Quality Management System
A Quality Management System (QMS) enables a company to be compliant with the relevant medical device regulations. The ultimate goal of a QMS is to ensure that all processes are optimized to guarantee the essential performance, i.e. the safety and effectiveness, of the product(s).
TAKSO can create, in co-operation with the customer, a completely new and customized Quality Management System to match the regulatory needs and dedicated requirements of the company. A Quality Management System comprises a QMS manual explaining all the company’s processes, work instructions, document templates and registers. We can also help customers modify an existing QMS to meet the latest regulatory requirements.
- Creating a new Quality Management System including the relevant processes
- Developing a QMS
- Updating the QMS manual
- Updating processes
- Work instructions, document templates and registers
- Implementing new regulatory requirements
- QMS training
- General introductions
- Deep-dive training for special issues
- Individual/group trainings
- QMS auditing services
TAKSO's experience in Quality Management Systems benefits both start-ups and global giants.