ISO 13485 Training

ISO 13485 Lead Auditor Training

In the ever-evolving landscape of medical device quality management, staying at the forefront is essential for professionals aspiring to excel in their careers. Integrated Assessment Services (IAS) presents ISO 13485 Lead Auditor Training, meticulously crafted to empower individuals with the skills and knowledge required to lead and conduct successful audits in alignment with the international standard for medical device quality management systems.

CQI-IRCA Certified ISO 13485 Lead Auditor Training

In collaboration with our sister organization, Empowering Assurance Systems (EAS), IAS provides CQI-IRCA Certified ISO 13485 Lead Auditor Training for those keen on auditing medical device quality management systems. This comprehensive ISO 13485 training program covers crucial aspects, including:

1. Review of the ISO 13485 Standard
2. Auditor Roles and Responsibilities
3. Audit Planning, Conducting, and Reporting
4. Nonconformity Identification and Reporting
5. Evaluating Corrective Action Proposals

Course Deliverables for ISO 13485 Training

Our ISO 13485 Training goes beyond traditional methods to offer a dynamic and comprehensive learning experience. Participants can expect a range of valuable ISO 13485 training course deliverables designed to enhance their understanding and application of medical device quality management principles. Here’s what you can anticipate:

1. Interactive Activities: Engage in a vibrant learning environment with interactive activities that stimulate participation and collaboration. These activities foster a deeper understanding of ISO 13485 concepts, encouraging active involvement and knowledge retention.
2. Exercises: Sharpen your practical skills through hands-on exercises that simulate real-world scenarios. These exercises provide a platform to apply theoretical knowledge to practical situations, preparing you for the challenges of auditing within a medical device manufacturing context.
3. Quizzes: Periodic quizzes are integrated into the ISO 13485 training to assess your grasp of key concepts. These quizzes serve as self-assessment tools, allowing you to gauge your progress, identify areas for improvement, and reinforce your understanding of ISO 13485 requirements.
4. Case Studies: Dive into real-world applications of ISO 13485 through case studies. These scenarios provide insights into practical challenges faced in medical device quality management and offer opportunities to analyze and apply learned principles to resolve complex situations.
5. Downloadable Course Material: Access a wealth of resources at your fingertips with downloadable course materials. These materials include additional readings, reference documents, and supplementary content that serve as valuable references for post-training review and ongoing professional development.
6. ISO 13485 Standard Copy: Receive a copy of the ISO 13485 standard, providing you with the foundational document to refer to during and after the training. Having direct access to the standard allows you to navigate and understand the requirements, facilitating a deeper comprehension of ISO 13485 principles.

Who Should Attend ISO 13485 Training?

This ISO 13485 lead auditor training program is tailored for professionals involved in medical device manufacturing, quality assurance, and those aspiring to become lead auditors. Whether you are from a medical device company, regulatory body, or research institution, our ISO 13485 training will equip you with the skills needed to ensure compliance and excellence in your organization.

ISO 13485 Lead Auditor Training Delivery Methods

IAS provides ISO 13485 training through various methods to accommodate diverse learning preferences and organizational needs. Throughout this 5-day, 40-hour program, candidates can choose the method of delivery that suits them:

• In-House ISO 13485 Training: Customize the training content to address specific organizational processes, challenges, and industry requirements. Foster team cohesion and ensure a shared understanding of ISO 13485 standards without the need for travel.
• Open Classroom ISO 13485 Training: Engage with professionals from various industries in a centralized training program. Benefit from a standardized curriculum and diverse perspectives, making it suitable for individuals or smaller teams.
• Tutor-Led Virtual ISO 13485 Training: Join training sessions remotely from anywhere with an internet connection. Enjoy interactive learning with elements like virtual breakout sessions and discussions. This flexible option reduces travel-related expenses.

Check out our ISO 13485 Lead Auditor Training Schedule to view upcoming course dates!

Assessments and Certification

Continuous Assessment: Candidates are evaluated throughout the course on attendance, active participation, completion of individual and group exercises, and professional engagement during class discussions.

IRCA Examination: At the end of the ISO 13485 Lead Auditor Training, whether delivered in a classroom, virtual, or in-house setting, participants must complete the IRCA examination conducted online. The examination specifications are as follows:

• Duration: 1 hour and 45 minutes
• Questions: 40, without options or negative marking
• Content: Covers five domains—concepts and principles, audit methodologies, audit planning, audit conducting, and reporting/closing
• Total Marks: 80, with a required minimum pass mark in each domain and an overall score of at least 50% (40 marks)
• Format: Open book, but internet searches are restricted; access to the relevant ISO standard (electronic or paper copy) is recommended
• Marking: All questions are computer-graded
• Security: Responses cannot be changed after submission
• Preparation: Sample questions are discussed to familiarize candidates with the format
• Proctoring: IRCA’s exams are proctored live to ensure integrity. Candidates verify their ID through a secure portal and are monitored via webcam by a proctor who ensures compliance with exam rules. Unauthorized resources or leaving the exam screen are prohibited. Sessions may be recorded for further review.

Candidates taking the exam in languages other than English, Spanish, Japanese, Arabic, or Traditional Mandarin will complete a paper-based version.

Certification: Participants achieving 70% or higher in continuous assessment, plus 50% or above in the final examination, will receive a CQI/IRCA-accredited certificate of successful course completion, recognized globally within certification standards. Candidates who do not meet this threshold will be issued a certificate of attendance.

Enrolment Process for the ISO 13485 Lead Auditor Training

1. Submit an Inquiry: Register your interest through our website.
2. Consultation: Our coordinators will promptly contact you to discuss available training schedules and formats.
3. Confirm Registration: Finalize your enrolment by completing the registration and payment.
4. Access Course Details: Receive your course login credentials and relevant materials upon confirmation.

Start your professional journey by contacting us  ISO 13485 Lead Auditor Training today.