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Title: ISO-9001-Lead-Auditor Test Centres Excellent Questions Pool Only at ExamsReviews
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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:
TopicDetails
Topic 1
  • Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.
Topic 2
  • Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.
Topic 3
  • Quality management system (QMS) requirements: It assesses your abilities to point out and explain different requirements for a quality management system based on ISO 9001.
Topic 4
  • Fundamental principles and concepts of a quality management system: The main objective of this domain is to evaluate your skills of explaining and applying ISO 9001 principles and concepts.
Topic 5
  • Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q165-Q170):NEW QUESTION # 165
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 oll 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 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.
Which of the following options for the best description of the nonconformity?
Answer: C
Explanation:
Clause Reference - ISO 9001:2015 Clause 8.6 (Release of Products and Services):
ISO 9001 requires that products and services are not released to the customer until:
* All planned verification activities have been completed.
* Acceptance criteria have been met.
* Any necessary approvals have been obtained.
In this scenario:
* The sacrificial anodes for Project DK were shipped before the galvanic efficiency test results were analyzed.
* This constitutes a nonconformity against Clause 8.6 because the products were released without completing the required tests.
Option Analysis:
* A. A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager:Incorrect. While obtaining a concession might mitigate the situation, the nonconformity pertains to the process failure of releasing the products without completing required tests, not the absence of a concession.
* B. Release of the product without acceptable test results has been accepted by the customer for Project DK:Incorrect. The customer was not informed before the release, and there is no indication that this was accepted beforehand. Furthermore, ISO 9001 requires planned processes to be followed, regardless of later acceptance.
* C. Products for Project DK have been released before product approval through the quality control process:Correct. This description accurately reflects the nonconformity. The quality control process required test results to be analyzed and verified before release, which did not happen.
* D. The untested product was not recalled until the galvanic efficiency of the anodes was verified:
Incorrect. The issue is not about recalling the product but about releasing it without completing the required tests. Recalling the product is not mentioned in the scenario.
Why C is Correct:
* The nonconformity is a clear breach of Clause 8.6, where the products were released without meeting the planned verification requirements.
* This demonstrates a failure in adhering to quality control processes, which is a critical aspect of ISO
9001 compliance.
Key ISO 9001 Reference:
* Clause 8.6: Products and services shall not be released to the customer until all planned activities (e.g., testing) have been satisfactorily completed, or the customer has approved the release with knowledge of deviations.

NEW QUESTION # 166
You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.
You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?" TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry." You: "How is their regulatory competence maintained?" TD: "They are dedicated individuals with lots of contacts in the sector." You: "How does the business enable them to maintain their understanding of current regulatory requirements?" TD: "We leave that up to them."

Answer:
Explanation:



NEW QUESTION # 167
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 # 168
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation which manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. As one of the auditors, you 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 rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
During the audit team meeting in preparation for the Closing meeting, the second auditor disagreed with the clause of ISO 9001 selected for the above nonconformity. He thinks it should be clause 9.1.1.
Choose three options for how the audit team leader should best respond to the situation:
Answer: B,C,E
Explanation:
As the audit team leader, it is crucial to manage differing opinions constructively and ensure that the correct clause is selected for the nonconformity based on solid evidence. Here's how the situation should be handled:
E:Invite you and the second auditor to fully explain your point of view and then decide which clause to select: This promotes collaboration and transparency, allowing both auditors to present their rationale for choosing the specific clause.
F: Review the evidence with you and the second auditor, and then decide which clause of ISO 9001 would best apply: Reviewing the evidence in relation to the specific requirements of ISO 9001 is essential for determining which clause is most appropriate.
H: Try to obtain a consensus between you and the second auditor after a discussion of the different opinions:
Consensus-building is a crucial skill for an audit team leader. Achieving agreement ensures the nonconformity is addressed accurately and with full team support.
Options such as overruling immediately (D) or deferring the decision without full discussion (B) could undermine team dynamics and the audit process. Consulting the quality manager (A) or selecting an entirely different clause (G) is unnecessary, as the team should resolve the issue internally.

NEW QUESTION # 169
Among others, what does Clause 4.4 (Quality Management System and Its Processes) of ISO 9001 require from organizations?
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 emphasizes continual improvement as a fundamental requirement of an effective Quality Management System (QMS).
Clause Reference:
* Clause 4.4.1 (Quality Management System and Its Processes) states that organizations must:
* Determine processes needed for the QMS
* Establish criteria and methods for process effectiveness
* Ensure continual improvement of the system
Why is the Correct Answer C?
* Continual improvement is a core principle of ISO 9001.
* Organizations must regularly assess and enhance their QMS to adapt to new challenges and maintain effectiveness.
Why are the Other Options Incorrect?
* A (To change the QMS quarterly) # ISO 9001 does not mandate a specific frequency for system changes.
* B (To review the QMS annually) # QMS reviews must be conducted as needed, not strictly annually.
* D (To conduct a QMS gap analysis every two years) # Gap analysis is useful but is not a mandatory requirement under Clause 4.4.
Reference:
ISO 9001:2015, Clause 4.4 - Quality Management System and Its Processes

NEW QUESTION # 170
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