ISO 13485 Lead Auditor Certification Training
ISO 13485 Lead Auditor Training equips participants with the necessary expertise to conduct thorough audits of Medical Devices Quality Management Systems (MDQMS) in accordance with ISO 13485 standards. This intensive training program not only covers the fundamental principles of MDQMS but also delves into practical audit techniques and best practices essential for leading successful MDQMS audits.
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About ISO 13485 Lead Auditor
Our ISO 13485 Lead Auditor Training is meticulously crafted to provide participants with a comprehensive understanding of MDQMS audit principles and procedures. Through a blend of theoretical lectures and hands-on exercises, participants will learn how to effectively plan, execute, and follow-up on MDQMS audits, ensuring compliance with ISO 13485 and other relevant regulatory frameworks. By mastering audit techniques and communication skills, participants will be well-prepared to lead audit teams and resolve conflicts in the audit process. Upon course completion, participants will possess the competencies required to conduct both internal and external MDQMS audits with confidence.
ISO 13485 Lead Auditor Key Features
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Why should I get the ISO 13485 Lead Auditor Certification Training?
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Sydney NSW
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A$ 2874 A$4311
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- 24x7 learner assistance and support
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A$ 5759 A$8638
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- We can deliver both In-Person or Live Online
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Course Agenda
Company Brochure
ISO 13485 Lead Auditor Certification Training - Course Overview
Sprintzeal’s comprehensively designed ISO 13485 Lead Auditor training program, powered by PECB, spans five days, delivering participants with the necessary expertise to conduct Medical Devices Quality Management System (MDQMS) audits effectively. Covering essential domains such as audit principles, planning, execution, and follow-up, this training course ensures a thorough preparation for both internal and external audits in compliance with ISO 19011 and the ISO/IECC 17021-1 certification process.
Through a combination of theoretical knowledge and practical exercises, participants will master audit techniques and gain proficiency in managing audit programs and teams, as well as handling customer communication and conflict resolution. Upon successful completion of the training and exam, participants will earn the esteemed "PECB Certified ISO 13485 Lead Auditor" credential, demonstrating their competency in auditing organizations based on industry best practices.
Program Highlights
- Expert Guidance:
Learn from certified professionals with practical experience in Medical Devices Quality Management, receiving invaluable insights and guidance throughout the training. - Hands-On Learning:
Engage in practical exercises, case studies, and discussions to apply audit principles and techniques to real-world scenarios, enhancing your understanding and skills. - Personalized Training:
Experience tailored learning experiences suited to your learning pace and proficiency level, ensuring comprehensive mastery. - Globally Recognized Certification:
Achieve the esteemed "PECB Certified ISO 13485 Lead Auditor" certification, bolstering your professional standing and marketability in the field.
Learning Objectives
- Understand the operations of a MDQMS based on ISO 13485.
- Recognize the correlation between ISO 13485 and other standards
- Plan, lead, and follow-up on a management system audit
- Lead an audit team effectively and manage audit communication
- Interpret the requirements of ISO 13485
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This training course is ideal for:
- Auditors seeking to conduct and lead MDQMS certification audits.
- Managers or consultants aiming to master the MDQMS audit process.
- Professionals responsible for ensuring compliance with MDQMS requirements.
- Technical experts preparing for MDQMS audits.
- Expert advisors specializing in Medical Devices Quality Management.
At Sprintzeal, we offer top-notch training that stands out for several reasons:
- Industry-Recognized Expertise:
Learn from certified professionals who possess extensive practical experience in MDQMS audits. - Interactive Learning:
Engage in hands-on exercises, case studies, and discussions to apply theoretical knowledge to real-world scenarios effectively. - Flexible Learning Options:
Choose from both in-person and online training formats to accommodate your schedule and preferences. - Post-Training Support:
Gain access to valuable resources and guidance to support continuous learning and career advancement in the field of MDQMS auditing.
Course Agenda
- Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
- Day 2: Audit principles, preparation, and launching of an audit
- Day 3: On-site audit activities
- Day 4: Closing the audit
- Day 5: Certification Exam
Examination
The "PECB Certified ISO 13485 Lead Auditor" exam assesses candidates on various competency domains, including:
- Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
- Medical Devices Quality Management System (MDQMS)
- Fundamental audit concepts and principles
- Preparation of an ISO 13485 audit
- Conducting an ISO 13485 audit
- Closing an ISO 13485 audit
- Managing an ISO 13485 audit program
Certification
Upon successfully passing the exam, participants can apply for the prestigious "PECB Certified ISO 13485 Lead Auditor" credential. The certification demonstrates their proficiency and competence in auditing organizations based on best practices in MDQMS.
Training Details:
- Training Days: 5
- CPD Certification (Credits): 31
- Exam Duration: 3 hours
- Retake Exam: Yes
At Sprintzeal, we are committed to providing high-quality training that equips professionals with the skills and knowledge needed to excel in their careers. Join us on this journey towards becoming a certified ISO 13485 Lead Auditor!
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Benny Rodriguez 5
Aug 9th, 24
Senior System Enginner
The session was awesome, interactive, and very educational all over. I enjoed my CompTIA Network+ session with the trainer
Ohiorenua Ahanmisi 5
Jun 19th, 24
Water/Wastewater Process Design Specialist
It was a really insightful and resourceful training session on the lean six sigma green belt. The trainer swati was very knowledgeable on the lean six sigma concept and was able to transfer the knowledge across effectively. I would recommend sprintzeal to my colleagues and friends.
