Question 1

A medical device company is undergoing an ISO 13485:2016 audit. The company uses a contract manufacturer to produce a critical component of their Class II medical device. 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. The company claims that these audits are not required if the component meets all the specifications and regulatory requirements. What should be the Lead Auditor’s MOST appropriate next action?

Options :

A : Accept the company-s justification and move on to the next area of the audit, documenting the rationale.

B : Issue a nonconformity because on-site audits are always mandatory for contract manufacturers of critical components.

C : Investigate the company-s rationale for not conducting on-site audits, considering the risk associated with the component and the effectiveness of other controls.

D : Require the company to immediately schedule an on-site audit of the contract manufacturer, regardless of the risk assessment or other controls.

Answer: C

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?

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 3

A medical device company is undergoing an ISO 13485:2016 audit. The company utilizes a cloud-based Enterprise Resource Planning (ERP) system for managing its inventory, purchasing, and production planning. The company 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, what aspect of validation and security is MOST important to investigate?

Options :

A : Confirm that the cloud provider-s ISO 27001 certification covers the specific services used by the medical device company.

B : Verify that the medical device company has a documented procedure for data backup and disaster recovery in case of a cloud outage.

C : Assess whether the medical device company has performed its own risk assessment to identify potential risks related to data integrity, data privacy and data availability when using the ERP.

D : Review the contract between the medical device company and the cloud provider to ensure it clearly defines responsibilities for data security and data privacy.

Answer: C

Question 4

A medical device company is undergoing an ISO 13485:2016 audit. The company outsources the manufacturing of a critical component to a supplier. During the audit, the Lead Auditor discovers the supplier performs 100% automated inspection of the critical dimensions of the component, and the medical device company's quality group does not perform incoming inspection. The Lead Auditor reviews the process for controlling these outsourced processes and confirms the supplier's automated inspection system used to verify critical product dimensions is validated. What additional action must be verified by the Lead Auditor to ensure compliance?

Options :

A : The Lead Auditor should verify that the medical device company’s quality control personnel are trained on the supplier’s automated inspection system.

B : The Lead Auditor should verify there is a procedure for periodic calibration of the automated inspection system, and for reviewing the results to evaluate the ongoing validity of the automated inspection data.

C : The Lead Auditor should verify the supplier performs a manual inspection, in addition to the automated inspection, to serve as a comparison between the two.

D : The Lead Auditor should verify the medical device company performs on-site audits of the supplier’s facility and evaluates the performance of the automated inspection system.

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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