Need to undertake an ISO 13485 2016 Migration soon?
Transitioning to ISO 13485:2016 is a challenge that Quality Managers and others responsible for their organization’s Medical Device Management System (MDMS) will face shortly.
When you’re ready to make the change, this ISO 1345 transition training course will take you step-by-step through the transition process and enable your organization to meet all of the requirements of ISO 13485:2016.
In addition, this program will provide you personally with Lead Implementer & Auditor Certification.
Who Should Enroll? in this course?
This ISO 13485 Transition Training Course is intended for:
- Senior quality managers
- Quality professionals and consultants
- Regulatory professionals
- Compliance professionals
- Project managers
- Design engineers
- Software engineers
- Process owners
- Quality engineers
- Quality auditors
This ISO 13485 Transition Training course is a comprehensive course divided into two Modules:
- Module 1: Knowledge of the Standard, ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes, and includes an Implementer’s Handbook plus the 33-step Path to ISO 13485 Certification.
Introduction to ISO 13485:2016
Developing & Implementing an MDMS
Terms & Definitions – ISO 13485:2016
Fundamentals of Quality Management Systems
MDMS Implementation and Certification to ISO 13485:2016 – the 33 Steps (3 modules)
- Securing Certification
Some Key aspects of QMS Auditing
Structure & content of ISO 9001:2015
Parts 1, 2 & 3
Part 4: Context of the organisation
Part 5: Leadership
Part 6: Planning for the Quality Management System
Part 7: Support (3 modules)
Part 8: Operation (2 modules)
Part 9: Performance evaluation
Part 10: Improvement
Advanced aspects of QMS Auditing
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?
These free course materials, invaluable when implementing ISO 13485:2016, include:
- ISO 13485:2016 Medical Device Management System Implementation Handbook – 100+ pages of detailed step-by-step instruction
Click the ‘Full Screen’ button below for best view of Contents ListdeGRANDSON Global UK ISO 13485 MDMS Lead Implementer Certification Guide
- Diagram: The 33-step Path to ISO 13485:2016 Certification
- 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
- 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?
All Modules (Lessons) have a full resume and scaling capabilities. This means, for example, you can:
- Start a Module at work on your Work Station running on Windows 11,
- Continue the Module on the train home on your iPad running on iOS 15 and,
- Complete the Module at home on your Notebook PC running on Windows 10.
Are there any pre-qualifications required?
If you have previously completed a Lead Implementer or Lead Auditor Program with deGRANDSON Global, you are pre-qualified. 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 this, 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, 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 by clicking on the image above for comparison or see our answers to frequently asked questions about ISO 13485 for more information.
ISO 13485 Internal Auditor Course – to conduct effective internal audits
ISO 13485 Internal Auditor Refresher Course – to refresh your knowledge and skills
ISO 1345 Lead Auditor Course – to programme and conduct audits
Have you tried this course?
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