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NEW QUESTION # 235
When should the certification body accept the audit?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Before accepting an audit, the certification body must assess the integrity of the auditee and the nature of its operations to ensure compliance feasibility.
Clause References:
* ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning:
* The certification body must review the auditee's background, reputation, and operational complexity before accepting the audit.
Why is the Correct Answer C?
* The auditee's integrity and reputation impact the credibility of certification.
* The nature of operations determines audit complexity and resource allocation.
Why are the Other Options Incorrect?
* A (Integrity and reputation only) # Correct but incomplete; nature of operations is equally important.
* B (Nature of operations only) # Integrity is also a factor, not just operations.
* D (No previous major nonconformities required) # Auditees with past major nonconformities can still be audited if corrective actions are taken.
Reference:
ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning
NEW QUESTION # 236
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.
Answer:
Explanation:
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. "
NEW QUESTION # 237
What is a horizontal audit?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
A horizontal audit examines one process across multiple departments to assess consistency.
Thus, A is the correct answer.
Reference:
ISO 19011:2018, Clause 6.2 (Audit Types & Scope)
NEW QUESTION # 238
How can an organization ensure the objectivity and impartiality of the internal audit function?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.1 (Impartiality):
* Internal auditors must not audit areas where they have direct responsibilities to avoid conflicts of interest.
* Outsourcing (C) is not required, as long as impartiality is maintained internally.
Thus, B is the correct answer.
Reference:
ISO 19011:2018, Clause 5.1 (Impartiality)
NEW QUESTION # 239
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:
According to Scenario 7, one of the auditors requested permission from Sean to audit the department in which he worked on a daily basis. Should Sean grant the auditor permission?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 19011:2018, Clause 5.1 (Impartiality) states that:
* Internal auditors must be independent of the processes they audit to ensure objectivity.
* Auditing one's own department introduces bias and is not permitted.
Thus, Sean must not allow the auditor to audit their own department.
Reference:
ISO 19011:2018, Clause 5.1 (Impartiality)
NEW QUESTION # 240
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