Nadia Ragnvald Caspersen
Senior consultant, Medical Device QA – GBA Key2Compliance
In the medical device industry, internal audits are a vital part of maintaining compliance, ensuring product safety, and preparing for regulatory inspections. But as companies face increasing complexity, limited resources, and the pressure of unannounced audits, many are asking: Is it acceptable to outsource internal audits?
Let’s address the elephant in the room—and explore why outsourcing internal audits is not only permissible, but often a strategic advantage.
Is it okay to outsource “Internal” Audits?
Yes, it is. The term “internal audit” refers to the scope and purpose of the audit—not the employment status of the auditor. Regulatory frameworks such as ISO 13485, MDSAP, MDR and IVDR allow organizations to use external resources for internal audits, provided the auditors are qualified and the organization maintains ownership of the audit program.
Outsourcing does not mean relinquishing responsibility. The company remains accountable for the audit outcomes, corrective actions, and overall quality system performance. What outsourcing offers is a way to strengthen the audit process without compromising compliance.
Why MedTech Companies should choose external auditors
1. Impartiality and objectivity
External consultants offer objective insight free from internal bias, helping identify issues and aiding in audit preparation. Their impartiality often surpasses internal teams, especially in small organizations where overlapping roles can hinder objectivity. This independence helps uncover blind spots and systemic problems that might be overlooked due to internal dynamics.
2. Specialized regulatory expertise
MedTech regulations change quickly. External auditors track ISO standards, EU MDR/IVDR, and global rules, and bring insights from many companies. Their broad experience reveals risks, opportunities, and best practices that internal teams may miss. With dozens of audits each year, they often know which solutions are effective.
3. Resource optimization
Internal teams, especially in smaller organizations or during product development, are often overextended. Outsourcing audits helps quality and regulatory staff focus on strategic goals, while consultants handle thorough and timely audits. This approach streamlines planning, improves predictability, and reduces costs.
4. Audit readiness under pressure
Unannounced audits have become an established practice. Engaging external consultants to replicate audit scenarios, assess documentation for deficiencies, and provide guidance on effective response strategies can enhance organizational preparedness.
This forward-thinking method fosters a culture of continuous readiness and resilience. External auditors possess the expertise to detect risks that may be overlooked by internal teams, drawing upon their experience across various sectors to recognize vulnerabilities and propose practical improvements. Such a proactive risk management strategy helps mitigate potential errors and reinforces the robustness of your quality management system.
5. Fresh Thinking and Continuous Improvement
Consultants bring insights from working across the industry.
- They can benchmark your processes against peers and introduce best practices that elevate your quality management system. Sometimes, the biggest value an external consultant brings is a new way of thinking.
- They challenge assumptions, question legacy processes, and encourage teams to rethink how things are done. Their recommendations often spark meaningful change and drive continuous improvement .
Strategic, not risky
Outsourcing internal audits within the MedTech sector should be regarded as a strategic initiative rather than a shortcut. When executed appropriately, it promotes impartiality, reinforces regulatory compliance, and enables internal teams to focus on innovation and business development. Success relies on selecting expert consultants, effectively incorporating them into the supplier management framework, and upholding clear accountability for quality obligations. Failure to address or postpone internal audits not only impedes progress but may also undermine confidence in quality systems.
Thinking about outsourcing your Internal Audit?
Ask yourself these questions
Before engaging external consultants, consider the following to ensure your organization is ready—and that you’ll get the most value from the partnership:
Strategic fit
- Are we clear on the scope and goals of our internal audit?
- Do we understand which regulatory frameworks apply (ISO 13485, MDR, IVDR, MDSAP)?
- Is our audit program structured to maintain internal ownership, even with external support?
Consultant selection
- Have we identified consultants with proven MedTech experience?
- Can they simulate unannounced audits and offer sector-wide insights?
- Are they integrated into our supplier management system?
Documentation & Systems
- Is our Quality Management System (QMS) current and accessible?
- Are our CAPA records and risk files complete?
- Do we have clear documentation trails and training records?
Execution & Follow-Up
- Are we prepared to support the audit with key personnel and documentation access?
- Do we have a plan for reviewing findings and implementing corrective actions?
- Are we committed to using audit insights for continuous improvement?
If you answered ‘no’ to any of these questions, it’s not just a sign that outsourcing could help—it’s a signal to act.
Our team specializes in closing these gaps and building audit-ready systems. Explore our MedTech audit packages or reach out for a tailored consultation.