Online Access Free ISO-9001-Lead-Auditor Practice Test

You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: " I ' d like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months? " Auditee: " We have made some strategic changes, the main one being that we no longer manufacture our own products in house. " You: " That sounds like quite a significant change. What has been the impact of that? " Auditee: " We now mainly sell other manufacturers ' products, under their brand names, and have outsourced manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging time. " This scenario presents a number of audit trails to different ISO 9001 requirements.
Which three of the following requirements would be relevant audit trails for this scenario?

• A.Measurement traceability
• B.Preservation of product
• C.Organisation roles and responsibilities
• D.Control of externally provided processes, products, and services
• E.Design and development of products and services
• F.Organisational knowledge
• G.Property belonging to customers or external providers
• H.Documented information

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:
According to Scenario 6, the audit team required DC's top management to submit corrective action plans within two weeks. Is this action acceptable?

• A.No, because the deadline for the client to present a corrective action plan is at least within 7 days
• B.No, because the decision for the deadline should have been suggested by the top management
• C.Yes, because a deadline from 10 to 60 days is a best practice for the submission of action plans

What does the application of the process approach in a QMS enable?

• A.The consideration of processes in terms of financial value
• B.The reduction of resource consumption
• C.The achievement of effective process performance
• D.The improvement of processes based on the needs and expectations of interested parties

Scenario 2:
Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company ' s production error rate increased significantly, leading to more customer complaints.
To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.
Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.
The team defined the QMS scope as:
" The scope of the QMS includes all activities related to food processing. " Leslie established a quality policy and presented it to the team for review before top management approval.
Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.
Which of the following indicates that Bell has defined its quality objectives?

• A.Assigning responsibilities for QMS roles
• B.Establishing a QMS implementation team of middle managers from various departments
• C.Implementing a QMS to increase efficiency in the manufacturing process and customer satisfaction
• D.Establishing a new strategy for handling customer complaints and requests

You are conducting a third-party audit to ISO 9001 and interviewing the Training Manager. She explains that training is more important than ever because the organisation has had to reduce the number of staff employed. Many of the remaining staff are now required to be ' multi-skilled ' . You ask to see plans for the multi-skilling training and are shown plans that look comprehensive, and include both ' on the job " training and internal and external training courses.
The records indicate that several staff required parts of their training to be repeated one month after the first training was provided. You ask why this was needed and are told that an investigation of customer complaints identified that several staff members did not complete certain tasks in the correct manner. The extra training was therefore recommended as a corrective action.
Based on this interview, which two of the tollowing audit trails would be the most appropriate to follow?
Select the two most appropriate audit trails from the following.

• A.Determine whether customers were consulted about the risks associated with the multi-skilling training.
• B.Determine whether management has assessed the impact of staff reduction on the organisation ' s ability to meet its objectives.
• C.Ask if customer complaints had ceased since the multi-skilled training finished.
• D.Review records to assess if all planned training has been completed.
• E.Ask the members of staff whether they found the training received useful.
• F.Assess whether Quality objectives are being met.