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>> ISO-9001-Lead-Auditor認定試験 <<
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質問 # 51
ISO 9001 addresses changes through several requirements, two examples of which are Clause 6.3 (Planning of Changes) and Clause 8.5.6 (Control of Changes). How do the requirements of Clause 8.5.6 differ from those of Clause 6.3?
正解：A
解説：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 recognizes change management as essential for maintaining process integrity and preventing nonconformities.
Clause References:
Clause 6.3 (Planning of Changes) # Focuses on long-term changes that may impact QMS integrity.
Clause 8.5.6 (Control of Changes) # Focuses on changes occurring during production and service provision to ensure conformity.
Why is the Correct Answer A?
Clause 8.5.6 applies specifically to operational changes, ensuring that modifications in production or service processes do not compromise quality.
Organizations must document who approves changes, how they are controlled, and how they affect product
/service conformity.
Why are the Other Options Incorrect?
B (Changes during design and development) # Covered under Clause 8.3 (Design and Development), not
8.5.6.
C (Changes to legal and regulatory requirements) # Addressed under Clause 4.2 (Interested Parties' Requirements).
D (Leadership responsibilities) # Covered under Clause 5.1 (Leadership and Commitment), not 8.5.6.
Reference:
ISO 9001:2015, Clause 6.3 - Planning of Changes
ISO 9001:2015, Clause 8.5.6 - Control of Changes
質問 # 52
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:
According to scenario 1, AL-TAX determined the factors that could hinder their processes from achieving the planned results and implemented preventive actions. This means they employed:
正解：A
解説：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 emphasizes risk-based thinking, which helps organizations identify factors that could prevent achieving planned results and take preventive action. Clause 6.1 (Actions to Address Risks and Opportunities) requires organizations to determine risks and opportunities and implement actions to mitigate potential negative impacts.
In the scenario, AL-TAX identified potential risks and implemented preventive actions, aligning with risk- based thinking. ISO 9001:2015 integrates risk management throughout the standard, ensuring processes are designed to minimize uncertainties.
Reference:
ISO 9001:2015, Clause 6.1 - Actions to Address Risks and Opportunities
ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking
質問 # 53
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oll and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
Which of the following options for the best description of the nonconformity?
正解：B
解説：
Clause Reference - ISO 9001:2015 Clause 8.6 (Release of Products and Services):
ISO 9001 requires that products and services are not released to the customer until:
All planned verification activities have been completed.
Acceptance criteria have been met.
Any necessary approvals have been obtained.
In this scenario:
The sacrificial anodes for Project DK were shipped before the galvanic efficiency test results were analyzed.
This constitutes a nonconformity against Clause 8.6 because the products were released without completing the required tests.
Option Analysis:
A). A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager:Incorrect. While obtaining a concession might mitigate the situation, the nonconformity pertains to the process failure of releasing the products without completing required tests, not the absence of a concession.
B). Release of the product without acceptable test results has been accepted by the customer for Project DK:
Incorrect. The customer was not informed before the release, and there is no indication that this was accepted beforehand. Furthermore, ISO 9001 requires planned processes to be followed, regardless of later acceptance.
C). Products for Project DK have been released before product approval through the quality control process:
Correct. This description accurately reflects the nonconformity. The quality control process required test results to be analyzed and verified before release, which did not happen.
D). The untested product was not recalled until the galvanic efficiency of the anodes was verified:Incorrect.
The issue is not about recalling the product but about releasing it without completing the required tests.
Recalling the product is not mentioned in the scenario.
Why C is Correct:
The nonconformity is a clear breach of Clause 8.6, where the products were released without meeting the planned verification requirements.
This demonstrates a failure in adhering to quality control processes, which is a critical aspect of ISO 9001 compliance.
Key ISO 9001 Reference:
Clause 8.6: Products and services shall not be released to the customer until all planned activities (e.g., testing) have been satisfactorily completed, or the customer has approved the release with knowledge of deviations.
