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

Comprehensive and Detailed In-Depth Explanation:

According to ISO 17021-1:2015, Clause 9.4.10 (Corrective Actions for Major Nonconformities):

If a major nonconformity is not corrected within six months, the certification body must reject the certification request.

Another Stage 2 audit (C) is not required unless the organization reapplies for certification.

Restarting all audit activities (B) is unnecessary; instead, certification is denied.

Thus, A is the correct answer.

Comprehensive and Detailed In-Depth Explanation:

Certification bodies must remain independent and impartial. If a certification body (ABC-CERT) provides consulting services to an organization through its subsidiary (Consultancy ABC), it cannot later certify the same organization.

Clause References:

ISO/IEC 17021-1:2015, Clause 5.2.5 – Impartiality Requirements:

A certification body must not certify an organization to which it has provided consultancy services.

ISO/IEC 17021-1:2015, Clause 5.2.6:

Subsidiaries of certification bodies must not provide consulting services to prevent conflicts of interest.

Why is the Correct Answer C?

Certifying a client after providing consultancy creates a conflict of interest and violates ISO/IEC 17021-1:2015 impartiality rules.

The certification body (ABC-CERT) and consultancy firm (Consultancy ABC) are related entities, making it impossible to remain objective and independent.

Why are the Other Options Incorrect?

A (Waiting two years) → ISO does not specify a time frame; the issue is impartiality, not just time.

B (Signing an agreement to ensure objectivity) → Conflicts of interest cannot be resolved through an agreement; independence is required.

Comprehensive and Detailed In-Depth Explanation:

ISO 19011:2018, Clause 5.4 (Audit Records Management) states that the audit schedule must be maintained as a key record.

Thus, C is the correct answer.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 promotes the process approach, which allows organizations to structure their activities into interrelated processes. This approach helps ensure that processes effectively achieve intended results.

Clause 0.3.1 (Process Approach) states that "The application of the process approach in a quality management system enables understanding and consistency in meeting requirements, considering processes in terms of added value, and achieving effective process performance."

This aligns directly with option C, making it the correct answer. The other options are either partially correct or do not fully capture the purpose of the process approach:

Option A (Improvement based on interested parties) is a benefit but does not define the main goal.

Option B (Financial value) is not the primary focus of the process approach.

Option D (Reduction of resource consumption) may be an indirect benefit but is not a core objective.

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.

The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.

Table

Audit evidence

ISO 9001 Clause 8.3 extract

Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.

“8.3.2 e) … internal … resource needs for the design and development of products …”

The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.

“8.3.5 … retain documented information …”

The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.

“8.3.6 … retain documented information …”

The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.

“8.3.4 d) … conducted to ensure that the resulting products and services meet the requirements …”

The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.

“8.3.2 e) … external … resource needs for the design and development of products …”

In this scenario, the organization has set a quality objective of achieving a 90% minimum exam pass rate for all courses. The auditor’s task is to assess whether this objective is being monitored effectively and if appropriate actions are taken when the objective is not met.

B. You would determine how the exam pass rate figures were analysed: ISO 9001:2015, particularly Clause 9.1 (Monitoring, measurement, analysis, and evaluation), requires organizations to evaluate performance data. The auditor should verify how the organization analyses the pass rate data to ensure trends are identified, and corrective actions are planned based on this analysis.

D. You would determine what corrective action was being taken to address the low pass rates: When performance falls short of the objective, as seen with Course 4 (where the pass rate is below 90% in all months), Clause 10.2 (Nonconformity and corrective action) requires organizations to take corrective actions to address issues. The auditor would need to check if corrective actions have been initiated to address consistently low pass rates.

Statements A, C, E, and F do not directly address the monitoring and corrective action required under ISO 9001:2015 in this context​​.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015, Clause 4.3 (Determining the Scope of the Quality Management System) states that when determining the QMS scope, an organization must consider:

External and internal issues (Clause 4.1)

The needs and expectations of interested parties (Clause 4.2)

The products and services provided by the organization

In the scenario, Bell only considered top management's input, which fails to address Clause 4.2 (interested parties' expectations)—such as customers, suppliers, and regulatory authorities.