ISO 13485 Training

About ISO 13485 Lead Auditor Training in the USA

In the ever-changing landscape of medical device quality management, staying ahead is crucial for professionals aiming to advance in their careers. Integrated Assessment Services (IAS) offers ISO 13485 Lead Auditor Training tailored for individuals seeking to lead successful audits in line with international standards for medical device quality management systems.

CQI-IRCA Accredited ISO 13485 Lead Auditor Training

In partnership with Empowering Assurance Systems (EAS), our CQI-IRCA Accredited ISO 13485 Lead Auditor Training provides comprehensive coverage of vital aspects, including:

  • Reviewing the ISO 13485 Standard
  • Understanding Auditor Roles and Responsibilities
  • Planning, Conducting, and Reporting Audits
  • Identifying and Reporting Nonconformities
  • Assessing Corrective Action Proposals


Course Benefits for ISO 13485 Training

Our ISO 13485 Training offers a dynamic learning experience with valuable course benefits aimed at enhancing understanding and application of medical device quality management principles. Here’s what participants can expect:

  • Engaging Activities: Participate in interactive activities to stimulate collaboration and deepen understanding of ISO 13485 concepts.
  • Practical Exercises: Hone practical skills through hands-on exercises that simulate real-world scenarios, preparing you for auditing challenges in medical device manufacturing.
  • Self-Assessment Quizzes: Periodic quizzes help assess your grasp of key concepts and identify areas for improvement.
  • Real-world Case Studies: Analyze practical challenges in medical device quality management through case studies, applying learned principles to complex situations.
  • Downloadable Resources: Access additional readings, reference documents, and supplementary content for post-training review and professional development.
  • ISO 13485 Standard Copy: Receive a copy of the ISO 13485 standard for reference during and after training, facilitating deeper comprehension of requirements.

Who Should Attend ISO 13485 Training?

This ISO 13845 training program is designed for professionals in medical device manufacturing, quality assurance, and those aspiring to become lead auditors. Whether from a medical device company, regulatory body, or research institution, our ISO 13485 training equips you with the skills for compliance and excellence.

Delivery Methods for ISO 13485 Lead Auditor Training

IAS offers ISO 13485 training through various delivery methods to accommodate diverse learning preferences and organizational needs:

  • In-House ISO 13485 Training: Customize content to address specific organizational processes and challenges, fostering team cohesion.
  • Open Classroom ISO 13485 Training: Engage with professionals from various industries in a centralized training program, benefiting from a standardized curriculum and diverse perspectives.
  • Tutor-Led Virtual ISO 13485 Training: Participate remotely with interactive learning elements, reducing travel expenses and providing flexibility.

ISO 13485 Training Course Duration: 5 days, 40 hours

Check out our ISO 13485 Training Schedule to see the upcoming course dates!

Invest in Your Professional Development with ISO 13485 Lead Auditor Training!

Enroll in our ISO 13485 Training program to invest in your professional development and contribute to your organization’s success. Stay updated with industry standards, enhance career prospects, and elevate the quality of medical device manufacturing processes. Join us on this journey toward excellence in quality management for medical devices. Take the next step in your career by attending ISO 13485 Lead Auditor Training with IAS. Contact us today or visit our frequently asked questions page!