Qase3D can provide you with a fully digital Quality Management Sytem, or eQMS, based on ISO 13485:2016.
- No paper-based QMS
- No Word documents
- No dedicated QMS software system
A paper based QMS can no longer comply with the requirements for document control as defined in ISO13485Dr. ir. Erik Boelen
eQMS is built in a popular software for team collaboration, which is simple and elegant and therefore easy-to-use. It completely eliminates the need for (and hassle with) paper or Word-based procedures and forms. It has built in versioning and permissions. It works in the cloud, but can also be run on a local server.
The QMS is fully customizable to your company’s scope and activities. It is especially suited for start-ups / scale-ups in additive manufacturing (3D printing) of (custom-made) medical devices.
Documented procedures and forms
eQMS is complete with:
- Quality Manual
- Quality Policy
- Quality Objectives
- Company Procedures
and also comes with convenient form templates:
- Management Review
A living Quality Management System
Because eQMS works inside a team collaboration platform, employees are (probably) using the platform on a daily basis and as a result eQMS is more accessible and becomes part of their workflow.
eQMS becomes a “living QMS” that works for the people, rather than being a bureaucratic burden!
Obviously, Qase3D can support you with the customization and implementation.
Let Qase3D kickstart your QMS towards ISO 13485 certification! The sooner you start with a Quality Management System, the easier it is to implement.
Your QMS is much more advanced than that of bigger companies I’ve auditedRonnie | External Auditor