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HOT Exam ISO-9001-Lead-Auditor Outline - The Best PECB QMS ISO 9001:2015 Lead Auditor Exam - Latest ISO-9001-Lead-Auditor Exam Pdf
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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:
Topic
Details
Topic 1
- Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.
Topic 2
- 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 3
- Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.
Topic 4
- 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 5
- Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
Topic 6
- Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q211-Q216):
NEW QUESTION # 211
You have been just hired as the Internal Lead Auditor of a large organisation, responsible for internal audits.
Your first job is to analyse the answers to nonconformities included in the report of a recent internal audit to Top Management.
The report contained one nonconformity as follows:
There is no evidence of Top Management ensuring the availability of resources to operate the QMS, the establishment of objectives, the promotion of continual improvement, and the promoting of the process approach.
Which four of the following Top Management actions can be considered 'corrections to the nonconformity'?
- A. Top Management appoints a senior manager to oversee the quality manangement system
- B. Improvement action has been promoted
- C. Resources have been provided
- D. Top Management review will be carried out every six months instead of annually
- E. Top Management completed a course on ISO 9001
- F. All these actions will be reviewed during the Top Management meetings
- G. Objectives have been established
- H. Process approach has been communicated to the personnel
Answer: B,C,G,H
NEW QUESTION # 212
At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only two people are present and waiting for them: the Health and Safety supervisor and the Administrative Officer.
Neither has participated in the audit. However, the team had previously agreed with the auditee Quality Manager on two nonconformities identified during the audit (NC1 and NC2).
They said:
Health and Safety Supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and the other two managers have had to leave urgently to attend to the emergency." The Administration Officer: "Concerning 'nonconformity 2', the General Manager left a message asking us to tell you that he does not accept it and requests you not to include it in the audit report. Here is a note in which he explains why." Which one of the following would be your preferred answer (as team leader) to the General Manager's request?
- A. OK. I will get in contact with my company tomorrow to ask for instructions on what to do with this non-conformity.
- B. Please tell him that I will phone him in two days and will discuss the issue. Could you please give me his mobile phone number?
- C. Please tell him that this nonconformity has been previously accepted by the quality manager during the audit and will stand. I will include it in the report, along with the concern of the General Manager about it.
- D. OK. Please, let me review the message. I will try to see if I can change the text of the nonconformity if necessary. Let's take a 10-minute break, as I would like to discuss this issue with the audit team.
Answer: D
NEW QUESTION # 213
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 # 214
When should the certification body accept the audit?
- A. Only if the auditee has no previous major nonconformities.
- B. Both A and B.
- C. After considering the integrity and reputation of the auditee.
- D. After considering the nature of the operations of the auditee.
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Before accepting an audit, the certification body must assess the integrity of the auditee and the nature of its operations to ensure compliance feasibility.
Clause References:
* ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning:
* The certification body must review the auditee's background, reputation, and operational complexity before accepting the audit.
Why is the Correct Answer C?
* The auditee's integrity and reputation impact the credibility of certification.
* The nature of operations determines audit complexity and resource allocation.
Why are the Other Options Incorrect?
* A (Integrity and reputation only) # Correct but incomplete; nature of operations is equally important.
* B (Nature of operations only) # Integrity is also a factor, not just operations.
* D (No previous major nonconformities required) # Auditees with past major nonconformities can still be audited if corrective actions are taken.
Reference:
ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning
NEW QUESTION # 215
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.
Answer:
Explanation:
Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8 extract
Four of the 10 pallets of stock sampled in the warehouse were not labelled.
"8.5.2 ... shall use suitable means to identify outputs ..."
A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor.
"8.7.1 ... shall ensure that outputs that do not conform to their requirements are identified and controlled ..." One of the fork-lift truck drivers had no fork-lift truck driving licence.
"8.5.1 e ... shall include, as applicable ... the appointment of competent persons ..." There was no pest control provision in the warehouse.
"8.5.4 ... shall preserve the outputs during production and service provision ..." Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full.
"8.1 ... shall plan, implement and control the processes ..."
NEW QUESTION # 216
......
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