Who should enrol in this course?

This ISO 13485 Lead Auditor Extension course is intended for: Senior quality managers Quality professionals Regulatory professionals Compliance professionals Project managers Design engineers Software engineers Process owners Quality engineers Quality auditors Medical affairs Legal Professionals

What course materials are included in the course?

This ISO 13485 Lead Auditor Extension course comes with: Diagram: ISO Auditor Certification Process Diagram: 6-Stage Audit Process Sample Code of Ethics Management of an Audit Programme Sample Audit Plan Sample Audit Work Order Sample Nonconformity Report Sample Working Document & Checklist Risk Assessment Tools and Methodologies Documented Information Requirements of ISO 13485:2016 Determining the Context of the Organization ISO 13485:2016 and Risk Management Risk Assessment Tools and Methodologies (with examples) Terms & Definitions Typical Process Map

ISO 13485:2016 Lead Auditor Extension Course

Name: ISO 13485 Lead Auditor Extension Online Course
Brand: deGRANDSON
SKU: Course 036X
Price: 950 GBP
Availability: InStock

With this Course, you can add ISO 13485 Lead Auditor certification to your current Lead Auditor Certification.

This will enable you to participate in Certification Body and Registration Body auditing.

Already a Lead Auditor for ISO 9001 or other Management System?

Add ISO 13485:2016 Lead Auditor Certification with this online program. It provides you with the Auditing Skills, the Knowledge of the Standard, Knowledge of Risk Management and associated Tools, and the practical application of that knowledge with Audit Scenarios to enable you, as Audit Team Leader, to undertake and manage Certification Audits.

Who should take this Extension Course?

This ISO 13485 Lead Auditor Extension course is intended for:

Senior quality managers
Quality professionals
Regulatory professionals
Compliance professionals
Project managers
Design engineers
Software engineers
Process owners
Quality engineers
Quality auditors
Medical affairs
Legal Professionals

What will I learn?

This comprehensive ISO 13485 Lead Auditor Extension course is divided into four modules:

Module 0: Introduction and background to the Standard and to Auditing.

Module 1: Knowledge of the Standard, ISO 13485:2016, Medical Devices – Quality management systems – Requirements for regulatory purposes:

Introduction to ISO 13485:2016

Includes EU, UK, USA Regulations & MDSAP

Developing & Implementing a QMS

Terms & Definitions – ISO 13485:2016

Some Key aspects of QMS Auditing

Fundamentals of Medical Device Management Systems

Structure & content of ISO 13485:2016

Parts 1, 2 & 3

Part 4: Quality Management System Requirements

Part 5: Management Responsibility

Part 6: Resources

Part 7: Product Realisation (3 lessons)

Part 8: Measurement, Analysis & Improvement (2 lessons)

Annexes ZA & ZB (New Anneses Amendment 11)

Advanced aspects of QMS Auditing (3 lessons)

FAQs about the Standard

Online Course Examination

Module 2: Practice with Scenarios, based on actual audits and includes advice on dealing with awkward situations and individuals.

Audit Scenarios – Internal Auditor

More Audit Scenarios – Lead Implementers

Yet more Audit Scenarios – Lead Auditors

FAQs about the Auditing Experience

Online Final Examination

What Course Materials are included?

This ISO 13485 Lead Auditor Extension course comes with:

Diagram: ISO Auditor Certification Process
Diagram: 6-Stage Audit Process
Sample Code of Ethics
Management of an Audit Programme
Sample Audit Plan
Sample Audit Work Order
Sample Nonconformity Report
Sample Working Document & Checklist
Risk Assessment Tools and Methodologies
Documented Information Requirements of ISO 13485:2016
Determining the Context of the Organization
ISO 13485:2016 and Risk Management
Risk Assessment Tools and Methodologies (with examples)
Terms & Definitions
Typical Process Map

How is the Course delivered?

This ISO 13485 Lead Auditor Extension course is delivered online from our Learning Management System (LMS) at www.degrandsonLMS.com (provided by Inquisiq).
All Lessons have a full resume and scaling capabilities. This means, for example, you can:

Start a Lesson at work on your Work Station running on Windows 10,
Continue the Lesson on the train home on your iPad running on iOS 11 and,
Complete the Lesson at home on your Notebook PC running on Windows 8.1.

What Qualifications do I need?

