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: Sep 22, 2026
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Online Users: 600
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Question 1
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A medical device manufacturer is undergoing an ISO 13485:2016 audit. They utilize a contract manufacturer to produce a critical component for one of their Class III devices. During the audit, the Lead Auditor reviews the medical device company's records pertaining to the oversight of the contract manufacturer. While the records show regular communication, agreed-upon specifications, and documented inspections of incoming components, the Lead Auditor discovers that the medical device company is performing no periodic on-site audits of the contract manufacturer's facility. What type of conclusion should the Lead Auditor draw?
Answer: C
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A medical device manufacturer is undergoing an ISO 13485:2016 audit. They utilize a contract manufacturer to produce a critical component for one of their Class III devices. During the audit, the Lead Auditor reviews the medical device company's records pertaining to the oversight of the contract manufacturer. While the records show regular communication, agreed-upon specifications, and documented inspections of incoming components, the Lead Auditor discovers that the medical device company is performing no periodic on-site audits of the contract manufacturer's facility. What type of conclusion should the Lead Auditor draw?
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Question 2
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A medical device manufacturer is using a cloud-based software platform for managing its quality management system (QMS) documentation, including procedures, work instructions, and records. The manufacturer claims that since the cloud provider is ISO 27001 certified, they do not need to perform their own validation of the software's suitability for managing their QMS data. As a Lead Auditor, how should you respond?
Answer: C
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A medical device manufacturer is using a cloud-based software platform for managing its quality management system (QMS) documentation, including procedures, work instructions, and records. The manufacturer claims that since the cloud provider is ISO 27001 certified, they do not need to perform their own validation of the software's suitability for managing their QMS data. As a Lead Auditor, how should you respond?
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Question 3
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During an ISO 13485:2016 audit, the Lead Auditor is reviewing the effectiveness of the company's Corrective and Preventive Action (CAPA) system. The auditor notes that the company's CAPA procedure includes a requirement for effectiveness checks to verify that implemented corrective actions have been effective in addressing the root cause of the problem and preventing recurrence. However, the Lead Auditor discovers that the effectiveness checks consistently focus on confirming the immediate resolution of the problem, with limited consideration of the long-term sustainability and robustness of the implemented corrective action, or its potential unintended consequences. What is the MOST appropriate next step for the Lead Auditor to take?
Answer: B
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During an ISO 13485:2016 audit, the Lead Auditor is reviewing the effectiveness of the company's Corrective and Preventive Action (CAPA) system. The auditor notes that the company's CAPA procedure includes a requirement for effectiveness checks to verify that implemented corrective actions have been effective in addressing the root cause of the problem and preventing recurrence. However, the Lead Auditor discovers that the effectiveness checks consistently focus on confirming the immediate resolution of the problem, with limited consideration of the long-term sustainability and robustness of the implemented corrective action, or its potential unintended consequences. What is the MOST appropriate next step for the Lead Auditor to take?
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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 design verification. As the Lead Auditor, you discover that the company has not formally validated the computer software used to perform finite element analysis (FEA) during design verification, where the FEA is part of the QMS and Clause 4.1.6 applies. The output of the FEA software is used as objective evidence that the design meets safety and performance requirements. The FEA software is commercial off-the-shelf software and not developed by the medical device manufacturer. The company states that they check the FEA software inputs and outputs against hand calculations as a form of verification. As the Lead Auditor, what is your MOST appropriate course of action?
Answer: D
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A medical device company is undergoing an ISO 13485:2016 audit. The company has a documented procedure for design verification. As the Lead Auditor, you discover that the company has not formally validated the computer software used to perform finite element analysis (FEA) during design verification, where the FEA is part of the QMS and Clause 4.1.6 applies. The output of the FEA software is used as objective evidence that the design meets safety and performance requirements. The FEA software is commercial off-the-shelf software and not developed by the medical device manufacturer. The company states that they check the FEA software inputs and outputs against hand calculations as a form of verification. As the Lead Auditor, what is your MOST appropriate course of action?
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Question 5
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A medical device company is undergoing an ISO 13485:2016 audit. The company has a well-defined process for handling customer complaints, including documentation, investigation, and corrective actions. The Lead Auditor discovers that the company is using an older version of a Customer Relationship Management (CRM) software to manage customer complaint records, where the software vendor no longer provides any security patches or updates. The company has a documented procedure for backing up the data stored within the CRM. What is the MOST appropriate response for the Lead Auditor?
Answer: C
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A medical device company is undergoing an ISO 13485:2016 audit. The company has a well-defined process for handling customer complaints, including documentation, investigation, and corrective actions. The Lead Auditor discovers that the company is using an older version of a Customer Relationship Management (CRM) software to manage customer complaint records, where the software vendor no longer provides any security patches or updates. The company has a documented procedure for backing up the data stored within the CRM. What is the MOST appropriate response for the Lead Auditor?