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 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 3

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 4

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?

Options :

A : Accept the Quality Manager-s explanation and close the audit finding, as long as working papers are available upon request.

B : Issue a minor nonconformity, since the objective evidence is available even if not included in the report.

C : Issue a major nonconformity, as the lack of objective evidence in the audit report hinders the effectiveness of the audit process and the ability to demonstrate QMS compliance.

D : Recommend the company outsource their internal audit program to ensure impartiality and objectivity.

Answer: C

Question 5

A medical device company is undergoing an ISO 13485:2016 audit. The company manufactures a Class IIa medical device. The Lead Auditor discovers that the company's internal audit program is conducted by personnel who have received training on auditing techniques but lack specific technical expertise related to the processes they are auditing (e.g., design, manufacturing, sterilization). The company claims that the auditors' general understanding of the QMS is sufficient. What is the MOST appropriate action for the Lead Auditor to take?

Options :

A : Accept the company-s rationale, as the personnel are trained auditors and possess a general understanding of the QMS requirements.

B : Issue a minor nonconformity, requiring the company to enhance the general QMS knowledge of the auditors.

C : Issue a major nonconformity, requiring the company to revise its internal audit program to ensure auditors possess the necessary technical expertise or involve technical experts in the audits.

D : Recommend that the company outsource all internal audits to a qualified third-party auditing firm.

Answer: C