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
ISO 13485 Lead Auditor
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The 1-on-1 Advantage

Get 1on-1 session with our expert trainers at a date & time of your convenience.
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Flexible Dates

Start your session at a date of your choice-weekend & evening slots included, and reschedule if necessary.
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4-Hour Sessions

Training never been so convenient- attend training sessions 4-hour long for easy learning.
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Destination Training

Attend trainings at some of the most loved cities such as Dubai, London, Delhi(India), Goa, Singapore, New York and Sydney.

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. & excluding VAT/GST
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 & excluding VAT/GST
Online
05 - 09 Jun 09:00 AM - 05:00 PM CST
(8 Hours/Day)
Online
03 - 07 Jul 09:00 AM - 05:00 PM CST
(8 Hours/Day)
Can’t Attend Live Online? Click to Buy Flexi For Only $199 (Video Recording of Live Online)
ISO 13485 Lead Auditor
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 ?
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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FAQ's

You will receive the digital certificate post training completion via learning enhancement tool after registration.
Yes, course requiring practical include hands-on labs.
Yes, we also offer weekend classes.
Buy-Now. Pay-Later option is available using credit card in USA and India only.
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Yes, we do. For details go to flexi
Yes, Koenig follows a BYOL(Bring Your Own Laptop) policy.
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.
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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.
Yes, we do offer corporate training More details
Yes, we do.
You can pay through debit/credit card or bank wire transfer.
Yes you can request your customer experience manager for the same.
Yes, this is our official email address which we use if a recipient is not able to receive emails from our @koenig-solutions.com email address.
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.
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We use the best standards in Internet security. Any data retained is not shared with third parties.
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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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Yes, fee excludes local taxes.
Yes, we do.
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 Public you can select your own schedule, other students can be merged. Choose 1-on-1 if published schedule doesn't meet your requirement. If you want a private session, opt for 1-on-1 Private.
Duration of Ultra-Fast Track is 50% of the duration of the Standard Track. Yes(course content is same).

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.
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)
Yes, if you send 4 participants, we can offer an exclusive training for them which can be started from Any Date™ suitable for you.
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.