FDA’s Quality Systems Regulation – 21 CFR Part 820 and the International Standard for Medical Device Quality Management Systems – ISO 13485, require Internal Audits to be conducted at planned intervals to ensure a Quality System complies with established quality requirements and is a tool to determine its effectiveness and proper implementation. Additional Internal Audits are also conducted in preparation for upcoming Notified Body audits.
Internal Audits are required to be performed by individuals who do not have direct responsibility for the matters being audited, along with having the necessary competence and training to perform such audits.
Top Quality Engineering has previous Lead Auditors from European Notified Bodies and ASQ Certified Quality Auditors to conduct Internal Audits on behalf of your company, for both 21 CFR Part 820 and ISO 13485 compliance.
Top Quality Engineering conducts Internal Audits by performing the following:
- Audit Schedule: Working with you to ensure your Internal Audit schedule is met, by covering all applicable sections of the Quality Management System within the predetermined intervals.
- Audit Preparation: Gathering key information regarding the upcoming Internal Audit, such as: upcoming Notified Body audits, previous audit results, recent changes to the design of your product, complaint records, etc.
- Pre-Audit: Working closely with you in developing an Audit Agenda, specifying the scope and duration of the audit. The finalized agenda is shared with your team through a Pre-Audit call, including introducing the audit-team, specifying expectations during the audit, and answering any questions.
- Audit: Top Quality Engineering’s certified Lead Auditor conducts the Internal Audit. At your request to evaluate additional technical details or specific design changes, the our Lead Auditor may be accompanied with a Top Quality Engineering engineer. All items and evidence reviewed during the audit are documented, and daily meetings are conducted with you to discuss that day’s activities, including any findings. On the final day of the audit, a Closing Meeting is conducted with your team, communicating the results of the audit.
- Audit Report: Top Quality Engineering provides an Audit Report within 15-days of completing the audit, summarizing the documents and evidence reviewed, any findings identified and recommendations.
- Audit Follow-up: Checking with you periodically to ensure you are on-track to provide responses, and working with you to finalize a corrective action plan and setting due-dates for each finding.
- Audit Closure: The audit is closed upon the closure of all Corrective Actions. Once all of the activities have been completed, a Final Audit Report is provided.
Top Quality Engineering’s industry experience and direct knowledge of Notified Body expectations, ensure performing Internal Audits with our auditors prepare you to successfully pass any Notified Body audits.