determine how to seek evidence) and F (Identify findings) involve both knowledge and skill but are more action-oriented and tied to situational judgment and auditor behavior.

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 4.1, the organisation must determine the external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended results of its quality management system. The organisation must also monitor and review the information about these issues. SWOT analysis is a tool that can help the organisation to identify its strengths, weaknesses, opportunities, and threats. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to review the information periodically and update it as necessary. Therefore, one audit trail would be to establish how the organisation reviews information about external and internal issues, such as how often, by whom, using what criteria, and with what results. 123

According to ISO 9001:2015, clause 10.3, the organisation must continually improve the suitability, adequacy, and effectiveness of the quality management system. The organisation must also consider the results of analysis and evaluation, and the outputs from management review, to determine if there are any needs or opportunities for improvement. SWOT analysis can help the organisation to identify the areas where improvement is needed or possible, such as addressing the weaknesses and threats, or exploiting the strengths and opportunities. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to take actions to implement the improvement, such as setting objectives, allocating resources, assigning responsibilities, and evaluating the effectiveness. Therefore, another audit trail would be to establish what actions were taken to improve the QMS, such as what, when, by whom, how, and with what results. 124 References:

1: ISO 9001:2015 - Quality management systems — Requirements

2: Advisera, “Context of the organization in ISO 9001:2015 explained”, https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/

3: ISO Templates, “ISO 9001 - Clause 4: Context of the organisation explained”, https://resources.iso-templates.com/blog/iso-9001-clause-4-context-of-the-organisation-explained

4: Advisera, “How to implement continual improvement in ISO 9001”, https://advisera.com/9001academy/knowledgebase/how-to-implement-continual-improvement-in-iso-9001/

Comprehensive and Detailed In-Depth Explanation:

ISO 19011:2018 requires auditors to conduct audits professionally and diligently.

Clause References:

ISO 19011:2018, Clause 4.4 – Professional Care: Auditors must exercise due diligence in conducting audits.

ISO 9001:2015, Clause 9.2 – Internal Audit: Requires objective and systematic audits to evaluate QMS effectiveness.

Why is the Correct Answer A?

The audit team followed best practices by gathering verifiable audit evidence through interviews, document reviews, and observations.

They ensured fair presentation of findings in the final audit report.

They complied with ISO 9001 and ISO 19011 guidelines for audit procedures.

Why are the Other Options Incorrect?

B (Ordinary negligence) → No evidence of negligence; the team followed structured audit processes.

C (Gross negligence) → No indication that the auditors ignored important responsibilities.

D (Willful misconduct) → The auditors acted professionally and did not intentionally disregard rules.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 17021-1:2015, Clause 9.4.10 (Corrective Actions for Major Nonconformities):

If a major nonconformity is not corrected within six months, the certification body must reject the certification request.

Another Stage 2 audit (C) is not required unless the organization reapplies for certification.

Restarting all audit activities (B) is unnecessary; instead, certification is denied.

Thus, A is the correct answer.