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
100% Satisfaction Guarantee
Get Benefits
Why should I get the ISO 13485 Lead Auditor Certification Training?
Mode Of Training
San Angelo TX
Live Online Training
$ 1996 $2994
- 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
$ 3992 $5988
- 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
People also searched for:
Lean Six Sigma Green Belt
ITIL 4 Specialist: Create, Deliver and Support
Complaints Handling Training
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!
Request More Information
Participant Reviews
Your career is our goal. We care for your professional empowerment. Don’t take it from us. Find out what our participants say about our service!
.webp)
Smitha Harish 5
Oct 25th, 24
Senior Business Analyst
Had a very good experience with the online CISSP class. Munavwar Sheikh, the instructor, explained each domain very well. He was very patient in answering our questions with pictorial examples. and his work experience. A great experience indeed and I recommend Munavvar for security related training courses.
Susan Combs-Foushee 5
Dec 2nd, 24
Sales Representative at Atlantic Corporate Interiors
Sprintzeal's preparatory course for PMI's "Project Management Professional" certification provides the knowledge base and test-taking strategies needed to pass the exam.The course fee includes all the study materials and the instructor guidance needed to succeed!
I highly recommend this experience and will consider taking additional Sprintzeal training courses in the future.
Hamzah Kchour 5
Jun 14th, 24
System Engineer
I cannot express how great the instructor was and the overall content of the material. The way he taught was very clear in his method of teaching and provided a wealth of information about the CompTIA Network+. All my questions were answered and the class interaction was very good.
Valerie Alexis-Seymore 5
Jan 11th, 25
Operations Manager at UT MD Anderson Cancer Center
The class was very informative. Great job Biswa.
Edward Lee 5
Mar 21st, 25
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.
Sean Davis 5
Oct 22nd, 24
Navy Veteran IT Professional
I had the opportunity to take the ITIL 4 Foundations course through Sprintzeal and it was a great experience. My instructor was Courtney, and I feel she prepared me to take and pass the exam on my first attempt. Courtney is very knowledgeable, and her instruction method was conducive for a positive learning environment. I will request her in the future as I plan to expand on my knowledge in ITIL. Alex was vital in my successful enrollment and always a trusted agent to aid in my self development plan. Sprintzeal is a great organization to aid in your ability to better yourself through expert instruction.
Cale Hansen 5
Feb 17th, 24
Transitioning Officer at US Army; Project Management; Military Aviation
Carmen did a fantastic job instructing our Class. From providing in depth analysis on course material to drawing from outside sources and personal experiences to fully flesh out the subject matter she placed a high level of importance on our understanding. Hoping all her hard work pays off on our success on the exam. I would unconditionally recommend her as an instructor and project manager!
Shawn Roberts 5
Jun 5th, 24
Information Technology and Services Professional
I attended Sprintzeal's AWS Solution Architect course the past two weekends. The live remote classes were very interactive and involved lots of labs and hands-on work to enhance learning. The instructor, Raj, is EXTREMELY knowledgeable about AWS and is a great teacher. I will come back for future training needs. Thanks, Shawn
Donato Viggiano 5
Jan 27th, 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.
Roger Cleuskens 5
Nov 24th, 24
IT Support Engineer
It was a good learning experience connected to practical aspects and real projects. I enjoed my CompTIA network+ session with the trainer.
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.
Corporate Training Solution
Looking for a personalized Corporate Training for a group at your preferred location?
Find ISO 13485 Lead Auditor in other cities
Atlanta GA Austin TX Bengaluru Boston MA Brisbane Brussels Chennai Chicago IL Dallas TX Delhi Denver CO Doha Dubai Frankfurt am Main Houston TX Hyderabad Ipoh Kuala Lumpur London Makati Manila Melbourne VIC Mumbai New York NY Phoenix AZ Riyadh Seattle WA Singapore Sydney NSW Washington DC ZurichOur Accreditations
USA : +1 315-666-4287
UK : +44 7700 174870
IND : +91 90361 08289
AUS : +61 480 005 455