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| Section | Weight | Objectives |
|---|---|---|
| Closing an ISO 9001 Audit | 5–10% | - Audit report, follow-up actions - Preparing conclusions, closing meeting |
| Conducting an ISO 9001 Audit | 15–20% | - Evaluating conformity, identifying nonconformities - Opening meeting, on-site activities, evidence collection - Team meetings, audit observations |
| Fundamental Audit Concepts and Principles | 10–15% | - Independence, evidence-based approach - Audit principles, types, roles and responsibilities - ISO 19011 and ISO/IEC 17021-1 requirements |
| Quality Management System (QMS) Requirements | 25–30% | - Scope, normative references, terms and definitions - Support, operation, performance evaluation, improvement - Context of the organization, leadership, planning |
| Preparation of an ISO 9001 Audit | 10–15% | - Document review and communication - Initiating audit, defining objectives and scope - Selecting audit team, preparing plan and checklist |
| Fundamental Principles and Concepts of Quality Management System | 10–15% | - Relationship between ISO 9001 and other standards - Quality management principles - Concepts of QMS, risk, process approach |
| Managing an ISO 9001 Audit Program | 5–10% | - Establishing, implementing and monitoring audit program - Competence and evaluation of auditors |
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NEW QUESTION # 131
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
Scenario 6 indicates that although the top management did not agree with the audit findings, the audit team began preparing the audit report. Is this acceptable?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 6.4.11 (Closing Meeting):
* The audit team must proceed with the audit report, even if the auditee disagrees with findings.
* Disagreements do not invalidate audit results.
* The auditee has the right to file a complaint or appeal, but this is handled after the audit report is submitted.
Thus, the audit team acted correctly by proceeding with the audit report despite top management's disagreement.
Reference:
ISO 19011:2018, Clause 6.4.11 (Closing Meeting & Handling Disputes)
NEW QUESTION # 132
ISO 9001 requires that the organisation shall continually improve the quality management system.
Select the two options for how this can best be achieved.
Answer: A,C
Explanation:
Comprehensive and Detailed Explanation From Exact Extract:
Correct Option B - "Communicate a policy commitment to continual improvement" This aligns directly with Clause 5.2.1(d) of ISO 9001:2015, which states that the quality policy shall include a commitment to continual improvement of the QMS:
"Top management shall establish, implement and maintain a quality policy that... includes a commitment to continual improvement of the quality management system." A clearly communicated policy sets expectations and a strategic direction that cascades throughout the organization, promoting a culture that values ongoing enhancement.
Correct Option F - "Use the management review process to identify improvements" This is based on Clause 9.3.3 of ISO 9001:2015, which specifies that outputs of management reviews must include decisions and actions related to:
"a) opportunities for improvement;
b) any need for changes to the quality management system;
c) resource needs."
The management review process is a structured mechanism to analyze data, monitor performance, assess risks and opportunities, and drive continual improvement initiatives.
Why the Other Options Are Incorrect:
A (Appoint external consultants to train staff): While training may help improve competence, ISO 9001 emphasizes internal process evaluation and strategic improvement. This option is not directly aligned with the systematic improvement of the QMS.
C (Require higher standards): Higher standards alone don't ensure continual improvement unless supported by a structured QMS approach involving evaluation, planning, and measurement.
D (Require fewer mistakes): Unrealistic or unqualified demands like "make fewer mistakes" don't support structured process-based improvement and may conflict with ISO's emphasis on risk-based thinking and root cause analysis.
E (Send Chief Executive on a course): While leadership involvement is vital (Clause 5), this action by itself does not constitute a continual improvement mechanism for the QMS.
References:
ISO 9001:2015 Clause 5.2.1(d) - Establishing the Quality Policy
ISO 9001:2015 Clause 9.3.3 - Management Review Outputs
ISO 9001:2015 Clause 10.3 - Continual Improvement
NEW QUESTION # 133
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:
Answer:
Explanation:
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.
NEW QUESTION # 134
You work for organisation A. You are asked to lead an internal audit of A's quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.
Which of the following actions would you consider appropriate when planning the internal audit of A's quality management system?
Answer: A
Explanation:
In this scenario, the organisation A has two plants, A1 and A2, but the production in A2 was discontinued due to the COVID-19 pandemic and the plant was rented to another organisation B. There are no A employees working in A2, and the organisation A expects to reassume production in A2 as soon as possible. Therefore, the appropriate action to plan the internal audit of A's quality management system is:
*Interview the A2 plant manager, now working in Plant A1: This action involves interviewing the person who is responsible for the management and operation of the plant A2, and who is currently working in the plant A1. The interview should aim to gather information about the status and condition of the plant A2, the impact of the COVID-19 pandemic on the quality management system, the arrangements and agreements with the organisation B, and the plans and actions to resume production in the plant A25 . This action is relevant and necessary for the internal audit, as it can help to assess the readiness and effectiveness of the quality management system, and to identify any gaps or nonconformities that need to be addressed.
The other options are not appropriate actions to plan the internal audit of A's quality management system, according to the web search results from my internal tool. They are:
*Visit Plant A2 to interview personnel of company B: This action involves visiting the plant A2 and interviewing the personnel of the organisation B, who are not related to the organisation A and who are not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
*Visit Plant A2 to interview B's quality manager: This action involves visiting the plant A2 and interviewing the quality manager of the organisation B, who is not related to the organisation A and who is not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
*Visit Plant A2 to interview A's security personnel and B's maintenance department: This action involves visiting the plant A2 and interviewing the security personnel of the organisation A and the maintenance department of the organisation B, who are not directly involved in the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
Therefore, the correct answer is D.
References: 1: Quality audit - Wikipedia 2: A step-by-step guide to internal quality audits 3: ISO 9001:2015 - Quality management systems - Requirements 4: ISO 19011:2018 - Guidelines for auditing management systems 5: Audit Process | Flowchart | Summary - Accountinguide : What are the Stages of the Auditing Process & Why it is Important ...
NEW QUESTION # 135
A Health Trust has contracted with Servitup, a catering services organisation that has been certified to ISO
9001 for one year. It provides services to
10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals, and loading heated trolleys for Ward Service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager (DCM).
DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff." You: "I see. It really shouldn't affect the QMS so the audit can progress as normal." DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is." You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?" DCM: "Give me a minute. I need to look at the Quality Policy on the noticeboard in his office." As the audit progresses, it is clear that the DCM has a very low knowledge of the QMS. He continually has to look up the answers to your questions or ask staff members about their processes. You decide to raise a nonconformity.
Select one of the following options that best describes the nonconformity.
Answer: A
NEW QUESTION # 136
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