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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | QMS ISO 9001:2015 Lead Auditor Exam |
| Exam Number: | ISO-9001-Lead-Auditor |
| Exam Format: | Scenario-based, Multi-response, Open-book, Multiple choice |
| Available Languages: | Arabic, Portuguese, Italian, French, Russian, Spanish, German, English, Chinese |
| Exam Price: | $1000 USD |
| Real Exam Qty: | 40–80 |
| Passing Score: | 70% (minimum 28/40 or 56/80 correct answers) |
| Exam Duration: | 180 (120 + 30 for non-native speakers) |
| Certificate Validity Period: | 3 years |
| Related Certifications: | ISO 9001 Provisional Auditor ISO 9001 Auditor ISO 9001 Foundation |
| Recommended Training: | PECB ISO 9001 Lead Auditor Training Course |
| Exam Registration: | PECB Official Registration |
| Sample Questions: | PECB ISO-9001-Lead-Auditor Sample Questions |
| Exam Way: | Online proctored via PECB Exams app or paper-based at authorized test centers |
| Pre Condition: | Recommended: ISO 9001 Foundation knowledge or certification; no mandatory prerequisites, but experience in quality management is advised |
| Official Syllabus URL: | https://pecb.com/en/education-and-certification-for-individuals/iso-9001/iso-9001-lead-auditor |
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NEW QUESTION # 107
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 # 108
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization 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.
Answer:
Explanation:
Explanation:
Nonconformity report
ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met." Evidence: 40 cleaning records are available for 63 batches.
NEW QUESTION # 109
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 # 110
Select the two activities which pertain to Third-Party Audit.
Answer: C,D
NEW QUESTION # 111
Which of the following is a record related to the audit program that should be managed and maintained?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 19011:2018, Clause 5.4 (Audit Records Management) states that the audit schedule must be maintained as a key record.
Thus, C is the correct answer.
NEW QUESTION # 112
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