ISO 13485 Implementation in 33 Steps

MedDev Assortment-1


A valuable aid to your developing a viable MDS Project Plan - to aid you to start on time, finish on time and leave nothing vital out.  And have a successful Certification Audit the first time.

The ISO 13485 Implementation Model developed by deGRANDSON Global

The 33 Steps to ISO 13485:2016 Implementation is the model we have developed for implementing a medical device management system (MDMS) to meet the requirements of ISO 13485 and to securing accredited Certification.

It is the foundation on which our Lead Implementer is built.

ISO 13485 Implementation Model

So where does it come from?

The International Standards Organisation (ISO) has published two standards that focus on developing and implementing an organization's QMS:

  • The quality management system standard: ISO 9001:2015. This standard is the specification for a QMS. It specifies the requirements of a quality management system for organizations seeking to establish implement and maintain a framework to consistently meet and exceed customer expectations.
  • The Regulations of UK MHRA, EU EMA. US FDA, Other MDSAP Adopters, and WHO Rest of the World.  Cognisance of this ever-changing mass of regulation and associated Guidelines has been taken in interpreting the Standard's implementation in compliance with the regulations as applicable.

To help make sense of it all from an MDMS Implementer/Project Manager’s viewpoint we have developed the 33-Step Infographic.ISO 13485 Implementation

33 Steps to ISO 13485:2016 Implementation

  1. Obtain Top Management Support
  2. Assemble MDMS Project Team
  3. Undertake a Gap Analysis of current QMS against ISO 13485 requirements and prepare Project Plan
  4. Identify the strategic purpose of the MDMS to the Organization
  5. Identify Regulatory and (for EU Market) the Annex requirements.
  6. Identify Regulator, Certification Body, Notified Body needs
  7. Establish MDMS and define Operational Processes
  8. Define Documentation including the Medical Device File
  9. Prepare a Quality Policy
  10. Define key Roles and Responsibilities
  11. Determine actions to address Risks
  12. Establish MDMS Objectives and plans to achieve them
  13. Establish Design & Development Processes
  14. Determine Operational Planning and Controls
  15. Decide monitoring measurement and calibration needs
  16. Establish Operational Controls and Monitoring
  17. Establish Feedback and Complaints Procedures
  18. Develop Mandatory and other Procedures
  19. Develop Mandatory and other Records
  20. Determine and secure required Resources
  21. Establish Procedurement provision (purchasing)
  22. Establish Internal and External Communications
  23. Develop general Staff Awareness
  24. Implement Operational Plans and issue documents
  25. Complete Job-Specific Training
  26. Go Live! Implement Procedures
  27. Determine and review Customers' requirements
  28. Manage Production and Service Provision including Non-conforming Product
  29. Establish Product & Service Release
  30. Conduct Internal Audits
  31. Conduct MDMS Performance Analysis & Evaluation
  32. Conduct Management Reviews
  33. Implement Improvement including CAPA

You are now ready for a successful initial certification audit.

Click here to download ’33-Steps to ISO 13485:2016 Certification’.

After downloading, please study it carefully and note…

  1. It’s a PDF file for you to print and/or save as you wish.
  2. The main headings throughout have numbers in brackets (e.g. #12) to indicate Step numbers.
  3. The numbers in brackets at the bottom of each activity box (e.g. 8.1 & 10.1) is the Clause Number(s) corresponding to the requirement that is being addressed by the activity in question.


For ease of understanding the 33 steps have been set out in a simple sequence.  In reality, you will frequently be working on several steps simultaneously.  This will help reduce the overall timescale for the project.  When project planning with your project team, you should seek out and document such opportunities.

Gap Analysis ISO 13485

Related Articles...

ISO 13485;2016 Lead Implementer Course

Overview - Lead Implementer & Auditor Courses

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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