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.
Do you have questions on this topic?
BEO BERLIN supports manufacturers with regulatory questions relating to MDR, technical documentation and market access.
