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?
Mode Of Training
Aberdeen MD
Live Online Training
$ 1996 $2994
- Live Online Training by Industry Experts
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- Flexible Learning Modes for Efficiency
- 24x7 learner assistance and support
Classroom Training
$ 3992 $5988
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- Access to Course and Study Materials
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- Flexible learning modes for efficiency
Corporate Training
- 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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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.
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Apr 29th, 24
Business Analyst at Allianz Partners
I have completed my six sigma green belt training. The admin staff, support team and the trainer were very helpful and flexible. The trainer was very good and helped understand the concepts well. Thank you for all the support.
Dhuha Qazwini 5
Oct 1st, 24
Logistics and procurement Analyst
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!
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Mar 22nd, 24
Project Manager
Our company had Six Sigma Green Belt Training at our facility, we had 4 of our employees attend. They were satisfied with the 3 day training.
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Feb 25th, 24
CNS Sales Specialist | ADHD Specialist
Lots a great data. Wish more pictures, graphics, and real life examples just to make it more interesting. Also, please provide an acronym and definitions list.
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Mar 16th, 24
Director of Client Delivery
Sprintzeal and Oscar "Dani" Chaparro were great! My training and experience with Sprintzeal and my trainer Dani, for my PMP certification, was excellent. I am preparing and getting ready to take the PMP certification exam and feel this certification preparation training has been instrumental and critical to passing the exam. Thank you Sprintzeal and Dani! Source - Trustpilot
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Jun 19th, 24
Senior Business Analyst
I participated to Lean Six Sigma Black Belt Training with Sprintzeal. The instructor, Swati Kondappali, is very knowledgeable and has a lot of experiences to share. The presentqtion is well structure and Swati took always the time to explain the techniques and tools with exemples through the full course. Thank you!
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Apr 6th, 24
Solutions orientated event and project management professional
I found that the course has been comprehensive with a lot of reference material available for personal study outside of the class content. Obviously there is a lot to learn moving forward and its great to know that we are provided with on going support up until we sit the exam.
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Jul 11th, 24
IT Product Development Specialist
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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
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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