ISO 13485:2016 Transition Training Course

Who Should Enrol

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.

Course Content

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) 

  • Initiation
  • Planning
  • Implementation
  • 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 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

Course Delivery Mode

The Program is delivered online from our Learning Management System (LMS) at www.degrandsonLMS.com (provided by Inquisiq). 

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.

Previous 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 list of ISO 13485 Auditor Training options for comparison or our Transition Courses for other alternatives.

Have you tried this course?

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