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Top features of PECB ISO-9001-Lead-Auditor Exam Practice Test Questions

The PECB ISO-9001-Lead-Auditor Certification Exam is one of the top-rated career advancement certifications in the market. With the QMS ISO 9001:2015 Lead Auditor Exam ISO-9001-Lead-Auditor certification exam everyone can validate their skills and knowledge after passing the ISO-9001-Lead-Auditor text. The PECB QMS ISO 9001:2015 Lead Auditor Exam certification exam will recognize your expertise and knowledge in the market. You will get solid proof of your proven skill set. There are other countless benefits that you can gain after passing the PECB QMS ISO 9001:2015 Lead Auditor Exam certification exam.

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

Topic
Details

Topic 1

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 2

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

Topic 3

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

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

Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.

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 (Q153-Q158):

NEW QUESTION # 153
During the opening meeting of a third-party audit of a pharmaceutical organisation (CD9000) with seven COVID-19 testing laboratories in various terminals at a major international airport, you are asked if you could visit all laboratories. As audit team leader you say that, based on sampling criteria, you had planned to audit only three of them as CD9000 is a multisite organisation.
They tell you that they have worked so hard to get ready for the audit that the supervisors of those laboratories that would not be visited would be quite disappointed.
The following are possible responses to the request, select the two best responses:

A. I could decide to extend the audit for an extra day.
B. I could try to revise the audit programme to see if I can audit all laboratories.
C. I could audit the other laboratories virtually at the end of this audit.
D. We could stay every day for one hour longer to see those supervisors and their laboratories.
E. Sorry, this is the plan, we cannot change it. However, they could attend the audit as observers.
F. The programme manager has selected the sample and we must follow it.

Answer: B,C

Explanation:
In this scenario, the audit team leader must balance maintaining the integrity of the audit plan while considering the auditee's request. The two best responses allow for flexibility without compromising the audit's rigor:
A: I could audit the other laboratories virtually at the end of this audit: Virtual audits can be a valid option, especially in multi-site audits. ISO 9001:2015 does not prohibit virtual audits, and in certain situations, they are practical for reviewing documentation or observing operations remotely.
C: I could try to revise the audit programme to see if I can audit all laboratories: Revising the audit programme to accommodate additional site visits is a reasonable compromise. ISO 9001:2015 audits are based on risk and sampling, but the audit team leader has the flexibility to adjust the audit scope if it fits within the audit duration and resources.
The other options, such as extending the audit duration (B, F) or strictly adhering to the original plan (D, E), may not be practical or necessary. Revising the plan to audit all laboratories or using virtual auditing ensures that the audit remains efficient while addressing the organization's concerns.

NEW QUESTION # 154
What is a combined audit?

A. Two or more auditing organizations cooperating to audit a single auditee.
B. Two or more management systems audited together at a single auditee.
C. Two or more management systems audited simultaneously at several auditees.

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:
A combined audit is when multiple management systems (e.g., ISO 9001 for Quality, ISO 14001 for Environmental Management, and ISO 45001 for Occupational Health & Safety) are audited together in a single organization.
Clause References:
* ISO 19011:2018, Clause 5.4 - Combined Audits:
* A combined audit is performed when two or more management systems are assessed simultaneously at the same auditee.
Why is the Correct Answer A?
* A combined audit reduces duplication of effort by auditing multiple standards together at a single organization.
* Example: A company certified to both ISO 9001 and ISO 14001 can have one audit covering both standards.
Why are the Other Options Incorrect?
* B (Two or more auditing organizations cooperating on a single auditee) # This is a joint audit, not a combined audit.
* C (Two or more management systems audited at multiple auditees) # This is a multiple-site audit, not a combined audit.
Reference:
ISO 19011:2018, Clause 5.4 - Combined Audits

NEW QUESTION # 155
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. All these actions will be reviewed during the Top Management meetings
B. Improvement action has been promoted
C. Top Management appoints a senior manager to oversee the quality manangement system
D. Objectives have been established
E. Process approach has been communicated to the personnel
F. Resources have been provided
G. Top Management review will be carried out every six months instead of annually
H. Top Management completed a course on ISO 9001

Answer: B,D,E,F

NEW QUESTION # 156
Match the process descriptions below to the process names:

Answer:

Explanation:

Explanation:
Match the process descriptions below to the process names:
The process by which the accuracy of test equipment is checked against a known standard. = Calibration The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation The process by which data is examined in detail to reach a specific answer or answers. = Analysis The process by which a parameter of a product or service is examined to determine a specific value. = Measurement According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, the definitions of the process names are as follows:
Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Analysis: detailed examination of the elements or structure of something.
Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.
Therefore, the process descriptions can be matched to the process names based on these definitions.
References:
ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary

NEW QUESTION # 157
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 # 158
......

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