Free GAQM ISO-QMS-13485 Exam Questions

Question 1

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?

A : Accept the company's approach because the software is commercially available and inputs and outputs are verified using hand calculations.

B : Consider the company's approach as verification and ask for the documented procedure for verification, objective evidence, and acceptance criteria for these hand calculations.

C : Document the lack of software validation as a finding and follow up during the next surveillance audit.

D : Issue a nonconformity because the FEA software used for design verification must be validated for its intended use.

Answer: D

Question 2

A medical device company is undergoing an ISO 13485:2016 audit. They have a well-defined process for handling nonconforming product, which includes identification, segregation, review, and disposition. The company has clearly defined responsibilities for each step of the process. However, the Lead Auditor discovers that the procedure does not specify timeframes for completing each step, particularly the review and disposition of nonconforming product. What is the MOST significant concern for the Lead Auditor?

A : The lack of timeframes could lead to delays in addressing nonconformities, potentially resulting in the use of nonconforming product.

B : The nonconforming product may lose traceability to the production lot.

C : Without timeframes, the process becomes too rigid and inflexible, inhibiting the investigation of non-conformances.

D : The lack of defined responsibilities in the process, even with the lack of time frames, allows for a clear assignment of responsibilities.

Answer: A

Question 3

A medical device company uses a commercial off-the-shelf (COTS) software program for managing its training records. The software is not directly used in the manufacturing process but is integral to personnel training and demonstrating compliance with ISO 13485:2016. The Lead Auditor reviews the company's training procedure and notes the procedure indicates the company must perform testing of software used within the QMS, and validation is not required. Which of the following would be the MOST appropriate determination for the Lead Auditor?

A : Accept the process, as long as the procedure indicates the software is not used in production, testing is sufficient.

B : Accept the procedure, so long as the organization keeps accurate training records, the process is valid.

C : Issue a minor nonconformity, because the software validation procedure has not been followed.

D : Issue a finding, because the company's documentation lacks justification for using a testing and not a validation approach for training software.

Answer: D

Question 4

A medical device company is undergoing an ISO 13485:2016 audit. The company uses a contract manufacturer for a critical component of their Class II medical device. The Lead Auditor reviews the company's **documented procedure**, or lack thereof, for controlling the outsourced process. The quality agreement with the contract manufacturer clearly defines the product specifications, quality requirements, and acceptance criteria. The medical device company performs a thorough risk assessment of any changes notified to them. 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 Lead Auditor should determine that the lack of a defined review frequency may represent a significant nonconformity, requiring corrective action.

B : The Lead Auditor should determine that the approach is acceptable because the ISO 13485:2016 standard doesn't explicitly state a specific frequency.

C : The Lead Auditor should determine that the lack of a defined review frequency could be a minor issue; however, the recent trend shows that performance data ensures sustained compliance. Sustained compliance is a good foundation, but a periodic review could improve the QMS.

D : The Lead Auditor should determine that the lack of a defined review frequency could be a potential area for improvement; however, the recent trend shows that performance data and clearly defined quality requirements and acceptance criteria ensure sustained compliance, therefore no corrective action is currently needed, but the area should be added to a preventative actions review at the next audit.

Answer: D

Question 5

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?

A : Accept the company's approach because the software is commercially available and inputs and outputs are verified using hand calculations.

B : Consider the company's approach as verification and ask for the documented procedure for verification, objective evidence, and acceptance criteria for these hand calculations.

C : Document the lack of software validation as a finding and follow up during the next surveillance audit.

D : Issue a nonconformity because the FEA software used for design verification must be validated for its intended use.

Answer: D