PECB/ISO 13485 Lead Auditor

Course Contents

ISO 13485 Lead Auditor Course Overview

ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.

Target Audience

  • Auditors 
  • Managers or consultants 
  • Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements
  • Technical experts seeking to prepare for a Medical Devices Quality Management System audit
  • Expert advisors in Medical Devices Quality Management

Learning Objective

  • Understand the operations of a Medical Devices Quality Management System based on ISO 13485
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
  • Learn how to lead an audit and audit team
  • Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
  • Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011

The 1-on-1 Advantage
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Flexible Dates

  • • Choose Start Date
  • • Reschedule After Booking
  • • Weekend / Evening Option
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4-Hour Sessions

Free Demo

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
  • Exam
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.

2150 + If you accept merging of other students.
4 Hours
8 Hours
Week Days
Weekend

Start Time : At any time

12 AM
12 PM

1-On-1 Training is Guaranteed to Run (GTR)
Group Training
1850 Per Participant
Online
03 - 07 Apr 09:00 AM - 05:00 PM CST
(8 Hours/Day)
Online
01 - 05 May 09:00 AM - 05:00 PM CST
(8 Hours/Day)
Can’t Attend Live Online? Click to Buy Flexi For Only $99 (Video Recording of Live Online)
Course Prerequisites

A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.

 

 

 

Student Feedback  (Check Koenig Feedback on Trustpilot)

Q1 Say something about the Trainer? Q2 How is Koenig different from other training Companies? Q3 Will you come back to Koenig for training ?
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Abu
United States
A1. Yes, she was very clear & a strong mastery of both English & Azure platforms hence following was easy. She was also patient and was answering every question asked, she also shared material & tips on how to pass the exam, Well done, and keep it up.
Nick Barker
United States
A1. Calm and understanding, she not only kept the course running well but also took time to help those with lots of questions. Very well done.
Robin Johnson
United States
A2. Individual attention during training, excellent customer service and coordination. Neha has been ever so helpful and is definitely an asset to Koenig.
Shivani Prasad
United States
A1. The trainer was great and his teaching methods were incredible. He used different teaching methods to ensure I was learning well. A fun trainer with lots of patience and understanding.
Adam
United States
A1. The trainer was very knowledgeable and well prepared about the presentation/training subject, with a positive attitude towards students and making every effort in answering questions during the training session. Top-notch service!
Suresh
United States
A1. Exceptional... recommend to everyone!
Shyam Vaddakapett
United States
A1. My trainer, Mohit Kakkar was excellent as he focused on hands-on assignments to supplement the concepts of AZ 900. The training coordinator Jasmeet as well as the ops manager Sheshadri are also very professional and customer-centric. I recommend Koenig for training courses, and I will take some more courses with them soon.
Gilles Chirlias
United States
A1. Chavi was a great teacher, I have learned a lot from her. I would like to have her for the next training, which would be the AZ 301 and AZ 500.
Abdulrahman Saad Alshahrani
United States
A1. Excellent trainer. I will take another course with him someday. He deserves a good appreciation from his Manager.
Anonymous
United States
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FAQ's

You will receive the digital certificate post training completion via learning enhancement tool after registration.
Buy-Now. Pay-Later option is available using credit card in USA and India only.
Yes, course requiring practical include hands-on labs.
Yes, we also offer weekend classes.
It is recommended but not mandatory. Being acquainted with the basic course material will enable you and the trainer to move at a desired pace during classes.You can access courseware for most vendors.
You can buy online from the page by clicking on "Buy Now". You can view alternate payment method on payment options page.
Yes you can.
Yes, we do. For details go to flexi
Yes, Koenig follows a BYOL(Bring Your Own Laptop) policy.
Yes, we do accept partial payments, you may use one payment method for part of the transaction and another payment method for other parts of the transaction.
Yes, we do offer corporate training More details
Yes, we do.
You can request a refund if you do not wish to enroll in the course.
To receive an acknowledgment of your online payment, you should have a valid email address. At the point when you enter your name, Visa, and other data, you have the option of entering your email address. Would it be a good idea for you to decide to enter your email address, confirmation of your payment will be emailed to you.
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.
You can pay through debit/credit card or bank wire transfer.
Yes you can request your customer experience manager for the same.
After you submit your payment, you will land on the payment confirmation screen.It contains your payment confirmation message. You will likewise get a confirmation email after your transaction is submitted.
We do accept all major credit cards from Visa, Mastercard, American Express, and Discover.
Credit card transactions normally take 48 hours to settle. Approval is given right away; however,it takes 48 hours for the money to be moved.
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We use the best standards in Internet security. Any data retained is not shared with third parties.
Yes, if we have an office in your city.
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Yes, fee excludes local taxes.
Yes, we do.
The Fee includes:
  • Courseware
Yes, Koenig Solutions is a PECB Learning Partner
Schedule for Group Training is decided by Koenig. Schedule for 1-on-1 is decided by you.
In 1-on-1 you can select your own schedule, other students can be merged but you select the schedule. Choose 1-on-1 if published schedule do not meet your requirement. If you also want a private session, opt for 1-on-1 Public.
Yes.
No, it is not included.

Prices & Payments

Yes of course.
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Travel and Visa

Yes we do after your registration for course.

Food and Beverages

Yes.

Others

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.
Yes, if you send 4 participants, we can offer an exclusive training for them which can be started from Any Date™ suitable for you.
Says our CEO-
“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)
Medical services in India are at par with the world and are a fraction of costs in Europe and USA. A number of our students have scheduled cosmetic, dental and ocular procedures during their stay in India. We can provide advice about this, on request.