Who should enrol in this course?

This ISO 13485 Consultant and Lead Auditor 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 Consultant and Lead Auditor course includes course materials invaluable when implementing ISO 13485:2016 like: ISO 13485:2016 Medical Device Management System Implementation Handbook – 100+ pages of detailed step-by-step instruction Diagram: The 33-step Path to ISO 13485:2016 Certification Documented Information Requirements of ISO 13485:2016 Determining the Context of the Organisation ISO 13485:2016 and Risk Management Risk Assessment Tools and Methodologies (with examples) Terms & Definitions Typical Process Map Sample MDMS Policy Manual Sample MDMS Maintained Documentation (procedures), including… Sample Procedures Sample Records Sample Audit Plan Sample Audit Work Order Sample Nonconformity Report Sample Working Document & Checklist Sample Management Review Record Diagram: Auditor Certification Process Diagram: 6-Stage Audit Process Sample Code of Ethics Management of an Audit Programme

How is the course delivered?

This ISO 13485 Consultant and Lead Auditor course is delivered online from our Learning Management System (LMS) at www.degrandson.inquisiqLMS.com . 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

ISO 13485:2016 Consultant & Lead Auditor Diploma Course Content

This ISO 13485 Consultant and Lead Auditor Course is ideal for:

An ISO 13485 Adviser: Where you wish to have a professional qualification to offer prospective clients.
Experienced Medical Device Management Professionals: to upgrade your qualifications to a recognized international standard.
Newcomers to MDMS: You don’t need to be an expert. You’ll be taken on a practical journey from getting started to Certification.

The course provides you with the Auditing Skills, the Knowledge of the Standard, and the practical application of that knowledge with Audit Scenarios to enable you to develop, implement and maintain an MDMS and to audit ISO 13485 to Lead Auditor standard.

Who should enroll in this ISO 13485 Consultant & Lead Auditor Diploma course?

This ISO 13485 Consultant and Lead Auditor 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 from this ISO 13485 Consultant & Lead Auditor Diploma course?

This comprehensive ISO 13485 Consultant and Lead Auditor course covers all aspects of Internal Auditing and is divided into four Courses:

Module 0: Introduction and background to the Standard and auditing.
Module 1: Auditing Skills to Lead Auditor Level and based on the auditing standard ISO 19011:2018

Auditing Skills

Terms and definitions

Principles of auditing

Auditor skills

Managing an audit programme

Audit Team Leadership

Overview of Audit activities

Audit activities – Step 1

Audit activities – Step 2

Audit activities – Step 3 (2 modules)

Audit activities – Step 4

Audit activities – Step 5

Audit Activities – Step 6

FAQs about Auditing

Online Course Examination

Module 2: Knowledge of the Standard, ISO 13485:2016, Medical Devices – Quality management systems – Requirements for regulatory purposes

Introduction to ISO 13485:2016

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

MDMS Implementation and Certification to ISO 13485:2016 – the 33 Steps (3 lessons)

Initiation

Planning

Implementation

Securing Certification

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 (Amendment 11 Annexes)

Advanced aspects of QMS Auditing (3 Lessons)

FAQs about the Standard

Online Course Examination

Module 3: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

FAQs about the Auditing Experience

Online Final Examination

What materials are included in this ISO 13485 Consultant & Lead Auditor Diploma course?

This ISO 13485 Consultant and Lead Auditor course includes course materials invaluable when implementing ISO 13485:2016 like:

ISO 13485:2016 Medical Device Management System Implementation Handbook – 100+ pages of detailed step-by-step instruction
Diagram: The 33-step Path to ISO 13485:2016 Certification
Documented Information Requirements of ISO 13485:2016
Determining the Context of the Organisation
ISO 13485:2016 and Risk Management
Risk Assessment Tools and Methodologies (with examples)
Terms & Definitions
Typical Process Map
Sample MDMS Policy Manual
Sample MDMS Maintained Documentation (procedures), including…
- Sample Procedures
- Sample Records
- Sample Audit Plan
- Sample Audit Work Order
- Sample Nonconformity Report
- Sample Working Document & Checklist
- Sample Management Review Record
Diagram: Auditor Certification Process
Diagram: 6-Stage Audit Process
Sample Code of Ethics
Management of an Audit Programme

How is this ISO 13485 Consultant & Lead Auditor Diploma course delivered?

This ISO 13485 Consultant and Lead Auditor course is delivered online from our Learning Management System (LMS) at www.degrandson.inquisiqLMS.com.

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

Are there any prequalifications to enroll in this ISO 13485 Consultant & Lead Auditor Diploma course?

The minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate, or similar National Vocational Qualification) combined with 5 years’ work experience 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 the Program.

ISO 21001 Educational Organization certified

Learn more about our ISO 21001 Certification

ISO 13485 Consultant and Lead Auditor Sample Certificate with QR code

Sample ISO 13485 Consultant and Lead Auditor Certificate with QR Code

Path to ISO 13485 MDMS Certification infographic

Download Copy of ISO 13485 Certification Process Chart

Download free ISO 13485 Certification FAQs eBook

Free ISO 9001 Implementation Handbook

This instruction manual is free with our ISO 13485 Lead Implementer Course. It is not for sale.

