ISO 13485 Internal Audit


Internal audits serve as a proactive mechanism to identify, rectify, and prevent potential pitfalls in your quality management processes. Beyond mere compliance, internal audits illuminate areas for improvement, fostering a culture of continuous enhancement that elevates your organization’s operations.

Why Choose Specculo for ISO 13485:2016 Audits?

Expertise in Medical Device Regulations: Our team comprises seasoned professionals with in-depth knowledge of ISO 13485:2016 and extensive experience in the medical device industry.

Tailored Audit Approach: We recognize that each organization is unique. Our audit process is customized to fit the specific needs and intricacies of your operations.

Comprehensive Assessment: Our audits cover all aspects of ISO 13485:2016, ensuring a thorough examination of your quality management system (QMS).

Risk-Based Methodology: We employ a risk-based approach, identifying potential areas of non-compliance and offering strategic recommendations for improvement.

Value-Added Insights: Beyond compliance, our audits provide actionable insights to enhance operational efficiency, reduce risks, and optimize your QMS.

Our ISO 13485:2016 Audit Process

Pre-Audit Consultation:

  • Initial discussion to understand your organization’s structure, processes, and current quality management system.
  • Preliminary assessment to identify potential areas of concern.


  • Conducting a detailed on-site or remote audit, engaging with key stakeholders and personnel.
  • Verification of compliance with ISO 13485:2016 standards and applicable regulatory requirements.

Audit Report and Findings:

  • Comprehensive report detailing audit findings, observations, and areas for improvement.
  • Clear documentation of non-conformities, if any, with guidance on corrective actions.

Corrective Action Assistance:

  • Collaborative support in developing and implementing corrective actions to address identified non-conformities.

Follow-Up Audit (Optional):

  • Subsequent audit to verify the effectiveness of corrective actions and ensure sustained compliance.

Contact Us for Your ISO 13485:2016 Audit Needs

Elevate your quality management system to meet and exceed ISO 13485:2016 requirements with our specialized Internal Audit Services.

Contact us today to discuss your requirements and schedule an initial consultation.

Simplify your compliance workflow.