+1 315 666 4295ISO 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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Malvern PA
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$ 1996 $2994
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$ 3992 $5988
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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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Lori Coleman 5
Jan 17th, 24
Lead Instructor for FSPCA for Human Food Curriculum
I was very apprehensive to take this class on-line.
The instructor was great. Very knowledgeable and helpful with all questions.
Regina Ogbone 5
Jul 11th, 24
Senior System Engineer
"I've never completed a course like this before (remotely) and 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. The instructor was very knowledgeable and provided a wealth of information about the current version of CompTIA Security+. All my questions were answered and the class interaction was very good. I loved the fact that even though I was in a class with other people, the actual physical space was quiet and very conducive to learning! Thank you.
Hamzah Kchour 5
Jun 4th, 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.
Judy Denny 5
Nov 20th, 23
Manager of Facilities Services Operations at University of Hartford Facilities Department
The support staff from Sprintzeal,Steve Jones, were very supportive in making this decision to take the PMP certification course. The course was very affordable and I was given an additional incentive to take another course which would supplement my knowledge which was the Agile course.
I was thinking about studying on my own for the exam but decided to sign up for the course on Sprintzeal to ensure that the material that I needed to study was accurate and efficient. I didn't want to waste anytime on taking the exam multiple times to pass due to being ill-prepared. The instructor Biswa, was great in covering what to know for the exam and I feel that the material he provided will prepare me to pass the exam my first time with confidence. Thank you for this opportunity and I look forward to taking more certification courses through Sprintzeal.
Christi Sifri 4
Jan 19th, 24
CHIEF NURSE EXECUTIVE | GLOBAL CLINICAL PROGRAM DIR ORG & STAFF LEADERSHIP | CLINICAL RESEARCH| REGULATORY COMPLIANCE
Dani is a very knowledgeable project manager, with real-life experiences and stories. He was able to take the slides provided by Sprintzeal and know if they were from PMBOK 5 or PMBOK 6, what was enhanced, what was deleted, and apply an example that made sense to the topic. Dani's biggest challenge was the GoToMeeting process and landing back on the slide deck after providing additional information to teach a particular point. It is challenging to teach people on different coasts, but he was able to and respect the time difference.
Review of Sprintzeal: Alex reached out to me and walked me through the entire registration process, answering all of my questions and there were many. I was supposed to have a live class, but because I ended up being the only person that did not cancel they transferred me into an on-line class and have offered an additional class to make up for that. I received my PMBOX 6 book ahead of class and found everything very straight forward. I hope that the three mock tests and assistance in completing my application are as clear and efficient as the rest of this has been.
I have 4 stars for the slide reading and technical challenges to date.
Thank you - Christi
Nageswararao Seemakurty 5
May 7th, 24
Cloud Engineer
Liked the AWS training course that I took at Sprintzeal. The content was good and the trainer took time to go back and answer any questions. The slides depicted the concept on each topic well. I recommend this course for quick grasp.
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
Margaret Tanner Glover 5
Nov 10th, 22
CMMI Certified V2.O and V1.3 High Maturity Lead Appraiser/ Instructor. Scaled Agile Framework PC, Certified DevOps, CSM
I found my instructor and the coordinator Alex Wood very easy to work with. They were VERY accommodating to my schedule, and I was very happy with the training, the presentation of the material and the quizzes that the instructor walked the class through at the end of each Chapter. I will take another class from them again.
Tony Mathew 5
Feb 14th, 24
Senior Program Manager
The training was very worthwhile and Mahesh the trainer was extremely knowledgeable. He provided real-world examples that assisted greatly. The content was well written, understandable and valuable. I would highly recommend this company and class for others. Lastly, the sign-up and coordination for the class was good as well.
Sarfaraj Alam 5
Mar 14th, 24
Network Security Engineer L3
Course Name: ITIL V4 Foundation
It was a great learning experience overall. The training session was very interactive with every question answered.Highly recommended.
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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