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.

 A → 8.4.3.a

 B → 7.2.b

 C → 10.2.2

 D → 10.2.1

 E → 6.2

Comprehensive and Detailed Explanation From Exact Extract:

✅ A. There is no specification for incoming materials → 8.4.3.a

Clause 8.4.3(a) relates to the control of externally provided processes, products, and services, specifically the requirement to communicate appropriate specifications and requirements to suppliers:

“The organization shall ensure the adequacy of requirements prior to their communication to the external provider.”

Failure to specify requirements for incoming materials (e.g., what is acceptable waste plastic) risks compromising product quality.

✅ B. The picking operators have been trained → 7.2.b

Clause 7.2(b) relates to Competence and mandates:

“Ensure that these persons are competent on the basis of appropriate education, training, or experience.”

Training is a critical part of establishing and maintaining operator competence in quality-affecting tasks.

✅ C. The picked reject materials are not documented → 10.2.2

This clause focuses on the retention of documented information regarding nonconformities and actions taken:

“The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken…”

If rejects are not recorded, traceability and root cause analysis for quality failures are weakened.

✅ D. The rejected materials are segregated → 10.2.1

Clause 10.2.1 relates to nonconformity and corrective action, including containment activities such as:

“Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment…”

Segregation ensures nonconforming material doesn’t contaminate acceptable output.

✅ E. Management has set an objective for the level of rejects → 6.2

Clause 6.2 is about quality objectives. It requires organizations to:

“Establish quality objectives at relevant functions... The quality objectives shall be measurable…”

Setting a measurable reject-level target aligns with improving process control and reducing waste.

According to the ISO 9000:2015 - Quality management systems — Fundamentals and vocabulary, correction is defined as “action to eliminate a detected nonconformity”. A nonconformity is defined as “non-fulfilment of a requirement”. Therefore, the process of modifying a non-conforming product to bring it within acceptance criteria is a correction, as it eliminates the non-fulfilment of the product specification. The other options are not correct, as they have different definitions and purposes:

•Concession: permission to release or use a nonconforming product, service or process

•Corrective action: action to eliminate the cause of a nonconformity and to prevent recurrence

•Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation