The method for 3D printing companies and Point-of-Care facilities to implement a Quality Management System (QMS) based on the requirements in ISO 13485
A 5-phase approach to build your QMS: the 5D Method
- Discover – the ISO 13485 standard and learn its purpose and spirit
- Deploy – an easy-to-use platform for your QMS and get familiar using it
- Design – a logical structure for your QMS documentation
- Document – your procedures conforming to the requirements
- Dashboard – for a high level overview of the status of your QMS
This method is a proven approach to build a “living” QMS that is not considered as overhead by your team, but that helps them with the right documentation/instruction at the right time and as such becomes a tool that helps you to improve continuously.
“You created a QMS that is truly disruptive“
Thomas Hanly – CEO Singular Health
First, you need to learn about the ISO 13485 standard, get familiar with the wording and the spirit of the standard with respect to 3D printing, and discover that you probably already have quite a few of its requirements covered, although not yet properly documented. Only with a good grasp of ISO 13485 can you start building your QMS.
An easy-to-use, yet powerful digital platform is necessary for proper document management. For this, we introduce Confluence. In this phase, you familiarize yourself and your team with Confluence, create dedicated spaces, set permissions and install some useful plugins. The result is a team platform for collaboration that also serves as the backbone for your QMS.
For an efficient QMS, we need a logical structure in its documentation. Visual workflows help clarify the various processes and smart hyperlinks connect procedures, instructions and templates. Define and document your Quality Policy and Quality Objectives. Convenient templates form the basis for decent records that in turn provide evidence that the system is used and works.
In this phase, we document your procedures (Tier 2 documentation). QasE3D offers turnkey documentation that can easily be adapted to reflect your processes. Again, we use visual workflows and hyperlinks to connect relevant processes. The collection of procedures should cover the requirements in ISO 13485 and the regulatory requirements that are applicable to your company.
A good QMS helps your organization to safeguard quality and work efficiently. When lots of records are being generated, it is critical for management to get a high level overview of the quality status in the company. So last, but not least, we build a Quality Dashboard. On this customizable dashboard, you visualize your quality records, like Non-Conformities, CAPA’s and Feedback.
Getting started with the Quality BluePrint Method
Do you want to know if the Quality BluePrint Method can help you with your QMS?
Then request a free 30-minute Quality Meeting. In this conversation, we’ll cover a number of questions about your quality challenges, current status and objectives. If it turns out that we can help you and you are open to help, we will talk further about that. If not, we will help you further with tips and advice, or refer you to another party.
About Erik Boelen and QasE3D
Dr. ir. Erik Boelen started QasE3D to address “Quality” challenges in medical 3D printing. As the former Chief Operations Officer of a company that produced patient-specific implants, Erik knows the challenges first-hand; after a thorough “Quest for Quality”, he built a QMS from scratch.
He started QasE3D and finetuned the Quality BluePrint Method to help other 3D printing companies in building their QMS according to the requirements in ISO 13485.