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100% Pass Quiz 2026 PECB Authoritative Valid Braindumps ISO-9001-Lead-Auditor Eb
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q219-Q224):NEW QUESTION # 219
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 have just completed the opening meeting. You are interviewing the Managing Director (MD).
You: "Good morning. I would like to gain an understanding of your business and its strategic direction." MD: "Of course. We are facing challenging times. The market is extremely competitive, and customers typically look for the least expensive option when arranging health and safety training. Our annual sales revenue has struggled to grow over the past two years. Most of our employed trainers are planning to retire over the next 12 months, and we are looking for more subcontract trainers. Achieving ISO 9001 certification will, I hope, give us the capability to improve our operational performance. Also, many of our competitors do not have any form of management system certification, so I hope it will give us that competitive edge needed to secure orders. We intend to promote our ISO 9001 certification on our website and across all other customer-facing media." Which three of the following audit trails would you take to explore the extent to which external and internal issues have been determined and used to enable the business to achieve the intended result(s) of its quality management system?
- A. Establish how the organisation determines subcontractor trainer competence.
- B. Establish how the organisation determines its relevant interested parties.
- C. Establish how the organisation documents its external and internal issues.
- D. Establish how the organisation determines employed trainer competence.
- E. Establish how the organisation reviews information about external and internal issues.
- F. Establish how the organisation specifies the structure for the training rooms.
- G. Establish how the organisation determined the scope of its quality management system.
- H. Establish how the organisation maintains its training products up to date.
Answer: B,C,E
Explanation:
ISO 9001:2015 requires organisations to determine external and internal issues relevant to their purpose and strategic direction and to use this understanding to support planning and achievement of intended QMS results.
The key requirement is Clause 4.1 - Understanding the organisation and its context, supported by Clause
4.2 - Understanding the needs and expectations of interested parties.
Explanation of the correct audit trails:
A). Establish how the organisation determines its relevant interested parties Clause 4.2 requires the organisation to determine interested parties that are relevant to the QMS and their requirements. Understanding interested parties is essential to identifying external and internal issues that influence strategic direction and QMS outcomes.
C). Establish how the organisation documents its external and internal issues Clause 4.1 requires the organisation to determine relevant external and internal issues. While documented information is not explicitly mandated, auditors must verify how these issues are identified and captured to demonstrate systematic application and use in planning.
D). Establish how the organisation reviews information about external and internal issues Clause 4.1 also requires the organisation to monitor and review information relating to external and internal issues. This audit trail confirms that context analysis is not static and is actively used to support QMS planning and intended results.
Explanation of why the other options are not selected:
* B: Determining scope (Clause 4.3) uses context as an input, but does not itself demonstrate how issues are determined and used.
* E and G: Trainer competence relates to Clause 7.2, not to determination and use of organisational context.
* F: Maintaining training products relates to operational control, not context analysis.
* H: Training room structure is an operational detail unrelated to external and internal issues.
ISO-aligned conclusion:
To explore how external and internal issues are determined and used to achieve intended QMS results, the auditor must follow audit trails that confirm:
* Identification of relevant interested parties,
* Determination and capture of issues affecting the organisation, and
* Ongoing review of those issues to support planning and performance.
NEW QUESTION # 220
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 have the results on one out of ten of our routine production samples double-checked by an external local laboratory.
- D. We will add this to our external issue register, assess its associated risk, and plan action to address that risk.
Answer: D
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 # 221
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 have the results on one out of ten of our routine production samples double-checked by an external local laboratory.
- D. We will add this to our external issue register, assess its associated risk, and plan action to address that risk.
Answer: D
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 # 222
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of
45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
Which stages of the audit were performed?
- A. Stage 1 and stage 2 audit.
- B. Audit follow-up and stage 1 audit.
- C. Stage 2 audit and surveillance audit.
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Understanding Audit Stages Based on ISO/IEC 17021-1:2015
ISO certification audits consist of two main stages:
* Stage 1 Audit (Readiness Review)
* The organization's documented information is reviewed to assess readiness for Stage 2.
* This ensures that the QMS is developed, implemented, and prepared for full assessment.
* Stage 2 Audit (On-Site Evaluation)
* Auditors assess process implementation and effectiveness through interviews, observations, and evidence collection.
* The audit team verifies if the organization meets ISO 9001 requirements in practice.
Why is the Correct Answer B?
* The audit team reviewed ME's documents, which is a Stage 1 activity.
* The audit team performed interviews, sampling, and on-site verification, which is a Stage 2 activity.
* There was no mention of an audit follow-up or a surveillance audit, which occur post-certification.
Why are the Other Options Incorrect?
* A (Audit follow-up and Stage 1 Audit) # Follow-up audits occur after certification, which was not the case here.
* C (Stage 2 Audit and Surveillance Audit) # Surveillance audits are post-certification audits and were not conducted yet.
NEW QUESTION # 223
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

Answer:
Explanation:

Explanation:

The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.
"8.3.2 e) ... internal ... resource needs for the design and development of products ..." The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.
"8.3.5 ... retain documented information ..."
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.
"8.3.6 ... retain documented information ..."
The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.
"8.3.4 d) ... conducted to ensure that the resulting products and services meet the requirements ..." The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.
"8.3.2 e) ... external ... resource needs for the design and development of products ..."
NEW QUESTION # 224
......
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