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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Columbus OH
Live Online Training
$ 1996 $2994
- Live Online Training by Industry Experts
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- 24x7 learner assistance and support
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$ 3992 $5988
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- We can customise the training
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- 24x7 learner assistance and support
- We can deliver both In-Person or Live Online
- Pay after the training completion
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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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Zaid AlBanna 5
Jan 22nd, 25
Technical Program Manager
I have taken my AWS training with Sprintzeal, the trainer was very knowledgeable and looking forward for project assistance.
Thank you Sprint zeal team for the discount provided I am glad I completed the training I hope this certification helps me changing my career in AWS field. Message to users, Sprintzeal gives quality training and very prompt in responding when you email
them for any questions. I strongly recommend Sprintzeal for training courses.
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Srikant Sunkara 5
Sep 16th, 24
Team Lead at Schroders
The training offered by Sprintzeal is one of the most comprehensive and complete training. Right from beginning of my interaction with support team especially Foram for registration of course to actual training by an expert trainer to conducting exam online it was a pleasant experience. The trainer Mr Faizal is very knowledgeable and made the topic very easy to understand by giving realistic example with support from a detailed training material offered. Would highly recommend the valuable training sessions at reasonable pricing point. Keep up the good job.
Rita Wiley 5
Mar 23rd, 24
Transitioning Officer in pursuit of PMP and MBA
Tim was beyond amazing. Not only did he know his craft, but he was also able to explain it to a level someone with the lowest level of knowledge could understand, without insulting the intelligence. I came in with barely any formal knowledge of the PM world and ended leaving with way more competency. Tim mixed personal experience and PMI terms/processes/knowledge areas to increase my understanding (it worked). Loved this class, loved the teacher. I will definitely recommend this class and more specifically, the teacher to other coworkers, friends and family. Thank you!
Elaine Park 5
Jan 30th, 25
Senior Manager
The course content is comprehensive and invaluable! I gained key understandings that I wouldn't have gained studying on my own. The instructor is extremely knowledgeable in PMI and PMP, with expert experience in project management. They made hard concepts easy to access through simplified visuals and ample resources! I am confident that this course has prepared me well to succeed and pass the PMP test. I highly recommend this course.
Paul Bentley 5
Jan 23rd, 25
Senior IT Project Manager
Excellent session with amazing professor who has great knowledge about CompTIA A+ and deal with doubts and questions brilliantly!
Neetha Kotagiri 5
May 6th, 24
System Administrator/ at AGCO Corporation
PMP Training provided by Sprintzeal The training is amazing. Trainer Tammy is so good she is very understanding, Patient and very good teacher. She made the most difficult topics very easy. I loved training with her. Alex Wood from Sprintzeal who help me with the process of the enrollment was very good. Answered each and every concern of mine and was very helpful.
Shaikh Rahman 5
Jan 6th, 25
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.
David Carnell 5
Jan 18th, 25
Healthcare Project Manager
I was very pleased with my PMP trainer and the content and materials. The slides were very well done and logical so you could learn the subject matter looking at the slides and listening to the trainer. The trainer was very patient and thorough in making sure that I understood the subject matter and made sure any questions i had or uncertainty was addressed. I am very pleased with my PMP training experience.
Valerie Alexis-Seymore 5
Jan 11th, 25
Operations Manager at UT MD Anderson Cancer Center
The class was very informative. Great job Biswa.
Osvaldo Rodrigues Batista 5
Feb 13th, 25
US Army
Hi, my name is Osvaldo Batista. I took the Network+ certification training with Sprintzeal. I love it. The trainer did a great job explaining the contents. Sprintzeal provided all the material to study e prepare for the exam. Also, did a great job scheduling the training session to fit into my busy schedule.
Thank you.
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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