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

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.

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