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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:

Topic
Details

Topic 1

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 2

Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.

Topic 3

Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.

Topic 4

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 5

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.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q199-Q204):

NEW QUESTION # 199
Which statement regarding the drafting of the audit conclusions is correct?

A. The audit conclusions must not include the revisions that resulted from the closing meeting
B. The audit conclusions must be drafted based on observation
C. The audit conclusions must be based on evidence that is examined and evaluated in terms of quantity and quality

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 6.4.9 (Audit Conclusions):
* Audit conclusions must be based on verified evidence.
* The evidence must be evaluated both quantitatively and qualitatively to ensure accuracy.
* Observations alone (A) are insufficient; conclusions must be supported by objective evidence.
Thus, B is the correct answer.

NEW QUESTION # 200
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 2 audit and surveillance audit.
B. Audit follow-up and stage 1 audit.
C. Stage 1 and stage 2 audit.

Answer: C

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.
Reference:
ISO/IEC 17021-1:2015, Clause 9.3.1 - Initial Certification Audit (Stage 1 & 2)

NEW QUESTION # 201
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?

A. During the Stage 1 audit, the audit team:
B. Verifies the compliance with legal requirements
C. Evaluates the conditions of all sites
D. Evaluates the results of the last management review
E. Verifies the degrees of customer satisfaction
F. Reviews the client's management system documented information
G. Reviews the processes with high level of risk

Answer: F,G

Explanation:
* Reviews the client's management system documented information: This activity involves checking the documentation of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team also evaluates the client's understanding and implementation of the standard, and identifies any gaps or nonconformities that need to be addressed before the Stage 2 audit123.
*Reviews the processes with high level of risk: This activity involves assessing the processes that have a significant impact on the quality of the products or services, or that pose a high risk of nonconformity or customer dissatisfaction123. The audit team also verifies the client's risk management approach, and evaluates the effectiveness of the controls and actions taken to mitigate the risks123.
The other options are not statements that are true for the Stage 1 audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.
Therefore, the correct answer is D and G.
References: 1: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified 2: Stage 1 of your Audit
| NQA Blog 3: Getting Certified to ISO 9001 - the Stage 1 Audit

NEW QUESTION # 202
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:

Explanation:
A screenshot of a computer Description automatically generated

NEW QUESTION # 203
Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.
Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled.
The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.
The top management, in cooperation with Sean, assigned 10 more employees to the audit team.
Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.
Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.
Based on the scenario above, answer the following question:
Sean requested unrestricted access to the employees, executives, and documented information of POLKA. Is this in accordance with audit best practices?

A. Yes, unrestricted access for the internal auditor should be provided by the company
B. No, such requests are acceptable only if a third-party audit is being conducted
C. Yes, but the internal auditor should make such a request to the CEO directly as only the CEO of the company can approve such a request

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.3.2 (Access to Information), internal auditors must have unrestricted access to:
* Employees and executives for interviews and observations.
* Documented information to verify compliance with ISO 9001.
This ensures a transparent and objective audit process. The CEO's approval (B) is not required unless restricted information is involved.
Reference:
ISO 19011:2018, Clause 5.3.2 (Access to Information)

NEW QUESTION # 204
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