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Course Contents

ISO 13485 Lead Auditor Course Overview

ISO 13485 Lead Auditor certification is an internationally recognized standard developed to assess the competency of medical device manufacturers. It also focuses on quality management systems, meeting regulatory and customer requirements, and achieving excellence in device safety and performance. Companies seek ISO 13485 certification to ensure regulatory compliance, reduce risk, increase efficiency, and foster continuous improvement. The certification process involves a third-party auditor, who has a critical role in assessing the organization’s compliance with ISO 13485 standards, identifying nonconformities, and recommending corrective actions. The Lead Auditor is a key position involving comprehensive knowledge and skills in auditing and the ISO 13485 standards.


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You will learn:

Module 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
  • Course objectives and structure
  • Standards and regulatory frameworks
  • Certification process
  • Fundamental principles of Medical Devices Quality Management Systems
  • Medical Devices Quality Management System (QMS)
  • Fundamental audit concepts and principles
  • Audit approach based on evidence and risk
  • Initiating the audit
  • Stage 1 audit
  • Preparing the stage 2 audit (on-site audit)
  • Stage 2 audit (Part 1)
  • Stage 2 audit (Part 2)
  • Communication during the audit
  • Audit procedures
  • Creating audit test plans
  • Drafting audit findings and non-conformity reports
  • Documentation of the audit and its review
  • Closing the audit
  • Evaluating action plans by the auditor
  • Beyond the initial audit
  • Managing an internal audit programme
  • Competence and evaluation of auditors
  • Closing the training
Live Online Training (Duration : 40 Hours)
We Offer :
  • 1-on-1 Public - Select your own start date. Other students can be merged.
  • 1-on-1 Private - Select your own start date. You will be the only student in the class.

2500 + If you accept merging of other students. Per Participant & excluding VAT/GST
4 Hours
8 Hours
Week Days

Start Time : At any time

12 AM
12 PM

1-On-1 Training is Guaranteed to Run (GTR)
Group Training
1850 Per Participant & excluding VAT/GST
02 - 06 Oct
09:00 AM - 05:00 PM CST
(8 Hours/Day)
06 - 10 Nov
09:00 AM - 05:00 PM CST
(8 Hours/Day)
Course Prerequisites
• Prior knowledge of ISO 13485 or similar quality management systems
• Understanding of medical device regulations
• Understanding of audit principles
• Familiarity with management concepts
• Medical device experience is beneficial but not required
• Training completion in ISO 9001 is advised

ISO 13485 Lead Auditor Certification Training Overview

ISO 13485 Lead Auditor certification training mainly focuses on developing a comprehensive understanding of quality management systems in the field of medical devices. The course covers topics like auditing principles, audit procedures, report writing, risk management, and regulatory requirements. The training provides the knowledge and skills necessary to conduct and lead effective audits in accordance with the principles, practices and processes of ISO 13485.

Why Should You Learn ISO 13485 Lead Auditor?

Learning the ISO 13485 Lead Auditor course equips individuals with understanding and skills to conduct and lead effective audits in the medical device industry. It enhances regulatory compliance expertise, fosters quality management skills, aids in risk management, and increases employability in a high-demand field.

Target Audience for ISO 13485 Lead Auditor Certification Training

• Quality Management professionals seeking to perform audits in accordance with ISO 13485.
• Professionals responsible for implementing and maintaining a quality management system (QMS) in a medical device company.
• Internal auditors in healthcare sector.
• Regulatory affairs managers.
• Medical device consultants and manufacturers.
• Health and safety managers in medical device industry.

Why Choose Koenig for ISO 13485 Lead Auditor Certification Training?

