ISO 13485 Training

Introduction to ISO 13485 Lead Auditor Training

Our comprehensive ISO 13485 Lead Auditor Training program is designed to equip professionals with the necessary knowledge and skills to become competent lead auditors in accordance with ISO 13485 standards.

ISO 13485 is an international standard that specifies the requirements for a quality management system in the medical devices industry. Lead auditors play a crucial role in ensuring that medical device manufacturers comply with the requirements of ISO 13485 and consistently produce safe and effective products.

By enrolling in our ISO 13485 Lead Auditor Training, you will gain a deep understanding of the standard, learn effective auditing techniques, and develop practical skills to conduct audits and assess compliance with ISO 13485. Our experienced instructors will guide you through interactive sessions, case studies, and hands-on exercises to enhance your learning experience.

CQI-IRCA Accredited ISO 13485 Training in Malaysia

In collaboration with our esteemed partner, Empowering Assurance Systems (EAS), our ISO 13485 Lead Auditor Training is proudly accredited by the Chartered Quality Institute (CQI) and the International Register of Certificated Auditors (IRCA). This accreditation highlights our commitment to providing ISO 13485 training programs of the highest quality, globally recognized for their effectiveness. By choosing our CQI-IRCA accredited ISO 13485 training, participants gain a competitive edge and the assurance of learning from industry-leading experts.

ISO 13485 Training Course Overview

Our ISO 13485 training program spans over 5 days, totaling 40 hours of instruction. During this time, participants will delve into the intricacies of ISO 13485, learning about the standard’s requirements, auditing principles, and best practices for effective auditing.

Through interactive sessions, group activities, and practical exercises, participants will gain a comprehensive understanding of quality management systems, risk management, design control, regulatory requirements, and corrective and preventive action processes specific to the medical devices industry. Our experienced instructors will provide real-life examples and insights to enhance participants’ learning experience.

Upon completion of the ISO 13485 training, participants will possess the knowledge and skills required to conduct audits, assess compliance with ISO 13485, and contribute to the improvement of quality management systems in the medical devices industry.

Embark on this 5-day journey of immersive learning and join our ISO 13485 Lead Auditor Training program to enhance your auditing expertise and unlock new opportunities in the field of medical device manufacturing and compliance.

ISO 13485 Training Course Delivery Methods

At Integrated Assessment Services, we understand the importance of flexibility in learning. Our ISO 13485 Training in Malaysia offers diverse course delivery methods to cater to the unique needs and preferences of our participants.

In-House Training

• Experience the convenience of having our expert trainers come directly to your organization.
• Tailored solutions within the familiar confines of your workplace.
• Focused learning environment, team collaboration, and specific organizational challenges addressed.

Open Classroom

• Engage in face-to-face learning in a neutral and collaborative environment.
• Networking opportunities with professionals from various organizations.
• Dynamic exchange of ideas, enriching the overall learning experience.

Tutor-Led Virtual Training

• Access our ISO 13485 Lead Auditor Training from anywhere in the world.
• Real-time interaction with expert trainers, discussions, and collaboration.
• Flexibility of remote learning, eliminating geographical barriers.

View our ISO 13485 Training Schedule to get the latest course dates!

Key Features of ISO 13485 Training

Our ISO 13485 Lead Auditor Training program offers several key features that ensure a comprehensive and practical learning experience:

• Comprehensive Curriculum: Our ISO 13485 training program covers all essential topics related to ISO 13485 and auditing principles. Participants will gain in-depth knowledge of quality management systems, risk management, design control, regulatory requirements, and corrective and preventive action processes specific to the medical devices industry.
• Practical Approach: We believe in learning by doing. Our ISO 13485 training program adopts a practical approach, including interactive sessions, case studies, and hands-on exercises. This methodology enables participants to apply their knowledge in real-world scenarios and enhance their understanding of auditing concepts in the context of the medical devices industry.
• Experienced Instructors: Our instructors bring a wealth of real-life expertise to the training sessions. They have extensive experience in ISO 13485 training and auditing practices, providing valuable insights and practical examples that enrich the learning experience.
• Simulated Audits and Mock Scenarios: Participants will have the opportunity to develop practical auditing skills through simulated audits and mock scenarios. These exercises simulate real-life audit situations, allowing participants to apply their knowledge, practice their auditing techniques, and receive constructive feedback to improve their skills.

With our ISO 13485 training program’s key features, participants can expect a comprehensive, practical, and engaging learning experience that equips them with the necessary skills and knowledge to become competent ISO 13485 lead auditors.

ISO 13485 Lead Auditor Training Examination and Certification

Upon completion of the ISO 13485 Lead Auditor Training program, participants will have the opportunity to take the IRCA examination. This examination is typically conducted after the course concludes and is designed to assess participants’ understanding of ISO 13485 principles and their ability to apply them in real-world auditing scenarios.

Candidates who successfully pass the examination and meet the certification requirements will be awarded the prestigious ISO 13485 Lead Auditor Certification. This globally recognized certification serves as a testament to their expertise and proficiency in conducting audits and assessing compliance with ISO 13485 standards.

Why Choose IAS-Malaysia?

Integrated Assessment Services in Malaysia is a leading provider of ISO training programs, including our ISO 13485 training programs. With years of expertise and experience in the field, we are dedicated to delivering high-quality training that empowers professionals to excel in their roles.

Our team of experienced trainers and auditors brings a wealth of industry knowledge and practical insights to our training programs. They possess extensive experience in ISO standards and auditing practices, ensuring that participants receive top-notch instruction and guidance.

At Integrated Assessment Services, we strive to provide exceptional ISO 13485 training that equips professionals with the skills and knowledge they need to succeed. Join us and experience the difference of training with a reputable and trusted provider in the industry.

Contact us today to learn more about ISO 13485 training and take a significant step forward in your career as an ISO 13485 lead auditor.

Visit our ISO 13485 Training frequently asked questions page!