質問 # 54
You are leading a Stage 2 certification audit of a multi-site organisation and have received the audit schedule below; Head Office and Site 1 - Day 1 Site 2 (150 Km from HQ) - Days 2 and 3 During Day 1 of the audit, the dient informs you that the laboratory at Site 2 has been dosed for decontamination due to a serious outbreak of an infectious disease among workers. In Site 2, all other functions could be audited as planned.
As the audit team leader, what would you do?
Choose the best acceptable action you could take:
Ask the audit Programme Manager for direction.
Complete the audit on day 3 and report back to the certification body for a certification decision.
Continue the audit on days 2 and 3 and return later to audit the Site 2 laboratory.
Immediately cancel the audit since the audit plan cannot be completed.
Who has the responsibility for assigning work to the audit team?
正解：B
解説：
In the context of ISO 9001:2015 audits, it is the audit team leader who holds the responsibility for assigning work to the audit team. According to ISO 19011:2018 (Guidelines for auditing management systems, which complements ISO 9001:2015), the audit team leader is responsible for the organization and direction of the audit, including assigning specific roles and responsibilities to audit team members. This includes preparation of the audit plan, leading the audit, and ensuring that each team member understands their tasks.
質問 # 55
The following are stages of an audit, put them in the order they would be conducted.
正解：
解説：
Explanation:
Establishing the audit programme objectives
Determining and evaluating the audit programme risks and opportunities
Establishing the audit programme
Initiating the audit
Preparing all audit activity
Conducting the audit activities
According to ISO 19011:2018, clause 5, the audit programme is a set of one or more audits planned for a specific time frame and directed towards a specific purpose. The audit programme includes all activities necessary to plan, organize, and conduct the audits. The audit programme management involves the following steps1:
Establishing the audit programme objectives: The audit programme objectives define the intended outcomes of the audit programme, such as verifying conformity, evaluating performance, identifying improvement opportunities, etc. The audit programme objectives should be aligned with the strategic direction and policies of the organization and the needs and expectations of the interested parties.
Determining and evaluating the audit programme risks and opportunities: The audit programme risks and opportunities are the factors that can affect the achievement of the audit programme objectives, such as changes in the internal or external context, availability of resources, competence of auditors, etc. The audit programme risks and opportunities should be identified, analyzed, and evaluated to determine the appropriate actions to address them.
Establishing the audit programme: The audit programme is established by defining the audit programme scope, criteria, methods, and resources. The audit programme scope defines the extent and boundaries of the audit programme, such as the processes, functions, sites, activities, etc. that will be audited. The audit programme criteria are the set of policies, procedures, or requirements used as a reference for the audits. The audit programme methods are the techniques used to conduct the audits, such as interviews, observations, document review, sampling, etc. The audit programme resources are the human, technical, and financial resources needed to implement the audit programme.
Initiating the audit: The audit initiation is the process of formally establishing the arrangements for an individual audit within the audit programme. The audit initiation involves contacting the auditee and the audit client, confirming the audit objectives, scope, and criteria, and obtaining the necessary information and access for the audit.
Preparing all audit activity: The audit preparation is the process of developing the audit plan and the audit work documents for an individual audit. The audit plan is a document that provides the basis for agreement regarding the conduct of the audit, such as the audit schedule, the audit team, the audit methods, the audit language, the audit report, etc. The audit work documents are the records that provide evidence of the audit activities, such as the audit checklist, the audit notes, the audit findings, etc.
Conducting the audit activities: The audit activities are the processes of collecting and verifying audit evidence and evaluating it against the audit criteria to make the audit conclusions. The audit activities include the opening meeting, the communication during the audit, the roles and responsibilities of the audit team and the auditee, the audit evidence collection and verification, the audit findings generation and recording, the closing meeting, and the audit report preparation and distribution.
References: ISO 19011:2018(en), Guidelines for auditing management systems
質問 # 56
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