PECB ISO-9001-Lead-Auditor Practice Test Questions Answers

According to the ISO 9001:2015 standard, clause 10.2 requires organizations to review nonconformities, including any arising from customer complaints, and to take appropriate actions to determine the cause, implement corrections and preventive actions, and verify their effectiveness. The organization must also monitor the effectiveness of the actions taken and make changes if necessary.

In this scenario, the auditee is facing a legal dispute with a customer over damage to an expensive cashmere coat. This is a nonconformity that arises from customer complaint and has a significant impact on customer satisfaction and reputation. Therefore, clause 10.2 applies to this situation.

The best option for how this should be handled by the Quality Management System is B.

B means that the organization should report the situation to the customer with suggested remedial action. This option follows the principle of transparency and accountability, as well as respecting the customer’s rights and expectations. The organization should also investigate the root cause of the damage and prevent it from happening again in other shops or products.

The other options are not appropriate because:

A means that the organization should settle the court case by negotiation with the customer. This option may not be feasible or satisfactory for both parties, especially if there is a large amount of compensation involved or if there are legal implications for other customers.

C means that the organization should make an offer to replace the coat with a new one. This option may not be sufficient or acceptable for both parties, especially if there is evidence of negligence or poor quality on behalf of the organization.

D means that the organization should give an explanation to the customer of what went wrong. This option may not be enough or convincing for both parties, especially if there is no evidence of negligence or poor quality on behalf of the organization.

Questions no: 1 Verified Answer: = C, D, E Comprehensive But Short Explanation: = Potential threats to impartiality in an audit context include familiarity (having a close relationship with the auditee), intimidation (being coerced or feeling pressured), and self-audit (auditing one’s own work). These factors can compromise the auditor’s objectivity and the audit’s integrity. References: = The information is based on the ISO 9001 Auditing Practices Group documents which discuss threats to auditor impartiality and how they may compromise an auditor’s objectivity123.

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.

Comprehensive and Detailed In-Depth Explanation:

One of the seven quality management principles in ISO 9001:2015 is Improvement, which emphasizes continual enhancement of processes, products, and services.

Clause 10.3 (Continual Improvement) states that organizations must continuously assess risks, consequences, and impacts to improve their QMS.

Risk-based thinking (Clause 0.3.3) supports improvement by identifying and mitigating risks before they affect performance.

Clause 6.1 (Actions to Address Risks and Opportunities) requires organizations to take a proactive approach, ensuring long-term success.

Other options do not fully align with the question:

Process approach (A) focuses on managing interrelated activities.

Leadership (B) ensures commitment but does not directly address risk assessment.

Relationship management (D) deals with interested parties, not risk mitigation.

ISO/IEC 17021-1 is the standard that specifies requirements for bodies providing audit and certification of management systems. It includes provisions for determining audit time for third-party certification audits, ensuring that the audits are conducted in a consistent, comparable, and reliable manner, which can be applied to a variety of management systems, including ISO 9001.