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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Closing an ISO 9001 Audit | 5–10% | - Audit report, follow-up actions - Preparing conclusions, closing meeting |
| Topic 2: Managing an ISO 9001 Audit Program | 5–10% | - Competence and evaluation of auditors - Establishing, implementing and monitoring audit program |
| Topic 3: Fundamental Principles and Concepts of Quality Management System | 10–15% | - Concepts of QMS, risk, process approach - Quality management principles - Relationship between ISO 9001 and other standards |
| Topic 4: Fundamental Audit Concepts and Principles | 10–15% | - Independence, evidence-based approach - ISO 19011 and ISO/IEC 17021-1 requirements - Audit principles, types, roles and responsibilities |
| Topic 5: Quality Management System (QMS) Requirements | 25–30% | - Support, operation, performance evaluation, improvement - Context of the organization, leadership, planning - Scope, normative references, terms and definitions |
| Topic 6: Preparation of an ISO 9001 Audit | 10–15% | - Initiating audit, defining objectives and scope - Document review and communication - Selecting audit team, preparing plan and checklist |
| Topic 7: Conducting an ISO 9001 Audit | 15–20% | - Team meetings, audit observations - Evaluating conformity, identifying nonconformities - Opening meeting, on-site activities, evidence collection |
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質問 # 244
You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as an internal auditor. The Quality Manager asks you to lead the next internal audit of Production and Logistics Dispatch. The audit team includes two other internal auditors.
正解：
解説：
Explanation:
Here is the correct matching of actions to the statements in the context of leading the internal audit:
* If practicablecarry out a formal opening meeting
* You should notaudit production (as you are a supervisor in that area, and this would compromise audit objectivity)
* You need notchange the audit team (unless there is a specific reason, such as conflict of interest)
* You mustraise audit findings if necessary (this is a key responsibility of an auditor when nonconformities are found)
* You must notsend the audit report to the Quality Manager (the audit report must be reviewed first; it is typically part of the internal audit process to go through necessary channels before final submission)
* You shouldsend the audit report to the Quality Manager (after appropriate reviews and approvals) This reflects key principles of conducting an internal audit according to ISO 9001:2015, ensuring objectivity, proper documentation, and clear reporting procedures.
質問 # 245
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services.
The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top-notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001.
During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS. They started by planning and developing processes and methods for the establishment of a QMS based on ISO
9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS. AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
As stated in scenario 1, AL-TAX tested the effectiveness of the intended actions as part of the QMS improvement through the PDCA cycle. Which stage did it perform in this case?
正解：C
解説：
Comprehensive and Detailed In-Depth Explanation:
The PDCA (Plan-Do-Check-Act) cycle is a continuous improvement model used in ISO 9001:2015. The " Check " phase involves monitoring, measuring, and analyzing the results to assess if the planned actions have been effective.
In scenario 1, AL-TAX tested the effectiveness of the intended actions, which aligns with the Check stage of the PDCA cycle. Clause 9.1.1 (Monitoring, Measurement, Analysis, and Evaluation) requires organizations to evaluate their QMS and determine whether improvements are necessary.
Reference:
ISO 9001:2015, Clause 0.3.2 - PDCA Cycle
ISO 9001:2015, Clause 9.1.1 - General (Performance Evaluation)
質問 # 246
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?
正解：B、E
解説：
The key expected results of a quality management system that conforms to the requirements of ISO 9001:2015 are stated in clause 0.1 of the standard, which says: "The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this International Standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements." Therefore, the two options that best match these benefits are A and E, as they directly relate to providing products and services that meet customer requirements and enhancing customer satisfaction. The other options are not explicitly mentioned as key expected results, although they may be possible outcomes of implementing a quality management system. References: ISO 9001:2015 - Quality management systems - Requirements, Key Elements of an ISO 9001:2015 Quality Management System, What is ISO 9001 2015 as a Quality Management Systems?
質問 # 247
What is a list of actions that should be performed during the audit with their respective timeline?
正解：D
解説：
Comprehensive and Detailed In-Depth Explanation:
The audit schedule provides a structured timeline of activities to be conducted during the audit.
Clause References:
ISO 19011:2018, Clause 6.4.2 - Preparing the Audit Plan:
Requires the development of an audit schedule, including the sequence and timing of activities.
ISO/IEC 17021-1:2015, Clause 9.1.3 - Audit Program:
Certification bodies must establish a schedule for conducting audits.
Why is the Correct Answer C?
The audit schedule ensures systematic execution of the audit by defining activities, responsible auditors, and timeframes.
A well-planned schedule improves efficiency and helps auditors cover all necessary areas within the given time.
Why are the Other Options Incorrect?
A (Audit objectives) # Define why the audit is conducted, not the schedule.
B (Audit criteria) # Define the standards and requirements to be evaluated, not the timeline.
D (Audit offer) # Refers to the initial proposal sent to the auditee, not the activity timeline.
Reference:
ISO 19011:2018, Clause 6.4.2 - Preparing the Audit Plan
ISO/IEC 17021-1:2015, Clause 9.1.3 - Audit Program
質問 # 248
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
Based on scenario 4, conducting which of the activities below is NOT the responsibility of Anne?
正解：B
解説：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires specific roles and responsibilities for audit leaders and certification bodies.
Clause References:
* ISO 19011:2018, Clause 5.5 - Conducting the Audit: Defines audit team leader responsibilities.
* ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning: Defines certification body responsibilities, including the certification agreement.
Why is the Correct Answer D?
* The certification agreement is signed between the certification body and the auditee (TD Advertising).
* Anne (audit team leader) does NOT have authority to sign the agreement-that is the responsibility of the certification body's management.
Why are the Other Options Incorrect?
* A (Establishing audit criteria and objectives) # Correct responsibility of the audit leader as per ISO 19011.
* B (Determining audit feasibility) # Audit leaders assess feasibility but do not sign agreements.
* C (Assigning responsibilities for the audit team) # This is part of the audit leader's role in planning audits.
Reference:
ISO 19011:2018, Clause 5.5 - Conducting the Audit
ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning
質問 # 249
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