PECB ISO-9001-Lead-Auditor Exam With Confidence Using Practice Dumps

According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:

•Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently.

•Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed.

•Select the external providers that have demonstrated their competence and conformity to the requirements. The selection should be based on the evaluation results and the organization’s needs. The selection should be documented and approved.

•Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely.

•Monitor the performance and conformity of the external provider, using the established criteria and methods. The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed.

In this case, the evidence statements that demonstrate a nonconformity with clause 8.4 are A and C, because they show that the organization did not retain documented information of the selection and evaluation of the external provider, and the monitoring of the external provider’s performance. These are requirements of the standard and essential for ensuring the quality of the externally provided processes, products, and services. The other options are not directly related to clause 8.4, although they may indicate other nonconformities or weaknesses in the organization’s QMS. For example, option B may relate to clause 7.1.3 on contingency planning, option D may relate to clause 8.2.3 on review of requirements, option E may relate to clause 8.6 on release of products and services, and option F may relate to clause 5.1.1 on leadership and commitment. References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires organizations to ensure that auditors have the necessary competence and knowledge to conduct audits effectively.

Clause References:

ISO 19011:2018, Clause 7.2.1 – Determining Competence of Auditors: Auditors must have knowledge of applicable legal and regulatory requirements that affect the scope of the audit.

ISO/IEC 17021-1:2015, Clause 7.1.2 – Competence Requirements: Certification bodies must ensure that auditors assigned to the audit team possess relevant knowledge in areas such as legal and regulatory compliance.

Why is the Correct Answer C?

Each audit team member should have sufficient knowledge of relevant legal and regulatory requirements to ensure compliance.

This helps auditors identify gaps or nonconformities related to compliance obligations.

Having multiple team members with knowledge reduces reliance on a single expert and ensures a comprehensive assessment.

Why are the Other Options Incorrect?

A (Only one team member needs knowledge) → Incorrect because audits involve various aspects, and all auditors should have basic awareness of legal and regulatory requirements.

B (Legal knowledge is not necessary) → Incorrect because compliance is essential for QMS effectiveness.

D (Only the lead auditor needs legal knowledge) → Incorrect because ISO requires all auditors to be competent in applicable laws, not just the leader.

ISO 9001:2015 requires organisations to understand their context and to use this understanding as an input to planning the quality management system. Tools such as PESTLE are acceptable methods, but auditors must verify how the outputs are used, not simply that the analysis exists.

Relevant ISO 9001 requirements:

Clause 4.1 – Understanding the organisation and its contextThe organisation shall determine external and internal issues that are relevant to its purpose and strategic direction and that affect its ability to achieve the intended results of the QMS.

Clause 6.1 – Actions to address risks and opportunitiesThe organisation shall plan actions to address risks and opportunities identified from context analysis and integrate these actions into the QMS processes.

Explanation of the correct audit trails:

C. What actions have been taken to address the risks and opportunities from the PESTLE analysis?

This audit trail directly links PESTLE outputs to Clause 6.1. It allows the auditor to determine whether the organisation has translated identified political, economic, social, technological, legal, and environmental issues into concrete actions within planning, operational control, or resource allocation. Without actions, the PESTLE analysis has no impact on QMS planning.

E. How has the PESTLE analysis contributed to the improvement of the QMS?

ISO 9001 requires context analysis to support improvement and strategic alignment of the QMS. This audit trail confirms whether PESTLE outputs are used as inputs to improvement activities, management review, or changes to processes, supporting Clauses 4.1, 6.1, and 10.3.

Explanation of why the other options are not selected:

A: Review by a specific manager is not a requirement of ISO 9001 and does not demonstrate impact on QMS planning.

B: PESTLE does not require consultation with external interested parties; that relates to Clause 4.2, not planning impact.

D: Training in SWOT is irrelevant, as ISO 9001 does not mandate any specific analysis tool.

F: Sharing information with external interested parties relates to communication, not to how PESTLE affects QMS planning.

ISO-aligned conclusion:

To determine how PESTLE analysis affects planning of a QMS, the auditor must follow audit trails that demonstrate:

Conversion of identified issues into risk-based actions, and

Use of those outputs to improve and adapt the QMS.

Therefore, the correct answers are C and E.