- Certified Instructor: Benefitting from top-quality instruction with a certified professional.
- Boost Your Career: Grabbing more lucrative opportunities after ISO 13485 Lead Auditor certification.
- Customized Training Programs: Training catered to specific needs and learning style.
- Destination Training: International exposure and multi-cultural learning experience.
- Affordable Pricing: High-quality training at competitive prices.
- Top Training Institute: Benefit from Koenig Solution's established reputation as a leading training provider.
- Flexible Dates: Training schedules that fit into busy calendars.
- Instructor-Led Online Training: Interactive sessions with professionals from anywhere.
- Wide Range of Courses: A vast selection of courses, allowing an individual to broaden their expertise.
- Accredited Training: Globally-recognized certificates upon successful completion.

ISO 13485 Lead Auditor Skills Measured

Upon completing ISO 13485 Lead Auditor certification training, an individual can earn skills in understanding and interpreting the ISO 13485 standards for Quality Management Systems for medical devices. They become proficient in planning, conducting, reporting and following up on audits, effectively analyzing all elements of the system to ensure compliance. Further, skills in leading and managing an audit team, understanding regulatory requirements, and managing an audit program can be gained. Lastly, they develop the ability to assess an organization's ability to meet customer requirements and legal compliance.

Top Companies Hiring ISO 13485 Lead Auditor Certified Professionals

Leading global companies hiring ISO 13485 Lead Auditor certified professionals include pharmaceutical giants like Pfizer, Johnson & Johnson, and Novartis. Also, medical device manufacturers like Medtronic, Boston Scientific, and Stryker. Tech companies like Siemens Healthineers also hire certified professionals to ensure regulatory compliance of their medical devices. Furthermore, renowned auditing firms such as TUV SUD and BSI Group also employ these specialized auditors.

Learning Objectives - What you will Learn in this ISO 13485 Lead Auditor Course?

The learning objectives of the ISO 13485 Lead Auditor course encompass a broad knowledge acquisition in the field of quality management for medical devices. Participants will gain an in-depth understanding of the ISO 13485:2016 standard and its application in the context of audit methodology based on ISO 19011. Trainees will learn to effectively plan, conduct, report and follow-up on a quality management system audit in a medical device manufacturing organisation. Skills to conduct third-party audits and prepare audit reports will also be part of the learning objectives. Moreover, understanding the roles and responsibilities of an auditor, comprehending the principles, practices and types of audits will be targeted. Participants will also learn to manage an audit program, including initiating, preparing, conducting and completing the audit.
Student Name Feedback
Pawel Barski
United States
A1. Very good knowledge of the relevant standard but I missed bit more examples from real audits
Marion Putto
United States
A1. Mala showed a lot of knowledge and training skills. She is patient and was able to answer every question we had.
Kevin Maguire
United States
A1. The trainer was really patient and confident she helped me to understand the requirements in such a way I will remember. She was extremely knowledgeable and knew all the answers of what was asked. Mala made the course


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1-on-1 Public - Select your start date. Other students can be merged.
1-on-1 Private - Select your start date. You will be the only student in the class.
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All our trainers are fluent in English . Majority of our customers are from outside India and our trainers speak in a neutral accent which is easily understandable by students from all nationalities. Our money back guarantee also stands for accent of the trainer.
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“It is an interesting story and dates back half a century. My father started a manufacturing business in India in the 1960's for import substitute electromechanical components such as microswitches. German and Japanese goods were held in high esteem so he named his company Essen Deinki (Essen is a well known industrial town in Germany and Deinki is Japanese for electric company). His products were very good quality and the fact that they sounded German and Japanese also helped. He did quite well. In 1970s he branched out into electronic products and again looked for a German name. This time he chose Koenig, and Koenig Electronics was born. In 1990s after graduating from college I was looking for a name for my company and Koenig Solutions sounded just right. Initially we had marketed under the brand of Digital Equipment Corporation but DEC went out of business and we switched to the Koenig name. Koenig is difficult to pronounce and marketeers said it is not a good choice for a B2C brand. But it has proven lucky for us.” – Says Rohit Aggarwal (Founder and CEO - Koenig Solutions)
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