Free ISO 13485 Implementation Handbook (100+ pages)

ISO 13485 Handbook

Get a free step-by-step guide to achieve ISO 13485 Certification

This 100+ page 'instruction manual' is available free with our ISO 13485 Lead Implementer Course.  It is not for sale. But it is everything you'll need to develop, implement and maintain a management system to ISO 13485 Certification standard.

If you want to be an MDMS Consultant or if you wish to develop and implement a Medical Device Management System (MDMS), our ISO 13485 Implementer & Auditor Course is ideal.  It will be especially beneficial to …

  1. Newcomers to MDMS:  You don’t need to be an expert. You’ll be taken on a practical journey from getting started through to Certification.
  2. ISO 13485 Consultants & Regulatory Affairs Advisors: Gives you the methodology on how to implement MDMS Projects faster and easier than ever before.
  3. Experienced Quality Management Professionals and other Executives: Those given responsibility to maintain their organizations ISO 13485 Certification will gain all the skills and knowledge they need plus state-of-the-art information on maintaining an MDMS.

Click here to view the Handbook's contents list 


Extensive Course Materials are included

These include ...

  • ISO 13485 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


ISO 13485 Lead Implementer Certificate for you

The course itself provides you with the Auditing Skills, the Knowledge of the Standard, and the practical application of that knowledge with Audit Scenarios to enable you, as Audit Programme Manager, to undertake and manage Internal Audits for your Organisation.

The Course, which is available on-demand and is self-paced, is delivered online in four Modules ...

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

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

Module 3: Practice with Scenarios, based on actual audits and includes advice on dealing with awkward situations and individuals.

On successfully completing the course you will receive an ISO 13485 Lead Implementer Certificate, the qualification of MDMS Consultants.


Our family of Lead Implementer Courses to implement and maintain ISO Management Systems

Check out this video for more on our Lead Implementer Courses.


Note: This ISO 13485 Course is just one of the eight such Courses we offer.

ISO 13485 Lead Implementer Certification


Written by Dr John FitzGerald

Director & Founder of deGRANDSON Global. He spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems

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