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Exam ISO-9001-Lead-Auditor Topic 4 Question 179 Discussion
Actual exam question for PECB's ISO-9001-Lead-Auditor exam
Question #: 179
Topic #: 4
Question #: 179
Topic #: 4
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 and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.
You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:
You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).
You: " Good afternoon. "
OD: " Good afternoon. "
You: " What responsibility do you have concerning the SWIFT database? " OD: " I maintain it. If anyone wishes to propose an update to the database, they send me an email with details of their proposal. I then either process the database update myself, or I send the request to the consultant who designed the database 20 years ago. The necessary software changes are made, and the amended software is immediately released to users. " You: " Would you explain how the software amendments are controlled? " OD: " Of course. I personally update every computer myself. " You: " Do you inform the database users of the changes? " OD: " No I don ' t. They find out for themselves by using the software, or they come to see me if they have any questions. " You: " How do you ensure that the database users use the latest version? " OD: " That ' s easy, I update every computer myself. " You: " During the audit, I noted there were several versions of SWIFT in use (you refer to your audit notes). " OD: " I know. That ' s because some versions work better than others, and depending on user needs and experiences, we allow users to revert to using an earlier version if they find it works better for them. " Based on the scenario, which two of the following statements are true? There is evidence of nonconformity with a requirement defined in ...
The
organisation 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. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.
You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:
You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).
You: " Good afternoon. "
OD: " Good afternoon. "
You: " What responsibility do you have concerning the SWIFT database? " OD: " I maintain it. If anyone wishes to propose an update to the database, they send me an email with details of their proposal. I then either process the database update myself, or I send the request to the consultant who designed the database 20 years ago. The necessary software changes are made, and the amended software is immediately released to users. " You: " Would you explain how the software amendments are controlled? " OD: " Of course. I personally update every computer myself. " You: " Do you inform the database users of the changes? " OD: " No I don ' t. They find out for themselves by using the software, or they come to see me if they have any questions. " You: " How do you ensure that the database users use the latest version? " OD: " That ' s easy, I update every computer myself. " You: " During the audit, I noted there were several versions of SWIFT in use (you refer to your audit notes). " OD: " I know. That ' s because some versions work better than others, and depending on user needs and experiences, we allow users to revert to using an earlier version if they find it works better for them. " Based on the scenario, which two of the following statements are true? There is evidence of nonconformity with a requirement defined in ...
Suggested Answer: C,E Vote an answer
Based on the scenario provided, there is evidence of nonconformity with the requirements defined in:
C). Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.
E). Clause 7.5.3 Control of documented information: The Operations Director's approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.
These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system.
The scenario described shows a casual approach to managing critical software updates, which could affect the organization's ability to consistently meet customer and regulatory requirements.
C). Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.
E). Clause 7.5.3 Control of documented information: The Operations Director's approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.
These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system.
The scenario described shows a casual approach to managing critical software updates, which could affect the organization's ability to consistently meet customer and regulatory requirements.
by Nelson at Aug 22, 2026, 08:25 AM
Here are all the actual test exam dumps for IT exams. Most people prepare for the actual exams with our test dumps to pass their exams. So it's critical to choose and actual test pdf to succeed.
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