If a manufacturer of medical devices adopted and maintains his own quality management system it must conform to EN ISO 13485. A certification according to EN ISO 13485 does not only have its advantages on the European market, but also worldwide. A certification is already a precondition for the entry into the market of other countries (e. g.: Canada, Japan, Taiwan, …).
It should be noted that in comparison to the full QM system (see above) there are restrictions regarding the requirements of the standard depending on the chosen procedure. The standard defines the organizational demands on the design and the manufacture of medical devices. Although the standards EN ISO 13485 and EN ISO 9001 have overlapping requirements they partially differ in their concept and specific requirements.
Basically the EN ISO 13485
standard is divided into five parts namely:
- QM system
- management responsibility
- resource management
- product realization
- measurement, analysis and improvement