CE Mark & Quality Management Systems - EN ISO 9001 & EN ISO 13485
A Management system is beneficial for any manufacturer to achieve an assured consistency in production and to meet customer requirements.
Within Europe the internationally recognized standards for Quality Management Systems (QMS) are: EN ISO 9001 and, for medical equipment, ISO 13485.
For all medical equipment, including In-Vitro Diagnostic Medical Devices, ISO13485 is usually mandatory.
If a Quality System is a requirement of the relevant European Directive, usually it must be independently certified by a Notified Body recognized by one of the countries within the European Union.
Is Quality Management Necessary?
In addition to the specific requirements of the CE Directives, the list of customers who insist on ISO9001 Registered suppliers and sub-contractors continues to grow; only those companies with certification or registration to ISO9001 are often able to tender in certain business sectors for major customers.
For the company, implementation of an effective Quality Management System should provide easier entry into new markets, improved efficiency, and an enhanced reputation. It will lead to fewer defects, reduced costs, and a more competitive position in the marketplace.