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

Understanding the Purpose of a Quality Management System (QMS):The primary objective of ISO 9001:2015 is to improve the overall performance of the organization by:

Ensuring consistent delivery of products and services that meet customer and regulatory requirements.

Focusing on enhancing customer satisfaction.

Promoting continual improvement of the organization’s processes and practices.

Comprehensive and Detailed In-Depth Explanation:

Stage 1 Audit (ISO 9001:2015, Clause 9.2.2) is a documentation review to assess the readiness for a Stage 2 Audit. The auditor must document:

Observations that could lead to nonconformities, ensuring they are addressed before Stage 2.

Areas needing improvement, such as missing documented information or unclear process definitions.

While understanding the auditee’s main processes is important, documenting interviews is not a requirement at Stage 1.

Here is the correct matching of ISO 9001:2015 clauses to the steps mentioned in the change management process:

We identified risks and opportunities and fed these into our risk management processes.

Clause 6.1 (Actions to address risks and opportunities)

We found a suitable supplier.

Clause 8.4 (Control of externally provided processes, products, and services)

We monitored customer feedback and noticed an increase in negative feedback about lead times.

Clause 9.1.2 (Customer satisfaction)

We put together a plan for implementation.

Clause 6.2.2 (Planning to achieve quality objectives)

We monitored the performance of the new supplier.

Clause 8.4.2 (Type and extent of control of external providers)

We noticed that productivity targets were being missed.

Clause 9.1.1 (Monitoring, measurement, analysis, and evaluation)

We communicated the plan internally.

Clause 7.4 (Communication)

We looked at the data at the management review and decided we needed to do something different.

Clause 9.3.2 (Management review inputs)

We reorganised the staffing and implemented redundancies.

Clause 7.1.2 (People)

We set an objective to effectively implement the transition and outsource manufacturing.

Clause 6.2.1 (Quality objectives and planning to achieve them)

This aligns the steps of the change process with relevant ISO 9001:2015 clauses related to risk, planning, communication, and monitoring.