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

Corrective action must eliminate the cause of a nonconformity and prevent recurrence. In this case, the problem is process variability causing bruised and over-ripe fruit and increasing complaints.

Option C is acceptable because applying improved process controls aligned with customer criteria directly addresses the cause and prevents recurrence.

A may help only if competence is the cause, which is not established. B is investigation, not corrective action itself. D disposes of rejected product but does not prevent recurrence.

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ISO 9001:2015 requires that nonconformities be objective, evidence-based, and referenced against defined requirements , not personal, prescriptive, or solution-driven.

When a nonconformity is raised, it must clearly show what requirement was not met and what objective evidence demonstrates this failure .

✅ Why D (Audit criteria) is required

A nonconformity must reference the requirement that was not fulfilled (e.g., ISO 9001 clause, procedure, contract, or legal requirement).

ISO 9001 defines nonconformity as “non-fulfilment of a requirement” .

Without audit criteria, there is no basis for declaring a nonconformity.

📌 Supported by:

Clause 9.2.2 – Internal audits must determine whether the QMS conforms to requirements

Clause 10.2.2 – Documented information shall describe the nature of the nonconformity

✅ Why E (Relevant audit evidence) is required

ISO 9001 requires decisions and conclusions (including audit findings) to be based on evidence .

Audit evidence ensures objectivity and prevents subjective or opinion-based findings.

📌 Supported by:

Clause 9.1.3 – Analysis and evaluation shall be based on data and information

Clause 9.2.2 – Audit results must demonstrate conformity or nonconformity based on evidence

❌ Why the other options are NOT correct

A (Name of person responsible) ISO 9001 focuses on system and process failures , not blaming individuals.

B (Target time for corrective action) This is part of corrective action planning , not the nonconformity statement itself (Clause 10.2).

C (Name of technical expert) ISO 9001 does not require identifying auditors or experts in the nonconformity statement.

F (Action to eliminate the nonconformity) Auditors must not prescribe solutions . The auditee determines corrective actions (Clause 10.2).

Comprehensive and Detailed In-Depth Explanation:

Before accepting an audit, the certification body must assess the integrity of the auditee and the nature of its operations to ensure compliance feasibility.

Clause References:

ISO/IEC 17021-1:2015, Clause 9.1.2 – Audit Planning:

The certification body must review the auditee’s background, reputation, and operational complexity before accepting the audit.

Why is the Correct Answer C?

The auditee’s integrity and reputation impact the credibility of certification.

The nature of operations determines audit complexity and resource allocation.

Why are the Other Options Incorrect?

A (Integrity and reputation only) → Correct but incomplete; nature of operations is equally important.

B (Nature of operations only) → Integrity is also a factor, not just operations.

D (No previous major nonconformities required) → Auditees with past major nonconformities can still be audited if corrective actions are taken.

B. Control of externally provided processes, products, and services: This is relevant because the organization has outsourced the manufacture of its own brand products to a supplier. According to ISO 9001, the organization must ensure that externally provided processes remain within the control of its quality management system.

C. Design and development of products and services: Even though the organization no longer manufactures in-house, it still needs to control the design and development of its products, especially since they are now being produced by an external provider.

F. Organisation roles and responsibilities: The change in strategy has led to a significant reduction in staff, which would have an impact on the roles and responsibilities within the organization. It is important to audit how these changes have been managed and communicated within the organization to ensure continued effectiveness of the quality management system.

These audit trails are aligned with the requirements of ISO 9001:2015, which emphasizes the importance of controlling externally provided processes and products, managing design and development, and clearly defining roles and responsibilities within the quality management system.

ISO 9001:2015 requires audits to be conducted in an objective and impartial manner . Although ISO 9001 does not list specific threats to impartiality, it explicitly refers to ISO 19011 for guidance on auditing principles, including impartiality.

ISO 9001:2015, Clause 9.2.2 (NOTE) states that guidance on auditing is given in ISO 19011 .

According to ISO 19011:2018 , one of the fundamental auditing principles is impartiality , defined as the basis for the objectivity of audit conclusions. ISO 19011 identifies several threats to impartiality , including self-interest and familiarity.

Explanation of the correct options:

C. Self-interest

ISO 19011 identifies self-interest as a primary threat to impartiality. This occurs when an auditor has a personal, financial, or professional interest in the outcome of the audit, which could influence audit judgement or conclusions.

Examples include financial gain, career advantage, or personal benefit linked to the audit outcome.

E. Your spouse is working in the organisation being audited

This represents a familiarity or relationship threat. ISO 19011 highlights that close personal relationships with the auditee can compromise, or be perceived to compromise, auditor impartiality. Even if the auditor remains objective, the relationship creates a clear conflict of interest.

Explanation of why the other options are not selected:

A. Competence : Competence supports effective auditing and is not a threat to impartiality.

B. Lack of Experience : This affects audit effectiveness, not impartiality.

D. Consulting : Consulting can create a conflict of interest in certain contexts, but on its own it is not necessarily an impartiality threat unless it involves consulting for the same organisation or system being audited, which is not stated here.

F. Expert knowledge of the process : Technical expertise improves audit effectiveness and does not threaten impartiality.

Summary aligned to ISO guidance:

The most likely threats to auditor impartiality are those involving personal interest or close relationships with the auditee. Therefore, self-interest and a spouse working in the audited organisation are the correct answers under ISO 9001–aligned auditing guidance.

According to the ISO 9001:2015 standard, clause 8.4.1 requires organizations to ensure that externally provided processes, products and services conform to requirements. Controls must be applied to externally provided processes, products and services when:

The products and services are intended for incorporation into the organization’s own products and services.

They are provided directly to customers by the external provider on behalf of the organization.

A process, or part of a process, is provided by an external provider as a result of a decision by the organization.

In this scenario, the auditee has chosen a supplier to manufacture their own brand products based on their design drawings, supplier questionnaire and trial batches. This means that the supplier is providing a process (manufacturing) as a result of a decision by the organization (the auditee). Therefore, clause 8.4.1 applies to this situation.

According to the ISO 9001:2015 standard, clause 8.7 requires that an organization identify and control any nonconforming outputs that do not conform to the requirements of the customer or other relevant requirements. Nonconforming outputs are any outputs from the process, product or service that do not meet the specified quality criteria. Nonconforming outputs must be dealt with in one or more of the following ways:

Correction of the nonconformity

Segregation, containment, return or suspension of provision of products and services

Informing the customer

Authorisation for acceptance under concession

The organization must also retain documented information on the description of the nonconformity, the actions taken, any concessions obtained, and the identification of the authority deciding the action to resolve the nonconformity.

In this scenario, you have interviewed a line supervisor who is responsible for managing a manual picking line where operators are removing contaminant materials from incoming products. The supervisor has explained that these plastic items are rejected at this stage because they do not meet their processing standards and they can damage their machinery and compromise their quality standards. The supervisor has also mentioned that some of these rejected items are melted down in another process later on and some are disposed of as waste products that cannot be recycled.

Based on this information, you can investigate further by taking two actions:

A. Check the process for handling nonconforming items: You can verify whether there is a documented procedure for identifying, segregating, containing, returning or suspending provision of nonconforming items at this stage. You can also check whether there is a system for informing customers about any nonconforming items that may affect their satisfaction or expectations.

D. Determine what happens to the waste products: You can verify whether there is a documented procedure for disposing of waste products that cannot be recycled as per environmental regulations and customer requirements.

These two actions would help you to determine whether there are any nonconforming outputs at this stage and how they are controlled by the organization.

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​​.

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.