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NEW QUESTION # 170
A person who provides specific knowledge or expertise to the audit team during the audit is known as a
/an:
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
A technical expert is someone with specialized knowledge that helps the audit team understand specific technical aspects of the auditee's processes.
Clause References:
* ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts:
* Technical experts support the audit team with specialized knowledge but do not perform the audit themselves.
Why is the Correct Answer B?
* A technical expert is needed when auditors lack deep expertise in specific areas, such as engineering, software, or medical devices.
* They assist in interpreting complex technical requirements but do not act as auditors.
Why are the Other Options Incorrect?
* A (Observer) # Observers do not contribute expertise; they only watch the audit (e.g., trainees).
* C (Guide) # Guides help with logistics but do not provide technical expertise.
NEW QUESTION # 171
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization 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.
Answer:
Explanation:
NEW QUESTION # 172
Who maintains ownership of the audit report?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting):
* The certification body retains ownership of the audit report as it is responsible for the certification decision.
* The auditee may receive a copy, but it does not own the report.
* The audit team leader compiles the report but does not own it.
Thus, C is the correct answer.
Reference:
ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting)
NEW QUESTION # 173
According to the guidance provided in ISO 19011, a second-party opening meeting should cover many elements.
From the following options, select the four items that should not be included in the opening meeting.
Answer: C,E,F,G
NEW QUESTION # 174
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:
Sean requested unrestricted access to the employees, executives, and documented information of POLKA. Is this in accordance with audit best practices?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.3.2 (Access to Information), internal auditors must have unrestricted access to:
Employees and executives for interviews and observations.
Documented information to verify compliance with ISO 9001.
This ensures a transparent and objective audit process. The CEO's approval (B) is not required unless restricted information is involved.
Reference:
ISO 19011:2018, Clause 5.3.2 (Access to Information)
NEW QUESTION # 175
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