ISO-9001-Lead-Auditor Exam Dumps - PECB ISO 9001 Questions and Answers

Top management is responsible for establishing, implementing, and maintaining the quality policy. The quality policy provides a framework for setting quality objectives and must be compatible with the context of the organization and support its strategic direction. It should also provide a commitment to satisfy applicable requirements and to continuous improvement.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 Clause 5.1.1 (Leadership and Commitment) states that top management must demonstrate leadership and commitment to the QMS by actively participating in QMS implementation, integration, and effectiveness.

In scenario 2, top management refused to be directly involved in the QMS implementation team, which violates Clause 5.1.1 because leadership involvement is essential for the system’s success.

Other options do not indicate nonconformance:

Option A (Middle managers in the QMS team) is acceptable.

Option C (Leslie assigning roles) is valid if competence is ensured (Clause 5.3 – Organizational Roles, Responsibilities, and Authorities).

Option D (Team reviewing the policy before approval) aligns with best practices.

A → 8.4.3.a

B → 7.2.b

C → 10.2.2

D → 10.2.1

E → 6.2

F → 5.2.2.c

8.4.3.a – No specification is issued to the suppliers of waste plastic:This clause refers to the information provided to external providers, including requirements for products and services. If no specification is issued, it means the organization is not complying with this clause, which states:

“The organization shall ensure that the requirements for the products and services to be provided are adequately defined prior to communication to the external provider.”

7.2.b – The picking operators have been trained:This falls under Competence requirements. Clause 7.2(b) requires that persons are competent on the basis of education, training, or experience:

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

10.2.2 – No documentation is retained for rejected materials:This relates to corrective action documentation. Clause 10.2.2 requires organizations to retain documented information as evidence of nonconformities and actions taken:

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

10.2.1 – The rejected materials are segregated:This links to the treatment of nonconforming outputs. Clause 10.2.1 discusses actions such as containment or segregation for nonconforming outputs:

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

6.2 – Management has set an objective for the level of recycling:This refers to quality objectives. Clause 6.2 requires that measurable quality objectives be established, and this includes setting performance targets:

“The organization shall establish quality objectives at relevant functions… The quality objectives shall be measurable…”

5.2.2.c – The quality policy appears in promotional material:Clause 5.2.2(c) requires the quality policy to be available to relevant interested parties. Using it in promotional material ensures that it is communicated externally:

“The quality policy shall be… available to relevant interested parties, as appropriate.”

The individual(s) managing the audit programme and the auditee are both roles that contribute to the audit outcomes. The individual(s) managing the audit programme are responsible for planning, conducting, and reporting on the audit activities, as well as ensuring that they are aligned with the organization’s quality objectives and risk management processes1. The auditee is the person or entity that is subject to an audit, and their participation, cooperation, and feedback are essential for achieving a successful audit outcome2. References:

ISO 9001 Lead Auditor Reference Materials

ISO 9001 Lead Auditor Candidate Handbook

ISO 9001 Lead Auditor Course Material

ISO 9001 Lead Auditor Training Course IRCA Certified

 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 9001:2015 standard, clause 8.7 requires that an organization identify and control any nonconforming outputs that do not conform to the requirements of the customer or other relevant requirements. Nonconforming outputs are any outputs from the process, product or service that do not meet the specified quality criteria. Nonconforming outputs must be dealt with in one or more of the following ways:

Correction of the nonconformity

Segregation, containment, return or suspension of provision of products and services

Informing the customer

Authorisation for acceptance under concession

The organization must also retain documented information on the description of the nonconformity, the actions taken, any concessions obtained, and the identification of the authority deciding the action to resolve the nonconformity.

In this scenario, you have interviewed a line supervisor who is responsible for managing a manual picking line where operators are removing contaminant materials from incoming products. The supervisor has explained that these plastic items are rejected at this stage because they do not meet their processing standards and they can damage their machinery and compromise their quality standards. The supervisor has also mentioned that some of these rejected items are melted down in another process later on and some are disposed of as waste products that cannot be recycled.

Based on this information, you can investigate further by taking two actions:

A. Check the process for handling nonconforming items: You can verify whether there is a documented procedure for identifying, segregating, containing, returning or suspending provision of nonconforming items at this stage. You can also check whether there is a system for informing customers about any nonconforming items that may affect their satisfaction or expectations.

D. Determine what happens to the waste products: You can verify whether there is a documented procedure for disposing of waste products that cannot be recycled as per environmental regulations and customer requirements.

These two actions would help you to determine whether there are any nonconforming outputs at this stage and how they are controlled by the organization.

