QMS ISO 9001:2015 Lead Auditor Exam Study Guide Provides You With 100% Assurance of Getting Certification - ITexamReview
QMS ISO 9001:2015 Lead Auditor Exam Study Guide Provides You With 100% Assurance of Getting Certification - ITexamReview
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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q204-Q209):
NEW QUESTION # 204
What should the auditor document during the Stage 1 audit?
- A. The observations that could result in nonconformities during the on-site audit
- B. The interviews with the auditee's employees
- C. The main processes of the auditee
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:Stage 1 Audit (ISO 9001:2015, Clause 9.2.2) is a documentation review to assess the readiness for a Stage 2 Audit. The auditor must document:
* Observations that could lead to nonconformities, ensuring they are addressed before Stage 2.
* Areas needing improvement, such as missing documented information or unclear process definitions
.
While understanding the auditee's main processes is important, documenting interviews is not a requirement at Stage 1.
NEW QUESTION # 205
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 # 206
Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.
- A. Conduct a minimum number of annual surveillance audits during the certification period.
- B. Review changes to the QMS since last visit.
- C. Failing to meet financial responsibilities.
- D. Audit use of certification marks on marketing materials.
- E. Verify legal compliance.
- F. Review the calibration status of the instrumentation.
- G. Handling of customer complaints since last visit.
- H. Confirm effectiveness of internal audit and management review.
- I. Complete a full document review of the quality management system.
- J. Review the status of previously raised findings and audit effectiveness of any outstanding findings.
Answer: B,D,E,G,H,J
Explanation:
The activities that are specifically required by ISO 17021-1 as part of third-party (Certification Body) surveillance audit processes are:
*Option A: Audit use of certification marks on marketing materials. This option is correct because ISO 17021-
1:2015 clause 9.6.2.2 requires the certification body to audit the client's use of marks and/or any other reference to certification, as applicable, to ensure conformity with the certification requirements.
*Option B: Review changes to the QMS since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review any changes affecting the client's quality management system and its ability to continue to fulfil the requirements of the standard used for certification.
*Option C: Confirm effectiveness of internal audit and management review. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to confirm the continuing effectiveness of the client's quality management system, including the effectiveness of the internal audit and management review processes.
*Option F: Review the status of previously raised findings and audit effectiveness of any outstanding findings.
This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the status of findings and any corrective actions taken by the client in response to previous audits, and to verify the effectiveness of the implemented corrective actions.
*Option H: Verify legal compliance. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to verify the client's compliance with applicable statutory and regulatory requirements related to the scope of certification.
*Option I: Handling of customer complaints since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the client's handling of customer complaints related to the certified activities since the last audit.
The following options are not correct:
*Option D: Complete a full document review of the quality management system. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to complete a full document review of the quality management system during surveillance audits. A full document review is only required during the initial certification audit or when there are significant changes to the quality management system or the certification requirements.
*Option E: Failing to meet financial responsibilities. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to audit the client's financial responsibilities during surveillance audits. The certification body may have contractual arrangements with the client regarding the payment of fees, but this is not part of the surveillance audit process.
*Option G: Review the calibration status of the instrumentation. This option is not correct because ISO 17021-
1:2015 clause 9.6.2.2 does not require the certification body to review the calibration status of the instrumentation during surveillance audits. The certification body may audit the client's monitoring and measuring resources as part of the quality management system requirements, but this is not a specific activity required by ISO 17021-1.
*Option J: Conduct a minimum number of annual surveillance audits during the certification period. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to conduct a minimum number of annual surveillance audits during the certification period. The certification body may determine the frequency and duration of surveillance audits based on the risk and performance of the client, but this is not a specific activity required by ISO 17021-1.
References:
*ISO 17021-1:2015 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements
*ISO 9001 Lead Auditor Course Material, Module 7: Audit Follow-up and Surveillance, Slide 8: Surveillance Audit
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 7.2: Audit Follow-up and Surveillance
*Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection
3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies
NEW QUESTION # 207
Which of the following three options could be considered potential threats to impartiality in an audit context?
- A. Experience
- B. Self-audit
- C. Intimidation
- D. Competence
- E. Familiarity
Answer: B,C,E
Explanation:
Questions no: 1 Verified answer: = C, D, E Comprehensive But Short Explanation: = Potential threats to impartiality in an audit context include familiarity (having a close relationship with the auditee), intimidation (being coerced or feeling pressured), and self-audit (auditing one's own work). These factors can compromise the auditor's objectivity and the audit's integrity. References: = The information is based on the ISO 9001 Auditing Practices Group documents which discuss threats to auditor impartiality and how they may compromise an auditor's objectivity123.
NEW QUESTION # 208
Which quality management principle does an organization fulfill when it assesses risks, consequences, and impacts before taking action?
- A. Leadership
- B. Process approach
- C. Relationship management
- D. Improvement
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:One of the seven quality management principles in ISO 9001:2015 is Improvement, which emphasizes continual enhancement of processes, products, and services.
Clause 10.3 (Continual Improvement) states that organizations must continuously assess risks, consequences, and impacts to improve their QMS.
* Risk-based thinking (Clause 0.3.3) supports improvement by identifying and mitigating risks before they affect performance.
* Clause 6.1 (Actions to Address Risks and Opportunities) requires organizations to take a proactive approach, ensuring long-term success.
Other options do not fully align with the question:
* Process approach (A) focuses on managing interrelated activities.
* Leadership (B) ensures commitment but does not directly address risk assessment.
* Relationship management (D) deals with interested parties, not risk mitigation.
NEW QUESTION # 209
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