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질문 # 152
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:
Why is it important to discuss the audit findings with DC's top management prior to the closing meeting and the submission of the final audit report?
정답：A
설명：
Comprehensive and Detailed In-Depth Explanation:Discussing audit findings before the closing meeting ensures that:
* The audit objectives have been met (ISO 19011:2018, Clause 6.4.10).
* The auditee has an opportunity to clarify misunderstandings or provide additional evidence.
* The audit team and the auditee agree on the accuracy of findings before finalizing the report.
While encouraging corrective actions (B) is beneficial, the primary purpose of discussing findings is to ensure that the audit was conducted effectively and aligned with objectives. Identifying responsible persons (C) is not the auditor's role.
질문 # 153
Select the words that best complete the sentence:
정답：
설명：
Explanation:
According to the ISO 19011:2018 document, the audit plan should provide the basis for agreement regarding the conduct and scheduling of the audit activities. The amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives1. The scope of the audit refers to the extent and boundaries of the audit, such as the audit criteria, the audit objectives, the organizational and functional units, and the processes to be audited1. The complexity of the audit refers to the degree of difficulty or intricacy of the audit, such as the number and diversity of the auditees, the audit criteria, the audit methods, and the audit team composition2. The risk of not achieving the audit objectives refers to the possibility that the audit may fail to provide reliable and sufficient audit evidence to support the audit conclusions and report1.
Therefore, the complete sentence is:
In the context of a third-party audit, the amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives.
References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Complexity - an overview | ScienceDirect Topics
질문 # 154
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.
How do you assess the situation presented in the last paragraph of scenario 4?
정답：D
설명：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires collaboration between the auditee (TD Advertising), the certification body, and the audit leader when making changes to audit scope.
Clause References:
* ISO/IEC 17021-1:2015, Clause 9.2.3 - Conducting the Audit: Any change in audit scope must be agreed upon by all parties before proceeding.
Why is the Correct Answer C?
* TD cannot unilaterally change the scope without agreement from the certification body and audit leader.
* The certification body must ensure the scope remains relevant and that resources are allocated properly.
Why are the Other Options Incorrect?
* A (Anne cannot withdraw) # Incorrect, Anne CAN withdraw if the changes make the audit unfeasible, but she must consult with the certification body first.
* B (TD cannot change the scope) # Incorrect, scope changes are allowed but must be formally approved.
* D (Anne has full authority to reject scope changes) # Incorrect, scope changes require mutual agreement among all parties.
Reference:
ISO/IEC 17021-1:2015, Clause 9.2.3 - Conducting the Audit
질문 # 155
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.
You are interviewing the Manufacturing Manager (MM).
You: " I would like to begin by looking at the cleaning controls. "
MM: " We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside.
"
Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.
You decide to raise a non-conformity.
정답：
설명：
Explanation:
Clause: 8.5.4
Nature of Problem: Cleaning and sanitising records are not available for every batch.
Unfulfilled Requirement: " The organization shall implement production provision under controlled conditions. "
질문 # 156
One of the conflict resolution techniques is toning down. How is the conflict managed in that case?
정답：A
설명：
Comprehensive and Detailed In-Depth Explanation:
Toning down (or de-escalation) is a conflict resolution technique where:
* Common agreements are emphasized to reduce tension.
* Disagreements are addressed with a rational and constructive approach.
Option A describes compromise, and Option B describes authoritative resolution, which are different conflict resolution techniques.
Reference:
ISO 19011:2018, Clause 7.1.3 (Managing Conflict During an Audit)
질문 # 157
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