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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Course Agenda
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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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Krishna Sripada 5
Jul 10th, 24
Tech Lead
I have taken the AWS Solution Architect Associate Certification training course. Toshal Kahawale was the trainer. Toshal had covered all the important topics required for a Solution Architect in a detailed manner. He had provided real-world application examples while explaining the topics. That was really helpful. Toshal has plenty of experience in designing & architecting cloud applications
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Sarfaraj Alam 5
Mar 14th, 24
Network Security Engineer L3
Course Name: ITIL V4 Foundation
It was a great learning experience overall. The training session was very interactive with every question answered.Highly recommended.
Tim Heverin 5
Oct 29th, 22
Systems Engineer
Taking the CISSP class has helped to prepare me for the exam. Munavwar is an excellent trainer and has helped me to expand my knowledge in this area. Having the class recorded was very helpful so that I can go back and review material. This was much better than just reviewing slides. The thing that I most enjoyed was really expanding upon my own experience and applying it to the learning material. I highly recommend Munavwar when training for the CISSP exam.
Dale Hansen 5
Oct 23rd, 24
Executive Assistant to the CEO & IT Administrator
Lean Six Sigma Black Belt
Nice to take session with Ashish as he has very good insight on topics both theoretical and hands on. Also, he has a lot of experiences to share.
David Smith 4
Feb 15th, 24
Telecommunications Administrator
Paul did a great job explaining AWS in great detail. He was informative in recommending test strategies. The only thing I would request is that the course documentation be updated a bit. Paul informed us that the lag time between class and test is significant, but it would be nice if we can improve this area.
Sarochin Tollette, BSEE, Certified ScrumMaster 5
Feb 12th, 24
Program Manager | Senior Technical Project Manager | Software Engineering Manager | Collaborator | Problem Solver
I'm glad I discovered SprintZeal on my journey to getting the PMP Certification and Lean Six Sigma Green Belt Certification. Their PMP Certification Exam Prep course and resources (videos, practice exams) are very effective and helpful. The teachers and support staff are top-of-the-line. When I have questions, I get almost instantaneous replies from the support focal (even during the holidays). The Lean Six Sigma Green Belt Certification on-line course is easy to comprehend. The on-line course gives me flexibility as I can take it anytime, on my own schedule. I look forward to taking the exams and getting my certification!
Shaun McElrath 5
Feb 17th, 24
Senior Manager, IT Business Enablement & Success
Understood the ITIL concepts very clearly. The trainer's faculty was so polite and ground to earth while explaining the concept and answering all the questions asked by the participants.
Mark Ridgely 4
Aug 9th, 24
Project Manager
Instructor very knowledgeable of the PMI content and provided solid instruction as such as well as practical experience in exam preparation and test taking strategy.
Online version of class was better than anticipated, but think I still would have preferred in person classroom setting.
Shaikh Rahman 5
Oct 25th, 23
Senior Cloud Network Security Engineer
It was an excellent live online training session. The Trainer ‘Munawar Ahmed Shaikh’ is an interactive person, and he has lots of industrial experience. He used to explain the project reference that he did on the industry that helped to understand the different CISSP domains.The training session was through GoToMeeting, and it interrupted the session. The trainer spent time troubleshooting the GoToMeeting, and why the drawing board was not displayed on the screen, voice breaks during the sessions. Sprintzeal should change GoToMeeting for better live online training sessions. I highly recommend ‘Munawar Ahmed Shaikh’ for CISSP training.
Russell Deatherage 5
Apr 12th, 24
Sr. Program Manager
PMP Boot camp by Syed M. Quadri on 21-25 Oct 2019. Excellent class. Mr. Quadri presented sound information and gave logic advice that was helpful to tie the information together for memory. Great point on the ITTO's that I and O are nouns and TT's are verbs or actions
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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