Free GAQM ISO-QMS-13485 Exam Questions

Question 1

During an ISO 13485:2016 surveillance audit, a Lead Auditor reviews the management review process of a medical device company. The company conducts management reviews quarterly, as required. However, the Lead Auditor notices that the documented outputs of these reviews consistently lack specific action items with assigned responsibilities and deadlines for addressing identified issues. Which of the following is the MOST significant concern regarding this situation?

A : The frequency of the management reviews is insufficient to address the company-s needs.

B : The lack of documented action items and responsibilities undermines the effectiveness of the management review process.

C : The documented outputs should also include a review of the company-s financial performance.

D : The management review process is compliant since the company is conducting reviews as frequently as documented.

Answer: B

Question 2

A medical device company is undergoing an ISO 13485:2016 audit. The Lead Auditor observes that the company uses a software program to manage customer complaints and track corrective actions. The software program allows users to easily generate reports and analyze trends in customer feedback. The manufacturer has performed initial validation and has documented a process for regular preventative maintenance of the software. What additional action must be verified by the Lead Auditor to ensure compliance?

A : The Lead Auditor should verify the integrity of the software is maintained and secured against unauthorized changes.

B : The Lead Auditor should verify that the software generates aesthetically pleasing and easily understandable reports.

C : The Lead Auditor should verify the software developers hold an ISO 13485:2016 Lead Auditor certification.

D : The Lead Auditor should verify the software is also used for other business functions such as marketing.

Answer: A

Question 3

During an ISO 13485:2016 surveillance audit, a Lead Auditor reviews the management review process of a medical device company. The company conducts management reviews quarterly, as required. However, the Lead Auditor notices that the documented outputs of these reviews consistently lack specific action items with assigned responsibilities and deadlines for addressing identified issues. Which of the following is the MOST significant concern regarding this situation?

A : The frequency of the management reviews is insufficient to address the company's needs.

B : The lack of documented action items and responsibilities undermines the effectiveness of the management review process.

C : The documented outputs should also include a review of the company's financial performance.

D : The management review process is compliant since the company is conducting reviews as frequently as documented.

Answer: B

Question 4

During an ISO 13485:2016 audit of a medical device company, the Lead Auditor discovers that the company has implemented a comprehensive training program for its employees. The program covers various aspects of the QMS, including document control, CAPA, and risk management. However, the effectiveness of the training is solely measured through post-training quizzes, with no documented evidence of how the learned knowledge and skills are applied in the employees' actual job performance. As a Lead Auditor, what is your PRIMARY concern?

A : The lack of a defined process for verifying the effectiveness of the training could lead to employees not applying the learned knowledge and skills in their work, potentially impacting product quality and safety.

B : The exclusive reliance on post-training quizzes is sufficient to demonstrate training effectiveness, as long as the quiz questions are comprehensive and cover all relevant aspects of the QMS.

C : The absence of documented evidence of training effectiveness is not a significant concern, as long as the training program is well-structured and covers all required topics.

D : The company should focus on improving the content of the post-training quizzes to better assess the employees' understanding of the QMS requirements.

Answer: A

Question 5

During an ISO 13485:2016 audit of a medical device company, the Lead Auditor discovers that the company has implemented a comprehensive training program for its employees. The program covers various aspects of the QMS, including document control, CAPA, and risk management. However, the effectiveness of the training is solely measured through post-training quizzes, with no documented evidence of how the learned knowledge and skills are applied in the employees' actual job performance. As a Lead Auditor, what is your PRIMARY concern?

A : The lack of a defined process for verifying the effectiveness of the training could lead to employees not applying the learned knowledge and skills in their work, potentially impacting product quality and safety.

B : The exclusive reliance on post-training quizzes is sufficient to demonstrate training effectiveness, as long as the quiz questions are comprehensive and cover all relevant aspects of the QMS.

C : The absence of documented evidence of training effectiveness is not a significant concern, as long as the training program is well-structured and covers all required topics.

D : The company should focus on improving the content of the post-training quizzes to better assess the employees' understanding of the QMS requirements.

Answer: A