From enrollment through to doing the course the process was helpful and flexible with plenty of date options offered including ability to re-attend other sessions. Lots of supporting materials were provided for support which you can keep including the PMBOK guide and lots of slides with detailed info. I was also offered opportunity to do Agile training course in the future which made Spritzeal good value. The designated trainer (Biswa) was very helpful, quite fast paced on occasion but always the opportunity to ask questions (in small group) and get feedback for the tests etc. All in all good online experience despite some initial concerns. I think you must remember the course alone will not allow you to pass the exam but will give the fundamentals and reading materials to do so.
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.
Training Options
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?
Mode Of Training
Frankfurt am Main
Live Online Training
€ 1896 €2844
- Live Online Training by Industry Experts
- Best Price Guaranteed in the Training Industry
- Flexible Learning Modes for Efficiency
- 24x7 learner assistance and support
Classroom Training
€ 3799 €5699
- Get Trained by Industry Experts
- Access to Course and Study Materials
- We Guarantee Best Price In Training Industry
- Flexible learning modes for efficiency
Corporate Training
- We can customise the training
- Flexible pricing options
- 24x7 learner assistance and support
- We can deliver both In-Person or Live Online
- Pay after the training completion
Download Course Agenda And Company Brochure
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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Participant Reviews
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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.
Mitul Prafulbhai Bharwad 5
May 6th, 24
Business Development Expert
The training material was well organized and clearly explained by trainer. It was a nice experience and all the queries were well taken and explained to clear the doubts.
Ken LeBlanc 4
Jan 16th, 24
Manager of Systems Development at Canada Council for the Arts
ITIL Foundation 4.0
Class, course and instructor were all first rate. Any issues that were raised were addressed immediately by Sprintzeal.
Rodney Bowers, MBA 4
Oct 2nd, 23
Program Manager
The course serves as a good guide as to what areas you should focus on in regards to taking the exam. Instructor actually cares about your success and is overly helpful in providing understanding of the concepts
Valerie Alexis-Seymore 5
Jan 11th, 24
Operations Manager at UT MD Anderson Cancer Center
The class was very informative. Great job Biswa.
Linda Parrish 5
Apr 18th, 24
Energy Contracts Administrator
Awesome CBAP Test Prep Course with Excellent Customer Service. In March 2019, select staff from two of our departments partnered up to undertake the CBAP Test Prep course offered by Sprintzeal. I learned the BABOK was difficult to comprehend until our trainer, Delilah Allison, explained the book's layout and the meaning behind each section. Her teachings enable me to grasp the Business Analysis concept (even though most of my tasks were in a project management world). Our Account Manager, Alex Wood, provided excellent customer service going above the call of duty to ensure our satisfaction. We did encounter some hiccups along the way which were either resolved or addressed in an expedited manner. Also, the price per person was reasonable compared to what was offered and what other companies offered. My overall experience with Sprintzeal is a positive one. I would definitely recommend the class. Source - Trustpilot
Jens Engstfeld 5
Mar 18th, 24
Senior Project Manager
It is really very nice experience for me to learn ITIL®V4 Foundation practices. Everything is defined in very well way. I strongly thankful to the trainer who has very good knowledge in this field. I recommend this course who want to learn more about ITIL.
David Bennett-Pencil 4
Jun 4th, 24
Highly certified Microsoft Engineer with a Masters degree in Engineering
Security Plus training course. Very good experience overall.
Edward Lee 5
May 21st, 24
Senior Manager
Lean Six Sigma Black Belt
Informative and practical approach of training session. Emphasizing more on the relevant tools that can be use depending on the project that you are working on.
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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