Question 1

A medical device company is undergoing an ISO 13485:2016 audit. The company utilizes a software program to manage supplier qualifications and track supplier performance. The software is commercially available and is not specifically designed for medical device manufacturing. The company claims that the software is 'intuitive' and easy to use, and that all personnel received verbal instructions on its use. The Lead Auditor discovers that there are no documented training records or competency assessments for personnel using the software. What is the MOST appropriate action for the Lead Auditor?

Options :

A : Accept the company-s explanation, as the software is 'intuitive' and easy to use.

B : Issue a minor nonconformity requiring the company to document the verbal instructions.

C : Issue a major nonconformity requiring the company to implement a documented training program and competency assessments for personnel using the software.

D : Recommend the company switch to a software program specifically designed for medical device supplier management.

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 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 4

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?

Options :

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 5

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?

Options :

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

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