It goes over everything you’ll need to develop, implement, and maintain a management system that can achieve ISO 13485 Certification. This includes learning how to:

Obtain Top Management Support (ISO 13485 Clause 0.1)
Assemble MDMS Project Team
Undertake a Gap Analysis of current QMS against ISO 13485 requirements and prepare Project Plan
Identify the strategic purpose of the MDMS to the Organization (ISO 13485 Clause 0.1)
Identify Regulatory and (for EU Market) the Annex requirements. ISO 13485 Clauses 4.1 and 5.2)
Identify Regulator, Certification Body, Notified Body needs
Establish MDMS and define Operational Processes (ISO 13485 Clause 4.1)
Define Documentation including the Medical Device File (ISO 13485 Clauses 4.2.1 and 4.2.3)
Prepare a Quality Policy (ISO 13485 Clauses 4.2.2 and 5.3)
Define key Roles and Responsibilities (ISO 13485 Clause 5.5)
Determine actions to address Risks (ISO 13485 Clauses 4.1.2, 4.1.5, 4.1.6, 6.2, 7.1, 7.3.3, 7.4.1,7.5.6, 7.6, and 8.2.1)
Establish MDMS objectives and plans to achieve them (ISO 13485 Clause 5.4.1)
Establish Design & Development Processes (ISO 13485 Clause 7.3)
Determine Operational Planning and Controls (ISO 13485 Clause 7.1)
Decide monitoring measurement and calibration needs (ISO 13485 Clause 7.6)
Establish Operational Controls and Monitoring (ISO 13485 Clauses 8.1 and 8.2.5)
Establish Feedback and Complaints Procedures (ISO 13485 Clause 9.1.2)
Develop Mandatory and other Procedures (ISO 13485 Clause 4.2.4)
Develop Mandatory and other Records (ISO 13485 Clause 4.2.5)
Determine and secure required Resources (ISO 13485 Clauses 6.1, 6.3, and 6.4)
Establish Procedure in provision (purchasing) (ISO 13485 Clause 7.4)
Establish Internal and External Communications (ISO 13485 Clause 7.2.3)
Develop general Staff Awareness (ISO 13485 Clause 5.5.2)
Implement Operational Plans and issue documents (ISO 13485 Clauses 7.1 and 7.5)
Complete Job-Specific Training (ISO 13485 Clause 6.2)
Go Live! Implement Procedures (ISO 13485 Clause 7.5)
Determine and review Customers’ requirements (ISO 13485 Clause 7.2)
Manage Production and Service Provision including Non-conforming Product (ISO 13485 Clauses 7.5 and 8.3 )
Establish Product & Service Release (ISO 13485 Clause 8.2.6)
Conduct Internal Audits (ISO 13485 Clause 8.2.4)
Conduct MDMS Performance Analysis & Evaluation (ISO 13485 Clause 8.4)
Conduct Management Reviews (ISO 13485 Clause 5.6)
Implement Improvement including CAPA (ISO 13485 Clause 8.5)

Download ISO 13485 Implementation Handbook Contents List

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

See our full suite of ISO 13485 courses or check out our answers to frequently asked questions about ISO 13485 on the same page for more information.

Related Courses

ISO 13485 Lead Auditor Course

ISO 13485 Lead Implementer Course

ISO 13485 Consultant and Lead Auditor Diploma Course

ISO 13485 Internal Auditor Course

Lead Implementer Courses: Overview

If you manage a QMS, don’t take a Lead Auditor Course!

ISO 13485 Implementation in 33 Steps

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 completed the Program?

Once you have 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 as 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: 36 hours approx. (including auditor certification exam)	Delivery: Online (on-demand and self-paced) CPD/CEU Units: 6.0
Description: This ISO 13485 Consultant & Lead Auditor Diploma, with a Certificate QR Code to permit instant confirmation of your qualifications to prospects, combines step-by-step guidance with a knowledge of the ISO 13485 standard that will enable you to implement and maintain a MDMS and act as a credible MDMS Consultant. Additionally, by combining skills in the practice of auditing with a knowledge of the standard, you will be ready to develop the practical skills to become certified as a Lead Auditor. Best of all, this course will grant you an internationally recognized Diploma issued under our ISO 21001 Certification – a university-grade accreditation – and with a QR Code to permit instantaneous verification of your qualification. No Expiry Date: This Diploma is valid indefinitely – No registration fees or recertifications are required.
Course Content: This is a comprehensive course that will let you learn the following: How to devise and structure the extensive documentation required (incl. sample documents, procedures, and forms); Step-by-step Path to ISO 13485 Certification – the detailed steps needed to get you from where you are now to being ISO 13485 Certified; Implementation Handbook (100+ pages) on implementing and maintaining a Medical Device Management System (MDMS); How to start an implementation project and get the support of Management Understanding the Standard and EU, UK & USA QSR & QMSR), Health Canada MDSAP Regulations; How to meet the requirements of the 2016 Standard (knowledge ofStandardndard), including Amendment 11 – EN Annexes; How to implement risk-based thinking for the delivery of products and services; How to implement risk management regarding medical device safety; How to maintain an MDMS (incl. Auditing Skills); Details of the Certification Process and how to prepare for it; How program, conduct, and record internal audits How program, conduct, and record certification body audits And all in language that’s easy to follow and understand. See below for Course Content details.
Related Courses: ISO 13485 Lead Auditor Extension – if you are already a Lead Auditor for another standard ISO 13485 Lead Auditor Refresher – if you need to update your knowledge and skills ISO 13485 Lead Implementer – if your focus is on implementing and maintaining an MDMS

ISO 13485 Consultant & Lead Auditor Diploma