Latest PECB ISO-9001-Lead-Auditor Exam Notes | Reliable ISO-9001-Lead-Auditor Braindumps Ppt
Latest PECB ISO-9001-Lead-Auditor Exam Notes | Reliable ISO-9001-Lead-Auditor Braindumps Ppt
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q125-Q130):
NEW QUESTION # 125
Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
Answer:
Explanation:
Explanation:
The quality system failed to control the laundry services provided for customers in five shops.
The equipment used was not capable of consistently producing the required service.
NEW QUESTION # 126
What should the auditor document during the Stage 1 audit?
- A. The main processes of the auditee
- B. The observations that could result in nonconformities during the on-site audit
- C. The interviews with the auditee's employees
Answer: B
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 # 127
Which one of the following documents addresses audit time calculation for third-party certification audits?
- A. ISO 9001
- B. ISO 19011
- C. ISO 9000
- D. ISO 17021-1
Answer: D
Explanation:
ISO/IEC 17021-1 is the standard that specifies requirements for bodies providing audit and certification of management systems. It includes provisions for determining audit time for third-party certification audits, ensuring that the audits are conducted in a consistent, comparable, and reliable manner, which can be applied to a variety of management systems, including ISO 9001.
References: ISO/IEC 17021-1; IAF Mandatory Document for the Determination of Audit Time of Quality and Environmental Management Systems Certification
NEW QUESTION # 128
During an internal audit, it was discovered that the calibration of a spectrometer used daily for production had expired, causing a nonconformance under Clause 7.1.5.2 of ISO 9001:2015. The root cause was the organization not considering the risk of the calibration provider leaving the country.
Which corrective action is the best one?
- A. We will select one sample, which we will send to an external laboratory and will use it as our internal standard.
- B. We will look for a local company to provide this service.
- C. We will add this to our external issue register, assess its associated risk, and plan action to address that risk.
- D. We will have the results on one out of ten of our routine production samples double-checked by an external local laboratory.
Answer: C
Explanation:
* Understanding Clause 7.1.5.2 - Measurement Traceability:ISO 9001:2015 requires organizations to ensure that measuring equipment (e.g., spectrometers) is calibrated and traceable to recognized standards. The failure to maintain calibration within valid dates directly violates this clause and raises concerns about the reliability of the measurement results.
* Root Cause of the Nonconformity:The organization failed to plan for the possibility that the calibration service provider (X-TECH) might become unavailable, leading to expired calibration. This indicates inadequate risk-based thinking, which is required under Clause 6.1 of ISO 9001:2015.
* Option Analysis:
* A. Select one sample for external lab analysis to use as an internal standard:Incorrect. While using an internal standard could provide short-term verification of results, this action does not address the root cause (failure to consider risks associated with external providers).
* B. Look for a local company to provide this service:Incorrect. While finding a new local service provider resolves the immediate calibration issue, it does not address the risk of future provider unavailability.
* C. Double-check one out of ten samples externally:Incorrect. This corrective action ensures some quality assurance for batch release but does not resolve the nonconformance related to expired calibration.
* D. Add this issue to the external issue register, assess its associated risk, and plan action to address that risk:Correct. This approach directly addresses the root cause (failure to anticipate the calibration provider leaving) and ensures proper risk management. ISO 9001:2015 emphasizes risk-based thinking under Clause 6.1, requiring organizations to identify risks and opportunities and implement plans to mitigate them.
* Why D is the Best Option:
* By adding the issue to the external issue register, the organization ensures it is monitored and tracked.
* Assessing the risk ensures proactive measures are in place for similar issues in the future.
* Planning actions to address the risk ensures a sustainable solution is implemented, such as identifying multiple service providers or ensuring backup plans for calibration services.
* ISO 9001 References:
* Clause 6.1 (Actions to Address Risks and Opportunities): Requires organizations to consider risks and opportunities that could affect the intended results of the QMS.
* Clause 7.1.5.2 (Measurement Traceability): Mandates that measuring equipment must be calibrated and traceable to ensure valid results.
* Clause 10.2 (Nonconformity and Corrective Action): Requires organizations to determine the root cause of nonconformities and take actions to ensure they do not recur.
NEW QUESTION # 129
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
In scenario 4, the audit team determined the audit feasibility by considering only the resources available for the audit. Is this acceptable?
- A. No, because other factors should be considered when determining the audit feasibility, such as information needed to plan the audit, the cooperation of the auditee, duration of the audit, etc.
- B. Yes, because the audit team leader has final authority over audit feasibility.
- C. No, the audit feasibility should be determined by TD's top management.
- D. Yes, considering only the resources available for the audit is sufficient for determining the audit feasibility.
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
An audit's feasibility must be assessed using multiple factors, not just resource availability.
Clause References:
* ISO 19011:2018, Clause 5.3 - Establishing the Audit Program: Requires consideration of logistical, technical, and cooperation factors when assessing audit feasibility.
* ISO/IEC 17021-1:2015, Clause 9.1.3 - Determining Feasibility of the Audit: Requires evaluating more than just resources to ensure a successful audit.
Why is the Correct Answer B?
* Audit feasibility should consider:
* Availability of information (documents, records).
* Cooperation from the auditee.
* Operational conditions that might affect the audit.
* Scope and complexity of the QMS being audited.
* Resource availability alone is not enough to determine feasibility.
Why are the Other Options Incorrect?
* A (Top management determines feasibility) # Incorrect because feasibility is determined by the certification body, not the auditee.
* C (Resources alone are sufficient) # Incorrect because other key factors must be evaluated.
* D (Final authority lies with the audit leader) # Incorrect because ISO requires multiple factors to be considered, not just an auditor's decision.
NEW QUESTION # 130
......
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