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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
- 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 3
- Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.
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
- Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q196-Q201):
NEW QUESTION # 196
Match the process descriptions below to the process names:
Answer:
Explanation:
Explanation:
A white background with black text Description automatically generated
NEW QUESTION # 197
You are auditing a manufacturer of specialty tea products during a Stage 2 certification audit. In the quality laboratory, you interview one of three operatives conducting sensory testing of a batch from the production line.
Select three options of evidence which could demonstrate conformance with clause 9.1.1 of ISO 9001:
2015.
- A. Outsourcing the sensory testing to an accredited laboratory
- B. The Hedonic Method is used to monitor the quality of the product
- C. Analysis of the results of sensory tests
- D. Safe disposal of the tested product
- E. Laboratory staff routinely tested for respiratory ailments
- F. Operatives having a university degree in food science
- G. Independent experts were brought in to review test processes
- H. Sensory testing results are recorded
Answer: B,C,H
Explanation:
Comprehensive and Detailed Explanation From Exact Extract:
Clause 9.1.1 - Monitoring, measurement, analysis and evaluation (General) requires the organization to:
"Determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results, and when results shall be analyzed and evaluated." The goal is to ensure valid, reliable, and consistent measurement of process and product performance. Here's how each correct option supports compliance:
# B. Analysis of the results of sensory tests
This directly aligns with the requirement for analysis and evaluation of monitoring results. Clause 9.1.3 also supports the use of such data for evaluating product conformity and process effectiveness.
# G. Sensory testing results are recorded
This supports documented evidence of monitoring results, as required under 9.1.1(e), to verify that quality checks (such as flavor and aroma assessments) are being done consistently.
# H. The Hedonic Method is used to monitor the quality of the product
Use of a standardized measurement method like the Hedonic Scale aligns with 9.1.1(b), which requires defined methods to ensure valid and reproducible results.
Why the Other Options Are Incorrect or Less Relevant:
* A. University degrees # Related to competence (Clause 7.2), not monitoring and measurement (Clause
9.1.1).
* C. Independent expert review # Not part of regular monitoring unless it's built into the process.
* D. Respiratory testing # Irrelevant to product quality monitoring.
* E. Outsourcing # Would shift responsibility but doesn't demonstrate internal conformance.
* F. Safe disposal # Pertains to Clause 8.5.4 (Preservation), not Clause 9.1.1.
References:
ISO 9001:2015 Clause 9.1.1 - Monitoring, measurement, analysis and evaluation ISO 9001:2015 Clause 9.1.3 - Analysis and evaluation ISO 9001:2015 Clause 7.2 - Competence (for contrast)
NEW QUESTION # 198
Technical experts must operate under the supervision of:
- A. The auditee
- B. An auditor
- C. The audit team leader only
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence), technical experts:
* Provide specialized knowledge in an audit.
* Must operate under the supervision of an auditor to ensure compliance with audit protocols.
* Cannot work independently or under the auditee's supervision, as they are not responsible for the audit's findings.
The audit team leader has overall responsibility, but technical experts are supervised by an auditor during the audit process.
Reference:
ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence)
NEW QUESTION # 199
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?
- A. Decreased number of warranty claims
- B. Decreased number of nonconforming products in all stages of the manufacturing cycle
- C. Decreased number of management system nonconformities
- D. Consistently provide products that meet customers' requirements
- E. Increased profits
- F. Enhanced customer satisfaction
Answer: D,F
Explanation:
According to the ISO 9001:2015 document, the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015 are:
*the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
*the enhancement of customer satisfaction.
These results are derived from the quality management principles of customer focus and process approach, which are the basis of the ISO 9000 family of standards1. Customer focus means understanding and meeting customer needs and expectations, as well as exceeding them when possible1. Process approach means managing activities as interrelated processes that function as a coherent system, which leads to consistent and predictable results1.
Therefore, the correct answer is C and F.
References: 2: ISO 9001:2015 - Quality management systems - Requirements 1: ISO - Quality management principles
NEW QUESTION # 200
According to ISO 9000, what is quality?
- A. The efficiency with which resources are utilized in achieving objectives
- B. The degree to which a set of inherent characteristics of an object fulfills requirements
- C. A set of conditions under which work is performed
- D. The ability of an object to realize an output that will fulfill the requirements for that output
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9000:2015 defines quality as "the degree to which a set of inherent characteristics of an object fulfills requirements." Clause 3.6.2 (Quality) confirms this definition.
Quality is determined by how well an object (product, service, or process) meets defined requirements (customer, regulatory, or internal).
The other options do not align with the official ISO definition:
Option A refers to performance capability but does not define quality.
Option C describes work conditions, not quality.
Option D focuses on efficiency rather than fulfilling requirements.
Reference:
ISO 9000:2015, Clause 3.6.2 - Quality
NEW QUESTION # 201
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