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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | QMS ISO 9001:2015 Lead Auditor Exam |
| Exam Number: | ISO-9001-Lead-Auditor |
| Exam Duration: | 180 (120 + 30 for non-native speakers) |
| Exam Price: | $1000 USD |
| Certificate Validity Period: | 3 years |
| Available Languages: | French, Chinese, Portuguese, Italian, German, English, Russian, Spanish, Arabic |
| Related Certifications: | ISO 9001 Foundation ISO 9001 Auditor ISO 9001 Provisional Auditor |
| Exam Format: | Multiple choice, Open-book, Scenario-based, Multi-response |
| Passing Score: | 70% (minimum 28/40 or 56/80 correct answers) |
| Real Exam Qty: | 40–80 |
| Recommended Training: | PECB ISO 9001 Lead Auditor Training Course |
| Exam Registration: | PECB Official Registration |
| Sample Questions: | PECB ISO-9001-Lead-Auditor Sample Questions |
| Exam Way: | Online proctored via PECB Exams app or paper-based at authorized test centers |
| Pre Condition: | Recommended: ISO 9001 Foundation knowledge or certification; no mandatory prerequisites, but experience in quality management is advised |
| Official Syllabus URL: | https://pecb.com/en/education-and-certification-for-individuals/iso-9001/iso-9001-lead-auditor |
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NEW QUESTION # 176
For a third-party, match the Activity with the Responsibility for conducting it.
Answer:
Explanation:
Explanation:
* Approve Certification Body: Accreditation Body
* Award certification: Certification Body
* Recommend certification: Audit Team Leader
* Maintain certification:
Comprehensive Detailed ExplanationIn the context of a third-party ISO 9001 audit, different entities play specific roles in the certification process. Here's a detailed explanation of the responsibilities:
* Approve Certification Body: Accreditation BodyThe Accreditation Body is responsible for approving Certification Bodies. Accreditation Bodies are independent entities that evaluate the competence of Certification Bodies, ensuring they meet international standards like ISO/IEC 17021, which sets out the criteria for bodies providing audit and certification of management systems. In this role, they confirm that the Certification Body is capable of conducting ISO 9001 audits and granting certifications in accordance with international guidelines.
* Award Certification: Certification BodyThe Certification Body is the entity that ultimately awards the certification to an organization after verifying that it meets the ISO 9001 standards. Certification Bodies conduct audits, either directly or through a team of auditors, and based on the audit outcomes, they issue the certification, indicating that the organization complies with ISO 9001.
* Recommend Certification: Audit Team LeaderThe Audit Team Leader is responsible for leading the audit and making a recommendation to the Certification Body. This recommendation is based on the audit findings-whether the organization meets the ISO 9001 requirements or if there are areas of non- compliance that need corrective action. The final decision on certification is not made by the Audit Team Leader but by the Certification Body.
* Maintain Certification: Certification BodyMaintaining certification refers to the ongoing process of ensuring that an organization continues to comply with ISO 9001 requirements. The Certification Body conducts regular surveillance audits (e.g., annually) and may also perform recertification audits (typically every three years). This ongoing monitoring ensures that the certified organization continues to adhere to the quality management standards over time.
This breakdown clearly assigns responsibility based on the defined roles of Accreditation Bodies, Certification Bodies, and Audit Teams in the ISO 9001 certification process.
NEW QUESTION # 177
According to the ISO 9001 standard, which one of the following is a defined responsibility of top management?
Answer: A
Explanation:
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.
References: ISO 9001:2015, Clause 5.2
NEW QUESTION # 178
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
The audit team delayed audit activities until DC's top management submitted their action plans. Is this acceptable?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting):
* The audit report must be submitted to the certification body regardless of corrective actions.
* Corrective actions are reviewed after the audit, but the audit process should not be delayed.
* Certification decisions should be made based on the audit findings and evidence, not pending corrective actions.
Thus, delaying audit activities until corrective actions are submitted is not acceptable.
Reference:
ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting)
NEW QUESTION # 179
For a third-party, match the Activity with the Responsibility for conducting it.
Answer:
Explanation:
Explanation:
* Approve Certification Body: Accreditation Body
* Award certification: Certification Body
* Recommend certification: Audit Team Leader
* Maintain certification:
Comprehensive Detailed Explanation
In the context of a third-party ISO 9001 audit, different entities play specific roles in the certification process.
Here's a detailed explanation of the responsibilities:
* Approve Certification Body: Accreditation BodyThe Accreditation Body is responsible for approving Certification Bodies. Accreditation Bodies are independent entities that evaluate the competence of Certification Bodies, ensuring they meet international standards like ISO/IEC 17021, which sets out the criteria for bodies providing audit and certification of management systems. In this role, they confirm that the Certification Body is capable of conducting ISO 9001 audits and granting certifications in accordance with international guidelines.
* Award Certification: Certification BodyThe Certification Body is the entity that ultimately awards the certification to an organization after verifying that it meets the ISO 9001 standards. Certification Bodies conduct audits, either directly or through a team of auditors, and based on the audit outcomes, they issue the certification, indicating that the organization complies with ISO 9001.
* Recommend Certification: Audit Team LeaderThe Audit Team Leader is responsible for leading the audit and making a recommendation to the Certification Body. This recommendation is based on the audit findings-whether the organization meets the ISO 9001 requirements or if there are areas of non- compliance that need corrective action. The final decision on certification is not made by the Audit Team Leader but by the Certification Body.
* Maintain Certification: Certification BodyMaintaining certification refers to the ongoing process of ensuring that an organization continues to comply with ISO 9001 requirements. The Certification Body conducts regular surveillance audits (e.g., annually) and may also perform recertification audits (typically every three years). This ongoing monitoring ensures that the certified organization continues to adhere to the quality management standards over time.
This breakdown clearly assigns responsibility based on the defined roles of Accreditation Bodies, Certification Bodies, and Audit Teams in the ISO 9001 certification process.
NEW QUESTION # 180
Which of the following is correct with regard to the internal audit?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 9001:2015, Clause 9.2 (Internal Audit):
* Internal audits can be conducted on an ongoing basis as part of continual improvement.
* Audits consider both conformity and effectiveness (A is incorrect).
Thus, C is the correct answer.
NEW QUESTION # 181
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