How to Implement ISO 13485: A 33 Step Guide

Medical devices awaiting evaluation against ISO 13485 (Medical Device Management System)

 

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:

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 (ISO 13485 Clause 0.1)
  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 (ISO 13485 Clause 0.1)
  5. Identify Regulatory and (for EU Market) the Annex requirements. ISO 13485 Clauses 4.1 and 5.2)
  6. Identify Regulator, Certification Body, Notified Body needs
  7. Establish MDMS and define Operational Processes (ISO 13485 Clause 4.1)
  8. Define Documentation including the Medical Device File (ISO 13485 Clauses 4.2.1 and 4.2.3)
  9. Prepare a Quality Policy (ISO 13485 Clauses 4.2.2 and 5.3)
  10. Define key Roles and Responsibilities (ISO 13485 Clause 5.5)
  11. Determine actions to address Risks (ISO 13485 Clauses 4.1.2, 4.1.5, 4.1.6, 6.2, 7.1, 7.3.3, 7.4.1,7.5.6, 7.6, and 8.2.1)
  12. Establish MDMS objectives and plans to achieve them (ISO 13485 Clause 5.4.1)
  13. Establish Design & Development Processes (ISO 13485 Clause 7.3)
  14. Determine Operational Planning and Controls (ISO 13485 Clause 7.1)
  15. Decide monitoring measurement and calibration needs (ISO 13485 Clause 7.6)
  16. Establish Operational Controls and Monitoring (ISO 13485 Clauses 8.1 and 8.2.5)
  17. Establish Feedback and Complaints Procedures (ISO 13485 Clause 9.1.2)
  18. Develop Mandatory and other Procedures (ISO 13485 Clause 4.2.4)
  19. Develop Mandatory and other Records (ISO 13485 Clause 4.2.5)
  20. Determine and secure required Resources (ISO 13485 Clauses 6.1, 6.3, and 6.4)
  21. Establish Procedure in provision (purchasing) (ISO 13485 Clause 7.4)
  22. Establish Internal and External Communications (ISO 13485 Clause 7.2.3)
  23. Develop general Staff Awareness (ISO 13485 Clause 5.5.2)
  24. Implement Operational Plans and issue documents (ISO 13485 Clauses 7.1 and 7.5)
  25. Complete Job-Specific Training (ISO 13485 Clause 6.2)
  26. Go Live! Implement Procedures (ISO 13485 Clause 7.5)
  27. Determine and review Customers' requirements (ISO 13485 Clause 7.2)
  28. Manage Production and Service Provision including Non-conforming Product (ISO 13485 Clauses 7.5 and 8.3 )
  29. Establish Product & Service Release (ISO 13485 Clause 8.2.6)
  30. Conduct Internal Audits (ISO 13485 Clause 8.2.4)
  31. Conduct MDMS Performance Analysis & Evaluation (ISO 13485 Clause 8.4)
  32. Conduct Management Reviews (ISO 13485 Clause 5.6)
  33. Implement Improvement including CAPA (ISO 13485 Clause 8.5)

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

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deGRANDSON Global is an ISO Certified Educational Organization

InISO 21001 ISO 29993 ISO 29994  October 2021 we secured certification to three education-related ISO Standards.  We now have a university-grade management system in place conforming to the requirements of  …

  • ISO 21001, Educational Organizational Management System,
  • ISO 29993, Learning Services outside formal Education,  and
  • ISO 29994, Learning Services – additional requirements for Distance Learning.

We have chosen ISO 21001 certification because, unlike IRCA and Exemplar badges (which in our opinion are commercially compromised), it is based on independent third-party assessment.  It is a ‘university grade’ standard in use globally by schools, colleges, and universities to demonstrate their competence.

 

Written by Dr John FitzGerald

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

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