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Course | Sprintzeal

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 PMP® Exam Prep Boot Camp

PMP is a globally recognized certification that is high in demand in the project management field. It is an objective-based and people-driven framework that’s widely used around the globe. Research says that a certified project manager has the potential to earn about $81,000 a year and when compared to the non-certified candidates, PMP certified professionals earn around $9000 more annually. As per PMI's Job Growth and Talent Gap report, employers will have to hire approximately 2.3 million project management-oriented workers annually until 2030. And it is estimated that millions of them shall go unfilled. The prestigious PMP is recognized as the gold standard of project management worldwide. This PMP Certification proves the credibility of a project manager. It confirms that a candidate possesses the knowledge and skills required to successfully lead the team in an organization and increase its profitability.

PMP® Exam Prep Boot Camp Key Features 100% Satisfaction Guarantee

  • Get 1 Year FREE E-learning Access
  • Get 35 Contact Hours Approved By PMI
  • 1000+ Mock Exam Prep Questions
  • We are a ATP (Authorized Training Partner) of PMI

Next Cohort Starts On 6th Dec

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Mode Of Training

Aberdeen MD

Live Online Training

$ 875 $1313

  • Flexi Pass Enabled: Flexibility to reschedule your cohort within first 90 days of access.
  • Live, online classroom training by top instructors and practitioners
  • Application Assistance & 1 Year Support
  • Guaranteed Best Value in the Training Industry

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Classroom Training

$ 875 $1313

  • Flexi Pass Enabled: Flexibility to reschedule your cohort within first 90 days of access.
  • Live, online classroom training by top instructors and practitioners
  • Application Assistance & 1 Year Support
  • Guaranteed Best Value in the Training Industry

Hurry, Only few seats left!

Corporate Training

Customized to your team's needs
  • Flexi Pass Enabled: Flexibility to reschedule your cohort within first 90 days of access.
  • Live, online classroom training by top instructors and practitioners
  • Application Assistance & 1 Year Support
  • Guaranteed Best Value in the Training Industry

Course description

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

  1. Expert Guidance:
    Learn from certified professionals with practical experience in Medical Devices Quality Management, receiving invaluable insights and guidance throughout the training.
  2. 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.
  3. Personalized Training:
    Experience tailored learning experiences suited to your learning pace and proficiency level, ensuring comprehensive mastery.
  4. 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!

ISO 13485 Lead Auditor

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.

Gaurav

Faqs

Looking for answers?

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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