100% Free GAQM ISO-QMS-13485 Practice Test Questions

Question 1

A medical device company is undergoing an ISO 13485:2016 audit. The company utilizes a contract manufacturer for a critical component of their Class II medical device. The Lead Auditor reviews the company's process for controlling the outsourced process. The quality agreement with the contract manufacturer clearly defines the product specifications, quality requirements, and acceptance criteria. There is evidence of recent performance data trending showing sustained compliance, however, the quality agreement does not define how frequently the quality agreement itself is reviewed or updated. As a Lead Auditor, what is the MOST appropriate determination regarding the company's approach?

A : The lack of a defined review frequency for the quality agreement is a critical nonconformity and must be cited, as all agreements need to be reviewed and updated annually.

B : The Lead Auditor should verify that there is a process in place to address changes to the contract manufacturer-s processes or requirements that would necessitate an update to the quality agreement.

C : The Lead Auditor should only be concerned with compliance to specifications, quality requirements, and acceptance criteria. The Lead Auditor should not focus on the frequency of reviewing agreements as that is an administrative burden.

D : As long as the medical device manufacturer has evidence to show compliance to specification, there is no need to verify that agreements have a process in place to address changes to the contract manufacturer’s processes or requirements that would necessitate an update to the quality agreement.

Answer: B

Question 2

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?

A : Accept the company's approach, as the immediate resolution demonstrates the corrective action was effective.

B : Review the rationale for the short-term effectiveness checks and evaluate whether it aligns with the nature of the identified problems and the implemented corrective actions.

C : Document a minor nonconformity, since some effectiveness checks are performed, and allow the company to fix the issue after the audit.

D : Issue a major nonconformity, as the procedure is well-documented and effectiveness checks are being performed, which indicates a systematic issue.

Answer: B

Question 3

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?

A : Accept the manufacturer-s reasoning, as ISO 27001 certification of the cloud provider sufficiently addresses data security and integrity concerns.

B : Inform the manufacturer that ISO 27001 certification is irrelevant to the validation requirements of ISO 13485:2016, and full validation is always necessary.

C : Acknowledge the ISO 27001 certification but require the manufacturer to demonstrate through documented evidence that the software platform is suitable for managing QMS data and meets applicable regulatory requirements, focusing on data integrity, security, and accessibility.

D : Suggest that the manufacturer only needs to validate the interfaces between the cloud-based system and any local systems, as the cloud provider is responsible for validating the core functionality.

Answer: C

Question 4

A medical device company has implemented a system for monitoring and measuring key processes within its Quality Management System (QMS). The system generates various performance metrics, which are regularly reviewed by management. However, the Lead Auditor discovers that the company has not established specific, measurable, achievable, relevant, and time-bound (SMART) objectives for these metrics. As a Lead Auditor, what is the MOST significant concern?

A : The lack of SMART objectives indicates a potential lack of commitment to continual improvement within the QMS.

B : Without SMART objectives, it will be difficult to determine whether the monitoring and measurement system is effective in achieving its intended purpose.

C : The absence of SMART objectives will likely lead to inconsistencies in data collection and analysis across different departments.

D : The company is not fully utilizing the available data to identify areas for improvement and optimize process performance.

Answer: B

Question 5

A medical device company is undergoing an ISO 13485:2016 audit. The 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, however, the medical device company has not performed any risk assessment to identify potential risks associated with data privacy.

A : Accept the company-s reliance on the software provider-s statement and the SOC 2 report as sufficient evidence of compliance.

B : Require the company to perform a data protection impact assessment (DPIA) or risk assessment to identify and mitigate potential data privacy risks.

C : Recommend that the company obtain a written guarantee from the software provider ensuring compliance with all applicable data privacy regulations.

D : Issue a nonconformity for the lack of a documented data privacy procedure, regardless of the risk assessment.

Answer: B

100% Free ISO-QMS-13485 Practice Exam Questions and Answers