Conducting and Preparing for FDA and ISO 13485 Audits

Auditing is an essential part of every organization’s overall quality management system. Not only does it help you stay in compliance with the appropriate regulations and standards, both of which require routine audits, but it can help you identify opportunities for improvement. QA audits can reveal underperforming techniques, knowledge gaps, material issues, and more.

Kapstone can help you create a documented process and fixed schedule for internal audits. Our framework goes beyond gap analysis to assess your procedures, how you’re utilizing them, and whether or not your team understands the system. With our guidance, you can feel confident about your systems and fully prepared for regulatory audits.

Conducting Internal Audits

Medical device companies will typically conduct an internal audit on a once or twice annual basis, at minimum. This is an appropriate opportunity for the management team to work with the QA (and RA) team to assess the health of the company according to its quality objectives and stated standards. As regulations can change, it’s important that even when a company feels complacent, management is keeping focused on continual adherence and improvement.

Kapstone can provide an auditor to conduct an audit appropriate for the scope of your company. We typically will visit on-site with your team but can also conduct the audit remotely. We can follow your procedure for auditing or provide you with a checklist and findings report from Kapstone’s templates.

Preparing for FDA Inspections

FDA inspections are a serious and impactful part of doing business as a medical device company. The FDA has license to inspect any company involved in the “manufacturing” of medical devices for compliance. This includes proof of regular internal auditing, annual management reviews, functional complaint reporting, and more.

Kapstone can help you prepare for these inspections—even when they come by surprise. We leverage our experience to build and maintain systems that are ready to be inspected at any point. We don’t just “check the boxes” for compliance; like you, we prioritize quality.

Preparing for ISO 13485 Audits

We can help your organization prepare for ISO 13485 audits, which differ from FDA inspections in a few key ways. Unlike the FDA, which can impose legal consequences on companies that are not compliant, ISO auditors award certifications to companies that meet their quality standards. In our experience, we’ve seen ISO auditors dig deeper into your protocols and systems to ensure that every component is working properly.

Kapstone is proudly ISO 13485 certified, meaning that our QMS passes the rigorous international standard set forth by ISO. We are happy to lend our expertise to your organization.

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