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 organization’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 Enroll in the ISO 13485 Transition Online Course?
This ISO 13485 Migration Training Program is intended for those who:
- are Management Representative for their organization 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 organization,
- want a career as a MDMS Consultant,
- are required to perform MDMS internal audits within their organization,
- 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 comprehensive program is divided into two courses:
- Course 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
- 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
Online Final Examination
Course Materials 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 ISO 13485 Transition Online 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 10,
- Continue the Module on the train home on your iPad running on iOS 11 and,
- Complete the Module at home on your Notebook PC running on Windows 8.1.
Are there any previous qualifications required for the ISO 13485 Transition Online Course?
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.
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