Free GAQM ISO-QMS-13485 Exam Questions
Absolute Free ISO-QMS-13485 Exam Practice for Comprehensive Preparation
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GAQM ISO-QMS-13485 Exam Questions
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Provided By: GAQM
- Exam: ISO 13485:2016 - Certified Lead Auditor
- Certification: GAQM ISO
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Total Questions: 300
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Updated On: Apr 02, 2026
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Rated: 4.9 |
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Online Users: 600
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Question 1
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During an ISO 13485:2016 audit, the Lead Auditor discovers that a medical device company uses a cloud-based software to manage its training records. The software provider states the system is fully compliant with all relevant data privacy requirements such as GDPR and HIPAA. The manufacturer performs an annual review of the software provider’s SOC 2 Type II report to verify its compliance with relevant security standards. Considering the requirements of ISO 13485:2016 regarding the control of outsourced processes, what should be your MOST appropriate next action?
Answer: B
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During an ISO 13485:2016 audit, the Lead Auditor discovers that a medical device company uses a cloud-based software to manage its training records. The software provider states the system is fully compliant with all relevant data privacy requirements such as GDPR and HIPAA. The manufacturer performs an annual review of the software provider’s SOC 2 Type II report to verify its compliance with relevant security standards. Considering the requirements of ISO 13485:2016 regarding the control of outsourced processes, what should be your MOST appropriate next action?
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Question 2
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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?
Answer: B
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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?
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Question 3
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During an ISO 13485:2016 audit, a Lead Auditor is evaluating the post-market surveillance system of a medical device company. The company primarily relies on customer complaints to identify potential issues. The Lead Auditor finds that while the company diligently collects and investigates customer complaints, the threshold for initiating a formal investigation and potential corrective action is based on a subjective assessment of the 'severity' of the complaint. There is no documented definition of 'severity' or objective criteria used to determine whether a complaint warrants a deeper investigation. What is the MOST appropriate course of action for the Lead Auditor?
Answer: C
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During an ISO 13485:2016 audit, a Lead Auditor is evaluating the post-market surveillance system of a medical device company. The company primarily relies on customer complaints to identify potential issues. The Lead Auditor finds that while the company diligently collects and investigates customer complaints, the threshold for initiating a formal investigation and potential corrective action is based on a subjective assessment of the 'severity' of the complaint. There is no documented definition of 'severity' or objective criteria used to determine whether a complaint warrants a deeper investigation. What is the MOST appropriate course of action for the Lead Auditor?
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Question 4
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A medical device company is undergoing an ISO 13485:2016 audit. The company has a documented procedure for supplier evaluation, and the company has several suppliers used to produce critical components. The company’s procedure outlines initial evaluation, periodic evaluation, and performance monitoring, however, for some suppliers that are deemed “low-risk” there is no *documented rationale* for why those suppliers were classified as such. As the Lead Auditor, what is the MOST appropriate action to take?
Answer: B
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A medical device company is undergoing an ISO 13485:2016 audit. The company has a documented procedure for supplier evaluation, and the company has several suppliers used to produce critical components. The company’s procedure outlines initial evaluation, periodic evaluation, and performance monitoring, however, for some suppliers that are deemed “low-risk” there is no *documented rationale* for why those suppliers were classified as such. As the Lead Auditor, what is the MOST appropriate action to take?
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Question 5
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During an ISO 13485:2016 audit, the Lead Auditor is reviewing the Supplier Quality Agreement between the medical device company and a contract manufacturer of a critical component. The Supplier Quality Agreement details the product specifications, quality requirements, and acceptance criteria. The Lead Auditor confirms there is evidence of recent performance data trending showing sustained compliance. However, the Lead Auditor discovers that the Supplier Quality Agreement does not define how the contract manufacturer must manage changes to its own suppliers, including sub-tier supplier changes. As a Lead Auditor, what is the MOST appropriate determination regarding the company's approach?
Answer: C
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During an ISO 13485:2016 audit, the Lead Auditor is reviewing the Supplier Quality Agreement between the medical device company and a contract manufacturer of a critical component. The Supplier Quality Agreement details the product specifications, quality requirements, and acceptance criteria. The Lead Auditor confirms there is evidence of recent performance data trending showing sustained compliance. However, the Lead Auditor discovers that the Supplier Quality Agreement does not define how the contract manufacturer must manage changes to its own suppliers, including sub-tier supplier changes. As a Lead Auditor, what is the MOST appropriate determination regarding the company's approach?