ISO-9001-Lead-Auditor Dumps With Exact Questions and Answers

According to the ISO 9001:2015 standard, clause 10.2.1 defines nonconformity as the non-fulfilment of a requirement. A requirement can be related to the quality management system, the products and services, the customer expectations, or the applicable statutory and regulatory requirements. Nonconformities can be detected through various sources, such as audits, inspections, tests, customer complaints, or internal reviews. Nonconformities must be addressed by taking appropriate actions to correct them and prevent their recurrence.

In this scenario, the auditee has shown several issues that indicate nonconformities in their quality management system. Two statements that apply to the term nonconformity are:

A. No quality objectives planned for the top management team: According to ISO 9001, clause 6.2.1, the organization must establish quality objectives at relevant functions, levels, and processes. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The top management team is responsible for providing leadership and direction for the quality management system and ensuring its alignment with the organization’s purpose and context. Therefore, the absence of quality objectives for the top management team is a nonconformity as it violates the requirement of clause 6.2.1.

E. Quality improvements not aligning with the quality policy: According to ISO 9001, clause 5.2.1, the quality policy is a statement of the organization’s intentions and direction regarding quality, as formally expressed by top management. The quality policy must provide a framework for setting quality objectives and be compatible with the context and strategic direction of the organization. The quality policy must also be communicated, understood, and applied within the organization. Therefore, if the quality improvements are not aligned with the quality policy, it is a nonconformity as it violates the requirement of clause 5.2.1.

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.