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>> ISO-9001-Lead-Auditor考試資訊 <<
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問題 #27
Among others, what does Clause 4.4 (Quality Management System and Its Processes) of ISO 9001 require from organizations?
答案：B
解題說明：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 emphasizes continual improvement as a fundamental requirement of an effective Quality Management System (QMS).
Clause Reference:
* Clause 4.4.1 (Quality Management System and Its Processes) states that organizations must:
* Determine processes needed for the QMS
* Establish criteria and methods for process effectiveness
* Ensure continual improvement of the system
Why is the Correct Answer C?
* Continual improvement is a core principle of ISO 9001.
* Organizations must regularly assess and enhance their QMS to adapt to new challenges and maintain effectiveness.
Why are the Other Options Incorrect?
* A (To change the QMS quarterly) # ISO 9001 does not mandate a specific frequency for system changes.
* B (To review the QMS annually) # QMS reviews must be conducted as needed, not strictly annually.
* D (To conduct a QMS gap analysis every two years) # Gap analysis is useful but is not a mandatory requirement under Clause 4.4.
Reference:
ISO 9001:2015, Clause 4.4 - Quality Management System and Its Processes
問題 #28
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The
organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.
You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:
You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).
You: "Good afternoon."
OD: "Good afternoon."
You: "What responsibility do you have concerning the SWIFT database?"
OD: "I maintain it. If anyone wishes to propose an update to the database, they send me an email with details of their proposal. I then either process the database update myself, or I send the request to the consultant who designed the database 20 years ago. The necessary software changes are made, and the amended software is immediately released to users." You: "Would you explain how the software amendments are controlled?" OD: "Of course. I personally update every computer myself." You: "Do you inform the database users of the changes?" OD: "No I don't. They find out for themselves by using the software, or they come to see me if they have any questions." You: "How do you ensure that the database users use the latest version?" OD: "That's easy, I update every computer myself." You: "During the audit, I noted there were several versions of SWIFT in use (you refer to your audit notes)." OD: "I know. That's because some versions work better than others, and depending on user needs and experiences, we allow users to revert to using an earlier version if they find it works better for them." Based on the scenario, which two of the following statements are true? There is evidence of nonconformity with a requirement defined in ...
答案：D,E
解題說明：
Based on the scenario provided, there is evidence of nonconformity with the requirements defined in:
C: Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.
E: Clause 7.5.3 Control of documented information: The Operations Director's approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.
These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system.
The scenario described shows a casual approach to managing critical software updates, which could affect the organization's ability to consistently meet customer and regulatory requirements.
問題 #29
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
答案：
解題說明：
A screenshot of a computer AI-generated content may be incorrect.
Comprehensive and Detailed In-Depth Explanation:
* Clause 8.3.2 e) - Internal Resource Needs:Delays due to staff shortages highlight a lack of internal resources, directly relating to this clause that requires internal resource planning for design and development.
* Clause 8.3.6 - Design and Development Changes:Ongoing formulation changes due to feedback need to be documented and reviewed. This clause requires retention of documented information on changes.
* Clause 8.3.5 - Design and Development Outputs:Customer approvals for formulations are outputs of the design process and must be retained as documented information, as per this clause.
* Clause 8.3.4 d) - Design and Development Controls:Consumer trials are a validation activity. This clause ensures such trials are conducted to confirm that resulting products meet defined requirements.
* Clause 8.3.2 e) - External Resource Needs:Shelf-life tests done by an external lab are part of the external resources needed for development and are referenced here.
問題 #30
Which of the options below is an example of minor nonconformity?
答案：A
解題說明：
Comprehensive and Detailed In-Depth Explanation:
Minor nonconformities are isolated issues that do not significantly impact the QMS but still require correction.
* Failure to close nonconformities on time (Answer A) is a procedural issue and is considered minor unless it leads to repeated failures.
Major nonconformities include:
* Lack of top management commitment (Answer B), which affects leadership and strategic direction.
* Failure to take corrective actions for recurrent issues (Answer C), which indicates systemic failure.
Reference:
ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action)
問題 #31
Which of the following is a responsibility of a guide in an audit?
答案：C
解題說明：
Comprehensive and Detailed In-Depth Explanation:
A guide is assigned by the auditee to assist the audit team by:
* Managing logistics, such as ensuring that relevant documents are available and arranging interviews.
* Assisting in the coordination of meetings and access to facilities.
* Helping the auditors navigate the organization during the audit.
However, the guide does not fill gaps in the auditor's knowledge or witness the audit for the certification body. Their primary function is logistical support, not providing interpretations or assessments.
Reference:
ISO 19011:2018, Clause 6.4.3 (Roles and Responsibilities of Guides and Observers)
問題 #32
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