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| Section | Weight | Objectives |
|---|---|---|
| Fundamental Principles and Concepts of Quality Management System | 10–15% | - Concepts of QMS, risk, process approach - Relationship between ISO 9001 and other standards - Quality management principles |
| Closing an ISO 9001 Audit | 5–10% | - Audit report, follow-up actions - Preparing conclusions, closing meeting |
| Conducting an ISO 9001 Audit | 15–20% | - Opening meeting, on-site activities, evidence collection - Evaluating conformity, identifying nonconformities - Team meetings, audit observations |
| Quality Management System (QMS) Requirements | 25–30% | - Support, operation, performance evaluation, improvement - Scope, normative references, terms and definitions - Context of the organization, leadership, planning |
| Preparation of an ISO 9001 Audit | 10–15% | - Document review and communication - Selecting audit team, preparing plan and checklist - Initiating audit, defining objectives and scope |
| Fundamental Audit Concepts and Principles | 10–15% | - ISO 19011 and ISO/IEC 17021-1 requirements - Independence, evidence-based approach - Audit principles, types, roles and responsibilities |
| Managing an ISO 9001 Audit Program | 5–10% | - Competence and evaluation of auditors - Establishing, implementing and monitoring audit program |
>> ISO-9001-Lead-Auditor최고패스자료 <<
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질문 # 150
What is reliability in the context of service quality?
정답：A
설명：
Comprehensive and Detailed In-Depth Explanation:
Reliability in service quality refers to the consistent and dependable delivery of promised services.
ISO 9001:2015 emphasizes reliability through:
* Clause 8.2.1 (Customer Communication) - Ensuring clarity in service commitments.
* Clause 8.5.1 (Control of Service Provision) - Ensuring processes meet requirements consistently.
Other options do not fully define reliability:
* Option A (Safe services) relates to safety, not reliability.
* Option B (Readiness and goodwill) relates to responsiveness, not reliability.
* Option D (Low cost) focuses on pricing, not quality.
Reference:
ISO 9001:2015, Clause 8.2.1 - Customer Communication
ISO 9001:2015, Clause 8.5.1 - Control of Service Provision
질문 # 151
Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.
Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled.
The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.
The top management, in cooperation with Sean, assigned 10 more employees to the audit team.
Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.
Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.
Based on the scenario above, answer the following question:
Based on Scenario 7, the team worked together to draft the final audit report. Is this acceptable?
정답：B
설명：
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 6.4.9 (Audit Conclusions & Reporting):
* One consolidated audit report should be drafted based on all team members' findings.
* Each auditor does not draft separate reports (B) unless explicitly required.
Thus, A is the correct answer.
질문 # 152
Which one of the following options is the definition of the context of an organisation?
정답：B
설명：
Understanding "Context of the Organization":
The term "context of the organization" is defined in ISO 9001:2015 Clause 4.1, which states:
"The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system." The definition emphasizes identifying both internal and external issues that influence the organization's approach to developing and achieving its objectives.
Option Analysis:
Option A:Correct. This option aligns with the standard definition as it explicitly mentions the combination of internal and external issues that affect the organization's approach to achieving its objectives, which is the essence of Clause 4.1.
Option B:Incorrect. The term "comparison of internal and external issues" does not reflect the ISO 9001 requirements. The standard does not require a comparison but rather an understanding of these issues.
Option C:Incorrect. Although it mentions "complexity," the focus of ISO 9001:2015 is on identifying relevant issues rather than the complexity of those issues.
Option D:Incorrect. This option mentions "coordination" and focuses only on the positive or negative effects.
ISO 9001 requires identifying issues but does not emphasize coordination.
Clause Reference and Relevance:
ISO 9001:2015 requires organizations to understand their context because internal and external factors can influence the Quality Management System's effectiveness. Understanding this context helps in:
Addressing risks and opportunities (Clause 6.1).
Aligning the QMS with the organization's strategic direction.
Why A is Correct:
"Combination of internal and external issues" captures the essence of Clause 4.1, making it the accurate definition of the context of the organization.
질문 # 153
Match each of the following statements into the table below to show whether they apply to first-party audits, second-party audits or third-party audits:
정답：
설명：
Explanation:
Table
Statement
First-party audits
Second-party audits
Third-party audits
The audit scope is typically determined by the organisation being audited.
Yes
No
No
The outcome of the audit is typically certification to a recognised standard.
No
No
Yes
The audit scope is typically confined to service/product provision capability.
No
Yes
No
Here is a brief explanation of each statement:
The audit scope is typically determined by the organisation being audited: This statement applies to first-party audits, also known as internal audits, where the organisation audits its own processes and activities to ensure conformity and improvement1. The organisation can decide the scope of the audit based on its own needs and objectives2. This statement does not apply to second-party audits, where the customer audits the supplier, or third-party audits, where an independent body audits the organisation. In these cases, the audit scope is determined by the customer or the certification body, respectively34.
The outcome of the audit is typically certification to a recognised standard: This statement applies to third- party audits, where an independent body audits the organisation to verify that it meets the requirements of a specific standard, such as ISO 9001, and issues a certificate of conformity if the audit is successful34. This statement does not apply to first-party audits or second-party audits, where the outcome of the audit is not certification, but rather self-improvement or supplier qualification13.
The audit scope is typically confined to service/product provision capability: This statement applies to second- party audits, where the customer audits the supplier to ensure that they are meeting the requirements specified in the contract, such as service or product quality, delivery, or performance34. The audit scope is usually focused on the specific aspects of the service or product that are of interest to the customer3. This statement does not apply to first-party audits or third-party audits, where the audit scope is broader and covers the entire quality management system or the relevant clauses of the standard14.
질문 # 154
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?
정답：C,F
설명：
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.
References: 2: ISO 9001:2015 - Quality management systems - Requirements 1: ISO - Quality management principles
질문 # 155
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