Medical Device Auditing

ISO 13485 Audit Expertise

auditing iconAudits provide necessary checks and balances on quality systems, confirm that suppliers meet expectations, and enable manufacturers to maintain their ISO 13485 certification.

Our team of ISO 13485 audit experts can help you conduct supplier and internal audits as well as prepare your team for a notified body audit.

ISO 13485 audit meeting

Internal Audits

Internal audits conducted by an unbiased second-party ensures an effective quality management system is not only established but effectively maintained by a medical device manufacturer. We assign one of our Lead or ASQ Certified Quality Auditors with expertise that best matches your therapeutic area, device type, and organization’s needs to perform your internal audit.

Our auditors are well equipped to conduct the audit in accordance with your company’s established procedures and will issue a report using either your desired format or QA Consulting’s proven report template that has been thoughtfully developed to meet 21 CFR 820, ISO 13485, and MDSAP requirements and exceed industry standards.

Supplier Audits

Outsourcing is prevalent throughout the medical device industry. Ensuring that your key suppliers are providing you with suitable components and services to support your medical device is imperative. Our team of qualified auditors know how to best approach supplier audits, focusing on the areas that are critical to your device’s quality and ensuring that your supplier matches your organization’s commitment to integrity of quality. We have experience assessing suppliers’ compliance with the niche industry standards that may apply to their component/service but don’t necessarily apply to your company’s operations such as ISO 17025, ISO 11135, ISO 14644 or 21 CFR Part 58..

Whether you need an individual supplier audit or help managing a portfolio of dozens of suppliers from initial outreach/scheduling through nonconformance remediation, our team has the experience to help. In 2019 alone, we successfully conducted more than 80 onsite or virtual supplier audits for our clients.

Product and Process Audits

Sometimes a more focused “for-cause” audit that drills down on an individual medical device or manufacturing process might be necessary to investigate recurring issues, identify sources for efficiency improvement, or perform a general check-in on the overall quality of a particular product or process. Our approach to these audits balances a “follow-the-path” method for logistical/efficiency checks while also being mindful of a comparison back to the applicable regulations and standards to ensure that regulatory compliance and product/process integrity is maintained.

Rather than simply assigning the next available quality auditor for your product or process audit, we pride ourselves in partnering you with a member of our team whose industry and consulting experience best aligns with the device, regulations and processes to be examined.

Mock Audits

Preparation is key and savvy executives and managers seek a trial-run or mock audit to get ready for a more official audit. Being a new company that has yet to be audited, operating under new or revised regulations/standards, having an upcoming certification audit, or expecting an FDA or other regulatory inspections are some of the reasons auditees look to perform mock audits. Our auditors bring their experiences in these types of audits to role-play or simulate that experience for you and your team. We will work with you to plan a mock audit which may be announced or unannounced to your staff and will focus on your particular areas of concern.

Mock audits are a tool not only for determining up front the potential nonconformities that could be identified in an audit, but also to receive feedback and coaching from our auditor on how the mock audit was handled by your team and how it could be improved prior to the real-world scenario.


Learn More


Learn More


Learn More

Talk to an expert

Contact Us