ISO 13485 Training

About ISO 13485 Lead Auditor Training

In the competitive and ever-changing medical device industry, it is crucial for professionals to stay up to date with international standards. ISO 13485, which sets the requirements for a comprehensive quality management system, plays a vital role in ensuring safety and efficacy. Integrated Assessment Services (IAS) offers ISO 13485 Training designed to equip professionals with the necessary skills to understand, implement, and audit medical device quality management systems effectively.

Comprehensive ISO 13485 Lead Auditor Training

For professionals aiming to become leaders in the medical device quality management field, IAS provides CQI-IRCA Certified ISO 13485 Lead Auditor Training. This advanced program, in collaboration with Empowering Assurance Systems (EAS), is designed to help individuals lead ISO 13485 audits with confidence and competence. The training covers essential topics that include:

  • In-depth Review of ISO 13485 Standard: Understand the clauses, requirements, and applications of the ISO 13485 standard in detail.
  • Roles and Responsibilities of an Auditor: Learn the key duties of a lead auditor and how to navigate the audit process successfully.
  • Audit Planning and Execution: Gain insights into how to plan, conduct, and report audits according to ISO 13485 guidelines.
  • Identifying and Reporting Nonconformities: Develop the skills to recognize nonconformities during audits and report them effectively.
  • Evaluating Corrective Actions: Understand how to assess corrective actions to maintain compliance and continuous improvement.

Key Learning Deliverables from ISO 13485 Training

IAS focuses on providing an engaging and thorough learning experience that prepares participants for real-world auditing challenges. Our ISO 13485 Training goes beyond theory, offering practical skills through:

  • Interactive Learning Activities: Engage in hands-on exercises and collaborative activities that encourage active participation and reinforce your understanding of key ISO 13485 concepts.
  • Practical Exercises: Simulate real-world scenarios to apply what you’ve learned, ensuring you are ready for challenges you might face in the medical device industry.
  • Quizzes: Regular quizzes help evaluate your understanding and provide feedback on areas that need improvement.
  • Case Studies: Dive deep into real-world case studies that showcase how ISO 13485 is applied across various situations in the industry.
  • Downloadable Course Materials: Access extensive resources such as reference documents, additional readings, and other supplementary materials to support your learning journey.
  • ISO 13485 Standard Copy: Receive an official copy of the ISO 13485 standard, which will serve as a vital reference during and after the training.

Who Should Attend ISO 13485 Training?

Our ISO 13485 Training is designed for professionals involved in medical device manufacturing, regulatory bodies, and quality assurance roles. Whether you’re looking to advance your auditing career or develop a deeper understanding of ISO 13485 requirements, this training program will enhance your ability to ensure compliance and quality within your organization.

Flexible Delivery Methods for ISO 13485 Training

IAS offers a variety of delivery methods for our 5-day, 40-hour ISO 13485 training program, ensuring that it suits different learning preferences and organizational needs:

  • In-House Training: Customize the training content to suit your organization’s specific processes and challenges. This approach allows you to train your team effectively without the need for travel.
  • Open Classroom Training: Join a diverse group of professionals in a classroom setting. This approach is perfect for individuals or smaller teams who wish to gain insights from professionals in various sectors.
  • Tutor-Led Virtual Training: Attend training remotely from anywhere with an internet connection. This flexible option provides interactive learning with virtual breakout sessions and discussions.

Assessments and Certification

Our ISO 13485 Lead Auditor Training includes continuous assessments throughout the course. Participants will be evaluated based on their engagement, completion of individual and group exercises, and active participation in class discussions.

At the end of the program, candidates will need to take the IRCA Examination to earn the CQI/IRCA-accredited certification. This globally recognized certification is essential for professionals looking to demonstrate their expertise in ISO 13485 auditing.

IRCA Examination Details:

  • Duration: 1 hour and 45 minutes
  • Questions: 40 questions (without multiple-choice or negative marking)
  • Content: The exam covers five domains: audit concepts, methodologies, planning, conducting, and reporting/closing
  • Passing Criteria: A minimum of 50% overall and 50% in each domain
  • Format: Open-book exam (ISO 13485 standard recommended, internet searches are prohibited)
  • Proctoring: Live proctoring ensures integrity, with candidates monitored through webcam

Candidates who achieve 70% or higher in the continuous assessment and 50% or more in the final exam will receive a CQI/IRCA-accredited certificate. Those who do not meet the required thresholds will receive a certificate of attendance.

Enrolment Process for ISO 13485 Lead Auditor Training

  • Submit an Inquiry: Register your interest by submitting an inquiry through our website.
  • Consultation: Our team will contact you to discuss your training preferences and available schedules.
  • Confirm Registration: Finalize your enrolment by completing the registration and payment process.
  • Access Training Details: Once enrolled, you will receive login credentials and access to course materials.

Contact us or visit our frequently asked questions to know more about ISO 13485 Training.