+1 315 666 4287ISO 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
Boston MA
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
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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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Participant Reviews
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Dave Sung 5
Jun 4th, 24
IT Project Manager
Good Work Sprintzeal! The Course helped me gain deep understanding of the CompTIA Security+. The hand-on approach used by the trainer was very helpful. The trainer was very patient and answered all questions satisfactorily. Really glad to have come across this course from Sprintzeal.
Lindsay Farrell 5
Nov 2nd, 24
Lead Campaign Manager at Salesforce Marketing Cloud
Clear and informative course to prepare for the PMP exam. The content was laid out well, and you could tell the instructor, Biswa, had plenty of experience teaching the course. The additional material provided was also very helpful.
Tina Brullo 5
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.
Bernadette Vida 5
Mar 12th, 24
IT Program Manager, Business Owner
Dana is an excellent instructor. He had a lot of test taking and industry experience. I noticed that the power point and test material references the 5th edition. For example, the reference to Quality Audit which is in the 6th Edition called Quality Assurance. Dana was able to point these out and reduce confusion.
Lynne Colley 5
Jan 19th, 24
Clarity | Action = Corporate Real Estate and FM Consulting Coach
Best training ever. Muhammad Faisal was just the best tutor. By the end of 4 days training from zero start I was already achieving over 60 percent and then just had to follow up with the study plan and go ahead with the momentum. Nothing was too much trouble. Extremely supportive tutor who also coached me with the application process and heaps of tips for the exam. I know I am ready and I will come back and let you know when I pass in the next month. for sure.
Anetra Doherty 5
Feb 17th, 24
SFL Career Counselor at Inverness Technologies
Kevin Davis Phenomenal instructor that provided actual conceptual scenarios that focused on the overall PMP concept that I could relate to in the corporate culture. He was very patient and determined to ensure we stayed on track w/ the focus of understanding the fundamentals of PMP.
Glenn Monroe 5
Aug 9th, 24
Project Development Officer at New Jersey Casino Reinvestment Development Authority
I highly recommend this course. The content is very challenging and extensive but well organized. The instructor - Biswal knows the material very well and moves at a very comfortable pace with lots of opportunity for questions. The Sprintzeal team is very helpful and now I feel confident in taking the PMP exam.
Ashhab Anwar 5
Mar 10th, 24
Cloud Infrastructure Engineer
It was a good experience. I have been working on ITIL report from past 2 years however never in-debt knowledge about it. These sessions helped a lot in understanding about change management, incident, service and release management. Overall experience was good.
Kimmie Edwards 5
Jan 31st, 24
Chief Executive Officer
It's really helpful training. I did learn a lot regarding the Lean Six Sigma Black Belt . I believe I am able to pass the exam and get certification after the training.
Bandar Al Jasser 4
Mar 3rd, 24
Continuous Improvement Manager
The facilitator, Ms. Noor Zohara was extremely helpful and made our life easy in registration any queries or information about the course. She is very organized, friendly and supportive of the applicants. The speaker Mr. Mohammad Al Rumaih, was knowledgeable, very nice, informative, skillful, highly professional and really made it real with real-life examples. We are feeling that we are confident enough to take the exams and start our own project management. There are some areas for improvement in the venue it’s relatively small, hot water is not available all the time for making hot beverages. Otherwise, everything was fine and thanks again. I will definitely repeat my experience with sprintzeal again and again.
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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