QMS Systems

A management system of an organisation can include different management systems, such as a Quality Management System or a Financial Management System.

A Quality Management System ensures that all activities with regard to quality are under control and all activities leading to a product or service are effective and efficient. This way a product or service can be delivered of consistent good quality.

mi-CE consultancy can help you with setting up you QMS system according to your specific wishes with the focus on:

• ISO 13485:2016

• MDSAP ISO 13485:2016

• ISO 9001: 2015

• Hospital QMS systems

Additionally, compliance to the specific QMS Annexes of the directives is guaranteed as well

• Annex IX, MDR

• Annex IX, IVDR

• 21 CFR 820 (FDA)