If you want to be certified according to EN ISO 13485, this standard requires a quality management manual (QMH).
The manual is usually structured in such a way that it provides a rough overview of your company without going into detail.
It must at least comment on the following topics
- The organisation and structure of the documentation used in the QMS
- Scope of the quality management system, including details and justifications for any exclusions or non-applications;
- Naming of the documented processes as well as a description of the interactions of these processes with each other.
We are happy to assist you with the preparation of a quality management manual and other aspects of the implementation of a quality management system. BEO BERLIN has extensive experience with QMS and in conducting internal and supporting with external quality audits.
