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

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.

Here is the correct matching of actions to the statements in the context of leading the internal audit:

If practicablecarry out a formal opening meeting

You should notaudit production (as you are a supervisor in that area, and this would compromise audit objectivity)

You need notchange the audit team (unless there is a specific reason, such as conflict of interest)

You mustraise audit findings if necessary (this is a key responsibility of an auditor when nonconformities are found)

You must notsend the audit report to the Quality Manager (the audit report must be reviewed first; it is typically part of the internal audit process to go through necessary channels before final submission)

You shouldsend the audit report to the Quality Manager (after appropriate reviews and approvals)

This reflects key principles of conducting an internal audit according to ISO 9001:2015, ensuring objectivity, proper documentation, and clear reporting procedures.

According to ISO 19011:2018, clause 6.3.2, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the following information1:

•the audit objectives, scope and criteria

•the audit team members and their roles and responsibilities

•the audit schedule, including the date, time and location of each audit activity

•the expected time and duration of meetings and interviews

•the allocation of appropriate resources to critical areas of the audit

•the identification of the audit client and the auditee

•the identification of the guides and observers, if any

•the documents and records to be reviewed before and during the audit

•the audit methods and tools to be used

•the audit language and terminology

•the audit report content, format, distribution and expected completion date

•the risk to achieving audit objectives and the contingency plan, if any

Therefore, the issue which is not expected to be included in the audit plan is C, expectations of the organisation’s management. This issue is not relevant to the conduct of the audit, as the audit is based on the audit criteria, not on the management’s expectations. The management’s expectations may be considered during the audit initiation or the audit programme management, but they are not part of the audit plan.

ISO 9001:2015 clause 9.1.1 requires the organisation to determine what needs to be monitored and measured, the methods needed to ensure valid results, when monitoring and measurement shall be performed, and when results shall be analysed and evaluated.

B is correct because recorded sensory testing results provide evidence of monitoring and measurement results.

C is correct because use of the Hedonic Scale shows a defined method for monitoring product quality.

D is correct because clause 9.1.1 requires monitoring and measurement results to be analysed and evaluated.

A relates more to competence under clause 7.2. E, F, G and H may be useful in some contexts, but they are not direct evidence of conformity with clause 9.1.1 in this scenario.

===========

 A → 8.4.3.a

 B → 7.2.b

 C → 10.2.2

 D → 10.2.1

 E → 6.2

Comprehensive and Detailed Explanation From Exact Extract:

✅ A. There is no specification for incoming materials → 8.4.3.a

Clause 8.4.3(a) relates to the control of externally provided processes, products, and services, specifically the requirement to communicate appropriate specifications and requirements to suppliers:

“The organization shall ensure the adequacy of requirements prior to their communication to the external provider.”

Failure to specify requirements for incoming materials (e.g., what is acceptable waste plastic) risks compromising product quality.

✅ B. The picking operators have been trained → 7.2.b

Clause 7.2(b) relates to Competence and mandates:

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

Training is a critical part of establishing and maintaining operator competence in quality-affecting tasks.

✅ C. The picked reject materials are not documented → 10.2.2

This clause focuses on the retention of documented information regarding nonconformities and actions taken:

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

If rejects are not recorded, traceability and root cause analysis for quality failures are weakened.

✅ D. The rejected materials are segregated → 10.2.1

Clause 10.2.1 relates to nonconformity and corrective action, including containment activities such as:

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

Segregation ensures nonconforming material doesn’t contaminate acceptable output.

✅ E. Management has set an objective for the level of rejects → 6.2

Clause 6.2 is about quality objectives. It requires organizations to:

“Establish quality objectives at relevant functions... The quality objectives shall be measurable…”

Setting a measurable reject-level target aligns with improving process control and reducing waste.