Course 035T: ISO 13485:2016 Transition Training Program Content
Need to undertake an ISO 13485 2016 Migration soon
Transition to ISO 13485:2016 is a challenge that Quality Managers and others responsible for their organisation’s Medical Device Management System (MDMS) will face shortly.
When you’re ready to make the change, this online program 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 take this Program?
This ISO 13485 Migration Training Program is intended for those who…
- are Management Representative for their organisation and are the Audit Programme Manager for MDMS internal audits,
- are Consultants seeking practical support in transitioning clients to the revised Standard,
- wish to develop and implement an ISO 13485 Transition for their organisation.
- want a career as a MDMS Consultant,
- are required to perform MDMS internal audits within their organisation,
- are required to perform supplier audits, and
- wish to improve your career prospects.
If unsure, check that you’ve made the best choice from our suite of eight ISO 13485 Training Programs.
This is a comprehensive Program divided into two Courses…
- Course 1: Knowledge of the Standard, ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatoru 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
On-line Course Examination
- Course 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
On-line Final Examination
Extensive Program Materials included for Free
These materials, invaluable when implementing ISO 13485:2016, include…
- ISO 13485:2016 Medical Device Management Systen Implementation Handbook – 100+ pages of detailed step-by-step instruction
Click below to view Content List
- 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 this ISO 13485:2016 transition program delivered?
All Modules (Lessons) have full resume and scaling capabilities. This means, for example, you can…
- Start a Module at work on your Work Station running on Windows 10,
- Continue the Module on the train home on your i-Pad running on iOS 11 and,
- Complete the Module at home on your Notebook PC running on Windows 8.1.
Are there any prerequisite requirements?
If you have previously completed a Lead Implementer or Lead Auditor Program with deGRANDSON Global, you are pre-qualified. Just log-in, enrol and start your Program immediately.
If you have NOT previously completed an Internal Auditor Program with deGRANDSON Global, you are advised to successfully 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 you qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with the Program.
Not sure this is the best ISO 13485 Program for you?
Click here to view all of the ISO 13485 Auditor Training options.
Click here to view all of our other Transition Courses options.