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

To certify an organization ' s ISO 9001:2015-based Quality Management System (QMS) for the first time, the correct sequence of activities would be:

Establish the management system (already in place).

Supplier audit

Internal audit

Management review

Initial certification audit – stage 1

Initial certification audit – stage 2 (already in place).

This sequence follows the typical path for preparing and ensuring that a QMS is functioning as required, leading up to certification.

Comprehensive and Detailed In-Depth Explanation:

The Stage 2 audit (ISO 17021-1:2015, Clause 9.3.1.3) is conducted to:

Verify whether the QMS is effectively implemented and operational.

Ensure compliance with ISO 9001 requirements in actual practice.

Identify nonconformities that may impact certification.

Reviewing documented information (Answer B) is part of Stage 1, and gathering scope information (Answer C) is done before the certification audit.

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.