Need to develop a viable Medical Device Management System (MDMS) Project Plan? And then secure ISO 13485 Certification? Our ISO 134851 Lead Implementer Course has all you need.
The ISO 13485 Implementation Model was developed by deGRANDSON Global: The 33 Steps to ISO 13485 Implementation is the model we have developed for implementing a medical device management system (MDMS) to meet the requirements of ISO 13485 and to secure accredited Certification.
It is the foundation on which our ISO 13485 course 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 for the rest of the World. Cognizance 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 this downloadable 33-Step Infographic.
After downloading, please study it carefully and note…
- It’s a PDF file for you to print and/or save as you wish.
- The main headings throughout have numbers in brackets (e.g. #12) to indicate Step numbers.
- 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.
33 Steps to ISO 13485:2016 Implementation
- Obtain Top Management Support (ISO 13485 Clause 0.1)
- Assemble MDMS Project Team
- Undertake a Gap Analysis of current QMS against ISO 13485 requirements and prepare Project Plan
- Identify the strategic purpose of the MDMS to the Organization (ISO 13485 Clause 0.1)
- Identify Regulatory and (for EU Market) the Annex requirements. ISO 13485 Clauses 4.1 and 5.2)
- Identify Regulator, Certification Body, Notified Body needs
- Establish MDMS and define Operational Processes (ISO 13485 Clause 4.1)
- Define Documentation including the Medical Device File (ISO 13485 Clauses 4.2.1 and 4.2.3)
- Prepare a Quality Policy (ISO 13485 Clauses 4.2.2 and 5.3)
- Define key Roles and Responsibilities (ISO 13485 Clause 5.5)
- 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)
- Establish MDMS objectives and plans to achieve them (ISO 13485 Clause 5.4.1)
- Establish Design & Development Processes (ISO 13485 Clause 7.3)
- Determine Operational Planning and Controls (ISO 13485 Clause 7.1)
- Decide monitoring measurement and calibration needs (ISO 13485 Clause 7.6)
- Establish Operational Controls and Monitoring (ISO 13485 Clauses 8.1 and 8.2.5)
- Establish Feedback and Complaints Procedures (ISO 13485 Clause 9.1.2)
- Develop Mandatory and other Procedures (ISO 13485 Clause 4.2.4)
- Develop Mandatory and other Records (ISO 13485 Clause 4.2.5)
- Determine and secure required Resources (ISO 13485 Clauses 6.1, 6.3, and 6.4)
- Establish Procedure in provision (purchasing) (ISO 13485 Clause 7.4)
- Establish Internal and External Communications (ISO 13485 Clause 7.2.3)
- Develop general Staff Awareness (ISO 13485 Clause 5.5.2)
- Implement Operational Plans and issue documents (ISO 13485 Clauses 7.1 and 7.5)
- Complete Job-Specific Training (ISO 13485 Clause 6.2)
- Go Live! Implement Procedures (ISO 13485 Clause 7.5)
- Determine and review Customers' requirements (ISO 13485 Clause 7.2)
- Manage Production and Service Provision including Non-conforming Product (ISO 13485 Clauses 7.5 and 8.3 )
- Establish Product & Service Release (ISO 13485 Clause 8.2.6)
- Conduct Internal Audits (ISO 13485 Clause 8.2.4)
- Conduct MDMS Performance Analysis & Evaluation (ISO 13485 Clause 8.4)
- Conduct Management Reviews (ISO 13485 Clause 5.6)
- Implement Improvement including CAPA (ISO 13485 Clause 8.5)
You are now ready for a successful initial certification audit.
- ISO 13485 Certification: 26 FAQs answered
- ISO 13485 Certification Process: How and What to Prepare
- ISO 13485:2016 vs EN ISO 13485:2016
- ISO 13485 and Supplying to the Medical Device Sector: 9 FAQs
- Overview - Lead Implementer & Auditor Courses
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