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.
33 Steps to ISO 13485:2016 Implementation
- Obtain Top Management Support
- 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
- Identify Regulatory and (for EU Market) the Annex requirements.
- Identify Regulator, Certification Body, Notified Body needs
- Establish MDMS and define Operational Processes
- Define Documentation including the Medical Device File
- Prepare a Quality Policy
- Define key Roles and Responsibilities
- Determine actions to address Risks
- Establish MDMS Objectives and plans to achieve them
- Establish Design & Development Processes
- Determine Operational Planning and Controls
- Decide monitoring measurement and calibration needs
- Establish Operational Controls and Monitoring
- Establish Feedback and Complaints Procedures
- Develop Mandatory and other Procedures
- Develop Mandatory and other Records
- Determine and secure required Resources
- Establish Procedurement provision (purchasing)
- Establish Internal and External Communications
- Develop general Staff Awareness
- Implement Operational Plans and issue documents
- Complete Job-Specific Training
- Go Live! Implement Procedures
- Determine and review Customers' requirements
- Manage Production and Service Provision including Non-conforming Product
- Establish Product & Service Release
- Conduct Internal Audits
- Conduct MDMS Performance Analysis & Evaluation
- Conduct Management Reviews
- Implement Improvement including CAPA
You are now ready for a successful initial certification audit.
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.