サンプル問題 1： Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.
A: To facilitate auditing for proof of conformity to the standard.
B: To provide confidence in the effectiveness of the quality management system.
C: To safeguard the integrity of the quality management system.
D: To support the operation of the processes of the quality management system.
正解：B
Explanation: According to ISO 9001:2015, clause 4.4, an organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are under control. The purpose of retaining documented information is to provide evidence of conformity to the standard, communicate information in the organization, maintain organizational knowledge, trace back changes or measurement used, and keep reference for improvement1. Reference: Guidance on the requirements for Documented Information of ISO 9001:2015 Maintain Documented Information in ISO 9001:2015 C NIIX Quality Management System Software Documented Information Required by ISO 9001:2015 - 9000 Store Quality Systems - Records required by ISO 9001:2015 A Quality Management System Based on ISO 9001 | PECB
サンプル問題 2： 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 nonconforming products in all stages of the manufacturing cycle
B: Decreased number of management system nonconformities
C: Consistently provide products that meet customers' requirements
D: Increased profits
E: Decreased number of warranty claims
F: Enhanced customer satisfaction
正解：A, C, 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. Reference: 2: ISO 9001:2015 - Quality management systems ― Requirements 1: ISO - Quality management principles
サンプル問題 3： Which two of the following aspects of a quality management system must the organisation continually improve?
A: Suitability
B: Adaptability
C: Effectiveness
D: Responsiveness
E: Efficiency
F: Applicability
正解：A, C, E
Explanation: According to the ISO 9001:2015 document, the organisation must continually improve the suitability, adequacy, and effectiveness of the quality management system1. However, among the six options given, only effectiveness is directly mentioned as an aspect of the quality management system that must be continually improved. Therefore, C is one of the correct answers. Efficiency, on the other hand, is not explicitly stated as an aspect of the quality management system that must be continually improved, but it is implied by the quality management principle of improvement, which states that successful organisations have an ongoing focus on improvement2. One of the key benefits of applying this principle is improving operational effectiveness and efficiency2. Therefore, E is another correct answer. Suitability, adaptability, responsiveness, and applicability are not aspects of the quality management system that must be continually improved, according to the ISO 9001:2015 document. They may be related to the quality management system, but they are not the focus of continual improvement. Therefore, the correct answer is C and E. Reference: 1: ISO 9001:2015 - Quality management systems ― Requirements 2: ISO - Quality management principles
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ISO-9001 Lead Auditor問題集の収録内容と更新状況はどうなっていますか？
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