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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | PECB Certified ISO 9001 Lead Auditor |
| Exam Number: | ISO-9001-Lead-Auditor |
| Available Languages: | English |
| Related Certifications: | PECB Master in Quality Management PECB Certified ISO 9001 Lead Implementer |
| Passing Score: | 70% |
| Certificate Validity Period: | 3 Years |
| Exam Duration: | 180 minutes |
| Exam Format: | Multiple Choice, Open Book |
| Real Exam Qty: | 80 |
| Exam Price: | USD 1000 |
| 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 |
>> Current PECB ISO-9001-Lead-Auditor Exam Content <<
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NEW QUESTION # 110
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: D,E
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 # 111
You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: "I'd like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months?" Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our own products in house." You: "That sounds like quite a significant change. What has been the impact of that?" Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging time." You: "I'm sure. What were the reasons for making the change?" Auditee: "Our manufacturing section was a small operation, and we struggled to cope with fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices that made our product uncompetitive." You: "How did you go about the change?" In relation to the auditor's question about how the change was managed, the auditee mentions the steps listed below. Match the ISO 9001 clauses to the steps.
To complete the table, click on the blank section you want to complete so it is highlighted in red and then click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which step the requirement applies to.
Answer:
Explanation:
Explanation:
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.
NEW QUESTION # 112
You are conducting 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 have gathered audit evidence as outlined below. Match the ISO 9001 Clause 8 extract to the audit evidence.
Answer:
Explanation:
Explanation:
Here is the correct matching of the ISO 9001 Clause 8 extracts to the audit evidence:
* Audit evidence: Three subcontract trainers who had delivered training were not approved as defined in procedure SA1 Supplier Approval revision 3.ISO 9001 Clause 8 extract: 8.4.1 ...shall apply criteria for
... external providers...(This clause requires the organization to control external providers, including ensuring their approval and competence.)
* Audit evidence: A training programme for a customer was not documented as required in procedure TD
2 Training revision 2.ISO 9001 Clause 8 extract: 8.3.5 ...shall retain documented information on design and development outputs.(This clause addresses the need to retain documented information related to design and development outputs, such as a training programme.)
* Audit evidence: One trainer had not recorded the damage to a customer's training room wall caused by using sticky tape to hang training aids, as required in procedure TD 2 Training revision 2.ISO 9001 Clause 8 extract: 8.5.3 ...shall retain documented information on what has occurred.(This clause relates to retaining documented information on activities and outcomes, including records of damage or issues encountered.)
* Audit evidence: Five sales orders had no record of having been reviewed to verify the ability to provide these courses.ISO 9001 Clause 8 extract: 8.2.3.1 ...shall conduct a review before committing...(This clause specifies the requirement to review and verify the organization's ability to meet customer requirements before accepting sales orders.) These mappings reflect the specific requirements of ISO 9001:2015 for managing external providers, retaining documented information, and reviewing contracts.
NEW QUESTION # 113
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented.
The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost.
Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?
Answer: A,C
Explanation:
According to ISO 9001:2015, clause 6.2.1, the organization is required to establish quality objectives at relevant functions, levels, and processes for the quality management system (QMS). The quality objectives must be consistent with the quality policy, measurable, monitored, communicated, and updated as appropriate.
The organization is also required to maintain documented information on the quality objectives, as per clause
7.5.1.
Therefore, in the scenario given, the quality objectives defined by the external consultant are not in alignment with the organization's quality policy, as they are based on those of a competitor, rather than the organization's own purpose, strategic direction, and customer requirements. This creates a mismatch between the organization's vision and goals, and the quality objectives that are supposed to guide and measure the QMS performance. Moreover, the quality objectives are not maintained as documented information, which makes it difficult to communicate, monitor, and update them, as well as to demonstrate evidence of their implementation and achievement.
Hence, the circumstances in which a nonconformity against clause 6.2 of ISO 9001 could be raised are B and C, as they indicate a failure to comply with the requirements of clause 6.2.1. The other options are either irrelevant or not directly related to clause 6.2, as they do not pertain to the establishment and documentation of quality objectives.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 6.2.1 and 7.5.1 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6
NEW QUESTION # 114
A person who provides specific knowledge or expertise to the audit team during the audit is known as a
/an:
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
A technical expert is someone with specialized knowledge that helps the audit team understand specific technical aspects of the auditee's processes.
Clause References:
* ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts:
* Technical experts support the audit team with specialized knowledge but do not perform the audit themselves.
Why is the Correct Answer B?
* A technical expert is needed when auditors lack deep expertise in specific areas, such as engineering, software, or medical devices.
* They assist in interpreting complex technical requirements but do not act as auditors.
Why are the Other Options Incorrect?
* A (Observer) # Observers do not contribute expertise; they only watch the audit (e.g., trainees).
* C (Guide) # Guides help with logistics but do not provide technical expertise.
NEW QUESTION # 115
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