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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 |
| Exam Duration: | 180 minutes |
| Related Certifications: | PECB Master in Quality Management PECB Certified ISO 9001 Lead Implementer |
| Real Exam Qty: | 80 |
| Available Languages: | English |
| Certificate Validity Period: | 3 Years |
| Exam Format: | Open Book, Multiple Choice |
| Passing Score: | 70% |
| 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 # 179
Scenario 3:
Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.
To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.
The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.
The audit team began by gathering information about Fin-Pro's understanding of ISO 9001 requirements.
While reviewing documented information, they noticed missing records of training and awareness sessions.
They conducted employee interviews to verify attendance.
The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company's working environment (social, psychological, and physical conditions).
The audit team analyzed the evidence and prepared an audit report with findings and conclusions.
Which statement below represents the level of responsibility demonstrated by the audit team in scenario 3?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 19011:2018 requires auditors to conduct audits professionally and diligently.
Clause References:
ISO 19011:2018, Clause 4.4 - Professional Care: Auditors must exercise due diligence in conducting audits.
ISO 9001:2015, Clause 9.2 - Internal Audit: Requires objective and systematic audits to evaluate QMS effectiveness.
Why is the Correct Answer A?
The audit team followed best practices by gathering verifiable audit evidence through interviews, document reviews, and observations.
They ensured fair presentation of findings in the final audit report.
They complied with ISO 9001 and ISO 19011 guidelines for audit procedures.
Why are the Other Options Incorrect?
B (Ordinary negligence) # No evidence of negligence; the team followed structured audit processes.
C (Gross negligence) # No indication that the auditors ignored important responsibilities.
D (Willful misconduct) # The auditors acted professionally and did not intentionally disregard rules.
Reference:
ISO 19011:2018, Clause 4.4 - Professional Care
ISO 9001:2015, Clause 9.2 - Internal Audit
NEW QUESTION # 180
An organization has decided to implement a QMS based on ISO 9001. What should they consider when determining internal issues?
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to assess both internal and external issues that could impact the effectiveness of their Quality Management System (QMS).
Clause Reference:
* Clause 4.1 - Understanding the Organization and Its Context states that organizations must determine external and internal issues that affect their ability to achieve intended results.
* Internal issues include:
* Knowledge within the organization (documented or undocumented)
* Organizational culture
* Resource availability
* Technological advancements
* Infrastructure and capabilities
Why is the Correct Answer C?
* Knowledge (Clause 7.1.6) is a critical internal factor that directly affects the implementation and maintenance of a QMS.
* Organizations must identify, maintain, and make available the necessary knowledge to achieve quality objectives and meet customer requirements.
Why are the Other Options Incorrect?
* A (Social and economic environments) # These are considered external issues rather than internal.
* B (Competitive environment) # Competition is external, not an internal issue affecting the QMS.
* D (Expectations of suppliers) # Supplier expectations relate to external interested parties, covered under Clause 4.2 (Understanding the Needs and Expectations of Interested Parties).
NEW QUESTION # 181
XYZ Corporation employs 100 people, and during a Stage 1 certification audit, certain issues are identified with the Quality Management System (QMS). Which two options describe the circumstances in which you could raise a nonconformity against Clause 6.2 of ISO 9001:2015?
Answer: C,E
Explanation:
Understanding Clause 6.2 of ISO 9001:2015:Clause 6.2 (Quality Objectives and Planning to Achieve Them) specifies that organizations must:
Establish measurable and relevant quality objectives consistent with the quality policy (Clause 6.2.1).
Include objectives applicable to product/service conformity and customer satisfaction.
Document these objectives and their planning as documented information (Clause 6.2.1 & 6.2.2).
Plan how to achieve the objectives, including defining actions, resources, responsibilities, timelines, and methods for evaluation.
Analysis of Options:
A). Quality objectives are not being implemented by the organisation ' s personnel:Incorrect. While implementation is critical, this relates more to operational aspects rather than the direct requirements of Clause 6.2. Implementation issues would typically raise concerns under Clause 9.1 (Performance Evaluation).
B). The consultant has not interpreted ISO 9001 correctly:Incorrect. The consultant ' s interpretation of ISO
9001 is irrelevant in terms of Clause 6.2 compliance. The focus is on whether the organization aligns with the requirements, not the consultant ' s role.
C). Establishing quality objectives did not include top management:Incorrect. While top management involvement is vital for QMS effectiveness (Clause 5.1), this is not a direct requirement of Clause 6.2. Top management alignment is implied but not explicitly mandated for establishing quality objectives.
D). Quality objectives were not established in alignment with the organisation ' s quality policy:Correct.
Clause 6.2.1 requires that quality objectives be consistent with the organization's quality policy, ensuring they reflect its purpose, strategic direction, and commitment to continual improvement. Misalignment would constitute a nonconformity.
E). The organisation cannot afford to undertake quality objectives all at once:Incorrect. Financial constraints are not directly addressed in Clause 6.2. The clause focuses on planning to achieve objectives, which includes defining the necessary resources but does not demand achieving all objectives simultaneously.
F). Quality objectives are not maintained as documented information:Correct. Clause 6.2.1 specifically requires that quality objectives be maintained as documented information. Failure to document the objectives is a direct violation of this clause.
Why Options D and F Are Correct:
D: Misalignment between the quality objectives and the quality policy directly violates Clause 6.2.1, which mandates that objectives support the strategic direction of the organization.
F: Lack of documentation for quality objectives breaches the requirement to maintain them as documented information under Clause 6.2.1.
Relevant References:
Clause 6.2.1: Establishing quality objectives aligned with the quality policy.
Clause 6.2.2: Maintaining documented information for quality objectives and planning to achieve them.
Clause 5.1.1: Top management ' s responsibility to ensure alignment between the QMS and strategic direction.
NEW QUESTION # 182
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: "I would like to begin by looking at the cleaning controls."
MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside." Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.
Answer:
Explanation:
Explanation:
Nonconformity report
ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met." Evidence: 40 cleaning records are available for 63 batches.
NEW QUESTION # 183
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 # 184
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