Aaron Coleman 5
Apr 13th, 24
Facility Manager
Jason and Shane were phenomenal. I scheduled the bootcamp and went through the training. I had a hiccup during the training and was unable to complete a portion. Jason made all of the resources available to me and accommodated me in moving forward. Jason from Sprintzeal was helpful from the start and through the finish of the process. Thank you all so much! You are all that you advertise and so much more. 100% great training and service!
Tony Mathew 5
Feb 14th, 24
Senior Program Manager
The training was very worthwhile and Mahesh the trainer was extremely knowledgeable. He provided real-world examples that assisted greatly. The content was well written, understandable and valuable. I would highly recommend this company and class for others. Lastly, the sign-up and coordination for the class was good as well.
Donato Viggiano 5
Jan 16th, 24
Network Engineer
I had the pleasant opportunity to follow the lessons of Toshal K. for the AWS Cloud Architect Associate, each explanation of the topics in the reference manual was followed by a meticulous investigation through the step-by-step creation of the inherent procedures. Overall, although I have not yet taken the exam, I can call it an extremely satisfying experience thanks to the availability and closeness of all staff members.
Murali Thimmegowda 5
Mar 23rd, 24
Senior Consultant at Capgemini
PSM 1 training by Sprintzeal was excellent. The trainer was very good and provided excellent training in a simple manner with lots of workshops, practices, and scenarios. I recommend Sprintzeal for PSM /CSM training.
Glenn Monroe 5
Aug 9th, 24
Project Development Officer at New Jersey Casino Reinvestment Development Authority
I highly recommend this course. The content is very challenging and extensive but well organized. The instructor - Biswal knows the material very well and moves at a very comfortable pace with lots of opportunity for questions. The Sprintzeal team is very helpful and now I feel confident in taking the PMP exam.
Aijaz Shaikh 5
Feb 2nd, 24
Agile Project Manager experienced in Information Exchange, Digital Transformation, Cyber Security & Cloud Computing
Indeed, A Great Learning Experience !!! I am very thankful for choosing Sprintzeal as my training medium for PMP. All the team members from Sprintzeal spent a whole lot of time with me right from the start of my application until my application was accepted by PMI. I am personally thankful to David Johnson and Alex Wood for all their assistance along the way. The training part from Sprintzeal has the class of its own. It has been such a good learning experience. I am jazzed to admit that Tammy (the instructor) made the entire journey of understanding PMP terminology and concepts a great experience. She is crystal clear about all of the mathematical concepts associated with PMP. This is really helpful in understanding the project management concepts She got the whole training properly structured and easy to follow Sprintzeal course material to meet the course learning objectives. She got right to the point and helped me understand all the important bits in a timely manner.. Tammy is very patient to answer our question and covered all materials within 4 days. Moreover, she shares her past real PM experience with us and make this class more "practical" and assist us to combine work experience with theory. I learned a great deal of knowledge as well as exam-passing-tips in this intensive/productive class. With Sprintzeal came Tammy, both of them are awesome. Thank you both.
Katrina Sarkisoff 5
May 14th, 23
Project Manager at Dealer-FX
Biswa was my teacher for the PMP prep and he was amazing I would defiantly recommenced for anyone interested n taking this course.
Nageswararao Seemakurty 5
May 7th, 24
Cloud Engineer
Liked the AWS training course that I took at Sprintzeal. The content was good and the trainer took time to go back and answer any questions. The slides depicted the concept on each topic well. I recommend this course for quick grasp.
To enroll in the ISO 13485 Lead Auditor training, participants should have a fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
The "PECB Certified ISO 13485 Lead Auditor" exam is conducted in accordance with the PECB Examination and Certification Programme (ECP). It covers various competency domains related to Medical Devices Quality Management System (MDQMS) audits.
Yes, certification and examination fees are included in the price of the training course.
The training spans 5 days, covering various topics including MDQMS principles, audit planning, on-site audit activities, and exam preparation.
Participants will receive comprehensive training materials containing over 450 pages of information and practical examples to aid their learning process.
Yes, we offer both in-person and online training formats to accommodate diverse learning preferences and schedules.
In the event of exam failure, candidates can retake the exam free of charge within 12 months.
Participants will receive an attestation of course completion worth 31 CPD (Continuing Professional Development) credits.
Certification validity periods may vary depending on the certification body. Check with PECB’s Certification Maintenance Policy for information on certification renewal and maintenance requirements.
Frequently Asked Questions
Sprintzeal offers a wide range of professional training courses, including project management, IT service management, quality management, cybersecurity, and more.
Sprintzeal's refund policy allows for cancellations and refunds within a specified timeframe, ensuring customer satisfaction and peace of mind. Please refer to our terms and conditions or Contact Us for details.
Our training courses are delivered through both in-person and online formats, providing flexibility for diverse learning preferences and schedules.
Yes, our training courses are accredited by relevant industry bodies and align with international standards, ensuring quality and credibility.
Yes, Sprintzeal provides training programs catering to all skill levels, from beginners to experienced professionals, ensuring comprehensive learning experiences for all participants. Explore our courses.
Our instructors are certified professionals with extensive industry experience and expertise in their respective fields.
Yes, we offer customizable training solutions tailored to meet the unique requirements of organizations, including on-site training and customized content options. Contact Us to customize your training needs and know more about group discounts.
Yes, participants receive access to comprehensive training materials, including slides, handouts, and additional resources, to support continued learning.
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