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

  • In-depth Coverage of ISO 13485 Standards
  • Hands-on Exercises and Case Studies
  • Industry-Recognized Certification
  • CPD Certification (Credits): 31
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Why should I get the ISO 13485 Lead Auditor Certification Training?

Expertise Development: Develop a comprehensive understanding of ISO 13485 and its application in medical device quality management through practical training and case studies.
Professional Certification: Achieve the prestigious "PECB Certified ISO 13485 Lead Auditor" credential, demonstrating proficiency in auditing medical device quality management systems.
Career Enhancement: Unlock new career opportunities and enhance credibility in the field of medical devices quality management and auditing.

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Seattle WA

Live Online Training

$ 2975 $4463

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Classroom Training

$ 3975 $5963

  • Get Trained by Industry Experts
  • Access to Course and Study Materials
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Course Agenda

Course Agenda

Company Brochure

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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!

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Course Completion Rate 70.1%

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.

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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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