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

ISO 9001:2015 requires top management to review the quality management system at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organisation . The auditor’s focus, especially during a surveillance audit covering improvement actions , must therefore be on evidence that management review is being carried out correctly and that it results in QMS-related decisions and changes .

Relevant ISO 9001 clauses include:

Clause 9.3.1 – Management review (General) Top management shall review the organisation’s quality management system at planned intervals.

Clause 9.3.3 – Management review outputs The outputs of management review shall include decisions and actions related to opportunities for improvement and any need for changes to the QMS.

Explanation of the correct options:

A. The date of the most recent management review meeting

This is directly relevant because ISO 9001 requires management reviews to occur at planned intervals . The auditor must confirm that the review has taken place and that it is current, especially during a surveillance audit.

E. Changes made to the quality system by the new Quality Manager

This is directly linked to management review outputs and improvement actions . Since a new Quality Manager has been appointed, the auditor must verify whether changes to the QMS were reviewed, approved, and monitored through management review in line with Clauses 9.3.3 and 10.3.

Explanation of why the other options are not relevant:

B : Workforce redundancies are a human resources or business decision unless they directly affect QMS effectiveness, which is not indicated here.

C : Increased profitability is a business outcome, not a required management review input or output under ISO 9001.

D : Pension scheme improvements are unrelated to QMS performance or improvement.

F : A bonus scheme may relate to productivity, but unless it directly affects QMS objectives or process performance reviewed in management review, it is not a required checklist item.

ISO-aligned conclusion:

For an audit focusing on improvement actions and management review , the auditor’s checklist should confirm:

That management review has been conducted as required, and

That QMS-related changes and improvements (especially under a new Quality Manager) are being reviewed and controlled.

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.

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The correct answer is:

Event

Selecting audit team = Individual(s) managing the audit programme

Conducting the audit = Audit team

Preparing the audit plan = Audit team leader

Requesting the audit = Audit client

To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below. Alternatively, drag and drop each option to the appropriate blank section. Responsibility:- Individual(s) managing the audit programme

Audit team

Audit team leader

Audit client

According to ISO 19011:2018, clause 5.3, the individual(s) managing the audit programme are responsible for selecting the audit team, taking into account the competence and availability of the auditors and any experts needed. 1

According to clause 6.2, the audit team is responsible for conducting the audit, which includes collecting and verifying audit evidence, evaluating audit findings, and preparing the audit report. 1

According to clause 6.1, the audit team leader is responsible for preparing the audit plan, which includes defining the audit objectives, scope, criteria, and duration, as well as assigning roles and responsibilities to the audit team members. 1

According to clause 5.2, the audit client is the person or organization that requests the audit, which can be the auditee (the person or organization being audited) or any other person or organization that has an interest in the audit results. 1