PECB ISO-9001-Lead-Auditor Exam With Confidence Using Practice Dumps

Comprehensive and Detailed In-Depth Explanation:

Clause 5.1.1 of ISO 9001:2015 – Leadership and Commitment – specifically mandates that top management must take accountability for the effectiveness of the QMS. They are also responsible for ensuring:

Integration of the QMS into business processes (5.1.1 c)

Promotion of customer focus and continual improvement (5.1.1 d, i)

Availability of necessary resources (5.1.1 e)

That the QMS achieves its intended results (5.1.1 g)

Let’s analyze the selected options:

✅ A. Top management is not accountable for the effectiveness of the QMS.

This directly violates clause 5.1.1 a, which explicitly requires top management to take accountability for the effectiveness of the QMS. Delegating this to a middle-level Quality Manager, as described in the scenario, constitutes a nonconformity.

✅ F. The Quality Manager does not have access to the resources needed for the QMS.

According to clause 5.1.1 e, top management must ensure the availability of required resources for maintaining and improving the QMS. If the Quality Manager is resource-constrained, it indicates top management has failed to meet this requirement.

Now, why the other options are incorrect in terms of direct clause 5.1.1 nonconformity:

❌ B. Avoiding giving improvement actions to the Chief Executive – While this may reflect poor communication, it is not, by itself, a clear breach of 5.1.1 unless linked directly to top management’s lack of accountability or commitment.

❌ C. Chief Executive never attending meetings – ISO 9001 does not require physical attendance of the Chief Executive at management reviews. What matters is whether top management is fulfilling their roles, not how.

❌ D. Completing only half of improvement actions – This indicates performance issues but does not necessarily indicate top management’s lack of accountability, unless they failed to monitor progress entirely.

❌ E. Reporting to one designated senior manager – This is not inherently nonconforming unless that senior manager does not fulfill top management’s responsibilities under 5.1.1.

Relevant ISO 9001:2015 Reference:

Clause 5.1.1 a, e, g, h:

"Top management shall demonstrate leadership and commitment with respect to the quality management system by:

a) taking accountability for the effectiveness of the quality management system;

e) ensuring that the resources needed for the quality management system are available..."

Nonconformity report

ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - “The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met.” Evidence: 40 cleaning records are available for 63 batches.

According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:

Understand the requirements of ISO 9001 and how they relate to the audit

Understand the organization’s quality management system and its processes

Understand the applicable legal, regulatory, contractual and other requirements that affect the audit

Understand the needs and expectations of interested parties other than customers

Plan and conduct audits in accordance with ISO 19011

Evaluate audit evidence and draw appropriate conclusions

Communicate audit findings effectively1

Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.