Question 1

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?

Options :

A : This is acceptable if the medical device company has a robust system for monitoring the quality of incoming components and the contract manufacturer maintains ISO 13485 certification.

B : This is a minor nonconformity because the medical device company is still communicating with the contract manufacturer.

C : This is a major nonconformity because the medical device company has not ensured compliance with ISO 13485:2016 requirements.

D : This is acceptable if the medical device company has a documented rationale explaining why on-site audits are not necessary.

Answer: C

Question 2

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?

Options :

A : The Lead Auditor should verify the integrity of the software is maintained and secured against unauthorized changes.

B : The Lead Auditor should verify that the software generates aesthetically pleasing and easily understandable reports.

C : The Lead Auditor should verify the software developers hold an ISO 13485:2016 Lead Auditor certification.

D : The Lead Auditor should verify the software is also used for other business functions such as marketing.

Answer: A

Question 3

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?

Options :

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 4

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?

Options :

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 5

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?

Options :

A : Accept the company-s classification of the suppliers as "low-risk" without further investigation, as long as the products they supply consistently meet specifications.

B : Issue a minor nonconformity, and require that the company either conduct a risk assessment or generate a documented rationale for why the suppliers were classified as low risk.

C : Accept the classification if these suppliers provide components to Class I devices.

D : Issue a major nonconformity, since all supplier evaluations must be documented with a detailed, objective risk assessment.

Answer: B

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