Free GAQM ISO-QMS-13485 Exam Questions

Question 1

A medical device company uses a contract manufacturer to produce a critical component for one of their Class III devices. During an ISO 13485:2016 audit of the medical device company (not the contract manufacturer), the Lead Auditor reviews the records pertaining to the oversight of the contract manufacturer. The records show regular communication, agreed-upon specifications, and documented inspections of incoming components. However, there is no documented evidence of periodic on-site audits of the contract manufacturer's facilities. What is the MOST appropriate conclusion for the Lead Auditor to draw?

A : The arrangement is acceptable, as long as the incoming inspections are thorough and meet acceptance criteria.

B : The absence of on-site audits is a minor nonconformity, requiring only a commitment to schedule future audits.

C : The lack of on-site audits is a major nonconformity, as it demonstrates a failure to adequately control outsourced processes.

D : The company is only required to audit the contract manufacturer if there are persistent quality issues with the incoming components.

Answer: C

Question 2

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?

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 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?

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

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?

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

Question 5

During an ISO 13485:2016 surveillance audit, a Lead Auditor reviews the management review process of a medical device company. The company conducts management reviews quarterly, as required. However, the Lead Auditor notices that the documented outputs of these reviews consistently lack specific action items with assigned responsibilities and deadlines for addressing identified issues. Which of the following is the MOST significant concern regarding this situation?

A : The frequency of the management reviews is insufficient to address the company-s needs.

B : The lack of documented action items and responsibilities undermines the effectiveness of the management review process.

C : The documented outputs should also include a review of the company-s financial performance.

D : The management review process is compliant since the company is conducting reviews as frequently as documented.

Answer: B