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 14, 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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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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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?
Answer: A
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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?
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Question 3
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A medical device company is undergoing an ISO 13485:2016 audit. The Lead Auditor discovers that the company's process for handling customer complaints includes detailed procedures for documentation, investigation, and corrective actions. However, the Lead Auditor also discovers that the company does not have a documented procedure for protecting patient confidentiality and complying with data privacy regulations (e.g., GDPR, HIPAA) when handling customer complaints that contain patient information. What is the MOST appropriate action for the Lead Auditor to take?
Answer: C
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A medical device company is undergoing an ISO 13485:2016 audit. The Lead Auditor discovers that the company's process for handling customer complaints includes detailed procedures for documentation, investigation, and corrective actions. However, the Lead Auditor also discovers that the company does not have a documented procedure for protecting patient confidentiality and complying with data privacy regulations (e.g., GDPR, HIPAA) when handling customer complaints that contain patient information. What is the MOST appropriate action for the Lead Auditor to take?
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Question 4
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A medical device company manufactures Class IIa devices and is undergoing an ISO 13485:2016 audit. The company performs internal audits. The Lead Auditor reviews the internal audit reports and discovers that the reports consistently lack objective evidence to support the audit findings and conclusions. The Quality Manager explains that while the audit reports may not contain direct objective evidence in the report, they maintain detailed working papers with all the objective evidence, that can be requested and reviewed upon request, and which support the report's findings. What should be the Lead Auditor's MOST appropriate course of action?
Answer: C
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A medical device company manufactures Class IIa devices and is undergoing an ISO 13485:2016 audit. The company performs internal audits. The Lead Auditor reviews the internal audit reports and discovers that the reports consistently lack objective evidence to support the audit findings and conclusions. The Quality Manager explains that while the audit reports may not contain direct objective evidence in the report, they maintain detailed working papers with all the objective evidence, that can be requested and reviewed upon request, and which support the report's findings. What should be the Lead Auditor's 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 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?
Answer: A
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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?