Last Attempt ISO-9001-Lead-Auditor Questions

Understanding Clause 6.2 of ISO 9001:2015:Clause 6.2 (Quality Objectives and Planning to Achieve Them) specifies that organizations must:

Establish measurable and relevant quality objectives consistent with the quality policy (Clause 6.2.1).

Include objectives applicable to product/service conformity and customer satisfaction.

Document these objectives and their planning as documented information (Clause 6.2.1 & 6.2.2).

Plan how to achieve the objectives, including defining actions, resources, responsibilities, timelines, and methods for evaluation.

Analysis of Options:

A. Quality objectives are not being implemented by the organisation's personnel:Incorrect. While implementation is critical, this relates more to operational aspects rather than the direct requirements of Clause 6.2. Implementation issues would typically raise concerns under Clause 9.1 (Performance Evaluation).

B. The consultant has not interpreted ISO 9001 correctly:Incorrect. The consultant's interpretation of ISO 9001 is irrelevant in terms of Clause 6.2 compliance. The focus is on whether the organization aligns with the requirements, not the consultant's role.

C. Establishing quality objectives did not include top management:Incorrect. While top management involvement is vital for QMS effectiveness (Clause 5.1), this is not a direct requirement of Clause 6.2. Top management alignment is implied but not explicitly mandated for establishing quality objectives.

D. Quality objectives were not established in alignment with the organisation's quality policy:Correct. Clause 6.2.1 requires that quality objectives be consistent with the organization’s quality policy, ensuring they reflect its purpose, strategic direction, and commitment to continual improvement. Misalignment would constitute a nonconformity.

E. The organisation cannot afford to undertake quality objectives all at once:Incorrect. Financial constraints are not directly addressed in Clause 6.2. The clause focuses on planning to achieve objectives, which includes defining the necessary resources but does not demand achieving all objectives simultaneously.

F. Quality objectives are not maintained as documented information:Correct. Clause 6.2.1 specifically requires that quality objectives be maintained as documented information. Failure to document the objectives is a direct violation of this clause.

Why Options D and F Are Correct:

D: Misalignment between the quality objectives and the quality policy directly violates Clause 6.2.1, which mandates that objectives support the strategic direction of the organization.

F: Lack of documentation for quality objectives breaches the requirement to maintain them as documented information under Clause 6.2.1.

Relevant References:

Clause 6.2.1: Establishing quality objectives aligned with the quality policy.

Clause 6.2.2: Maintaining documented information for quality objectives and planning to achieve them.

Clause 5.1.1: Top management's responsibility to ensure alignment between the QMS and strategic direction.

Comprehensive and Detailed In-Depth Explanation:

A technical expert is someone with specialized knowledge that helps the audit team understand specific technical aspects of the auditee’s processes.

Clause References:

ISO 19011:2018, Clause 7.3.4 – Use of Technical Experts:

Technical experts support the audit team with specialized knowledge but do not perform the audit themselves.

Why is the Correct Answer B?

A technical expert is needed when auditors lack deep expertise in specific areas, such as engineering, software, or medical devices.

They assist in interpreting complex technical requirements but do not act as auditors.

Why are the Other Options Incorrect?

A (Observer) → Observers do not contribute expertise; they only watch the audit (e.g., trainees).

C (Guide) → Guides help with logistics but do not provide technical expertise.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence), technical experts:

Provide specialized knowledge in an audit.

Must operate under the supervision of an auditor to ensure compliance with audit protocols.

Cannot work independently or under the auditee’s supervision, as they are not responsible for the audit's findings.

The audit team leader has overall responsibility, but technical experts are supervised by an auditor during the audit process.

Table

Statement

First-party audits

Second-party audits

Third-party audits

The audit scope is typically determined by the organisation being audited.

Yes

No

No

The outcome of the audit is typically certification to a recognised standard.

No

No

Yes

The audit scope is typically confined to service/product provision capability.

No

Yes

No

Here is a brief explanation of each statement:

The audit scope is typically determined by the organisation being audited: This statement applies to first-party audits, also known as internal audits, where the organisation audits its own processes and activities to ensure conformity and improvement1. The organisation can decide the scope of the audit based on its own needs and objectives2. This statement does not apply to second-party audits, where the customer audits the supplier, or third-party audits, where an independent body audits the organisation. In these cases, the audit scope is determined by the customer or the certification body, respectively34.

The outcome of the audit is typically certification to a recognised standard: This statement applies to third-party audits, where an independent body audits the organisation to verify that it meets the requirements of a specific standard, such as ISO 9001, and issues a certificate of conformity if the audit is successful34. This statement does not apply to first-party audits or second-party audits, where the outcome of the audit is not certification, but rather self-improvement or supplier qualification13.

The audit scope is typically confined to service/product provision capability: This statement applies to second-party audits, where the customer audits the supplier to ensure that they are meeting the requirements specified in the contract, such as service or product quality, delivery, or performance34. The audit scope is usually focused on the specific aspects of the service or product that are of interest to the customer3. This statement does not apply to first-party audits or third-party audits, where the audit scope is broader and covers the entire quality management system or the relevant clauses of the standard14.