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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q114-Q119):

NEW QUESTION # 114
You are carrying out 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. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.
You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:

You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).
You: "Good afternoon."
OD: "Good afternoon."
You: "What responsibility do you have concerning the SWIFT database?"
OD: "I maintain it. If anyone wishes to propose an update to the database, they send me an email with details of their proposal. I then either process the database update myself, or I send the request to the consultant who designed the database 20 years ago. The necessary software changes are made, and the amended software is immediately released to users." You: "Would you explain how the software amendments are controlled?" OD: "Of course. I personally update every computer myself." You: "Do you inform the database users of the changes?" OD: "No I don't. They find out for themselves by using the software, or they come to see me if they have any questions." You: "How do you ensure that the database users use the latest version?" OD: "That's easy, I update every computer myself." You: "During the audit, I noted there were several versions of SWIFT in use (you refer to your audit notes)." OD: "I know. That's because some versions work better than others, and depending on user needs and experiences, we allow users to revert to using an earlier version if they find it works better for them." Based on the scenario, which two of the following statements are true? There is evidence of nonconformity with a requirement defined in ...

A. clause 7.5.3 Control of documented information
B. clause 7.5.2 Documented information - Creating and updating
C. clause 7.1.3 Infrastructure
D. clause 7.5.1 Documented information - General
E. clause 7.1.4 Environment for the operation of processes

Answer: A,D

Explanation:
Based on the scenario provided, there is evidence of nonconformity with the requirements defined in:
C: Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.
E: Clause 7.5.3 Control of documented information: The Operations Director's approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.
These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system.
The scenario described shows a casual approach to managing critical software updates, which could affect the organization's ability to consistently meet customer and regulatory requirements.

NEW QUESTION # 115
Which statement regarding the drafting of the audit conclusions is correct?

A. The audit conclusions must be drafted based on observation
B. The audit conclusions must not include the revisions that resulted from the closing meeting
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 # 116
You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as an internal auditor. The Quality Manager asks you to lead the next internal audit of Production and Logistics Dispatch. The audit team includes two other internal auditors.

Answer:

Explanation:

Explanation:
Here is the correct matching of actions to the statements in the context of leading the internal audit:
* If practicablecarry out a formal opening meeting
* You should notaudit production (as you are a supervisor in that area, and this would compromise audit objectivity)
* You need notchange the audit team (unless there is a specific reason, such as conflict of interest)
* You mustraise audit findings if necessary (this is a key responsibility of an auditor when nonconformities are found)
* You must notsend the audit report to the Quality Manager (the audit report must be reviewed first; it is typically part of the internal audit process to go through necessary channels before final submission)
* You shouldsend the audit report to the Quality Manager (after appropriate reviews and approvals) This reflects key principles of conducting an internal audit according to ISO 9001:2015, ensuring objectivity, proper documentation, and clear reporting procedures.

NEW QUESTION # 117
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: "I would like to begin by looking at the cleaning controls."
MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside." Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

You decide to raise a non-conformity.

Answer:

Explanation:

Explanation:
Clause: 8.5.4
Nature of Problem: Cleaning and sanitising records are not available for every batch.
Unfulfilled Requirement: "The organization shall implement production provision under controlled conditions."

NEW QUESTION # 118
You are conducting a Stage 1 audit at an organisation that services refrigeration equipment for a large customer base.
The scope of certification is "Provision of refrigeration equipment maintenance and repair services". You are interviewing the Managing Director to learn more about the organisation and to explore how the requirements for policy, objectives, and risks and opportunities in ISO 9001 are addressed.
The Managing Director explains that they only use sub-contract refrigeration engineers and do not have any full-time refrigeration engineers, which helps to optimise overhead costs. The full-time staff employed are essentially a small team of office staff who process customer enquiries, schedule jobs and process invoices.
The Managing Director adds that the ISO 9001 requirements for competence of personnel extends to both sub- contract and full-time staff. He also states that the full-time staff are aware of the Quality Policy, objectives and plans to address risk and opportunities.
You ask if the sub-contract engineers have been informed of the Quality Policy, objectives and plans to address risks and opportunities, to which the Managing Director replies that this is not applicable as they only use sub- contractors who operate ISO 9001 certificated quality management systems. The documented information provided to the auditor confirms this.
Which clause in ISO 9001 is most likely not to have been fulfilled in this instance?

A. 7.3 Awareness
B. 7.2 Competence
C. 7.4 Communication
D. 7.5 Documented information

Answer: C

Explanation:
Questions no: 16 Verified = C. 7.4 Communication Comprehensive But Short Explanation: = Clause
7.4 of ISO 9001:2015 requires the organization to determine the internal and external communications relevant to the quality management system, including what will be communicated, when, with whom, and how. The scenario indicates a potential gap in communication with subcontractors regarding the Quality Policy, objectives, and plans to address risks and opportunities, which is a requirement even if the subcontractors have their own ISO 9001 certified systems123. References: = This response is based on the general requirements of ISO 9001:2015 related to communication with external parties, such as subcontractors, as outlined in various resources discussing Clause 7.4123.

NEW QUESTION # 119
......

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Free PDF Quiz PECB - Efficient ISO-9001-Lead-Auditor - QMS ISO 9001:2015 Lead Auditor Exam Exam Test

QMS ISO 9001:2015 Lead Auditor Exam exam test torrent & ISO-9001-Lead-Auditor updated training vce & ISO-9001-Lead-Auditor test study dumps

PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q114-Q119):

ISO-9001-Lead-Auditor - High Hit-Rate QMS ISO 9001:2015 Lead Auditor Exam Exam Test

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