Comprehensive and Detailed In-Depth Explanation:

ISO 19011:2018, Clause 5.4 (Audit Records Management) states that the audit schedule must be maintained as a key record.

Thus, C is the correct answer.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires organizations to ensure competence of personnel whose work affects quality performance.

Clause References:

Clause 7.2 – Competence: Organizations must determine, provide, and evaluate competence of employees performing work under the QMS.

ISO 19011:2018, Clause 6.4.6 – Audit Evidence: Auditors should use a combination of document review, interviews, and observation to verify competence.

Why is the Correct Answer C?

The organizational chart shows reporting structures and helps verify roles and responsibilities.

Job descriptions outline required qualifications, skills, and competencies for each role.

These documents provide objective audit evidence that personnel meet the required competencies for their positions.

Why are the Other Options Incorrect?

A (Sufficient evidence) → Partially correct, but competence verification often requires multiple sources of evidence, including training records, certifications, and observations.

B (Not relevant) → Incorrect because verifying competence is crucial for ensuring effective QMS implementation.

D (Direct observation only) → Observation alone is insufficient; documentation and interviews are also required to confirm competence.

The actions that should be taken in the context of the audit are:

•Option B: Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body. This option is correct because the auditor has found serious and significant gaps in the QMS processes that affect the health and safety of the patients, which is a major nonconformity that may warrant suspension of certification. The auditor should inform the individual(s) managing the audit programme of the situation and the audit findings, and recommend immediate suspension of certification to protect the integrity of the Certification Body and the credibility of the certification scheme. The auditor should also follow the Certification Body’s procedures and rules for suspension of certification and communicate the decision and the consequences to the auditee.

•Option C: Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course. This option is correct because the auditor should not terminate or postpone the closing meeting due to the absence of the Catering Manager, as the DCM is the auditee’s nominated representative for the audit. The auditor should continue with the meeting, present the audit conclusions and the audit findings, and inform the DCM that the organisation will receive the audit report in due course. The auditor should also explain the audit outcome recommendation and the suspension of certification, and request the DCM to acknowledge the receipt and understanding of the audit results.

The following options are not correct:

•Option A: Close the meeting immediately after the DCM’s response and advise that the issues will be addressed at the next surveillance visit. This option is not correct because the auditor should not close the meeting without presenting the audit conclusions and the audit findings, as this would violate the audit principles of fairness and transparency. The auditor should also not advise that the issues will be addressed at the next surveillance visit, as this would imply that the auditor is accepting the auditee’s delay and inaction, and that the auditor is not taking the major nonconformity seriously.

•Option D: Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work. This option is not correct because the auditor should not conclude the meeting early or reschedule it due to the absence of the Catering Manager, as this would disrupt the audit process and the audit schedule. The auditor should also not wait for the Catering Manager to return to work, as this would delay the communication and resolution of the major nonconformity, and potentially compromise the health and safety of the patients.

•Option E: Recommend that all personnel should be given urgent in-depth training in the QMS. This option is not correct because the auditor should not recommend or prescribe specific corrective actions to the auditee, as this would violate the audit principles of independence and objectivity. The auditor should only report the audit findings and the audit outcome recommendation, and leave the responsibility and authority for determining and implementing the corrective actions to the auditee.

•Option F: Thank the DCM for his time and express an expectation that improvements will be made in the QMS. This option is not correct because the auditor should not thank the DCM for his time and express an expectation that improvements will be made in the QMS, as this would imply that the auditor is satisfied and optimistic with the auditee’s performance and response, and that the auditor is not taking the major nonconformity seriously. The auditor should instead express the concern and dissatisfaction with the auditee’s QMS processes and the impact on the health and safety of the patients, and communicate the suspension of certification and the need for urgent and effective corrective actions.

In this scenario, the audit team leader must balance maintaining the integrity of the audit plan while considering the auditee’s request. The two best responses allow for flexibility without compromising the audit's rigor:

A. I could audit the other laboratories virtually at the end of this audit: Virtual audits can be a valid option, especially in multi-site audits. ISO 9001:2015 does not prohibit virtual audits, and in certain situations, they are practical for reviewing documentation or observing operations remotely.

C. I could try to revise the audit programme to see if I can audit all laboratories: Revising the audit programme to accommodate additional site visits is a reasonable compromise. ISO 9001:2015 audits are based on risk and sampling, but the audit team leader has the flexibility to adjust the audit scope if it fits within the audit duration and resources.

The other options, such as extending the audit duration (B, F) or strictly adhering to the original plan (D, E), may not be practical or necessary. Revising the plan to audit all laboratories or using virtual auditing ensures that the audit remains efficient while addressing the organization's concerns​.