If you have previously completed a Lead Auditor Program with deGRANDSON Global, you are pre-qualified for this ISO 13485 lead auditor extension program. Just log-in, enroll and start your program immediately.

If you have NOT previously completed an Internal Auditor Program with deGRANDSON Global, you are advised to complete a free Pre-Test first on order to demonstrate adequate auditing skills.

The Pre-Test will take 30 minutes approx. and is FREE. Click this link to begin: Check your Lead Auditor Skills.

Regarding prerequisite qualifications generally for Lead Auditor Programs, the minimum of a Secondary School Certificate (such as a GCSE, High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 5 years’ work experience, with 2 at managerial/supervisory level, is recommended.

You do not have to provide us with any evidence of your qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with this program.

Not sure this is the best ISO 13485 Program for you?

See our full list of ISO 13485 courses for comparison or see our answers to frequently asked questions about ISO 13485 for more information.

Related Courses

ISO 13485 Lead Auditor Course – to programme and conduct audits

ISO 13485 Lead Auditor Refresher Course – to refresh your knowledge and skills

ISO 13485 Internal Auditor Course – to conduct effective internal audits

ISO Transition, Migration, Conversion & Extension Explained

ISO 13485 and Supplying to the Medical Device Sector: 9 FAQs

Have you tried this course?

Let us know what you think by rating it and leaving a comment below!

Frequently Asked Questions

Is the Program Certified?

Yes, deGRANDSON is an ISO 21001 certified educational organization certified by BQAI, an internationally accredited certification body.

ISO 21001 is a university grade standard used globally by schools, colleges, and universities. We are also certified to ISO 29993: 2017 (Learning services outside formal education and Service requirements) and ISO 29994:2021 (Education and learning services; Requirements for distance learning).

Are there corporate discounts?

Yes, details of discounts, based on numbers enrolled, can be found on the Corporate Discounts page.

How can I pay?

You can pay by Debit Card, Credit Card or PayPal during the Program Enrolment procedure. Click on this link to view the Payment Process.

Is there an Examination?

Yes. In addition to the Quizzes at the end of each Module, there is at the end of each Course (set of Modules/Lessons) a formal Examination. The decision to award a Certificate is based on the combined scores achieved. The Examinations are open-book (you can have the Standard and other notes open beside you), time-limited and taken on-line. There are no extra costs involved.

What do I get when I’ve successfully completed the Program?

Once you have successfully completed the Examination, your Certificate is immediately available to you. Your Certificate will e forwarded to you as an email attachment that you may print a often as you like. There is no time limit on the validity of your Certificate.

What else will I need to become a competent auditor?

Provided you have the required personal attributes, all you need to add is auditing experience.

Who can I contact for more information?

Just send an e-mail to [email protected] or, for other options, see Contact Us.

Standard: ISO 13485 Latest Version: ISO 13485:2016 Revision of: ISO 13485:2003	Duration: 26 hours approx. (including auditor certification exam)	Delivery: Online (on-demand and self-paced) CPD Units: 26
Description: This ISO 13485 lead auditor extension course is an ISO 21001 certified lead auditor training course that will provide you with the knowledge and skills that you need to audit medical device management systems. It is based on the requirements of ISO 13485:2016, known in full as Medical devices — Quality management systems — Requirements for regulatory purposes. If you are already a certified lead auditor for another standard, this extension course will also help you add ISO 13485 to your certification.
Course Content This is a comprehensive Program covering all aspects of ISO 13485 Internal Auditing is divided into two Courses… Module 0: Introduction and background to the Standard and to auditing including EMA, MHRA & FDA Regulations and MDSAP requirements. Module 1: Knowledge of the Standard, ISO 13485:2016, Medical Device – Quality management systems – Requirements for regulatory purposes Module 2: Knowledge of the Standard, ISO 14971, Application of Risk Management for medical devices (includes Amendment 11) Module 3: Practice with Scenarios, based on actual audits and includes advice on dealing with awkward situations and individuals. Note: Includes a 30 min Pre-Test to confirm that you have suitable auditing skills.
Related Courses: ISO 13485 Lead Auditor – if you have no Lead Auditor certification yet and wish to be certified to ISO 13485 ISO 13485 Lead Auditor Extension – if you are already a certified lead auditor for another standard and wish to add ISO 13485 to your certification ISO 13485 Lead Implementer – if your focus is on implementing and maintaining an MDMS

ISO 13485 Lead Auditor Extension