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The questions for ISO-9001-Lead-Auditor were last updated on Feb 11, 2025.
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An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the release of the anodes to avoid late delivery as penalties would be Imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
At the Closing meeting, the audit team leader presents the findings of the audit and comes to the above
nonconformity. The Quality Manager produces the test report for Project DK, which shows an acceptable galvanic efficiency, and presents an email from the customer confirming acceptance of the anodes. He asks that the nonconformity be withdrawn.
Which two of the following responses by the audit team leader would be acceptable?
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?
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.
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
Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit
of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.
The auditor samples the design records for a recently completed course for the 247 Insurance organisation. Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage
was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.
The auditor raises a nonconformity against ISO 9001. Which one of the following options is the basis for the nonconformity?
Clause 8.3.4.d of ISO 9001:2015 requires that design and development validation be performed to ensure that the resulting products or services meet the requirements for their specified application or intended use. Validation is critical to confirm that the product works as intended in real-world conditions.
In this case, Noitol omitted the design validation step approximately 50% of the time, which is a direct violation of Clause 8.3.4.d. Although they collect feedback after the fact, this is not a substitute for formal validation before the product is released. The nonconformity arises because the process of validation was neglected, not the recording of improvements or feedback.
Other options, such as documenting improvements (A) or issues with planning verification (B), are important but do not directly address the primary concern: the lack of consistent design validation before product release. Option D (8.6) concerns product release, but this nonconformity focuses on the validation stage, not just approval for release.
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?
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.
You are a member of the audit team of a second-party audit of an organisation with 625 employees. The audit procedure recommends using sampling criteria which requires the review of the documented competence for 25 personnel. The audit team leader developed an audit plan allocating one hour to audit the Human Resources department (from 11:30 am to 12:30 pm). She told you that she could not allocate any additional time.
What would you do?
In this scenario, the time allocated by the audit team leader for the Human Resources audit is fixed, and as an auditor, you must work within that constraint. Although the sampling criteria suggests reviewing 25 personnel files, it is acceptable to adjust the sample size based on time and resource limitations. ISO 9001:2015 emphasizes risk-based thinking and practical resource management (Clause 7.1), so it is reasonable to review a smaller sample if the time is insufficient.
Option B is a pragmatic approach, allowing you to focus on quality over quantity by reviewing as many cases as time allows without compromising the audit schedule.
Options like extending the audit (A, C, D) are impractical in a structured audit environment, especially for second-party audits where maintaining the agreed schedule is important.
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