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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | PECB Certified ISO 9001 Lead Auditor |
| Exam Number: | ISO-9001-Lead-Auditor |
| Exam Price: | USD 1000 |
| Passing Score: | 70% |
| Exam Duration: | 180 minutes |
| Certificate Validity Period: | 3 Years |
| Related Certifications: | PECB Certified ISO 9001 Lead Implementer PECB Master in Quality Management |
| Real Exam Qty: | 80 |
| Exam Format: | Multiple Choice, Open Book |
| Available Languages: | English |
| Sample Questions: | PECB ISO-9001-Lead-Auditor Sample Questions |
| Exam Way: | Online (PECB Exams application) or Paper-based (at training centers) |
| Pre Condition: | None (Recommended: Training course and experience in Quality Management) |
| Official Syllabus URL: | https://pecb.com/en/education-and-certification-for-individuals/iso-9001-lead-auditor |
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NEW QUESTION # 32
Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.
Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled.
The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.
The top management, in cooperation with Sean, assigned 10 more employees to the audit team.
Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.
Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.
Based on the scenario above, answer the following question:
Sean requested unrestricted access to the employees, executives, and documented information of POLKA. Is this in accordance with audit best practices?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.3.2 (Access to Information), internal auditors must have unrestricted access to:
* Employees and executives for interviews and observations.
* Documented information to verify compliance with ISO 9001.
This ensures a transparent and objective audit process. The CEO's approval (B) is not required unless restricted information is involved.
Reference:
ISO 19011:2018, Clause 5.3.2 (Access to Information)
NEW QUESTION # 33
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:
2015 are true?
Answer: B,G
Explanation:
The Stage 1 audit is a readiness review that verifies the organization's ability to conduct the Stage 2 audit. It involves reviewing the documented information, evaluating the site-specific conditions, and having discussions with personnel. The auditor does not verify the degrees of customer satisfaction, the compliance with legal requirements, or the results of the last management review during the Stage 1 audit. These are done during the Stage 2 audit or later in the certification process. 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
NEW QUESTION # 34
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements.
The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You are interviewing the Training Manager (TM).
You: "What quality objectives apply to the training process?"
TM: "One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses." You: "How do you measure this objective?" The Training Manager shows you a record on her computer and you see the following:
Which two of the following statements are true?
Answer: C,F
Explanation:
In this scenario, the organization has set a quality objective of achieving a 90% minimum exam pass rate for all courses. The auditor's task is to assess whether this objective is being monitored effectively and if appropriate actions are taken when the objective is not met.
B: You would determine how the exam pass rate figures were analysed: ISO 9001:2015, particularly Clause
9.1 (Monitoring, measurement, analysis, and evaluation), requires organizations to evaluate performance data.
The auditor should verify how the organization analyses the pass rate data to ensure trends are identified, and corrective actions are planned based on this analysis.
D: You would determine what corrective action was being taken to address the low pass rates: When performance falls short of the objective, as seen with Course 4 (where the pass rate is below 90% in all months), Clause 10.2 (Nonconformity and corrective action) requires organizations to take corrective actions to address issues. The auditor would need to check if corrective actions have been initiated to address consistently low pass rates.
Statements A, C, E, and F do not directly address the monitoring and corrective action required under ISO
9001:2015 in this context.
NEW QUESTION # 35
Which type of audit risk is the risk that a significant defect may occur in the QMS, although the organization has internal control mechanisms in place?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Audit risks are categorized into different types based on where failures may occur in the QMS audit process.
Clause References:
* ISO 19011:2018, Clause 6.3 - Managing Audit Risk: Defines different audit risks, including control risk.
Why is the Correct Answer A?
* Control risk occurs when internal controls fail to prevent or detect nonconformities.
* Even if controls exist, the risk remains if the QMS fails to identify or correct defects.
Why are the Other Options Incorrect?
* B (Inherent risk) # This refers to risks naturally present in processes, even before controls are applied.
* C (Detection risk) # This is the risk that an auditor fails to detect nonconformities.
* D (Operational risk) # This refers to risks related to day-to-day business operations, not QMS audits.
Reference:
ISO 19011:2018, Clause 6.3 - Managing Audit Risk
NEW QUESTION # 36
Match each of the following statements into the table below to show whether they apply to first-party audits, second-party audits or third-party audits:
Answer:
Explanation:
Explanation:
Table
Statement
First-party audits
Second-party audits
Third-party audits
The audit scope is typically determined by the organisation being audited.
Yes
No
No
The outcome of the audit is typically certification to a recognised standard.
No
No
Yes
The audit scope is typically confined to service/product provision capability.
No
Yes
No
Here is a brief explanation of each statement:
The audit scope is typically determined by the organisation being audited: This statement applies to first-party audits, also known as internal audits, where the organisation audits its own processes and activities to ensure conformity and improvement1. The organisation can decide the scope of the audit based on its own needs and objectives2. This statement does not apply to second-party audits, where the customer audits the supplier, or third-party audits, where an independent body audits the organisation. In these cases, the audit scope is determined by the customer or the certification body, respectively34.
The outcome of the audit is typically certification to a recognised standard: This statement applies to third- party audits, where an independent body audits the organisation to verify that it meets the requirements of a specific standard, such as ISO 9001, and issues a certificate of conformity if the audit is successful34. This statement does not apply to first-party audits or second-party audits, where the outcome of the audit is not certification, but rather self-improvement or supplier qualification13.
The audit scope is typically confined to service/product provision capability: This statement applies to second- party audits, where the customer audits the supplier to ensure that they are meeting the requirements specified in the contract, such as service or product quality, delivery, or performance34. The audit scope is usually focused on the specific aspects of the service or product that are of interest to the customer3. This statement does not apply to first-party audits or third-party audits, where the audit scope is broader and covers the entire quality management system or the relevant clauses of the standard14.
NEW QUESTION # 37
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